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Articles from 2019 In April

“FDA Approved” in OTC Advertising

“FDA Approved” in OTC Advertising
Image by IO-Images from Pixabay

Medical devices may be described as “approved” if they are Class III and have gone through the PMA process, or they may be “cleared” if they are Class II and used the 510(k) process. If they are Class I, there is no particular term to describe their marketability. There is also the DeNovo pathway for new low- to moderate-risk devices that would otherwise have to go through the PMA process. A successful De Novo application results in permission to market and classification as Class I and Class II. It is generally agreed that obtaining approval via a PMA is a more-demanding process than receiving clearance.

For prescription and professional medical devices, most manufacturers are careful to use the correct term and in particular to not use the term “approved” inappropriately. This is addressed in 21CFR 807.97, which states that clearance “does not in any way denote official approval of the device” and that “Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.” A reference to this regulatory language is briefly provided in clearance letters that state, “Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97).”

FDA has advised consumers (or at least those who visit the FDA website) in this regard. For example, there is a 2017 post entitled “Is It Really 'FDA Approved?” that also briefly addresses misuse of the FDA logo. There is also a post with a November 2018 updated date entitled “Consumers (Medical Devices)” that addresses the difference between cleared and approved and provides links to a number of individual device types.

Despite these regulations and resources, some marketers of medical devices sold directly to consumers appear to show less care about what terminology they use, or they are being deliberately misleading. This can be demonstrated by doing a general search for particular devices with “FDA approved.” For example, “FDA approved TENS unit” produces many hits, including a “Top 10 FDA Approved” list, none of which is actually approved. A search at Amazon produces similar results. If you type “FDA approved” in the search box, you get a number of specific suggestions including blood pressure monitor, pulse oximeter, TENS units, and thermometers. Looking at just “FDA approved” reveals a knee brace product and a blackhead remover that both include the FDA logo. A back brace includes the logo with “Approved” under it. None of these products is actually approved. A CPAP mask cleaner being advertised on TV in New York includes the words “FDA approved,” which it is not.

The medical device industry should do its part in not only using proper terminology but also in objecting to the use of incorrect terminology by others.

2019 Medical Design Excellence Awards Finalists

2019 Medical Design Excellence Awards Finalists

The Medical Design Excellence Awards competition is the medical technology industry's premier awards program. Since 1998, the MDEAs have recognized achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility.

Each year, a panel of jurors comprised of designers, engineers, and clinicians awards bronze, silver, gold, and best-in-show honors to the most innovative products on the market in nine categories.

Take a look at this year's finalists. We'll announce the winners June 11, 2019, in a special ceremony at MD&M East. Vote for your selection for the 2019 Readers' Choice winner below or by clicking here.

1. Digital Health Products and Mobile Medical Apps - devices and equipment that incorporoate either artificial intelligence or algorithms to help treat or monitor a patient's condition.

2.  Drug-Delivery and Combination Products—including pre-filled syringes, misting devices, dry powder inhalers, patches, pouches, or combination implants with biologic agents, etc.

3. ER and OR Tools, Equipment, and Supplies— including critical care, general surgery, plastic surgery, and anesthesiology products

4.  Gastrointestinal and Genitourinary Devices — devices and equipment to treat the gut and stomach.

5. Implant and Tissue-Replacement Products—including cochlear, corneal, orthopedic, neurological, and tissue implants and instruments

6. Nonsurgical Hospital Supplies and Equipment—including general medical equipment and supplies used in hospitals and doctor's offices, such as stethoscopes, blood lancets, medical carts, ventilators, hospital beds, blood pressure monitors, etc.

7.  Over-the-Counter and Self-Care Products — category include a wide assortment of treatments available to patients. 

8. Radiological, Imaging, and Electromechanical Devices — products include a wide assortment of diagnostics technology.

9. Testing and Diagnostic Products and Systems—including products that fall into FDA categories of chemistry, hematology, immunology, microbiology, pathology, and toxicology.

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Digital Health Plays Larger Role in MDEA for 2019

Pixabay Digital Health Plays Larger Role in MDEA for 2019

For more than 20 the Medical Design Excellence Awards have celebrated medtech products that improve the quality of healthcare and accessibility. From prosthetic legs to breast pumps, over the years, MDEA has always been a spotlight of the greatest innovation in medtech.

