Archive for ‘Medical Equipment Financing’

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Covidien’s New iDrive Ultra Powered Stapling System

Covidien’s New iDrive Ultra Powered Stapling System

Covidien’s New iDrive Ultra Powered Stapling System

Covidien received FDA 510(k) clearance for its iDrive Ultra stapling system, which according to the company is the world’s first “fully powered, reusable, battery-operated endoscopic surgical stapler in the world.”

covidien idrive ultra closeup Covidiens New iDrive Ultra Powered Stapling System (video)

The iDrive Ultra features one handed operation, full articulation of the stapling tool, and help with dexterity since the surgeon doesn’t have to power squeeze the trigger to apply the staples.

More from the press release:

The iDrive Ultra system is the second offering in Covidien’s line of powered stapling devices and the first that is compatible with the Company’s entire portfolio of Endo GIA™ reloads with Tri-Staple™ technology for use in laparoscopic and open surgical procedures. The iDrive Ultra system combines the precision and control of a powered device with proprietary Tri-Staple technology that provides less stress on tissue during compression and clamping, potentially greater perfusion into the staple line and the ability to manage tissue variability.

Source : http://vimeo.com/

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Nonsurgical circumcision device for adults to be tested in Africa

Nonsurgical circumcision device for adults to be tested in Africa

“PrePex, a bloodless circumcision device for adults, will be tested in at least nine African countries in the next year, according to the backers of the tests,” the New York Times reports. PEPFAR “will pay for PrePex circumcisions for about 2,500 men in Lesotho, Malawi, South Africa, Tanzania and Uganda, said Dr. Jason B. Reed, a technical adviser to the plan,” the newspaper writes. “The Bill & Melinda Gates Foundation will pay for similar studies in Kenya, Mozambique, South Africa, Zambia and Zimbabwe,” it adds. According to the New York Times, the device “was approved by the Food and Drug Administration in January, and World Health Organization approval is expected soon.” The newspaper notes, “No surgeon is needed for the procedure; a two-nurse team slides a grooved ring inside the foreskin and guides a rubber band to compress the foreskin in the groove,” and adds, “After a week, the dead foreskin falls off like the stump of a baby’s umbilical cord or can be painlessly clipped off, said Tzameret Fuerst, chief executive of PrePex” (McNeil, 8/13).

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

source : http://www.news-medical.net/news/20120815/Nonsurgical-circumcision-device-for-adults-to-be-tested-in-Africa.aspx

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The Smart Baby Scale

The Smart Baby Scale

Withings Introduces the Smart Baby Scale; Ready to Keep the World Posted on Your Baby’s Growth

If your company already released innovative “connected” versions of the body scale, blood pressure monitor and baby monitor, what’s next? For Withings, the answer is a smart baby scale. The Withings Smart Baby Scale is an internet-connected baby and toddler scale with WiFi, Bluetooth and Bluetooth Smart (Bluetooth Low Energy) connectivity. It has many of the same features as the adult body scale, and we can imagine the Twitter and Facebook integration on this device to be quite a bit more popular than on its adult counterpart.

The Smart Baby Scale is one of the devices that has been awarded with the CES Innovation Award and it will be available in the second quarter of 2012.

From the press release:

By using the Withings Smart Baby Scale, parents can access their child’s weight readings from any connected device, such as an Internet-connected computer or an iPad, iPhone or iPod touch using the already existing WiScale app. Also, parents can easily communicate the progress of their child’s weight with their doctor, pediatrician, family and friends. The scale can be set to instantly update Facebook, Twitter or send an email to private email addresses with new readings. Parents can attach notes and photos to weight charts to build detailed memories of their child’s growth.

The Smart Baby Scale features two weighing configurations: the first is for weighing infants with a removable baby basket, and the second is the toddler scale that emerges once the baby basket is removed. The main part of the scale (the weighing unit) is extra-slim and features a central cutout that serves as the insertion area for the baby basket. The scale features a large graphical screen for animations and instructions, plus a tactile button that helps parents easily record their baby’s length.

The baby basket is made up of two pieces that naturally interlock and then can be inserted into the scale’s base. This bi-fold design is perfect for storage and travel. Once the child grows out of the baby basket and can stand up on his own, the basket can be removed and the scale used as a toddler scale.

