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Boston Sci Initiates Controlled Launch of Acurate Neo 2 in Europe

Courtesy of Boston Scientific IMG_Sep282020at32657PM.jpg

Boston Scientific broadened its reach in the transcatheter aortic valve implantation (TAVI) market with a controlled launch of Acurate Neo 2 in Europe. The Marlborough, MA-based company said the device first received CE mark in April.

The Acurate Neo 2 valve system also has an expanded indication for patients with aortic stenosis – with no specified age or risk level – who are considered appropriate candidates for the therapy by their heart team, including a cardiac surgeon.

"We believe having this differentiated valve with the enhanced sealing technology will further drive favorable market experience and growth," said Joe Fitzgerald, president, Interventional Cardiology, Boston Scientific. "Combined with the Lotus Edge Aortic Valve System and SENTINEL Cerebral Protection System to protect the brain against the risk of TAVI-related stroke, the Acurate Neo 2 valve represents the natural evolution of our complementary dual-valve TAVI toolkit that covers the needs of a wide range of patient cases."

Boston Scientific said data from the Acurate Neo 2 CE-Mark study showed at 30 days and 1 year after implantation, respectively, 97% and 97.5% of patients experienced ≤ no/trace or mild PVL, 3.0% and 2.5% of patients experienced moderate PVL and 0% of patients experienced severe PVL.

The device is not yet approved by FDA and is currently being evaluated in the ACURATE IDE trial in the U.S.

Boston Scientific gained access to Acurate when it closed its $435 million acquisition of Symetis.


Abbott Pushes CGM Boundaries with Freestyle Libre 3

Image Courtesy of Abbott Laboratories IMG_Sep282020at22604PM.jpg

Abbott Laboratories has scored a CE mark for the Freestyle Libre 3. The approval in Europe comes a few months after the Abbott Park, Il-based company won a nod from FDA for a second-generation version of the continuous glucose monitoring (CGM) technology.

The FreeStyle Libre 3 technology provides continuous, real-time glucose readings automatically delivered to smartphones every minute, offering 14-day accuracy in the smallest and thinnest sensor design. The firm said the device is the same price as the Freestyle Libre 2.

Abbott said that it designed its next-generation FreeStyle Libre 3 system to be more sustainable for the environment with a smaller and more discreet sensor, reducing the total volume by more than 70%. With a 41% reduction in plastic use and a 43% reduction in carton paper, the new sensor design aligns with the company's continued commitment to sustainability. The sensor is about the size of a penny. 

"Abbott won't stop innovating when there's room to raise the bar,” Jared Watkin, senior vice president, Diabetes Care, Abbott, in a release. “We've done that again with FreeStyle Libre 3, the smallest sensor that delivers life-changing benefits and best-in-class accuracy. People living with diabetes are at the center of our design process, and we made our next-generation technology even more discreet for a better user experience to make managing diabetes as easy and seamless as possible."

The original Freestyle Libre was one of Abbott’s most anticipated devices. The first generation of the device scored a nod from FDA back in 2017 and the news of the approval sent rival DexCom’s shares into shock.

“Libre 3 was widely anticipated – a U.S. study of the system was started this summer – but management had stayed mum on the exact timing of regulatory clearances, Marie Thibault, a medtech analyst at BTIG and a former managing editor at MD+DI, wrote in a research note. “To us, Libre 3 seems easier and more convenient for users than prior versions of the platform, since they no longer need to scan the sensor to receive their glucose reading, history, or trend information.”

She added the new device fits in with the overall picture of CGM’s improving. She noted that the CGM market was healthy enough to support multiple players.  

“Both Abbott and competitor DexCom continue to push the CGM field forward with new capabilities, smaller sizes, and entry into new patient populations,” Thibault wrote. “While investors are likely to focus on the competitive dynamic between the two companies and compare device capabilities, we believe there can be more than one winner since there is plenty of room for both players to grow CGM adoption quickly within traditional and new markets.”