This year was no different – with a wide variety of innovations coming from all segments of medtech. Just like any other year, jurors from all over the country shuffled into a conference room at the Anaheim Convention Center to see which products would be finalists for the MDEA. One trend seemed to stand out – the increasing presence and digital health technologies.

MD+DI has been tracking trends in past awards programs, so they’re not necessarily new. When the program was launched in 1998, we noted a trend in the very first group of MDEA finalists toward “meaningful focus on the patient.”

Nearly two years ago, MD+DI reported that due to the increasing adoption of health apps and other tools, the digital health market is expected to grow to $60 billion in 2020 – an increase of 33%. Those stats began bleeding into this year’s MDEA awards. (It should be noted that in 2018 digital health products did not make it as finalists for MDEA.)

It can be difficult to judge the design of a digital health technology especially if it’s an app. During the February judging, one juror joked, “the apps are not that shiny.”

But the concept of medical devices is changing with the addition of algorithms and artificial intelligence. Peerbridge Health’s wearable ECG sensor is perhaps an example of this. The technology is a finalist in for the 2019 MDEAs.

The Peerbridge Cor Wearable ECG sensor provides real time continuous, multi-channel ECG recording and patient-activated event data transmission for up to 7 days. Peerbridge's sensor records 2-channel, 3-lead ECG data continuously, with the goal of improving patient compliance via its minimal size and simplicity of operation.

“The presence of multiple channels is important,” a juror said regarding one of the features on Peerbridge Health’s technology.

Michael Wiklund, a General Manager – Human Factors Engineering, Emergo by UL and juror for MDEA, told MD+DI about the size of past ECG monitors and the space these devices occupied. He noted past iterations of ECG technology weren’t as convenient for the patient or the clinician.

“They’ve done a good job of collecting the information and providing it to the clinician,” Wiklund said in reference to Peerbridge’s technology.

New York-based Peerbridge’s technology automatically brought up comparisons to the iRhythm’s Zio Patch. iRhythm has been making a sizeable dent in the market and has helped bolster the importance of wearables to monitor cardiovascular activity.

Another technology that brought in a significant amount of attention in the digital health category was the Pulm Ex. It is a mobile-based video game that presents interventional pulmonologists with challenging clinical and surgical scenarios using ultra-realistic, virtual patients.

From training on medical devices to performing life-like virtual bronchoscopies, Pulm Ex prepares physicians using real cases submitted by peers. Pulm Ex offers CME and available free in the Apple Store.

The gammaCore Sapphire is another digital health solution that managed to catch the attention and eye of jurors. The device is a non-invasive vagus nerve stimulator (nVNS), that prevents cluster attacks and relieves migraine and episodic cluster headache pain. Placed on the neck over the vagus nerve, gammaCore sends an electric current through the skin to the nerve, toward the brain, disrupting processes that cause certain types of pain.

ElectroCore launched the device in the Summer of 2018.

The Abbott Freestyle Libre Flash was one of the most popular technologies in the category (see MDEA Finalist list to see how well it fared in the competition). The FreeStyle Libre, which won approval from FDA about two years ago, offers people with diabetes a way to track glucose levels without fingersticks. In July of last year, the company won a nod from FDA for a 14-day version of the device.

Here’s how the device works. A quick scan of the handheld reader over a sensor worn on the back of the upper arm gives users a visual snapshot of their current glucose levels and patterns, providing actionable information that empowers them to better manage their health.

“You’re talking about a real breakthrough in terms of giving people greater freedom because the technology is closed-loop,” Wiklund said. “I think this is the kind of product that signifies where the industry is going. We’re going to smaller and smaller devices to sometimes rid people of tedious and sometimes painful interventions to administer medication or monitor their glucose levels.”

Beyond Digital

But it wasn’t all about digital products.

There were a few devices in the Over-the-Counter and Self-Care Products category that led to some very significant discussion about the Elvie Pump and the Willow Breast Feeding Pump. Last year, the Willow breast pump (developed by the Willow team) was the gold winner in MDEA. This year, the Elvie Pump was thrown into the competition and caused quite a stir.

The Elvie Pump is the first silent wearable breast pump and is also the world’s smallest, lightest wearable breast pump. It sits discreetly inside a standard nursing bra and silently expresses milk. offering greater mobility and freedom to breast pumping mothers to carry out everyday activities.