The Withings Smart Body Scale can be used in conjunction with an adult Withings WiFi body scale, and/or the Withings Blood Pressure Monitor. When done so, it allows parents to monitor their child’s weight on the same dashboard they view their own weight and/or blood pressure.

Along this new device, Withings also evolves its Health Cloud platform’s API to allow third party service providers to retrieve readings recorded by the Smart Baby Scale, and thus offer parents additional services and guidance to monitor their child’s growth.

The Smart Baby Scale press release (EN)

Withings Unveils World’s First Internet Connected Baby and Toddler Scale

Awarded with the prestigious 2012 CES Innovations Award, the Withings Smart Baby Scale is a new innovative device that finally extends connected weight tracking to newborns and children.

Las Vegas Nevada, CES – January 8, 2012 — Today, French technology company Withings is announcing its Internet-connected baby and toddler scale, the Withings Smart Baby Scale. With WiFi, Bluetooth and Bluetooth Smart (Bluetooth Low Energy) connectivity, it is the next evolution in home baby and toddler weight tracking. Withings has combined cutting edge technology and exquisite design to create a scale that will give parents all over the world a very simple to use and extremely accurate way to monitor, understand and share their child’s growth.

Ce?dric Hutchings, Withings co-founder says, “We are very excited to announce our Smart Baby Scale and offer parents an amazing new way to take care of their newborn or young child. The success of our WiFi Body Scale has proven the benefits of connected weight tracking on adults and we were eager to also bring these benefits to babies and children. We are thrilled that our Smart Baby Scale was awarded the prestigious CES Innovation Award and this further reinforces our vision of designing smart communicating devices that help families take better charge of their health”.

By using the Withings Smart Baby Scale, parents can access their child’s weight readings from any connected device, such as an Internet-connected computer or an iPad, iPhone or iPod touch using the already existing WiScale app. Also, parents can easily communicate the progress of their child’s weight with their doctor, pediatrician, family and friends. The scale can be set to instantly update Facebook, Twitter or send an email to private email addresses with new readings. Parents can attach notes and photos to weight charts to build detailed memories of their child’s growth.

The Smart Baby Scale features two weighing configurations: the first is for weighing infants with a removable baby basket, and the second is the toddler scale that emerges once the baby basket is removed. The main part of the scale (the weighing unit) is extra-slim and features a central cutout that serves as the insertion area for the baby basket. The scale features a large graphical screen for animations and instructions, plus a tactile button that helps parents easily record their baby’s length.

The baby basket is made up of two pieces that naturally interlock and then can be inserted into the scale’s base. This bi-fold design is perfect for storage and travel. Once the child grows out of the baby basket and can stand up on his own, the basket can be removed and the scale used as a toddler scale.

The Withings Smart Body Scale can be used in conjunction with an adult Withings WiFi body scale, and/or the Withings Blood Pressure Monitor. When done so, it allows parents to monitor their child’s weight on the same dashboard they view their own weight and/or blood pressure.

Along this new device, Withings also evolves its Health Cloud platform’s API to allow third party service providers to retrieve readings recorded by the Smart Baby Scale, and thus offer parents additional services and guidance to monitor their child’s growth.

Withings Smart Baby Scale Technical Specifications:

• Weighing Range: 0-55 lbs

• Accuracy: 10g (0.02lb)

• Connectivity: WiFi, Bluetooth, Bluetooth Smart

• Display: Graphical Screen 2.4” x 1.6”

• Power Supply: 4 AAA Batteries

• Dimensions: 11” x 9.1” x 1” (without baby basket) / 22” x 10” x 3.7” (with baby basket)

• Weight: 3.3 lbs

The Withings Smart Baby Scale will be available in Q2 2012. The WiScale app is available for free from the App Store on iPad, iPhone and iPod touch, or at www.itunes.com/appstore.

For more information on Withings, please visit www.withings.com/press. To request additional information or images of the Smart Baby Scale or other Withings products, please contact PR representative Jessica Darrican at (305) 576-1171 ext.16 or jessica@maxborgesagency.com.

About Withings:

Withings is a leading force in the personal healthcare revolution. It designs, develops, and industrializes health and wellness connected devices that help families across the world take better charge of their health.

