Archive for December 16th, 2016

Authoring lacking errors: most appropriate punctuation, spelling and grammar

Authoring lacking errors: most appropriate punctuation, spelling and grammar For many people in this age of advanced technology, the question of how to learn to write without errors still remains without answer, even though

It may sound paradoxical.

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Human Insulin Market Poised to Hit US$ 49,197.3 Million by 2020

Human Insulin Market Poised to Hit US$ 49,197.3 Million by 2020

Insulin-Pen-5

 

Globally, the human insulin market is witnessing significant growth due to increasing prevalence of diabetes and increasing awareness among people about diabetes care. In addition, technological advancements in insulin delivery devices and increasing prevalence of lifestyle related disorders such as obesity are also driving the growth of the market. However, uneven pricing and limited access to human insulin in emerging countries such as Brazil, India, and China are inhibiting the growth of the human insulin market. In addition, strict regulatory requirements for drug approval are also restraining the growth of the market.

The global human insulin market was valued at USD 24,332.6 million in 2014 and was expected to grow at a CAGR of 12.4% from 2014 to 2020, to reach an estimated value of USD 49,197.3 million in 2020.

In addition, increasing prevalence of lifestyle associated disorders such as obesity is also boosting the growth of the human insulin market in this region. For instance, according to the Centers for Diseases Control and Prevention (CDC), a U.S.-based national public health institute, over one-third children and adolescents were obese in 2012 in the U.S.

In North America, increasing prevalence of diabetes with growing age and availability of advanced human insulin infusion devices are driving the use of human insulin in the market.

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In Europe, the human insulin market is driven by rising aging population and increasing prevalence of diabetes. In addition, in Germany the market is evolving due to rising prevalence of diabetes and increasing awareness among people about diabetes care. However, in Asia-Pacific the growth for human insulin is much higher than developed countries due to increasing prevalence of diabetes and increasing government initiatives for improving healthcare.

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Novo Nordisk A/S, Eli Lilly and Company, Sanofi, Biocon, Tonghua Dongbao Pharmaceutical Co., Ltd., Adocia, Merck & Co., Inc., Pfizer, Inc., Wockhardt, Julphar, Bristol-Myers Squibb Company, GlaxoSmithKline Plc and Oramed Pharmaceuticals, Inc. are some of the major players in human insulin market.

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Persistence Market Research (PMR) is a full-service market intelligence firm specializing in syndicated research, custom research, and consulting services. PMR boasts market research expertise across the Healthcare, Chemicals and Materials, Technology and Media, Energy and Mining, Food and Beverages, Semiconductor and Electronics, Consumer Goods, and Shipping and Transportation industries. The company draws from its multi-disciplinary capabilities and high-pedigree team of analysts to share data that precisely corresponds to clients’ business needs.

PMR stands committed to bringing more accuracy and speed to clients’ business decisions. From ready-to-purchase market research reports to customized research solutions, PMR’s engagement models are highly flexible without compromising on its deep-seated research values.

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Diagnostic Imaging Device Market on Track to US$ 35,793.4 Million by 2020

Diagnostic Imaging Device Market on Track to US$ 35,793.4 Million by 2020

Infusion-pumps

 

The global diagnostic imaging devices market is growing at a moderate rate owing to increasing prevalence of chronic diseases and injuries, and growing aging population. Moreover, factors such as rising initiatives undertaken by government associations to boost awareness of the effects and complications of tuberculosis, cardiovascular diseases, and cancer, and technological advancement and widening application of diagnostic imaging devices are driving the global diagnostic imaging devices market. In addition, increasing funding from government bodies is also promoting the use of diagnostic imaging devices in the regions. However, factors such as strict regulatory requirements and heightened risk of cancer owing to exposure to radiation are inhibiting the market growth.

The global diagnostic imaging devices market was valued at USD 26,477.1 million in 2014 and is expected to grow at a CAGR of 5.2% from 2014 to 2020, to reach an estimated value of USD 35,793.4 million in 2020.