“It seems as if [Elvie] has addressed some of the weaknesses Willow has had,” a juror noted.

It would be interesting to see what would happen if both the Willow and the Elvie Pump could be put in front of MDEA jurors – but alas.

To hear the Gold, Silver, and Bronze MDEA winners as well as the Best in Show winner announced, join us June 11 at the Jacob K. Javits Center in New York City. The ceremony is open to all attendees of Medical Design & Manufacturing East, held June 11-13. Click here to register for the show.

5 Reasons This Will Be Zimmer Biomet's Comeback Year

5 Reasons This Will Be Zimmer Biomet's Comeback Year

Bryan Hanson had a tall order to fill when he accepted the job of CEO of Zimmer Biomet in December 2017.

The company was dealing with complex challenges that involved quality control and supply chain problems that began a year earlier, which created distrust among the sales organization for corporate, and a culture gap between the "Zimmer camp" and "Biomet camp."

But Hanson quickly identified several short-term priorities that Zimmer Biomet (ZB) has been working toward for the past 15 months and it appears that 2019 will be Zimmer Biomet's comeback year. Here are five reasons why.

1. Shifting from Supply Stability to Supply Efficiency

During Zimmer Biomet's first-quarter earnings call, Hanson said the company is shifting its focus from supply stability to initiatives aimed at increasing the overall supply chain efficiency.

"We see continued progress in our ability to regain the full trust of our commercial organization as we move to offense and focus on winning new business," he said, according to SeekingAlpha transcripts of the call.

Boosting confidence in the supply chain, the company is planning new product launches in the knee implant market later this year along with the launch of knee, spine, and brain applications for its Rosa robotic system.

"Relative to new products, 2019 will be an important year for Zimmer Biomet's pipeline and commercial strategy," Hanson said. 

In March, the company showcased its latest products and offered a preview of its next-generation solutions at the annual meeting of the American Academy of Orthopaedic Surgeons (AAOS).

"We saw keen interest in both the existing and new technologies across our entire portfolio. There was a high level of energy at the booth this year from all of our key stakeholders, including surgeon customers, investors, and our team members," he said. "We even had the FDA participate in a tour of the booth, providing an excellent opportunity for us to share our newest products and solutions with one of our key regulating bodies."

Hanson noted that the rollout of the ROSA robotics platform was a major focus at AAOS as Zimmer Biomet is now the only company that has robotic offerings across knee, brain, and spine applications.

The company is currently in a limited launch phase with its Rosa Knee product but Hanson said the cases that have been completed since commercialization began has generated a positive response from surgeons.

"We have seen tremendous interest from physicians and institutions, and that feedback increases our confidence that we have the right platform for growth in the second half of 2019 and well beyond," Hanson said.

2. Quality Remediation Is on Track

Hanson said Zimmer Biomet made good progress on quality remediation in the first quarter and the company is on track to complete its remediation plan on the Warsaw North campus by the end of the year.  At that time the facility will be ready for reinspection by FDA, he said.

The company's quality control problems first cropped up in December 2016 when FDA sent the company a rather long Form 483.  The agency re-inspected the facility in April 2018 and made some additional observations, but Zimmer Biomet pushed back on some of those findings. Then, in August 2018, FDA sent the company a warning letter related to observations stemming from the April 2018 inspection.

"Going forward, we'll continue to shift our focus from quality remediation to building best-in-class quality systems and culture to ensure the sustainability of those changes throughout the organization," Hanson said during the recent earnings call.

3. Zimmer Biomet Is Becoming More Agile and Results-Driven

Hanson has also placed a fair amount of emphasis on optimizing the company's talent and structure, and he said the company has made good progress toward becoming a more agile and results-driven organization. This includes bringing in new talent as well as broadening expertise across the business and implementing a new organizational structure that supports streamlined reporting and decision-making, he said.

4. The "One ZB" Mission Is Making a Difference

Although Zimmer and Biomet merged in 2015, the former rivals had a tough time integrating. From his very first earnings call at the company, Hanson began correcting analysts who referred to the company as "Zimmer."

"This is Zimmer Biomet, not Zimmer," Hanson said. "There are still camps of Zimmer and Biomet and we need to create Zimmer Biomet, forget the legacy companies."