French start-up founded by two executives with a technology and telecom industry background, Withings has proven its capability to turn health sensor into simple, popular, and enjoyable connected devices. In September 2009, Withings launched its WiFi Body Scale, the first ever Internet-connected body scale. This distinctively designed object was rapidly enriched with additional services provided by third parties. Many international sports and fitness online coaching websites see the Withings body scale as the ideal interface for providing rich and non-binding online services. Withings is as such a pioneer in health 2.0. In April 2011, Withings launched the Smart Blood Pressure Monitor in Europe first and then in May 2011 in the US. In November 2011, Withings launched the Smart Baby Monitor in Europe.

Instead of concentrating its distribution in pharmacies and specialized stores, Withings distributes its products in the most prestigious retailers of consumer electronics and cultural products in North America and Europe such as FNAC, Apple Stores or Best Buy.

Withings is a major player in the Internet of Things. The company’s increases the capabilities of an object by the addition of network resources that allows access to infinite calculation and storage capacities without increasing costs. The object’s interfaces are also ported to devices such as mobile phones or computers, to benefit from their resources and capabilities.

Source : http://www.withings.com/en/babyscale/keepmeinformed

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FDA approves mechanical cardiac assist device for children with heart failure

FDA approves mechanical cardiac assist device for children with heart failure

Having received unanimous recommendation from its Circulatory System Devices Advisory Panel to grant a humanitarian device exemption to the Berlin Heart Excor Pediatric Ventricular Assist Device (VAD), the FDA did just that.berlin-heart-excor

Here are some details from our earlier postabout the study that led to the approval:The sponsors of the VAD presented data from a recent prospective, non-randomized, multi-center, single arm study assessing the safety and probable benefit of the device.  48 children were enrolled in the trial and their outcomes were compared to those receiving ECMO (extracorporeal membrane oxygenation), which is considered the standard of care for bridging children to transplant.  Regardless of a 29% stroke rate, 90% of the children survived to transplant or were successfully weaned off the VAD.  The overall rate of serious adverse events was less in the Excor group versus the ECMO group.  Although the committee wants further investigation of the stroke rates with better-defined outcomes and causes, they do suggest this can be done in the setting of post-approval studies.

The U.S. Food and Drug Administration today approved a medical device that supports the weakened heart of children with heart failure to help keep them alive until a donor for a heart transplant can be found.

The mechanical pulsatile cardiac assist device is called the EXCOR Pediatric System, made by a German company, Berlin Heart. The device comes in graduated sizes to fit children from newborns to teens.

“This is a step forward, it is the first FDA-approved pulsatile mechanical circulatory support device specifically designed for children,” said Susan Cummins, M.D., M.P.H, chief pediatric medical officer in the FDA’s Center for Devices and Radiological Health. “Previous adult heart assist devices were too large to be used in critically ill children to keep them alive while they wait to get a new heart.”

The device consists of one or two external pneumatic (driven by air) blood pumps, multiple tubes to connect the blood pumps to heart chambers and the great arteries, and the driving unit.

Heart failure in children is much less common than in adults. Heart transplantation offers effective relief from symptoms. However, far fewer pediatric sized donor hearts are available for transplantation than for adults, limiting the use of heart transplantation in children and prolonging the waiting period until transplant can occur. In infants, the median waiting time for a donor heart is 119 days. Overall a reported 12-17 percent of children and 23 percent of infants die while on the wait list for a heart transplant.

In the primary U.S. study group of 48 patients, the use of the device was found to improve survival to transplant in patients when compared with the use of extracorporeal membrane oxygenation (ECMO) which is the current standard of care, although not FDA approved. Stroke, which can cause serious brain deficits, is a risk of the EXCOR Pediatric System.

The EXCOR was designated as a Humanitarian Use Device (HUD) by the Office of Orphan Products Development at the FDA. This designation is for medical devices intended to benefit patients in the treatment or diagnosis of a disease or condition that affects fewer than 4,000 individuals in the United States annually. The device was approved under a Humanitarian Device Exemption (HDE), a type of marketing application that is similar to a premarket approval application in that the level of safety required for approval is the same. Rather than having to show a reasonable assurance of effectiveness, devices submitted under the HDE marketing route need to prove that the probable benefit from use of the device outweighs the probable risk of illness or injury from its use to obtain the FDA’s approval.

The FDA approval of an HDE authorizes an applicant to market the device subject to certain use restrictions. After the passing of the Pediatric Medical Device Safety and Improvement Act of 2007, HUDs intended and labeled for use in a pediatric population are permitted to be marketed for profit.