Medtech in a Minute: It's All About Those M&A Deals

Image by OpenClipart-Vectors on Pixabay Medtech

Illumina and Grail Want to Reunite

The rumors are indeed true – Illumina is attempting to acquire early cancer detection specialist Grail for about $8 billion. Grail was spun off from Illumina in 2016. The proposed acquisition comes hot on the heels of Grail announcing it was seeking to go public.

EU Investigation into Google's Fitbit Deal

An investigation by EU antitrust regulators concerning Google’s pending acquisition of Fitbit has been extended to Dec. 23, according to a report from Reuters. Regulators began a probe into the deal in August. The main concern from regulators seems to be the amount of data Google would have access to if the deal were to come to pass.

Boston Sci Gains Exclusive Option to Buy Farapulse

Boston Scientific has signed an investment agreement and an exclusive option to acquire Farapulse, the developer of the pulsed-field ablation (PFA) system. The move has the potential to strengthen the Marlborough, MA-based company’s position in the treatment of atrial fibrillation. Farapulse received breakthrough designation for the PFA system last year. The device – comprising a sheath, generator, and catheters – is intended to ablate heart tissue via the creation of a therapeutic electric field instead of using thermal energy sources such as radiofrequency ablation or cryoablation.

And in case you missed last week's Medtech in a Minute article ...

The Apple Watch Rumors Were True

As speculated, blood oxygen (SpO2) tracking will be enabled on the Apple Watch Series 6. The sensor uses infrared lights to measure your blood oxygen in seconds, and can take measurements while you sleep. The company is working with various research teams to examine how longitudinal measurements of blood oxygen and other physiological signals can help manage and control asthma; how blood oxygen measurements and other Apple Watch metrics can help with management of heart failure; and how Apple Watch apps such as heart rate and blood oxygen could serve as early signs of respiratory conditions like influenza and COVID-19.

Speaking of Apple ...

Fitbit Moves in on Apple's ECG Turf

Fitbit’s ECG app is slated to be available in October. The product winning a nod in both the United States and Europe comes about two years after Apple's FDA nod for an ECG app. It also comes at a time when Fitbit is in the middle of being acquired by Google.

Illumina May Want Another Chance with Grail

Illumina could be interested in (re-)acquiring liquid biopsy startup Grail, according to a recent report from Bloomberg. The gene sequencing company could pay more than $8 billion for Grail which now has a valuation of $6 billion, Bloomberg reported citing people familiar with the matter. The rumored deal comes about a week after Grail's IPO news (see below), and about four years after Illumina spun Grail off into a separate company.

Or if you missed Medtech in a Minute the week before ...

Grail Wants to Go Public

Liquid biopsy specialist Grail is set to go public four years after it was spun out from Illumina. The Menlo Park, CA-based company is developing early cancer detection tests and has set a placeholder amount of $100 million for its IPO. The company is known for its exorbitant financings and has thus far brought in about $1.9 billion in venture capital funding.

FTC to Send Out Refunds to Some Users of NeuroMetrix's Quell

Users of NeuroMetrix’s Quell wearable pain-relief device could be eligible for payments from the Federal Trade Commission (FTC) by check or through PayPal. FTC recently announced it was refunding almost $3.9 million to purchasers of the Waltham, MA-based company’s device that was designed to treat chronic pain throughout the body when placed below-the-knee. In a release, FTC said NeuroMetrix and its CEO, Shai Gozani, sold Quell to consumers, touting it as “clinically proven” and “FDA cleared” for widespread chronic pain relief. However, the agency said the defendants lack scientific evidence to support widespread chronic pain-relief claims, and their claims about clinical proof and the scope of FDA clearance for this use are false.

Chembio Gives COVID-19 Antibody Testing Another Go

Nobody can accuse Chembio Diagnostics of giving up too easily. FDA revoked the emergency use authorization (EUA) for Chembio Diagnostics' first antibody test. Now the company seeks an EUA for a new rapid COVID-19 antibody testing system. The company said new performance criteria from FDA regarding COVID-19 antibody testing provided clarity and direction for its development objectives.

