Healcerion, based in South Korea, was the first company to receive FDA clearance for a wireless, app-based ultrasound system back in 2015. The groundbreaking work done by South Korean engineers and scientists laid the foundation for the development of an ultrasound transducer that works with most smartphones or tablets. Since introducing the SONON 300C convex transducer, the company has been making progress to further advance this branch of ultrasound devices. Their latest, the SONON 300L linear transducer, weighs only 13 ounces (370 grams) including the battery, and features color Doppler mode for easier musculoskeletal (MSK), vascular, small parts (breast, thyroid), lung, and other types of imaging.

We had a chance to ask Dr. Benjamin Ryu, the CEO of Healcerion, some questions about how his company got to where it is and where it is going.

Yuriy Sarkisov, Medgadget: Please tell us a little about yourself, how did you get involved in the ultrasound market?

Dr. Benjamin Ryu:  Before becoming involved in developing the first FDA approved wireless ultrasound system, I worked as an ER doctor for seven years. Working as a doctor in South Korea comes with certain advantages; we had several stationary ultrasound machines at our disposal and never had problems with access to quality diagnostic equipment. But one day, everything changed. My ambulance crew responded to a call for a pregnant unconscious woman and when we got there she was dead on arrival. We immediately began CPR and loaded her into the ambulance to transport her to the hospital. Although we managed to stabilize the woman, her unborn baby’s condition was still unknown. The baby was preterm, making it even more difficult to gauge whether it was alive or not. This nerve-wracking experience is what inspired me to create a pocket ultrasound device. With the help of such a system, we can provide better care to patients, especially in emergency situations.

Medgadget:  What inspired you to develop not only an app-based system, but a wireless system?

Dr. Benjamin Ryu:  My reason for developing a wireless ultrasound system was a practical one. Because I had worked in the ER, I knew the problems doctors there faced. Emergency rooms are full of different types of equipment and space is limited. Plus, there are tons of wires everywhere that can get in the way, and we can’t risk stepping on them and putting the machine out of commission. Also, the multi-pin connectors used in conventional ultrasound systems are very fragile, making them an additional point of vulnerability. So app-based ultrasound with a wireless system makes perfect sense. Healcerion developed the world’s first wireless, app-based device that fits in your pocket.

Medgadget: What do you think the future holds for app-based ultrasound, and what are the main obstacles in this field?

Dr. Benjamin Ryu:  Whether wired or wireless, app-based ultrasound has to be able to connect to PACS and other cloud-based services. This capability allows doctors to easily transfer and share images. The future of app-based ultrasound, in my opinion, will lie in connectivity to other machines, especially those used for patient monitoring. The main obstacles I would say have to do with regulation issues, like security and communications. Because many countries don’t have definite regulations, this becomes a problem for expanding the device’s market. Additionally, engineering problems like firmware and software updates are exacerbated by regulatory issues like clinical data security.

Medgadget:  What sets the Healcerion system apart from other offerings on the market?

Dr. Benjamin Ryu:  I started Healcerion because I found a need for an ultra-portable app-based system. Unlike other companies, my clinical and technical background give Healcerion distinct advantages. I worked for a digital signal processing company as an engineer, and also as a researcher in complicated fields like MRI and PET. It just so happens that one of my professors developed the world’s first PET scanner.

When I started working on a first of my own, app-based ultrasound, it was tough because we didn’t start from ultrasound tech. We had to build everything from scratch, assimilate new information, and develop new technologies. Healcerion wrote the book on app-based ultrasound.

Medgadget: What telemedicine trends do you see happening in the future and what is Healcerion’s approach to telemedicine in general?

Dr. Benjamin Ryu:  Many companies are interested in adapting to keep up with the future of medicine. In my view, telemedicine is a promising field but the clinical aspects are difficult. In South Korea, we don’t have telemedicine thanks to accessible medical facilities. Any Korean can visit a hospital within an hour’s drive. In other countries, however, the situation is different and some remote regions may not have access to high-quality healthcare. The main obstacle for telemedicine is regulation issues, reimbursement, and other issues.

Medgadget:  Can you tell us about the experiences that clinicians and patients have had with the Healcerion system?

Dr. Benjamin Ryu:  Doctors praise Healcerion for being not only portable, but wireless. It’s invaluable for trauma care, where a quick handheld ultrasound unit is extremely useful. One example was sent to us by a doctor in Costa Rica. A person was scanned with the Healcerion system and local doctors were able to identify a tumor in the patient’s throat. Because this was in a rural area, that patient would have faced serious problems down the road. Thanks to accessible ultrasound scanning with our device, it’s easy to quickly scan even in the most remote areas of the world.

Medgadget: What’s next for Healcerion?

Dr. Benjamin Ryu: We are looking forward to improving our current devices and producing better, more high-quality systems. We are also focused on cloud-based solutions so we can build the future of mobile healthcare platforms. New Healcerion ultrasound scanners will take advantage of next-gen technology, making them more compact and easier to use.