Source:http://medgadget.com/2011/12/berlin-heart-excor-pediatric-heart-pump-gets-fda-approval.html,http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm283956.htm

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OraSure Technologies Subsidiary, DNA Genotek Receives FDA 510(k) Clearance for Oragene(R) Dx Collection Device

OraSure Technologies Subsidiary, DNA Genotek Receives FDA 510(k) Clearance for Oragene(R) Dx Collection Device

DNA Genotek, a subsidiary of OraSure Technologies, received FDA clearance to market the Oragene Dx saliva DNA collection device. According to the company this is the first 510(k) approval for a DNA collection and stabilization device.Oragene Dx DNA Collection Device

The device promises reliable collection of DNA samples and the ability to use it to transport and store the samples for an extended time period.

  • Painless, non-invasive collection
  • Median A260/280 of 1.7‡
  • Easy collection and transportation
  • Oragene•Dx/saliva samples are stable for long-term room temperature storage
  • Standardized tube format
  • Oragene•Dx solution is bacteriostatic

DNA Genotek’s lead product line, Oragene, provides an all-in-one system for the collection, stabilization, and transportation of DNA from saliva. The product is currently used by thousands of academic and research customers in over 100 countries worldwide. Oragene provides substantial advantages over traditional DNA collection methods such as blood or buccal swabs. These include the reliable collection of high quality DNA samples using a simple, non-invasive method and the ability to transport and store collected samples for extended periods at ambient temperatures.

Securing FDA 510(k) clearance of Oragene•Dx ensures that clinical diagnostic and personalized medicine test providers can now experience the benefits of Oragene using a family of products cleared for use by the FDA. This FDA clearance will provide added flexibility to diagnostic customers who wish to offer their patients the non-invasive, reliable and easy-to-use Oragene•Dx saliva sample collection device as an alternative to invasive blood collection. In addition, the FDA 510(k) clearance of Oragene•Dx will enable molecular diagnostic test manufacturers to streamline their own regulatory submissions and potentially broaden market accessibility for their genetic tests.

“We have responded to our customers’ requests to integrate the utility and performance of Oragene with an FDA cleared status,” said Ian Curry, President of DNA Genotek Inc. “The 510(k) clearance of Oragene•Dx should enhance patient access to genetic testing by offering proven, easy-to-use, non-invasive sample collection and stabilization. The clearance further demonstrates our longstanding commitment to produce high quality products that meet the demands of our customers.”OraSure Technologies is a leader in the development, manufacture and distribution of oral fluid diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its innovative products include rapid tests for the detection of antibodies to HIV and HCV at the point of care and testing solutions for detecting various drugs of abuse. In addition, through its wholly-owned subsidiary, DNA Genotek Inc., the Company also is a leading provider of oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications. OraSure’s portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians’ offices, and commercial and industrial entities. The Company’s products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health. For more information on OraSure Technologies

Source:http://medgadget.com/2011/12/oragene-dx-dna-collection-device-gets-fda-clearance.html,http://www.globenewswire.com/newsroom/news.html?d=240238

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Intuitive Surgical Announces New Single-Site(TM) Instrumentation for the da Vinci(R) Si(TM) Surgical System

Intuitive Surgical Announces New Single-Site(TM) Instrumentation for the da Vinci(R) Si(TM) Surgical System

According to The Oklahoman, the FDA approved the EZ Vein, a new device developed by an Oklahoma doctor for easing the placement of intravenous catheters in challenging patients.  Much like with a blood pressure cuff, the device is inflated using a hand pump and vasculature within the window opening is more readily seen.

Dr. Robert Perry, a resident at Oklahoma University Medical Center, is the tinkerer that developed the device in his home workshop and managed to score one of the fastest FDA approvals ever: 17 days from submission.

Single-Site Instrumentation provides da Vinci Si customers with a technology that enables cholecystectomy via a single incision, while providing the benefits of traditional multi-port da Vinci Surgery— enhanced surgical precision, control and stability and 3D HD visualization.

The Single-Site suite of instruments and accessories consists of the Single-Site Port, specialized curved cannulae and 5mm semi-rigid instruments, which are compatible with any da Vinci Si Surgical System. The design of the instruments and the da Vinci System’s Remote Center Technology are intended to reduce instrument crowding and external collisions typically associated with hand-held, laparoscopic single-incision devices.