Medtronic Takes the Gloves Off in Patent War with Axonics

Image by kittipong - AdobeStock Axonics

Medtronic and Axonics are at it again, and the gloves are definitely off now. To be fair, the proverbial gloves probably came off a long time ago, but the latest spat between the two companies makes it clear that neither is pulling any punches.

What you need to know about the ongoing feud between Medtronic and Axonics

Here's a quick refresher on this story:

  • Medtronic pioneered the sacral neuromodulation (SNM) market over 20 years ago with its InterStim device, used to treat various bladder and bowel conditions.
  • Along came Axonics Modulation Technologies with FDA approval last year for a rechargeable version of a similar device.
  • The market incumbent almost immediately filed a lawsuit against Axonics, alleging infringement on certain claims in seven patents related to Medtronic's SNM lead placement procedure and implant recharging technologies. Or, as Axonics CEO Raymond Cohen puts it, "We said, 'look, this is typical big company anti-competitive behavior ... and we think it's bogus'."
  • Axonics filed seven petitions with the U.S. Patent and Trademark Office (USPTO) requesting an inter partes review (IPR) of each of the Medtronic patents in question.
  • Medtronic catches up with the market challenger by winning FDA approval of its rechargeable SNM device.

Here is the latest development in the story

Background image by kittipong - AdobeStock; Graphic by Amanda Pedersen, MD+DIAxonics

Axonics found out Wednesday that the Patent Trial and Appeal Board (PTAB) of the USPTO has decided to review the validity of six of the seven Medtronic patents in question. This means that the PTAB has reason to believe that at least some, if not all, of the claims in each of those six patents will be found invalid.

"They would not have issued the statement if they did not believe there was a 'reasonable likelihood that some if not all of the claims in those patents would be found to be invalid', Axonics CEO Raymond Cohen told MD+DI, emphasizing that he was quoting directly from the PTAB's statement. "We didn't just make this shit up."

However, the PTAB decided not to institute a review of one of the patents — (U.S. Patent No. 9,463,324 ('324 patent) — because there is not a reasonable likelihood that any of the claims in that particular patent would be found to be invalid. According to Medtronic, the '324 patent protects key technology related to implant recharging and temperature control and is central to the infringement case pending against Axonics.

Axonics issued a press release Thursday to update the market on the latest developments in the case.

"We put out a release, it wasn't filled with vitriol, I didn't make any inflammatory statements," Axonics CEO Raymond Cohen told MD+DI referring to the company's press release. "I just simply said that we're pleased that the PTAB instituted these petitions, and it means that Axonics has demonstrated that there is a 'reasonable likelihood that at least some, if not all, of the claims in each of the patents would be found to be invalid."

Medtronic followed up with its own press release on Friday.

"Frankly, it wasn't really a response [to Axonics' press release]," Brooke Story, vice president and general manager of Medtronic's pelvic health and gastric therapies business, told MD+DI. "We wanted to make sure that the market and our customers and our patients knew the results of the [PTAB]."

To read just Axonics' press release, a lay person might conclude that the PTAB's decision at this point is a victory for Axonics. To read just Medtronic's press release, the same lay person might conclude that it is a victory for Medtronic because of the '324 patent.

Story said that typically in cases like these the PTAB institutes a review of all of the patents in question. "So we were very excited about that and felt that was a big victory, and wanted to make sure that message was clear," she said. "For the other six patents ... we still feel really good about those patent claims, the fact that [the PTAB instituted a review on those patents] is not a decision. It just means that they're still up for review."

At least that's one point that both companies agree on.

"This is a nothing burger, which is why we didn't make a big deal about it," Cohen said. "We didn't claim victory, we just said we're providing an update on proceedings."

Meanwhile, in Medtronic's press release, Story essentially says the same thing.

"Contrary to Axonics' assertions, the PTAB has not made any final determination that any of Medtronic's patent claims are invalid. The full IPR process will begin now, and the PTAB will issue a decision within the next 12 months," she said.

Cohen seemed amused by Medtronic's press release.

"I'm cracking up because they flipped this around and said, 'well we only lost six of seven, and it's really the seventh one that's the most important," he said. "...How can you have the PTAB say that six of your seven patents are presumed invalid and somehow you think that's a victory?"