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Healcerion, the South Korean firm that introduced truly wireless ultrasound probes that work with smartphones and tablets, is releasing its SONON 300L ultrasound in the United States. The device was cleared last fall by the FDA and Healcerion has been working on manufacturing and preparing it for distribution.

The SONON 300L works with most Android and iOS phones and tablets, requiring the user to simply download the Healcerion app and to pair the ultrasound to the device being used. The ultrasound itself weighs 13 ounces (370 grams), is powered by a rechargeable battery that can scan continuously for up to three hours, and even features Wi-Fi and 3G/LTE capabilities.

The device can produce DICOM images, send the data to a hospital’s PACS (Picture Archiving and Communication System), and become a standard tool for a family physician, a doctor working outside of a clinical environment, and should be popular in urgent care clinics, remote areas, and home healthcare providers.

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SuperSonic Imagine, a French firm, has announced that its Aixplorer MACH 30 ultrasound has been cleared in the U.S. and Europe. The system works as a traditional high power ultrasound, but also features the company’s elastography technology called ShearWave PLUS that measures tissue elasticity, or stiffness, in 3D. Elastography is now commonly used for identifying mammary and hepatic lesions and helping to grade breast and liver cancers.

The MACH 30 offers higher power compared to its older cousins from Supersonic Imagine, making it faster and more efficient during imaging. B-mode quality has been improved within the system while new transducers help improve image quality in Angio PL.U.S and TriVu ( (all-in-one B-mode / SWE / Color+) modes.

The firm is particularly proud of a large touchpad, which it calls SonicPad, as the central controller for the MACH 30. “During clinical evaluations performed in the US, we received enthusiastic customer feedback from those who used the Aixplorer MACH 30 and its touchpad,” said Kurt Kelln, Chief Business Officer of Sales for SuperSonic Imagine, in a press release. “The SonicPad permits quick and intuitive control of all functions needed for a successful examination. It lets users improve their workflow while concentrating on the analysis of on-screen clinical information rather than which buttons to push for optimal image acquisition. The same enthusiastic reception was observed globally.”

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Hologic is releasing a new fluid management system specifically designed for hysteroscopic procedures. The Fluent system aims to simplify, make more efficient, and less frustrating fluid management tasks.

The setup is simplified with a modern touchscreen interface, there’s only a one waste bag to worry about, the machine is purportedly quieter and doesn’t shake around like a lot of existing devices.

The screen runs the operator through all the steps to setup the machine so everything goes smoothly and quickly, and the same happens when it’s time to wrap things up.

Data on the pressure, fluid deficit (within +/- 50 mL), bags running low, and if the waste bag is close to capacity, are displayed during the procedure.

“We developed the Fluent system with a deep understanding of the hectic workflow that often characterizes the patient and staff experience,” said Sean Daugherty, President of GYN Surgical Solutions, Hologic. “This launch is a testament to how our strong customer partnerships and unique technological innovations enable us to provide healthcare professionals the advanced equipment they need to improve lives.”

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Researchers at TU Wien in Vienna have developed a placenta-on-a-chip microfluidic device which uses a femtosecond laser-based 3D-printing method to create a customized hydrogel membrane. The printed membrane is populated with placental cells and mimics the microstructure of the placental barrier. This allows researchers to study how substances, including drugs and nutrients such as glucose, travel across the placental barrier.

“The transport of substances through biological membranes plays an important role in various areas of medicine,” said Aleksandr Ovsianikov, a researcher involved in the study. “These include the blood-brain barrier, ingestion of food in the stomach and intestine, and also the placenta.”

At present, it is difficult to study how substances travel across the placental barrier. Drug treatments during pregnancy can be risky, as there is a chance that the drug could cross the barrier and affect the fetus. Diseases affecting the mother may also affect the fetus. For instance, previous research has shown that diabetes or high blood pressure in the mother can affect the unborn child. However, it is difficult to know how exactly this happens, or how to prevent it, given that we don’t fully understand how the placental membrane functions.

Researchers are working to develop new devices to help study the placental barrier. One of the most promising approaches involves organ-on-a-chip devices, which can be seeded with human placental cells to mimic the placental membrane. This group of researchers in Austria have developed a new approach to recreating the placental membrane in a microfluidic device.

“Our chip consists of two areas – one represents the fetus, the other the mother,” said Denise Mandt, another researcher involved in the study. “We use a special 3D printing process to produce a partition between them – the artificial placenta membrane.”

The researchers used the high-resolution 3D printing method to recreate microstructures in the placental membrane. The technique involves using lasers to solidify printed materials, allowing 3D structures to be created in the micrometer range. “In our case this involves a hydrogel with good biocompatibility,” said Ovsianikov. “Based on the model of the natural placenta, we produce a surface with small, curved villi. The placenta cells can then colonize it, creating a barrier very similar to the natural placenta.”

