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 […]
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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 […]
Abiomed stock falls on Q4 results
Abiomed (NSDQ:ABMD) stock is recovering slightly today — a day after its stock fell on fourth-quarter results. ABMD shares were up 0.4% at $324.18 per share in mid-morning trading today, rebounding from a -8% slide to $322.94 per share upon the release of the earnings report yesterday. MassDevice’s MedTech 100 Index — which includes stocks […]
Merit Medical rises on Street-beating Q1
Merit Medical (NSDQ:MMSI) shares ticked up today on first-quarter results that beat the consensus forecast. The South Jordan, Utah–based company posted profits of $11 million, or 19¢ per share, on sales of $248.9 million for the three months ended March 31, 2021, pulling its bottom-line from out of the red year-over-year on sales growth of […]
Olympus launches five single-use bronchoscopes
Olympus today said it has launched its product line of five H-SteriScope single-use bronchoscopes. The single-use endoscopes are for diagnostic and therapeutic procedures. They resulted from a collaboration between Olympus subsidiary Veran Medical Technologies and Hunan Vathin Medical Instrument Co. Get the full story on our sister site, Medical Tubing + Extrusion.