Story emphasized, both in her interview with MD+DI and in Medtronic's press release, that the '324 patent is most important of the seven contested patents because it relates to implant recharging and temperature control. That patent, she said, is central to Medtronic's infringement lawsuit against Axonics.

What to expect going forward

Now that the PTAB has instituted a review of six of the contested Medtronic patents, the board has a full year to issue a decision on those patents.

"What I've heard from our legal team is we feel really good about our case ... we don't take these things lightly," Story said. "We wouldn't bring forward a claim if we weren't really confident about it."

Then Medtronic will need to make a decision as to whether or not it will go through with its patent infringement lawsuit against Axonics on whichever patents are ultimately found to be valid.

"If they choose to take this to court, if they chose to pursue this further, then we'll obviously present all the arguments that say, 'we're not infringing on your patent, we did it in a different way'," Cohen said.

Can't they all just get along?

Background image by kittipong - AdobeStock; Graphic by Amanda Pedersen82e8ab44-1b72-4ece-956f-dfd77305ab87 (1).png

"We don't want to poke the bear," Cohen told MD+DI. "We just want to go out there and be successful as a company ... we didn't pick this fight, you know? But Medtronic does not have a God-given right to a monopoly in sacral neuromodulation."

There seems to be a perception among urologists, patients, and financial analysts that Medtronic had the capability to put out a rechargeable version of its InterStim implant, but without competition in the space the company became complacent and did very little innovation in sacral neuromodulation until Axonics came onto the scene. MD+DI asked Story how she responds to such frustrations.

Story has been leading the pelvic health business (part of the restorative therapies group) at Medtronic for almost two years. In December 2018 the company launched a smart programmer for the InterStim system that was intended to streamline multiple devices into a single, intuitive, touchscreen mobile device. This year, FDA approved Medtronic's InterStim Micro neurostimulator and InterStim SureScan MRI leads.

"I absolutely heard the feedback you're telling me, but what I will tell you is for the last six months I haven't heard that," Story said. "The customers I'm talking with are really excited about what we've done, and they are starting to have trust, I think, in me and my leadership team, and they're seeing all the innovation we have brought to the market. They love the fact that we have both a rechargeable and a recharge-free system. Axonics has brought one thing to the market."

Axonics does, however, plan to bring a recharge-free version of its SNM system to the U.S. market. The company also began shipping its second-generation implantable pulse generator (IPG) in August following a nod from FDA. The second-generation IPG is designed to extend the time between recharging intervals to once a month.

25 Teams Advance in $1 Million XPRIZE Next-Gen Face Mask Challenge

Image courtesy of XPRIZE XPRIZE Next-Gen Mask Challenge

In July, XPRIZE challenged young designers around the world to devise the next generation of surgical-grade consumer face masks. Sponsored by Salesforce CEO Marc Benioff and CNBC Host Jim Cramer, the XPRIZE Next-Gen Mask Challenge set out to “reimagine protective face masks used to prevent the spread of COVID-19 by making them more comfortable, functional, accessible, and even stylish,” according to the nonprofit’s Web site.

Twenty-five teams representing 12 countries have now advanced through qualifying round one on to round two judging. After that round, 10 semi-finalists will then face in-lab testing and cultural ambassador judging, narrowing the group of competitors to 5 finalists. In November, a grand prize winner along with two additional teams will split a $1 million prize award, XPRIZE reported. All competitors range in age from 15 to 24 years old, and the winning teams are listed here.

“We are in the midst of an unprecedented global crisis,” said Peter H. Diamandis, XPRIZE founder and executive chairman, in a news release. “We know that wearing a mask is an effective way to curtail the spread of COVID-19, yet many find masks undesirable for many reasons from comfort to fashion. The mission of the Next-Gen Mask Challenge is to resolve this situation, to drive innovation that results in a new generation of masks that are comfortable, safe, fashionable and ultimately desirable, encouraging mask wearing behavior. Thus far, we’ve been so impressed with what our competing teams have developed. Our next step is to connect these teams with our ecosystem manufacturing partners who will provide mentorship, resources and guidance.”