EZ-Vein-device

Gary Guthart, CEO, Intuitive Surgical Inc., stated, “We are pleased with this clearance for our Single-Site instruments for use in laparoscopic cholecystectomy using the da Vinci System. We plan to immediately initiate a controlled rollout of these products in the US, while continuing our rollout in Europe. As we learn more about our customers’ needs within single-incision surgery, we anticipate future submissions to the US FDA and other global regulatory agencies related to expansion of the cleared indications for use, as well as additional Single-Site instruments.”

All da Vinci Si Surgical Systems are compatible with Single-Site™ Technology. The standard da Vinci and the da Vinci S Systems are not compatible with Single-Site Technology.

About Intuitive Surgical, Inc.

Intuitive Surgical, Inc. (Nasdaq:ISRG), headquartered in Sunnyvale, California, is the global technology leader in robotic-assisted, minimally invasive surgery (MIS). Intuitive Surgical develops, manufactures and markets robotic technologies designed to improve clinical outcomes and help patients return more quickly to active and productive lives. The company’s mission is to extend the benefits of minimally invasive surgery to the broadest possible base of patients. Intuitive Surgical – Taking surgery beyond the limits of the human hand.™

About the da Vinci Surgical System

The da Vinci Surgical System is a breakthrough surgical platform designed to enable complex surgery using a minimally invasive approach. The da Vinci Surgical System consists of an ergonomic surgeon console or consoles, a patient-side cart with three or four interactive robotic arms, a high-performance vision system and proprietary EndoWrist instruments. Powered by state-of-the-art robotic and computer technology, the da Vinci Surgical System is designed to scale, filter and seamlessly translate the surgeon’s hand movements into more precise movements of the EndoWrist instruments. The net result is an intuitive interface with breakthrough surgical capabilities. By providing surgeons with superior visualization, enhanced dexterity, greater precision and ergonomic comfort, the da Vinci Surgical System makes it possible for more surgeons to perform minimally invasive procedures involving complex dissection or reconstruction. This ultimately has the potential to raise the standard of care for complex surgeries, translating into numerous potential patient benefits, including less pain, a shorter recovery and quicker return to normal daily activities. Source:http://investor.intuitivesurgical.com/phoenix.zhtml?c=122359&p=irol-newsArticle&ID=1638907&highlight=, http://medgadget.com/

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Robotized Transcranial Magnetic Stimulation (TMS) Coil Positioning System

Robotized Transcranial Magnetic Stimulation (TMS) Coil Positioning System

Robotized TMS is a novel approach in the application for image guided transcranial magnetic stimulation (TMS).

SmartMove allows planning of a complete stimulation session ahead by defining stimulation sites based on anatomical MRI information and functional information like fMRI, PET or EEG/MEG. During the execution of the TMS stimulation sequence, the system places the coil at the predefined target positions and keeps the coil in place even if the head of the patient/subject moves.

The robotic system is able to define stimulation targets based on the individual anatomy of the brain. Based on the intended target, it calculates the optimal position of the TMS coil. Because of the optical position sensor the system is provided with, movements of the patient’s head are constantly monitored. When the patient’s head moves, the position and the orientation of the TMS coil are adjusted accordingly. SmartMove is able to perform a wide range of tasks, from the simple maintenance of the TMS coil at the intended target to the definition and performance of complex stimulation protocols.


SmartMove is currently applied in a number of research labs, in studies ranging from cognitive research to precise mapping of motor cortex locations in animal studies.

ey features
  • Highly accurate automatic positioning of TMS coil.
  • Easy target and grid definition.
  • Placement of the coil tangentially to the head.
  • After the target is reached, the coil is kept at the desired position and targeting precision information is displayed to the user.
  • Head movement compensation.
  • Defining of entire stimulation protocols.
  • Repetition of previous stimulation target positions.
  • Online mapping of evoked responses based on user given values.
  • Compatible with all TMS stimulation, including Magstim and Magventure.

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SUDS machine designed to reduce infections and cut back on expensive disposables

SUDS machine designed to reduce infections and cut back on expensive disposables

BRING ON THE “SUDS”: PROTOTYPE, 7-FOOT-TALL SANITIZER AUTOMATES DISINFECTION OF HARD-TO-CLEAN HOSPITAL EQUIPMENT

- SUDS machine designed to reduce infections and cut back on expensive “disposables”

July 30, 2009- Hopkins experts in applied physics, computer engineering, infectious diseases, emergency medicine, microbiology, pathology and surgery have unveiled a 7-foot-tall, $10,000 shower-cubicle-shaped device that automatically sanitizes in 30 minutes all sorts of hard-to-clean equipment in the highly trafficked hospital emergency department. The novel device can sanitize and disinfect equipment of all shapes and sizes, from intravenous line poles and blood pressure cuffs, to pulse oximeter wires and electrocardiogram (EKG) wires, to computer keyboards and cellphones.