Hanson also made sure the management team started referring to the manufacturing facility where the quality control issues occurred as the "Warsaw North Campus" rather than "the legacy Biomet facility."

While it may have come off as just PR spin at first, these not-so-subtle changes do appear to be making a difference.

"Zimmer Biomet feels like a different company compared to a year ago, and you could definitely feel that at the AAOS meeting," Hanson said. "We owe much of that success to open dialogue and transparency with the team. And as such, directly connecting with our team members will stay a top priority in 2019 as we continue to benefit from the energy and focus around the One ZB corporate mission and culture."

The company plans to continue holding "mission ceremonies" to "let team members at every level know that leadership is behind them, and that we are as excited about the future as they are," Hanson said.

5. First-Quarter Results Elicit Confidence

"First quarter results were slightly above our expectations and, probably more importantly, further supports our ongoing confidence that we are making real progress in reshaping the business and positioning ZB for success," Hanson said.

Looking ahead to 2020, the CEO said Zimmer Biomet aspires to be a top quartile performer in terms of total shareholder return.

"As we continue to stabilize the business and begin to deliver consistent growth in 2020, we will be well-positioned to execute against a five-year plan that will accelerate revenue growth, drive margin expansion and increase free cash flow."

That confidence certainly appears to be resonating with analysts. Needham & Co. recently upgraded Zimmer Biomet's stock to a "strong buy" rating.

Mike Matson, a medtech analyst at Needham, said he expects Zimmer Biomet's revenue growth to accelerate during 2019 as the company shifts back to offense after addressing its supply issues and as it benefits from the new product launches.

Matson also noted that he sees the potential for Zimmer Biomet to pursue acquisitions that could increase its organic growth and diversify its business.

In a separate note issued Tuesday, Matson hypothesized that Utica, NY-based Conmed would be a good acquisition for Zimmer Biomet. He said the note was purely a hypothetical exercise on Needham's part and not in response to any news or speculation of a potential deal. Acquiring Conmed would serve to bolster Zimmer Biomet's sports medicine and powered instrument businesses while beginning to diversify the company outside of orthopedics into general surgery.

Hanson didn't mention anything about an M&A strategy during the most recent earnings call.

2 of Edwards' Pediatric Catheters Face Class I Recall

Pixabay 2 of Edwards' Pediatric Catheters Face Class I Recall

Two of Edwards Lifesciences’ pediatric catheters are facing a Class I recall. The Irvine, CA-based company’s Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter are in a Class I recall because of the possibility of difficulty in balloon deflation after deployment.

The balloon deflation could lead to balloon fragmentation or detachment upon attempted retrieval. Edwards said it has received reports of balloon fragmentation or detachment, which may cause serious adverse health consequences including: damage to the heart, the inferior vena cava, and/or the femoral and iliac veins; additional procedures to retrieve the fragments; permanent patient disability; pulmonary embolism; stroke; damage to other organs; or death.

One serious injury was reported in which an infant underwent an invasive, but successful surgical procedure to retrieve a detached balloon, according to a release from FDA’s website. There were no deaths reported.

The Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter are used by health care providers to enlarge the opening between the two upper chambers of the heart (the atria).

This is done either to increase oxygenated/deoxygenated blood mixing, which then improves the baby’s overall oxygen level, or to decompress one of the atria when drainage is obstructed, which then improves blood flow and cardiac output.

The recall comes shortly after competition intensified for transcatheter aortic valve replacement procedures – a market Edwards is a pioneer in. Just last week, Boston Scientific entered the U.S. market with FDA approval for its Lotus Edge Valve.

Now Edwards squares off against Medtronic and Boston Scientific in both the U.S. and Europe markets.

New Solution for Soaking, Transporting Reusable Surgical Instruments

New Solution for Soaking, Transporting Reusable Surgical Instruments
The InstruSafe XL Transport Container for soaking and transporting long surgical instruments. Images courtesy of Summit Medical, an Innovia Medical Co.