XPRIZE’s industry partners will be on hand to assist the competitors with prototypes, prepare them for testing and, ultimately, support the production and adoption of the winning team’s mask, according to the release. The competition partners are described as follows:

  • 3M – A manufacturing partner that is prototyping, testing, judging, and potentially manufacturing the winning designs.
  • Autodesk Inc. – Providing free access to its professional design software to participating student teams and design training resources to all competitors. While eligible students will have access to Autodesk’s full design suite, specialized learning assets and webinars for Fusion 360 will be made available to participants. 
  • Bryan Cave – Offering pro-bono legal counsel on intellectual property rights for competitors.
  • Honeywell – A manufacturing partner that is prototyping, testing, judging, and potentially manufacturing the winning designs.
  • Lydall Performance Materials – Donating fine fiber meltblown filtration media, the same material used in N95 respirators and surgical masks, to competing teams, as well as resources to educate competitors on the importance of filters in masks.
  • NAM – Supporting recruitment, team mentorship, prototyping support, and other services to democratize the competition and support teams.
  • Under Armour – Providing team mentorship on fashion, design, and the use of performance materials.

Said Denise Rutherford, 3M’s senior vice president of corporate affairs, in the release: “XPRIZE and 3M have a shared goal of inspiring the next generation of scientists and innovators who are challenging the status quo and daring to create a better world. At 3M, we believe that science, creativity and collaboration are critical in helping to solve the world’s biggest challenges. We are excited to participate in this important challenge, and to mentor XPRIZE contestants in order to accelerate their dreams into reality.”

In 2017 XPRIZE challenged innovators to develop a consumer-focused, mobile integrated diagnostic device inspired by the medical Tricorder of Star Trek fame, MD+DI reported. Final Frontier Medical Devices (now known as Basil Leaf Technologies) won the $2.6 million XPRIZE competition and financial assistance to bring its device to market. A second-place prize of $1 million was granted to Dynamical Biomarkers Group.

Medtech & COVID-19

From Bombs to SARS-CoV-2: One Company's COVID-19 Pivot Story


As the coronavirus 2019 (COVID-19) evolved from being an isolated disease in China to becoming a global pandemic over the course of just a few months, nearly every industry faced major disruptions. That's why we've seen big automotive companies like General Motors (GM), Ford, and Tesla take medical device production (namely ventilators) for a spin.

So it shouldn't come as too big of a surprise that DetectaChem, a global provider of portable bomb and drug detection technology, has added COVID-19 detection to its portfolio. Specifically, the Sugar Land, TX-based company is trying to address the need for widely accessible point-of-care COVID-19 testing.

"A lot of companies had to reinvent themselves and super pivot in order to keep viable as a business," Travis Kisner, DetectaChem's chief operating officer, told MD+DI. "We didn't actually have to pivot that hard. We were already in the detection business for explosives and drugs, and we have the only automated cell phone mobile detection platform, pretty much in the industry, using a phone's optics to detect a variety of things."

DetectaChem frequently works with U.S. and foreign government agencies which were all busy addressing the pandemic, so it made sense for DetectaChem to switch gears too. Kisner said the company realized that it only needed to make a slight pivot in order to add a COVID-19 detection solution to its existing mobile detection platform.

RADx initiative for COVID-19

This week DetectaChem announced that its MobileDetect Bio (MD-Bio) BCP19 test pouch for COVID-19 detection passed the initial "deep dive" phase in July and is currently advancing through phase I of the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative. The RADx initiative was created to rapidly accelerate innovation in the development, commercialization, implementation, and mass deployment of technologies for COVID-19 testing.

Coming into the RADx program, DetectaChem’s predicate and currently available BCC19 COVID-19 detection kit achieved 100% accuracy for positive and negative samples and has FDA emergency use authorization. The upcoming RADx BCP19 Test Pouch is a simplified evolution of the same core technology.

