Edwards Lifesciences (NYSE:EW) announced today that it received regulatory approval in China for its Sapien 3 transcatheter heart valve. Sapien 3 TAVR (transcatheter aortic valve replacement) is used in the treatment of patients suffering from severe, symptomatic aortic stenosis (AS) who are at high risk for or unable to undergo open-heart surgery. According to a news […]
The George Floyd case has rocked a major U.S. medtech hub: Here’s what industry leaders think
Major medtech companies with a presence in the Minnesota and elsewhere have been calling for peace, unity and racial justice following the death of George Floyd in police custody and the resulting demonstrations and violence. Executives from Boston Scientific, Medtronic and the Medical Alley Association have penned open letters expressing their concerns and pledging to […]
The secret to building a successful medtech career
In this week’s DeviceTalks Weekly podcast, Edwards Lifesciences executive Dr. Todd Brinton shares the one trait he looks for in job candidates that can trump talent and ability. Brinton, who is VP of advanced technology and chief scientific officer at Edwards Lifesciences (NYSE:EW), also offered tips on when candidates need to shift from conforming to differentiating. […]
Edwards lands CE Mark for Pascal transcatheter valve repair system to treat TR
Edwards Lifesciences (NYSE:EW) announced today that it received CE Mark approval for its Pascal transcatheter valve repair system for treating tricuspid regurgitation (TR). Pascal won its indication in Europe for the percutaneous reconstruction of the tricuspid valve through leaflet repair by tissue approximation. The device uses clasps and paddles to grasp the leaflets and facilitate coaptation, […]
What medtech’s top CEOs are saying about COVID-19
The COVID-19 pandemic is drying up sales for many large medical device companies, but there’s hope for a recovery later this year. That’s the big message from medtech’s top CEOs as they issue financial predictions and engage in earnings calls with analysts. Governments around the world are calling on medical device companies to make the […]
These medical devices are getting ready to launch in 2020
Despite the COVID-19 pandemic, medical device companies are still working to gain regulatory approvals and launch new devices this year. The pandemic has largely fixed the FDA’s focus on emergency use authorizations (EUAs), leaving more typical device approvals waiting. At press time, the regulatory agency had granted 84 EUAs beginning Feb. 4 and had approved […]
DeviceTalks Weekly: Ep.7 – Edwards, employment news, update on clinical trials from Avania
In this week’s episode of DeviceTalks Weekly, Tom Salemi and Chris Newmarker stare at each other through the Zoom lens while talking about the positive employment news from Baxter International and Conformis, the hopeful news from Edwards Lifesciences, and the cautionary tone from Medtronic. What can we expect from the rest of medtech? In the […]
Edwards Lifesciences beats The Street on Q1 results, expects a tough Q2
Edwards Lifesciences (NYSE:EW) posted first-quarter results this evening that beat The Street but cut its outlook for the rest of the year as health providers and patients grapple with the COVID-19 pandemic. The Irvine, Calif.–based structural heart disease and critical care monitoring company reported profits of $310.6 million, or $1.47 per share, on sales of $1.1 […]
How will coronavirus affect medtech companies that rely on elective surgeries?
One thing is likely to hurt some medtech companies more than others during the coronavirus pandemic: an elective surgical procedure slowdown. This thought had begun to emerge last week among industry watchers, but a pair of tweets over the weekend gained thousands of “likes” and retweets. The American College of Surgeons called for hospitals to […]
U.K. court bars Edwards TMVR sales, gives Abbott win in patent spat
A judge in the England issued an injunction yesterday barring Edwards Lifesciences from selling its Pascal transcatheter mitral valve repair (TMVR) device in the U.K. A different judge had previously denied Abbott’s petition for such an injunction. Yesterday, Judge Colin Birss of the High Court of England and Wales also ruled that two patents held […]
Is Medtronic eyeing LivaNova for a takeover?
Some industry analysts are speculating that Medtronic (NYSE:MDT) might want to acquire LivaNova (NSDQ:LIVN) for its neuromodulation business. A source told financial intelligence company Reorg last week that someone pitched the idea to Medtronic, which would divest LivaNova’s cardiovascular business and “certain MDT cardiac surgery products.” “Five sector advisors said such a deal would make sense as […]
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