Requirements for reprocessing certain reusable surgical instruments have changed. Some manufacturers are now instructing reprocessors to soak certain instruments in a pre-enzymatic cleaner. The implementation of this soaking step is further complicated by the growing popularity of laparoscopic procedures and robotic-assisted surgeries, which typically involve use of very long instruments. “It’s difficult for facilities to comply with the instructions for use because there really haven’t been containers large enough for such long devices,” Kevin McIntosh, president of Summit Medical, told MD+DI. Before such long devices became commonplace, reprocessors typically used a sink basin or purchased something from a hardware store.” But even the latter wasn’t really ideal, he explained, because “these generic containers might have chemicals in the plastic that could leach out.”

To help users meet these new soaking requirements for long instruments, Summit Medical, an Innovia Medical Co., has developed the new InstruSafe XL Transport Container designed to accommodate da Vinci SP, XiScopes, EndoWrist, and other long laparoscopic surgical instruments. The XL Transport Container is the newest addition to the InstruSafe Instrument Protection family. The new container had its public debut during the AORN Global Surgical Conference & Expo in April and then demonstrated at the IAHCSMM Annual Conference.

McIntosh is thrilled to “be able to add something new to address a problem looming for some years,” he said. “It is also another way to provide protection [for staff] from soiled instruments.”

The InstruSafe XL Transport Container features an inner gasket, a splash-proof lid, and four silicone latches to reduce spills along with a drain to accommodate soiled liquid removal. “Fluids cannot escape during transport” to the reprocessing area, said McIntosh. “We wanted to protect the instruments, but we also felt it was important to protect users from the biological tissue on the instruments. That drove the need for the container to be well sealed.”

Summit selected a material that was compatible with sanitation processes and temperatures and provided impact resistance, McIntosh explained. The company identified a copolymer that could handle the repeated cycles, and “extensive” drop tests and shipping tests were conducted, he said. The system was also tested “to some extent” according to ISO 10993, he added.

To ensure that the new container design would meet user needs, company representatives worked with “key accounts to observe how large instruments were being processed,” he said. “Design requirements came from users.” The XL container also features similar organizing and nesting mechanisms used throughout the InstruSafe Instrument Protection family.

“If instruments are organized well, scrub techs can hand off instruments easily,” he said. “All instruments are organized and protected so that they are not damaged before, during, and after sterilization. They are also nested in specific locations at all times, but they are not snap-fit. Soft silicone mechanisms hold the instruments in positions that can be adjusted as needed. We call it 360 degrees of protection so that you could shake the container, and the instruments won’t move.”

The driving need for the InstruSafe XL Transport Container was its larger size of 30 in. in length. But now that an IntruSafe design has been developed specifically for accommodating instruments for robotic surgery, the company anticipates future models for smaller instruments.

For its range of InstruSafe Instrument Protection Trays (an example of which is shown below), Summit has 510(k) clearance for seven different sterilization modalities. “Companies can partner with us to put their devices in our 510(k) cleared trays,” he said. The company can also develop custom-designed containers.

Physician’s Device Puts a New Spin on Ultrasound

Courtesy of CoapTech Physician’s Device Puts a New Spin on Ultrasound
Point-of-care Ultrasound Magnet Aligned (PUMA-G) System platform

Five years ago, Steven Tropello, M.D., a critical care and emergency medicine physician, became frustrated with the limitations he had in placing feeding tubes in patients. Tropello saw numerous patients needing a simple G-tube insertion or replacement, who wound up staying multiple days in the hospital waiting for a specialist and an operating room.

Tropello’s frustration led to the physician developing the Point-of-care Ultrasound Magnet Aligned (PUMA-G) System platform, a device that enables ultrasound-based placement of percutaneous gastrostomy feeding tubes. He also co-founded CoapTech, the company that markets the device. The Baltimore-based firm recently received a nod from FDA for the technology.

“[Ultrasound] is a ubiquitous tool,” Tropello, who also serves as CoapTech’s CMO, told MD+DI. “When I had that moment of anger and frustration …I said what tool do colleagues like myself and specialists, have in our pocket to use to safely insert feeding tubes and use ultrasound. The idea could not have happened if ultrasound wasn’t  ubiquitous.”

Conventional procedures to place feeding tubes typically require a surgical suite, additional specialty consultant providers, and expensive and invasive imaging. The PUMA-G System, allows physicians to place gastrostomy tubes at the point of care, using solely ultrasound imaging.