How the MD-Bio BCP19 test detects COVID-19

DetectaChem’s MD-Bio BCP19 test pouch is a high throughput, portable, point-of-care test designed to produce results for numerous samples simultaneously in 30 minutes. According to the company, the test detects nucleic acids from the SARS-CoV-2 which produces a clear colorimetric reaction to determine positive or negative infection results for active RNA. The solution combines a unique single-use test where the swabbed sample is inserted directly into the pouch combining with reagents, primers, and viral transfer medium and then uses a single-button-operation MD-Bio Thermal Heater. The BCP19 pouch and MD-Bio Thermal Heater are designed from the ground up for maximum ease of use for all point-of-care applications, DetectaChem said.

The MobileDetect App (currently available globally on Apple and Android app stores) can also be used as an optional tool for automated infection result report generation. After analysis, the app automatically generates a PDF result report with time, date, GPS location, test ID, reaction picture, and also allows users to add more pictures, custom patient information, and notes. The user can then send this result report via email or SMS as needed.

“Accurate, fast, easy-to-use, and widely accessible point-of-care testing is required before the nation can safely return to normal life. DetectaChem began intense work on a COVID-19 test immediately when the pandemic began in early 2020, as we knew our detection and manufacturing capabilities would provide a significant advantage in delivering and deploying these tests to the market,” Kisner said. “Our team has been working tirelessly and collaborating with the RADx team to ensure our tests can be delivered to market in the near future while providing the unprecedented reliability and ease-of-use the world needs so urgently in the fight against the COVID-19 pandemic.”

The RADx initiative is providing clinical, technical, and regulatory support, one-on-one guidance to project teams, and funding for solutions like DetectaChem’s BCP19 test pouch that make tests easier to use, access, and scale for mass manufacturing. Through this initiative, the NIH has rigorously reviewed and selected companies to move diagnostic technologies swiftly through the development pipeline toward commercialization and broad availability — with the goal of making millions of tests per week available to Americans, particularly those most vulnerable to and/or disproportionately impacted by COVID-19.

“Testing for COVID-19 is a critical part of bringing the pandemic under control and safely reopening the economy in the U.S. and worldwide. DetectaChem decided early on to develop a COVID-19 test, knowing the unprecedented demand for it, and our expertise in serving first responders, military, and law enforcement customers around the world who count on precision, accuracy, reliability, and accessibility of our tests in large quantities” Kisner said. “The RADx initiative is providing the assistance and funding resources to bring our BCP19 test pouch to the masses in an unprecedented way.”

Kisner told MD+DI that the company also has the ability to further develop its diagnostics technology for the detection of other viruses down the road.

Leveraging manufacturing robotics for quick scale-up

Because DetectaChem's traditional government customers tend to place orders of varying size and often require a short turnaround on orders, the company already has adopted automation in manufacturing in order to be able to scale up quickly and also scale back as needed. Kisner said the company has several robots that it uses in its manufacturing process and those will also be used for COVID-19 testing production. RADx also helps selected companies scale up in manufacturing, not so much in terms of capability but in terms of financial support, he said.

Coupling the company's automated manufacturing process with the help it receives from RADx should enable DetectaChem to produce a large volume of COVID-19 tests.

Siemens Healthineers to Develop Assays for Novartis’s Therapeutics

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Siemens Healthineers is in a collaboration agreement that will see it develop assays across Novartis’s therapeutic pipeline. The initial focus will be centered around the development of serum neurofilament light chain (NfL) immunoassay for patients with Multiple sclerosis and other neurological diseases.

NfL is a highly specific biomarker for nerve cell injury measured in cerebral spinal fluid and blood. Blood NfL levels have been reported to change in a variety of serious neurological conditions, including MS, and have been related to disease activity and disability outcomes.

This collaboration will use Erlangen, Germany-based Siemens Healthineers’ expertise in the development of solutions that can run on its ADVIA Centaur and Atellica immunoassay platforms designed for use in hospitals, reference laboratories, and specialty laboratories.

“We are looking forward to our collaboration with Novartis as it promises to yield innovative diagnostic solutions to address critical unmet clinical needs,” Deepak Nath, PhD President, Laboratory Diagnostics, Siemens Healthineers, said in a release. “Our initial focus on blood-based diagnostic solutions for MS patients is another example of Siemens Healthineers commitment to shape the future of precision medicine.”

