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The 18 most innovative medical devices of 2020

The Galien Foundation recently announced nominees for most innovative medical devices for its 14th Annual Prix Galien USA Awards.

The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical and technology products that are designed to improve the human condition.

“As we celebrate 50 years of the Prix Galien process, we are honored to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release. “The awards committee applauds the nominees for their commitment to ensure a healthier future for generations to come.”

Nominees need to be FDA-approved for the market within the last five years, and show major potential to affect healthcare. The winners will be announced in October th…

The top 5 medtech stories of the week — July 24, 2020

COVID-19 is surging back in the U.S., new jobless claims are up, but MassDevice’s most-read stories this week were mostly optimistic.

That’s the takeaway from our inaugural MassDevice Top Five — a weekly recap of the most-read stories on MassDevice, the online business journal of the medical device industry. Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss during our DeviceTalks Weekly podcast.

Without further ado, here’s this week’s MassDevice Top Five:

5. Better than expected results from Edwards Lifesciences

Officials at Edwards Lifesciences (NYSE:EW) had warned that it was going to be a tough Q2 amid the COVID-19 pandemic. Sure enough, it was. But the Irvine, Calif.–based artificial heart valves and hemodynamic monitoring company results still beat Wall Street expectations — with the company even upping its earnings guidance for the year. “Irrespective of the unpre…

People can now control their Abbott neuromod device over their iPhone

Abbott (NYSE:ABT) announced today that it received FDA approval for the use of its Patient Controller app on compatible Apple smartphone devices.

The company’s Patient Controller app offers management tools for patients with neurological conditions, such as chronic pain or movement disorders. Now, with the latest approval from the FDA, therapy can be managed directly from a personal smartphone.

According to a news release, the approval removes any need for people to carry a separate patient programmer device, streamlining the patient experience and integrating therapy management into everyday life.

Abbott Park, Ill.-based Abbott said the app will be integrated into its broader NeuroSphere Digital Care connected care management platform which became available in May. Other compatibilities for the system include neuromodulation technologies like Abbott’s Infinity DBS system, Proclaim XR SCS system and Proclaim DRG neurostimulation system.

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AdvaMed unveils COVID-19 diagnostic supply registry

AdvaMed announced today that it created a comprehensive national COVID-19 diagnostic supply registry to aid state and federal pandemic responses.

According to a news release, AdvaMed is launching the registry in partnership with 13 commercial diagnostics manufacturers: Abbott (NYSE:ABT), Becton Dickinson (NYSE:BDX), bioMérieux, Bio-Rad Laboratories (NYSE:BIO), Beckman Coulter, Cepheid, Hologic (NSDQ:HOLX), Ortho Clinical Diagnostics, Qiagen (NYSE:QGEN), Roche Diagnostics, Sekisui Diagnostics, Siemens Healthineers (ETR: SHL), and Thermo Fisher Scientific (NYSE:TMO).

The AdvaMed registry is designed to compile information from the diagnostic companies, along with public data, to create a centralized and standardized COVID-19 diagnostic supply registry to update on weekly numbers at state and national levels regarding molecular, antigen and serology tests shipped in the U.S.

AdvaMed said in the release that the registry will also help streamline communicati…

MedTech 100 roundup: Industry hits pandemic peak

After five months since medtech stocks peaked before the COVID-19 pandemic rocked the markets, the industry inched back toward that pre-pandemic high.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 88.9 points at the end of last week (July 17). That total represents just a -3.7% dip from the Feb. 19 high point of 92.32, marking the smallest margin of decline over the past five months.

Medtech stocks saw a 5.1% increase from the 84.39-point total at the same time a week prior (July 10), highlighting a large improvement after last week saw almost no material change in the index.

Meanwhile, the S&P 500 Index saw a 1.2% bump from July 10 to July 17, and the Dow Jones Index fared even better, posting a 2.3% increase over the same period of time. Both indexes mirrored the medtech industry’s changes as far as increases, but didn’t see as drastic a change.

Medtech’s lowest point du…

COVID-19 diagnostics sales boost Abbott’s Q2 results

Abbott (NYSE:ABT) beat the consensus forecast on Wall Street today — with sales of molecular diagnostics including COVID-19 tests more than tripling.

The Abbott Park, Ill.-based healthcare giant reported profits of $537 million or 57¢ per share, on sales of $7.33 billion for the three months ended June 30, 2020, for a bottom-line plunge of –47% on sales that dropped -8.2.% compared with Q2 2019.

After suspending its year-end forecast in April due to uncertainty related to the pandemic, Abbott projected EPS of $3.25 for the full year 2020, which compares with analysts’ projection of $2.87 per share.

Medical device sales were down more than -21% worldwide to $2.423 billion for the quarter, with diabetes care sales the only category in the black, with a 27.2% increase. Notably, the company received FDA clearance in mid-June for its FreeStyle Libre 2 continuous glucose monitoring system for adults and children ages four and older with diabetes.