The device is significant because it allows for ultrasound procedures in hollow organs. Typically, ultrasound doesn’t work when it hits air because the image becomes distorted.

Plans call for the company to focus on a launch plan for the newly-cleared technology, said Howard Carolan, co-founder and CEO of CoapTech.

“We’re doing a very controlled targeted launch with a few key early adoption sites where we can demonstrate the value of this new model,” Carolan, told MD+DI. “The goal for the year is ensuring those priorities have been met.”

CoapTech isn’t revealing whether it will go outside of the U.S. for additional approval,  however, company executives noted they would shed more light on their overall plans in in the near future.

Tropello said the availability of ultrasound now is becoming a game-changer for healthcare.

"When I started training you might have hard luck to find an ultrasound on the medical floor, on an ICU,” Tropello said. “Fast forward [today], now you can virtually find ultrasound on any medical floor, ICU, and sometimes multiple machines. Some people are saying that ultrasound is replacing the stethoscope.”

What’s the Latest in Robotics?

What’s the Latest in Robotics?
Image by janjf93 from Pixabay

There’s no question that robotics is poised to transform healthcare, manufacturing, and much more. The market for medical robots is expected to reach USD 16.74 billion by 2023 up from about $6.46 billion in 2018, predicts Markets&Markets. The research firm also predicts the industrial robotics market to reach USD 71.72 billion by 2023.

Attendees to BIOMEDevice Boston and ESC Boston will have the opportunity to see robotics in action and hear the latest developments and best practices from several experts. The shows are co-located together May 15-16.

For instance, the CorPath GRX system from Corindus Vascular Robotics Inc. is on display in the Surgical Suite at Booth 110 at BIOMEDevice Boston. The CorPath platform is described as the first FDA-cleared medical device to bring robotic precision to percutaneous coronary and vascular procedures. Last November Mark Toland, president and CEO of Corindus, told MD+DI that “this technology offers optimized robotic techniques that can tackle even the most complex procedures,” Toland said. He added that the company is also exploring the safety and feasibility of remote treatment with the CorPath GRX System.

Per Bergman, vice president, research and development for Corindus Vascular Robotics, will also be participating in the panel discussion, “Solving R&D Productivity Challenges,” today from 8:30 AM - 10:00 AM in the Research & Development track (Track B) of the BIOMEDevice Boston conference. Panelists will examine ways to overcome organizational constraints that could impact R&D.

Roger Smith, PhD, chief technology officer, AdventHealth Nicholson Center, who told MD+DI last year that he was tracking nearly 60 medical robots,  and explored what the next five to 10  years could hold for surgical robotic innovation in “Advanced Research Efforts Changing the Way Medtech Uses Robotics” Wednesday, May  in the R&D track of the BIOMEDevice Boston conference. He’ll discussed 70 unique surgical robots and explore their impact.

Smith will also moderate the Center Stage panel discussion, “Robotic Surgery: Visions of the Future,”  today  at 2:45 PM - 3:45 PM. He will be joined by Richard Leparmentier, vice president of engineering for Auris; Doug Teany, chief operating officer for Corindus Vascular Robotics; and Tom Calef, chief technology officer for Activ Surgical. Panelists will share their thoughts about the state of surgical robotics technology and where it's headed in the next five to10 years.

Scott Huennekens, former president & CEO of Verb Surgical,  discussed how the intersection of robotics, AI, and medical devices will change the future of care in a fireside chat with MassMEDIC President Brian Johnson yesterday at Center Stage.

For industrial uses of robotics, Patrick Sobalvarro, co-founder & CEO of Veo Robotics, will discuss how robots and humans could work together safely in “Advanced Vision Systems for Safe Human-Robot Interaction” on Thursday during the ESC Boston conference. The company has developed an advanced vision application with 3D sensing for safe human-robot interaction.

For the basics on robotics, Michael Anderson, director of technology for The PTR Group LLC, will present an “Introduction to the Robot Operating System” on today  at 10:15 AM - 11:00 AM during the ESC conference. He will introduce the Robot Operating System (ROS), a control framework for implementing distributed control in applications such as robotics.

Kent Gilson, founder/inventor, Haddington Dynamics, discussed the progress industrial robots are making and their role in Industry 4.0 in “Robots Aren't Just Coming, They're Here … And That's a Good Thing” yesterday in the ESC Boston Engineering Theater. He’ll also explore changes in IoT and connected devices and the opportunities and challenges in system integration and security.