In Europe, the diagnostic imaging devices market is driven by rising diagnostic requirements due to increasing prevalence of chronic diseases and injuries, and aging population. For instance, according to a paper published on Cancer Incidence and Mortality Pattern in Europe, by International Agency for Research on Cancer in France, approximately, 3.45 million new cases of cancer were diagnosed in Europe in 2012.

In North America, growing aging population, increasing health awareness, rising chronic diseases and injuries, large number of ongoing research activities and faster adoption of technologically advanced imaging systems are driving the use of diagnostic imaging devices in the market.

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However, in Asia-Pacific the growth for diagnostic imaging devices is much higher than developed countries due to growing awareness about benefits of early diagnosis of disease among individuals, large population base, upgradation of health care systems and increasing prevalence of chronic diseases.

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Siemens Healthcare, Hitachi, Ltd., Carestream, Health, Inc., Samsung Electronics Co., Ltd., Toshiba Corporation, Koninklijke Philips N.V., and General Electric Company are some of the major players in diagnostic imaging devices market.

About Us

Persistence Market Research (PMR) is a full-service market intelligence firm specializing in syndicated research, custom research, and consulting services. PMR boasts market research expertise across the Healthcare, Chemicals and Materials, Technology and Media, Energy and Mining, Food and Beverages, Semiconductor and Electronics, Consumer Goods, and Shipping and Transportation industries. The company draws from its multi-disciplinary capabilities and high-pedigree team of analysts to share data that precisely corresponds to clients’ business needs.

PMR stands committed to bringing more accuracy and speed to clients’ business decisions. From ready-to-purchase market research reports to customized research solutions, PMR’s engagement models are highly flexible without compromising on its deep-seated research values.

Contact

Persistence Market Research

305 Broadway

7th Floor, New York City,

NY 10007, United States

USA – Canada Toll Free: +1 800-961-0353

Email: sales@persistencemarketresearch.com

media@persistencemarketresearch.com

Web: http://www.persistencemarketresearch.com

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ProNova SC360, a New Proton Therapy System Cleared in U.S.

ProNova SC360, a New Proton Therapy System Cleared in U.S.

sc360

 

ProNova Solutions, a division of Provision Healthcare based in Tennessee, won FDA clearance for its ProNova SC360 proton therapy system. It took the firm only four years to develop the system and get it cleared, but Tennessee is famous for its high energy physics expertise, going back to the Manhattan Project. The first SC360 installation already happened at the Provision CARES Proton Therapy Center in Knoxville, TN and the first patients are expected to be treated in the coming year.

The ProNova SC360 allows patients to be treated at any angle without having to move them, instead directing the beam to come from any direction chosen by the clinical team. This should allow for faster treatment times as patients don’t have to be repositioned to deliver energy from different angles.

It features pencil beam scanning and a built-in cone-beam CT for imaging the patients. Positron emission tomography (PET) capabilities are optionally available as well.

The system is designed to be able to power two treatment rooms at the same time, but single and three-room options can be made available as well.

Product page: ProNova SC360…

Via: Provision Healthcare…

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Horus Recognizes Faces, Reads Text, Describes World Around for Blind People

Horus Recognizes Faces, Reads Text, Describes World Around for Blind People

horus

 

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A new device is expected to soon be made available for visually impaired people that uses voice to describe the world in front of them. The Horus is essentially a headset with a 3D forward facing camera and a small computer that it’s connected to. The computer constantly runs a computer vision algorithm that recognizes objects and places in front of the user. Once identified, the system reads aloud what it’s seeing.

The system also spots obstacles, thanks to its 3D vision, and warns wearers using various tones. It can read text placed in front of it as well, and it can even tell faces apart. The user can essentially save images of faces of friends and relatives within the Horus, so that when a familiar person comes within view the device lets the user know.

The Horus is not yet available, but Eyra LTD, the company behind the device, has a waiting list for early access.