Siemens Healthineers has been keeping itself busy during the pandemic. In addition to developing a new diagnostic for the virus that causes COVID-19 and winning emergency use authorization for a gaming changing antibody test, the company announced one of the largest deals of the year.

In early August, the company said it would acquire Varian Medical Systems for $16.4 billion in a deal set to close in the first half of 2021. The deal would give Siemens Healthineers a broader reach into cancer care.

FDA Will Allow At-Home Administration of Capsule Endoscope During COVID-19

Product image courtesy of CapsoVision capsule endoscope

One concern that hasn't been clearly addressed during the ongoing COVID-19 pandemic is how to ensure that patients continue to receive preventative care and early-detection screening without increasing their risk of contracting SARS-CoV-2, the coronavirus that causes COVID-19. Recent news from CapsoVision suggests that FDA is beginning to address those concerns.

Saratoga, CA-based CapsoVision reported this week that FDA will apply enforcement discretion allowing at-home administration of the CapsoCam Plus small bowel capsule endoscope during the COVID-19 pandemic for patients who are determined eligible for at-home administration.

The labeling addendum permits a fully remote capsule endoscopy procedure for eligible patients, eliminating the need for in-person interaction between clinic staff and the patient.

"CapsoVision's advanced capsule technology delivers high-quality diagnostic images without creating a risk of in-person exposure to COVID-19," said Johnny Wang, president and chief technology officer at CapsoVision. "Our team is proud to contribute during the pandemic and to continue to innovate within the emerging telehealth paradigm." 

Along with its 360° panoramic view, CapsoCam Plus is a self-contained capsule endoscopy system that does not require external equipment for patients to wear and return to the clinic in 8-12 hours and disinfected between each use, the company noted. Patients simply ingest the capsule and return to their normal activities while the exam data is being captured. The images can then be reviewed by the physician via the CapsoCloud cloud-based software.

"The COVID-19 pandemic has challenged all physicians to rethink the way we deliver care now, and going forward," said Javier Parra, MD, a Miami, FL-based gastroenterologist with Gastro Health. "We need to do everything possible to continue to deliver healthcare in a timely and safe manner, while making an effort to reduce in-person contact and potential Coronavirus exposure. The CapsoCam Plus system will now allow us to offer this procedure to the appropriate patients efficiently and effectively, without the patient needing to visit the clinic. This is an added value to our practice and enables us to reduce exposure risks to our patients and staff while continuing the normal volume of office visits."

The CapsoCam Plus video capsule system is intended for the visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel. CapsoCam Plus is also distributed by Pentax Medical in the United States and Canada.

Product image courtesy of CapsoVisioncapsule endoscope

EU Investigation into Google’s Fitbit Deal Extended to the End of the Year

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An investigation by EU antitrust regulators concerning Google’s pending acquisition of Fitbit has been extended to Dec. 23, according to a report from Reuters.

Regulators began a probe into the deal in August. The main concern from regulators seems to be the amount of data Google would have access to if the deal were to come to pass.

Google pledged it would acquire Fitbit for $2.1 billion last November. Such a move would boost Google’s position in wearables significantly and give it the ability to more effectively compete with Apple.

Fitbit hasn’t let the acquisition’s delay slow it down. The San Francisco, CA-based company has become further entrenched into medtech, going so far as to obtain emergency use authorization for the Fitbit Flow, a low-cost ventilator. The device was inspired by the MIT E-Vent Design Toolbox and based on specifications for Rapidly Manufactured Ventilation Systems.

Recently, Fitbit added firepower to its wearable offerings by securing a nod from FDA for a new electrocardiogram app. Apple secured a nod for an ECG app back for its smartwatch in September of 2018.

Google has also been busy since the deal. In an announcement that most likely ‘broke the Internet’ Google and Apple announced working together to develop and launch a software tool kit that would notify someone if they may have come in contact with a person that was diagnosed with COVID-19.