.The Johns Hopkins designed and built “SUDS,” a self-cleaning unit for the decontamination of small instruments.
The Johns Hopkins designed
and built “SUDS,” a self-cleaning
unit for the decontamination of
small instruments.

The invention, nicknamed “SUDS” for self-cleaning unit for the decontamination of small instruments, has already been shown to initially disinfect noncritical equipment better than manual cleaning, they report in the Annals of Surgical Innovation and Research online July 30.

Study senior author and surgeon Bolanle Asiyanbola, M.D., says the four-year SUDS project was initially sparked by the rapid rise in use of expensive disposable items, a trend linked to efforts to prevent bacterial infections among and between patients in hospitals.

Drawing on her experience in the operating room, where many batches of surgical clamps, retractors and scalpels have been sterilized, decontaminated and safely re-used for decades, Asiyanbola put together a team to end what she calls the “wasteful and unnecessary” practice of wiping down a lot of heavily used items with disinfectants and applying a lot of elbow grease. “If we can safely re-use equipment in the operating room, then we can do it elsewhere in the hospital for non-critical equipment,” she says.

In the study, the Johns Hopkins team showed that SUDS was able to disinfect some 90 pieces of used emergency-room equipment, placing as many as 15 items in the device and “fogging” the equipment with an aerosolized, commercially available disinfectant chemical, or biocide, called Sporicidin. None of the electronic circuitry appeared to be damaged by the decontamination process. Instruments tested were of the type that comes in direct contact with a patient’s skin, the body’s key barrier to infection.

Repeated swabbing and lab culture testing of each decontaminated instrument showed that all items remained free of so-called gram-positive bacteria for two full days after cleaning, even after the equipment was returned to the emergency department and re-used. On the bacteria-free list were such potentially dangerous superbugs as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE).

By contrast, testing of an equal number of similar items that were manually scrubbed down with a disinfectant solution, called Airex, showed that 25 percent of the devices had bacterial growth after two days, including growth of potentially dangerous gram-positive bacteria, such as MRSA and VRE, as well as gram-negative type bacteria, most notably, Pseudomonas aeruginosa, and Acinetobacter baumannii, plus some types of fungi.

“Our study results with the prototype offer strong evidence that more can be done to disinfect noncritical equipment through automated decontamination processes in heavily trafficked areas of the hospital,” says Asiyanbola, an assistant professor at the Johns Hopkins University School of Medicine. “We believe this SUDS device has the potential to further protect our patients and staff from hospital infections and save health care dollars by making it possible to clean and re-use more kinds of hospital equipment.”

The Hopkins inventors, who have patent applications pending, say more studies must be done to determine if SUDS is effective for other hospital superbugs, notably, Clostridium difficile.

Asiyanbola worked closely with Karen Carroll, M.D., director of microbiology and a professor of pathology and medicine, and Allison Agwu, M.D., an assistant professor, both at Johns Hopkins, to assemble the necessary team to help test the prototype. Funding was provided by a grant from the Department of Surgery at The Johns Hopkins Hospital.

Besides Asiyanbola, Carroll and Agwu, other Johns Hopkins University researchers involved in this study were C. Obasi, M.D., Richard Rothman, M.D., and T. Ross, M.T., at the School of Medicine; W. Akinpelu, M.Sc., and R. Hammons, Ph.D., at the University’s Applied Physics Laboratory; C. Clarke, Ph.D., and R. Etienne-Cummings, Ph.D., at the University’s Whiting School of Engineering; P. Hill, M.D., and S. Babola, Ph.D., at the University’s Bloomberg School of Public Health.

For additional information, go to:
http://www.hopkinsbayview.org/surgery/faculty/bola.html
http://www.hopkinsmedicine.org/microbiology/faculty/carroll.html
http://www.asir-journal.com/content/3/1/8

Photo caption: The Johns Hopkins designed and built “SUDS,” a self-cleaning unit for the decontamination of small instruments.