The device allows the researchers to study disease progression and treatment, and monitor a variety of parameters including temperature and pressure, and how substances such as glucose or drugs travel across the placental membrane. So far, the printed membrane appears to behave similarly to a natural placental membrane, but further tests are required to validate this.

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UVision360, based in Raleigh, North Carolina, has announced that its Luminelle DTx hysteroscopy and cystoscopy system is now FDA cleared. The device is designed to give doctors an option to perform hysteroscopy procedures in the office, without having to rely on more expensive OR equipment.

“Since the best technology is typically only available in the operating room, many physicians and patients opt to skip the hysteroscopy and either perform a blind biopsy or go straight to surgery, without taking a good look inside of the uterus,” in a statement said Dr. Amy Garcia, MD, FACOG, Institute for Hysteroscopy Training, Albuquerque, NM. “An in-office system that is easy to use, prevents a blind biopsy and allows the physician to offer either a therapeutic diagnosis or a biopsy under visualization elevates the standard for uterine care.”

The Luminelle DTx essentially combines the features of more conventional hysteroscopy and cystoscopy systems, allowing imaging of the internal lining of the uterus and performing a biopsy in a single session. UVision360 claims that using its product, physicians can save up to 75% when compared to some existing endoscopic tower systems. According to the company, “We accomplish this through employing the latest in
high-tech optics and our understanding of the clinicians’ behavior and practice. The Luminelle DTx Hysteroscopy System is designed to enable physicians to perform diagnostic and operative procedures in the office which patients may prefer.”

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Gynesonics, a Redwood City, CA firm, won clearance from the FDA for its Sonata (Sonography-Guided Transcervical Fibroid Ablation) System. The device already has the CE Mark clearing it for sale in Europe.

The Sonata combines ultrasound visualization with a proprietary ablation device to allow for transcervical, incisionless removal of most intrauterine fibroids. Currently, only a small portion of diagnosed fibroids are removable using the transcervical approach.

The system comes with its own software that helps to plan and execute procedures with confidence. The software shows the tissue area, including size and location, that would be affected by the RF energy before the ablation begins. The physician can use this to target the tissue as well as set the length and energy level of the ablation, as well as position mechanical stoppers to avoid moving the introducer and needle electrode too far in.

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Robotic surgical systems, such as those from Intuitive Surgical and TransEnterix, can be prohibitively expensive for many, if not most, hospitals. FlexDex, a company based outside of Detroit, Michigan, offers a much more affordable alternative for performing many minimally invasive procedures. Unlike existing laparoscopic devices, FlexDex’s technology relies on a so called “virtual center” to transfer the movement of the wrist to the tip of the instrument in an intuitive fashion. This allows the user to move the wrist in the same direction as the intended movement of the instrument’s tip and therefore makes training and execution much easier and simpler. We recently tried using a FlexDex device and, having played with laparoscopic tools before, were very much impressed.

Now Olympus has just announced that it’s partnering with FlexDex to distribute FlexDex’s Needle Driver instrument in the United States. This represents a comprehensive launch of FlexDex’s technology to the U.S. market, since until now FlexDex only provided its technology to a few hospitals in order to learn and collect data for publication.

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At KAIST, a major South Korean science and technology university, researchers have developed a flexible robotic surgical system that is designed to work on difficult to reach places. The K-FLEX endoscopic surgical robot has arms that are only 3.7 mm in diameter, allowing them to work through standard 4.2 mm internal channels of an endoscope. Since each robotic arm doesn’t need its own incision, as is usual with current robotic surgical systems, using the K-FLEX is a lot less invasive and should lead to fewer complications for patients. Moreover, it can be delivered through natural orifices, such as the mouth and anus, to sites that otherwise would require an external incision.

The device has recently been tried on a pig in a procedure in which a lesion was removed from the pig’s gallbladder. The device was used to reach the organ via the navel, pushing other tissues out of the way and cauterizing the lesion using a special needle attached to the robotic arms.

The robot relies on so-called “mini-joints” developed at KAIST that offer a great deal of flexibility while maintaining the strength necessary to work inside the human body. Since it is operated through an endoscope, the arms can be moved in and out of the surgical scene with ease while the endoscope provides the visualization inside.

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Embolx, out of Silicon Valley, won the European CE Mark for its latest Sniper Balloon Occlusion Microcatheters. The devices are used to help deliver embolic agents in such varying procedures as helping to treat tumors, uterine fibroids, and enlarged prostate. The new family of the devices include features to make them easier to navigate through small vascular structures. They were recently cleared in the United States.

Often, the blood flow near a site that you want to deliver drugs to is so overwhelming, that drugs don’t have much chance to settle in and penetrate a tumor or some other object. The basic idea of Sniper microcatheters is that their balloon is used to block some of the blood flow near where you want to deliver the drug. The blockage creates a change in the local hemodynamics that sends the agents toward their intended target.

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