Check out this video that shows off how the system works:

Info page: Horus…

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Exclusive: Eko Core Advanced Digital Stethoscope Now Cleared and Available in Europe

Exclusive: Eko Core Advanced Digital Stethoscope Now Cleared and Available in Europe

eko-core

 

Eko Core, the digital stethoscope from Eko Devices, a Berkeley, CA firm, is now CE Mark cleared for introduction in Europe. We reviewed the Eko Core a few months ago and discovered that it’s much more than a high-fidelity amplified stethoscope. You can store and share auscultations, as well as analyze and annotate them using a paired app, which wirelessly connects to the Eko Core. You can even listen to recordings shared by other clinicians through the Eko Core, so you can hear exactly what they heard when they conducted the exam.

eko

Everything can be stored to an electronic medical record (EMR), just like a radiologist would save patient CT scans, and these can be compared during future exams. The data can even be live-streamed for tele-medicine applications, such as allowing cardiology specialists to help to diagnose patients in remote and understaffed clinics. All the sharing and streaming is done using HIPAA-compliant software, allowing it to be used and integrated into existing clinical practices and their IT systems.

The Eko Core was approved by the a little over a year ago and CE Mark now allows it to be distributed in Europe, including UK. It has already been adopted by over 3,000 U.S. clinicians at over 400 hospitals and clinics.

Flashbacks: Review: Eko Core Digital Stethoscope…Eko Core Stethoscope with Novel Digital Capabilities FDA Cleared…

Product page: Eko Core…

Link: Eko’s announcement…

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FDA Efforts to Regulate Innovative Technologies and Facilitate Market Access

FDA Efforts to Regulate Innovative Technologies and Facilitate Market Access

The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. U.S. health officials unveiled plans to fight avoidable injuries from medication errors or misuse, a problem that harms hundreds of thousands of people each year and can be deadly. REUTERS/Jason Reed (UNITED STATES HEALTH) - RTXQCTX

 

At Medgadget we cover regulatory approvals of devices on a daily basis, and many of our readers are involved in these affairs at the companies they work for. The regulatory scene is changing to adapt to technological changes that are blurring the previously clear lines between software and devices, and between prescriptions and advice. We asked Rachelle D’Souza, an expert on these matters atRegulatory Heights Inc., to give our readers an overview of the latest regulatory adaptations the FDA has been undertaking.

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Innovative technologies that are medical devices and are used for the diagnosis, treatment and prevention of diseases or conditions, are regulated by the United States Food and Drug Administration (FDA). This usually involves FDA approval / clearance for market launch of the medical device, the design and maintenance of a quality and safety reporting system and facility registration / listing. FDA’s medical device approval or clearance decision depends on FDA’s benefit risk assessment of the device. Various factors are considered by the FDA during their decision making. These include the medical necessity of the medical device, the type, magnitude and duration of its benefits, the medical device’s risks, uncertainties and risk mitigation controls, and patient and user preferences.  Today, many manufacturers are offering patients innovative medical device technologies or technologies that are new to medical care. FDA has stepped up to provide regulatory oversight and guidance for these innovative technologies and to facilitate medical device market access. Here’s how.

 

Regulating Innovative Technologies

Mobile Medical Applications (MMA)

Increasingly today, mobile apps are involved in patient care. FDA has stepped up to regulate certain mobile apps used in medical care. Mobile apps connect to electrode sensors, speakers, microphones, cameras for active patient monitoring and / or patient data modification or analysis, to diagnose or treat disease. Examples include mobile apps associated with pulse oximeters or ECGs. Mobile apps control the function, operation or energy source of medical devices. Examples include mobile apps that alter the settings of cochlear implants, infusion pumps, CT or X-Ray machines. These are mobile medical applications (MMA) and are subject to all the regulatory compliance activities identified in the first paragraph above including FDA approval for market launch. Mobile apps that may be MMAs and are of lower risk are subject to FDA’s enforcement discretion and therefore should comply with FDA’s quality system regulation. Examples include mobile apps that support patient adherence to medications or use gaming technology for physical therapy. Manufacturers of mobile apps in health care must therefore first consult with a regulatory professional to determine whether their mobile app is a medical mobile app and then to determine the regulatory compliance activities appropriate for their MMA or medical device.

