The U.S. Department of Justice today announced a $4.4 million settlement with spine surgeon Wilson Asfora in a whistleblower case. According to a news release from the Joseph Greenwald & Laake law firm, which represented the whistleblowers, Asfora settled for the $4.4 million sum and a six-year exclusion from all federal payer programs, effectively precluding […]
Featured
Siemens Healthineers ticks up on Q2 earnings, raised guidance
Siemens Healthineers (ETR:SHL) shares ticked up today on strong second-quarter results and raised guidance for 2021. The Erlangen, Germany-based company posted profits of $539 million (€447 million), or 50¢ per share, on sales of $4.8 billion for the three months ended March 31, 2021, for an 8% bottom-line gain on sales growth of 7.6%. Adjusted […]
FDA revokes Battelle mask decontamination EUA
The FDA has revoked its authorization for Battelle Memorial Institute to decontaminate used N95 respirators for healthcare workers. In a letter dated April 30, 2021, the agency said it revoked the EUA at Battelle’s request. The Columbus, Ohio-based research organization asked to withdraw the EUA for its Critical Care Decontamination System (CCDS) in an April 2 letter. […]
Medtronic wins CE mark approval for Evolut Pro+ TAVI system
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its next-generation Evolut Pro+ TAVI system. Fridley, Minn.-based Medtronic’s Evolut Pro+ transcatheter aortic valve implantation (TAVI) system is the newest version of the company’s self-expanding, supra-annular Evolut TAVI platform. It won U.S. FDA approval in 2019. The latest edition of the platform includes four […]
MedTech 100 roundup: Return to normal following recent spike
After back-to-back all-time best performances, the medtech industry had a slight regression over the course of the last week. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — had been continuously ticking up since the beginning of April, with its mark of 112.25 on April 16 representing an all-time […]
DTW Podcast: Can Proximie bring safer surgery to the wider world?
In this week’s podcast, senior executives from Getinge and Proximie – two very different sized companies – explain how the COVID-19 pandemic accelerated their business. In the opening keynote conversation, Eric Honroth, president, Getinge North America, explained how the company more than doubled its production of ventilators in 2020. He also discusses recent FDA clearances […]
Pfizer and BioNTech seek EMA nod for younger adolescents
After announcing that its vaccine was 100% efficacious in a Phase 3 trial involving adolescents aged 12 to 15, Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) are seeking authorization from the European Medicines Agency (EMA) to distribute the vaccine to that age group. BioNTech’s CEO, Uğur Şahin, estimated that the vaccine would be available to early adolescents in 27 European countries […]
Side effects relatively rare for Pfizer-BioNTech vaccine, study says
A recent study found that only 13.5% of recipients of the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) had systemic side effects after the first dose. That figure climbed to 22.0% after the second dose. Conversely, just over one-third (33.7%) of recipients of the first dose of vaccine from AstraZeneca (LON:AZN) had systemic side effects, according to the […]
5 IP tips for medical device entrepreneurs
Taking certain steps — including some that are easily overlooked — can better protect your intellectual property. Thinking of designing your own medical device or launching a company? In recent DeviceTalks Weekly podcasts, two partners from the intellectual property law firm Finnegan, Henderson, Farabow, Garrett & Dunner, LLP shared several tips medical device company executives […]
BD’s Alaris pump hit with another serious recall
A medical supply company is recalling BD (NYSE:BDX) Alaris infusion pumps — the third Class I recall for the pumps in recent months, according to the FDA. North Carolina-based Avante Health Solutions issued the Alaris pump recall March 24, 2021, because the bezel repair posts may crack or separate, leading to the inaccurate delivery of […]
CMS extends joint replacement pricing by 3 years
The Centers for Medicare and Medicaid Services (CMS) has extended bundled pricing for hip and knee replacements for three years. The final rule, published in the Federal Register, extends the “Comprehensive Care for Joint Replacement” cost-bundling program through Dec. 21, 2024. The cost-cutting program began in January 2016, when CMS required all hospitals in 67 geographic […]