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BREAKING: Abbott, Edwards settle heart device patent spats

Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) said this afternoon that they have agreed to settle all outstanding patent disputes related to transcatheter mitral and tricuspid repair products, and Edwards has made an one-time payment of $368 million to Abbott, according to an SEC filing.

The agreement will result in the dismissal of all pending cases or appeals in courts and patent offices worldwide, and includes a provision that the parties will not litigate patent disputes with each other in the field of transcatheter mitral and tricuspid repair and replacement products for the next 10 years. Any injunctions currently in place will be lifted.

A judge in England issued an injunction in April barring Edwards from selling its Pascal transcatheter mitral valve repair (TMVR) device in the U.K. Judge Colin Birss of the High Court of England and Wales also ruled that two patents held by Abbott unit Evalve for its MitraClip TMVR device were valid and that Edwa…

What kinds of COVID-19 tests are out there?

(Image from Mayo Clinic)

Months into the pandemic, the FDA continues to grant emergency use approval (EUA) to new tests to detect the virus that causes COVID-19 and the antibodies that indicate a person has had it.

To date, the FDA has granted EUAs for 171 tests —142 molecular tests, 27 antibody tests, and 2 antigen tests. Given the ever-changing landscape of tests for COVID-19 and the rapid rise of coronavirus cases in the parts of the country, we thought an overview of these tests might be helpful.

Get the full story on our sister site, Medical Design & Outsourcing.

Abbott wins FDA approval for Bluetooth heart rhythm devices

Abbott (NYSE:ABT) announced today that it received FDA clearance for its next-generation Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices.

The next-generation devices offer a patient-preferred design with Bluetooth technology and a new patient smartphone app while sidestepping any compromise of battery longevity and MRI compatibility, according to a news release.

Gallant, which received CE Mark approval in February, pairs with Abbott’s myMerlinPulse mobile smartphone app designed to streamline communication between doctors and patients to enhance remote monitoring and enable physicians to identify asymptomatic episodes of cardiac arrhythmias or abnormal heart rhythms, leading to earlier intervention.

In a news release, Mills, N.J.-based Deborah Heart & Lung Center director of electrophysiology and pacing Dr. Raffaele Corbisiero said the capabilities offered by Gallant could…

MedTech 100 roundup: Stocks tick back up to open July

After a solid start to July, the medtech industry continues to experience a stock market roller coaster amid the COVID-19 pandemic.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 84.25 points at the end of last week (July 3). That total represents a 2.9% increase from the 81.88-point total at the same time a week prior (June 26), resulting in another significant direction change, following a -3.7% dip just one week before.

Meanwhile, the S&P 500 Index saw a 4% bump from June 26 to July 2 (market close before a holiday), and the Dow Jones Index fared similarly well, posting a 3.2% increase over the same period of time. Both indexes mirrored the medtech industry’s changes, having each posted decreases the week prior.

Medtech’s lowest point during the COVID-19 pandemic remains at 62.13 on March 23. Since then, the industry’s stocks have experienced 35.6% growth in total. Stocks in the indu…

Abbott, Tandem seal deal to combine CGM, insulin delivery tech

Abbott (NYSE:ABT) and Tandem Diabetes Care (NSDQ:TNDM) announced today that they have completed their agreement to combine the former’s glucose-sensing technology with the latter’s insulin delivery systems.

The deal, announced in October, will combine Abbott’s Freestyle Libre CGM with Tandem’s t:slim X2 pump to monitor glucose without fingersticks. The agreement covers the technical development of device integration and associated commercial support activities.

“We’re excited to integrate our insulin delivery systems with Abbott’s glucose-sensing technology, and we look forward to expanding options for our customers so that they can combine devices that best suit their personal needs,” said Tandem president & CEO John Sheridan in a news release. “We are proud to have an insulin pump capable of remote software updates that can make access to future integrations possible for in-warranty t:slim X2 users at the time of release without requiring a new pump.”

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Abbott, Tandem seal deal to combine CGM, insulin delivery tech

Abbott (NYSE:ABT) and Tandem Diabetes Care (NSDQ:TNDM) announced today that they have completed their agreement to combine the former’s glucose-sensing technology with the latter’s insulin delivery systems.

The deal, announced in October, will combine Abbott’s Freestyle Libre CGM with Tandem’s t:slim X2 pump to monitor glucose without fingersticks. The agreement covers the technical development of device integration and associated commercial support activities.

“We’re excited to integrate our insulin delivery systems with Abbott’s glucose-sensing technology, and we look forward to expanding options for our customers so that they can combine devices that best suit their personal needs,” said Tandem president & CEO John Sheridan in a news release. “We are proud to have an insulin pump capable of remote software updates that can make access to future integrations possible for in-warranty t:slim X2 users at the time of …