Wireless Medical Devices & Cybersecurity

As medical devices use wireless technology, FDA has made recommendations with respect to the selection, quality of service (QoS), coexistence, security and electromagnetic compatibility (EMC) of the wireless technology. Packet loss, signal to noise ratio, bit error rate are useful parameters for assessing wireless data integrity and transmission. The network’s signal priorities, accessibility, acceptable latency and acceptable probability level for information loss can be used to assess the QoS. Coexistence can be addressed by addressing adjacent channel and co-channel interference of the RF band from other medical devices and users. Wireless encryption and data access controls among others may be considered to address cybersecurity issues. To prevent EMI with other equipment, manufacturers can comply with FDA recognized standards with respect to EMC testing of their wireless technology.

For quality assurance and control, wireless technology and cybersecurity should be considered when designing a manufacturer’s quality system. For instance, a quality system can include a comprehensivepremarket and post market cybersecurity risk management program based on the NIST framework for improving critical infrastructure cybersecurity. This would include identifying cybersecurity signals and defining essential clinical performance, characterizing and assessing vulnerability, performing risk analysis and threat modeling, analyzing threat sources, incorporating threat detection capabilities, analyzing cybersecurity signal impact across devices, assessing and prescribing compensating controls, and mitigating risk to essential clinical performance, perhaps through routine cybersecurity patches. FDA also recommends that manufacturers address cybersecurity of networked medical devices containing off-the-shelf (OTS) software.

Design Considerations for Interoperable Devices

Medical devices are often interconnected via an electronic data interface and so FDA is tackling the interoperability of medical devices to ensure their safety and effectiveness. FDA recommends that a manufacturer’s quality system design and medical device design consider the electronic data interface’s purpose, anticipated users of the medical device(s), risk management, verification & validation and labeling.

When designing the electronic data interface, for instance, a medical device manufacturer will need to consider the devices being connected, the data being exchanged, the data transmission method, any time synchronization requirement, the reliability of information like the sample or transmission rate, the medical device’s clinical context for the data exchanged, device functional and performance requirements, the effect of application programming interface (API) commands on device safety and effectiveness and other interface interoperability situations.

Malfunctions or failures could arise from device connections, direct or indirect, receiving and processing of invalid commands or data errors, or non-adherence to specifications. All potential and actual risks to device safety and effectiveness need to be adequately addressed through a suitable risk management plan in the medical device manufacturer’s quality system which may include device / system verification and validation activities and labeling controls. Manufacturers also need to appropriately inform anticipated device users in accordance with user interaction / function. For instance, a clinician would be interested in the clinical uses and risks of the device and electronic data interface, that the clinician would interact with. On the other hand, an engineer would need to know the functional performance requirements for network operation and maintenance or verification and validation activities.

IVD Co-development

Often today, in vitro devices are used along with therapeutic drug products for diagnostic purposes. These may include monitoring patient response to a therapeutic drug to alter treatment for greater drug safety or efficacy, identifying patients who will be more likely to have serious adverse reactions to the drug therapy, identifying patients who would most chance to benefit from a drug therapy or identifying a patient population where a therapeutic drug is found to be safe and effective after adequate study. When an vitro device is purposed as above and is essential to a therapeutic drug’s safe and effective use, such a device is considered to be an in vitro companion diagnostic device, and FDA regulates its co-development with that of the therapeutic drug product.

There are many FDA considerations and suggestions concerning the co-development of an in vitro companion diagnostic device (IVDD). These include the use of pre-analytical and analytical studies for demonstration of assay reliability and safety, analytical validation of all IVDD clinical performance parameters prior to any pivotal trial, utilizing clinical trial enrichment strategies, using a single study protocol for multiple sites, and more. Regulatory strategy and counsel are involved in pre-submission FDA consultations, determining the appropriate regulatory submission pathway and in co-ordinating drug and device regulatory timelines.