- JHM -

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The Business of Personal Genomes,At $100,000, Knome’s product

The Business of Personal Genomes,At $100,000, Knome’s product

In some ways, Jorge Conde, cofounder of the genomics startup Knome, knows his clients more intimately than any other company president. Knome is the first company to sequence and analyze a consumer’s complete genome. And Conde and his team have spent a full day with each member of their select clientele, going through the minute details of the results in search of hidden genomic time bombs, subtle health risks, and other information.

At $100,000, Knome’s product is still out of reach for most consumers. But that could change fast. The cost of genome sequencing is dropping by an order of magnitude every one to two years, and the cost of Knome’s product will drop with it, though not quite as fast. (When the company debuted its service in late 2007, it cost $350,000.) That means that within the next few years, having your genome sequenced will cost about the same as cataract surgery, making it affordable to include your genome sequence as an integral part of your medical record.

When launching Knome in 2007, Conde wandered into largely uncharted territory–only a handful of complete human genomes had been sequenced at the time. That meant that the company had to figure out how to select and analyze the most relevant information in the genome and then deliver that information to clients in a useful and digestible way. “We have to make sure they are not overwhelmed and don’t misunderstand the information,” says Conde. “This hadn’t been done before, so we wanted to be responsible, informative, and entertaining.”

So far, scientists understand only a tiny fraction of the 3 billion letters of the human genome. Knome’s team developed software that combs both public and private genome databases for the latest in scientific research and then applies the findings to an individual’s genome. The company has also developed new ways to filter and sort that information, developing a genome browser that allows users to search their genome by disease or by chromosome, and presents disease risk based on the level of confidence that can be gleaned from the existing research on the topic. The strength of the link between a genetic variation and a disease varies widely. Some genetic variants are definitively linked to specific diseases, such as cystic fibrosis or Huntington’s disease, others are associated with a high risk of a disease, such as the BRCA mutations and breast cancer, while still others have been linked to a negligible increased risk for common diseases, including heart disease and diabetes.

Conde won’t disclose how many people the company has sequenced so far–only that Knome’s goal for 2008 was to sequence 20 people. “In comparison to the genomes that have been published, we think we’ve done more than anyone,” says Conde. Some clients buy their genome sequence to help plan how to maintain their health. “Others do it for the shear thrill of having a front-row seat of what’s going on in science,” says Conde.

Customers so far have been mostly men–about 80 percent–and mostly in their mid-50s. A significant fraction of Knome’s clients are from outside the United States, thanks to word-of-mouth recommendations from early customers. Dan Stoicescu, a millionaire living in Switzerland who was profiled last year in the New York Times, was the company’s second client. Knome recently signed up two new customers, Harvard professor Henry Louis Gates Jr. and his father, Henry Louis Gates Sr., as part of a new documentary series slated to run on PBS next year.

People interested in having their genomes sequenced first go through an initial consultation “to make sure they understand what we can and cannot do,” says Conde. “When you’re operating at this price point, you don’t want an unsatisfied customer.” One of the biggest controversies in personal genomics to date has been the utility of currently available genetic information, especially for variations that have been only weakly linked to disease. For this reason, consumer genomics companies, including Knome, specify that they are not providing a medical service.

DNA is then isolated from a client’s blood sample and sent to the Beijing Genomics Institute in China to be sequenced. Once complete, the sequence is analyzed at Knome. In order to assuage privacy concerns, the sequence data, along with the genome browser, reside only on a USB key given to the individual. “With this approach, you are the gatekeeper of your information,” says Conde.

Clients get their key at an in-person meeting devoted to their genomes, where they are schooled by a clinical geneticist, a genetic counselor, a bioinformatician and others. (Clients are invited to bring their personal physicians, says Conde, though most don’t.) “We spend the entire day going through genetics and sequencing 101, and then walking them through their genome,” says Conde. “People often start out tense, thinking there will be a ticking time bomb in their genome. But then they start to relax and ask questions.”

Knome hasn’t yet found any ticking time bombs, such as the genetic variant that causes Huntington’s disease. But Conde says that a couple of people were found to be carriers of genetic variants linked to rare diseases–meaning they will not develop the condition themselves, but might pass it to their children if their mate is also a carrier. And the company has found some rare variants that are highly associated with a particular condition. “One person has a high risk for developing age-related macular degeneration,” says Conde. That gives him the option of doing early screening for the disease, though few preventative treatments are currently available.