And Fady Saad, co-founder and director of partnerships, MassRobotics, discussed the “relevant opportunities” in robotics in “Robotics Between Fantasy & Reality” Wednesday in the ESC Boston Engineering Theater. He’ll shared his experience in co-founding the robotics startups innovation hub, MassRobotics.

Mobile robots are also on their way. Kevin Blankespoor, VP of product engineering, Boston Dynamics, will share the latest developments in the keynote, “Exploring Real World Applications for Dynamic Robots” today at 1:15 PM - 2:30 PM at Center Stage. The company has developed a number of different dynamic robots, drawing from its capabilities in dynamic mobility, mobile manipulation, and systems engineering. Boston Dynamics also just acquired Kinema Systems, which provides Pick deep-learning technology for industrial robotic arms to enable them to locate and move boxes on complex pallets. Pick is now part of Boston Dynamics’s Handle platform for logistics.

BIOMEDevice Boston and ESC Boston continues today.  

Cardiac Dimensions Spot on with FMR Treatment

Pixabay Cardiac Dimensions Spot on with FMR Treatment

Cardiac Dimensions reported new data confirming significant reduction in regurgitant volume directly after implantation of its Carillon Mitral Contour System at the German Society of Cardiology annual congress, DGK 2019.

The Kirkman, WA-based company’s Carillon System is a right-heart transcatheter mitral valve repair (TMVr) device designed to treat the primary cause of FMR in patients with MR grades 2+, 3+ and 4+. The findings presented in the study confirmed the acute hemodynamic effects of the Carillon device on mitral valve morphology and demonstrated an acute reduction in regurgitant fraction in 83% of patients, as documented by transthoracic echo after device implantation.

Greg Casciaro, President and CEO of Cardiac Dimensions, said the study helped validate the immediate impact of the Carillon System on mitral regurgitation for a large percentage of FMR patients.

"This study adds to the growing body of evidence demonstrating the effectiveness and safety of the Carillon System in two key measurements of FMR - a significant MR reduction and favorable left ventricular remodeling, observed most recently in the REDUCE FMR trial, the first and only randomized, blinded, sham-controlled trial conducted in structural heart,” Casciaro said in a release.

Cardiac Dimensions has been building itself up as a powerful competitor in the FMR market. A year ago, the company raised $39 million to build strong clinical evidence for its Carillon Mitral Contour System. And in September of last year, Cardiac Dimensions launched its pivotal trial.

How POC Diagnostics Are Becoming the Norm

Pixabay How POC Diagnostics Are Becoming the Norm

Point-of-care (POC) testing is a rapidly growing market. As healthcare starts to shift toward consumers, the demand for tests that can be performed anywhere the patient is located, is increasing. With the promise to reduce costs and give quicker results, with industry zeroing in on the prospects of these tests, POC’s are becoming the norm.

On May 16 at BIOMEDevice Boston, a panel will be held, titled: POC IVD and Core Lab Innovations: Making Precision Diagnostics a Reality. The panel will discuss the myriad of ways to design rapid, portable diagnostics, and innovation that is driving POC IVD product development. The session will also discuss the marketplace appetite for POC products and how some are replacing more traditional diagnostic tools.

An example of the growing appetite for POCs can be traced back to when Abbott’s acquisition of Alere. Not including the drama, the Abbott Park, IL-based company picked up Alere for about $5.3 billion – an amount that’s considered pretty sizeable for medtech.

Abbott was able to significantly boost its POC offerings and indulge in a rich opportunity that could help reduce hospital costs and make testing for diseases a bit easier.

Another deal that arose from Abbott’s acquisition was Quidel putting up $400 million to buy some of the assets of the Waltham, MA-based Alere. Through the transaction, Quidel gained Triage MeterPro products and B-type Naturietic Peptide assays. Quidel said acquiring Alere's triage business and (BNP) assay business could give the company a boost in the point-of-care diagnostics market.

Deals have had a tremendous impact as well as the availability of technology. POC testing was once thought of as something for developing markets. But the incorporation of some tests with smart phones has given tremendous bandwidth to hit the everyday consumer – thus encouraging product and market growth.