Device Specialties

As medical device manufacturers continue to innovate and improve on technology, FDA is setting forth its expectations with respect to device design / manufacturing and testing / performance evaluation, including clinical design. Moreover, FDA’s expectations are increasingly specific to device category or product line. Consider as examples, the following device types and some of their corresponding FDA expectations.

 

Facilitating Market Access

Expedited Access Pathway (EAP) Program

Devices for the diagnosis or treatment of life threatening or irreversible debilitating conditions or diseases usually require premarket approval (PMA) or de novo regulatory applications for FDA clearance. Manufacturers of such devices may opt for expedited market access if their devices have no legally marketed alternative, or where an alternative exists, the device is in the best interest of patients, has a clinically meaningful, significant advantage over the legally marketed device and is of a breakthrough technology. An expedited access pathway (EAP) designation by FDA is based on FDA’s consideration of a draft data development plan that forms part of the EAP submission and includes a synopsis and time plan of premarket and post market study data. An EAP designation from FDA entitles a manufacturer to FDA EAP program features including FDA interactive review, senior FDA management involvement, an FDA assigned case manager and priority review by FDA.

Patient Preference Information (PPI)

Sometimes there is no clear superior treatment option among a series of multiple therapies, evidence for any one therapeutic option may be inconclusive. Patients may differ in views on significant benefits and acceptable risks from health care professionals. In the past, FDA has found that information on patient preferences has facilitated market access and so, in 2015, established a Patient Engagement Advisory Committee (PEAC) for engagement with patients. Medical device manufacturers filing premarket approval applications (PMA), humanitarian device exemption (HDE) applications or de novo requests with FDA can now leverage the use of patient preference information (PPI) in their regulatory submission for market approval. Various medical devices can benefit from the use of PPI. These include devices of novel technology, high risk life saving devices, devices for unmet needs or rare diseases and conditions, devices affecting the quality of life, with significant health and appearance benefits, or with alternative benefits to marketed devices, and devices with a direct patient interface.

Leveraging Clinical Strategies

Medical devices subject to premarket approval applications (PMA), humanitarian device exemption (HDE) applications or de novo requests may be able to potentially extrapolate adult clinical data to the pediatric population. Additionally, electronic health record (EHR) data may be considered in clinical investigations provided that EHR data validity, reliability and integrity can be verified through inspection by FDA.

In conclusion, FDA is keenly monitoring the evolution of medical device technologies. Medical device manufacturers need to leverage regulatory intelligence, such as has been presented here, for expedited market access and avoid costly delays for regulatory compliance. This goal is attainable if medical device manufacturers and regulatory professionals work together, ideally from the earliest phases of device design, to design a viable strategic plan or path to market that is amenable to changing business objectives, budget constraints and regulatory compliance expectations.

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Cambridge Medical Robotics Shows Off Its New Versius System

Cambridge Medical Robotics Shows Off Its New Versius System

versius

 

Cambridge Medical Robotics, a UK firm, is revealing its Versius robotic surgery system. The system consists of modular robotic arms, any number of which can be used depending on a procedure. The arms can have a camera or any one of the dozen or so tools attached, and they can be quickly swapped for other tools as necessary.

Each of the arms can be placed around the patient table or even hung from above to save valuable space. The surgeon wears a pair of 3D glasses and operates by looking at a monitor instead of peering into a scope common on existing systems. This can help improve ergonomics and allow the surgeon to see and interact easier with clinicians managing the patient and the robot. The robot is operated using a controller similar to video game joysticks and the system delivers haptic feedback from the instrument to the controller, so the surgeon can actually feel the anatomy being worked on.

Unlike existing robotic surgical systems, the Versius can work with instruments requiring only a 5 mm incision. Typically the smallest instrument sizes on robotic systems is 8 mm, and unlike 5 mm incisions these typically require suturing and maintenance.

The company has already performed a number of studies, including on cadavers, and is compiling responses and data from 32 surgeons that has already used the Versius system. The firm hopes to receive the CE Mark in Europe in 2018 and FDA regulatory green light shortly thereafter.

More info from CMR…

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