Part of the service is figuring out what consumers understand, an issue that geneticists and ethicists have been grappling with as genomic information becomes more complex. “You don’t realize which concepts will connect, which are understood and misunderstood,” he says, adding that clients to date have run the gamut from very knowledgeable to minimally informed about genetics. He says it has been difficult for people to grasp the difference between genetic variations that cause disease, such as the Huntington’s mutation, and those that are merely associated with different diseases–meaning that research studies have found a link between these genetic sequences and a disease, but it’s not clear what role the gene plays or how strongly it increases disease risk in an individual. The latter represent the majority of disease-linked mutations identified to date.

Conde says that the lessons learned from the early adopters will serve the company well as more people can afford to invest in genome analysis. The company is currently developing a new, more-automated genome-interpretation service that will be offered in conjunction with genome sequencing from Illumina, a genomics technology company headquartered in San Diego. Illumina announced last month that it would offer personal genome sequencing for $48,000, but with minimal analysis of the data included. Analysis of the meaning of the human genome is proving to be more much more complicated than the sequencing itself. “In the long-term, that will be a big driver of value,” says Conde. “We will see the high price point go away, and the real value for both individuals and companies will be to provide an ongoing narrative.”

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The Gene Expression Laboratory Five-Year $145 Million Contract

The Gene Expression Laboratory Five-Year $145 Million Contract

Covance Inc. (CVD) (JOBS) to Acquire Seattle-Based Gene Expression Laboratory from Merck & Co., Inc. (MRK) (JOBS); Five-Year $145 Million Contract
7/30/2009gene kit

PRINCETON, N.J., July 29 /PRNewswire-FirstCall/ — Covance (NYSE: CVD – News) today announced it has entered into a definitive agreement with Merck & Co., Inc. relating to the supply of genomic analysis services. Under the terms of the agreement Merck has committed to a five-year $145 million contract to purchase genomic analysis services from Covance. In addition Covance will acquire Merck’s Seattle-based Gene Expression Laboratory that performs genomics services such as genotyping, gene sequencing and gene expression profiling.”The acquisition of this laboratory brings world-class talent and technologies to Covance and further expands our capabilities in genomics testing and personalized medicine,” said Joe Herring, Chairman and Chief Executive Officer of Covance Inc. “We recognized the need to expand our footprint in the important and growing genomics testing market and this transaction provided both a superior and quicker entry point than the build or buy options we considered. The overall size of the genomics market is estimated at several hundred million dollars per year, including services for discovery/preclinical and clinical trials support.”

“We believe this acquisition establishes Covance as the largest genomics service provider in the world,” said Deborah Tanner, Corporate Senior Vice President, President, Central Laboratory Services at Covance. “This agreement will broaden our participation in projects and partnerships with clients in the drug discovery process.”

Covance expects to offer employment to the majority of current employees and is scheduled to assume occupancy of the site and operation of the Gene Expression Laboratory on August 17, 2009.

“The Gene Expression Laboratory has established a strong reputation for consistent delivery of high quality experimental data in support of Merck’s external collaborations and internal research projects,” said Dr. Rupert Vessey, Vice President, Merck Research Laboratories. “This agreement assures continued access to these services for our researchers while securing a future for the facility as an integral part of a world leading drug development service provider.” About Covance

Covance, with headquarters in Princeton, New Jersey, is one of the world’s largest and most comprehensive drug development services companies with annual revenues greater than $1.7 billion, global operations in 25 countries, and more than 10,000 employees worldwide. Information on Covance’s products and services, recent press releases, and SEC filings can be obtained through its website at www.covance.com.

Statements contained in this press release, which are not historical facts, such as statements about prospective earnings, savings, revenue, operations, revenue and earnings growth and other financial results are forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All such forward-looking statements including the statements contained herein regarding anticipated trends in the Company’s business are based largely on management’s expectations and are subject to and qualified by risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the closing of the announced transaction, competitive factors, outsourcing trends in the pharmaceutical industry, levels of industry research and development spending, the Company’s ability to continue to attract and retain qualified personnel, the fixed price nature of contracts or the loss of large contracts, risks associated with acquisitions and investments, the Company’s ability to increase order volume, the pace of translation of orders into revenue in late-stage development services, fluctuations in currency exchange rates, and other factors described in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no duty to update any forward looking statement to conform the statement to actual results or changes in the Company’s expectations.

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