Edwards Lifesciences (NYSE:EW) issued a product recall for its guide sheath used with the Edwards Pascal transcatheter valve repair system. The company is recalling all lots of the product after it identified potential for damage to the Pascal guide sheath’s inner line due to a manufacturing issue. Edwards found that the issue has occurred in 0.5% […]
Study: Apple Watch can identify heart rhythm irregularities
Results from a new study observed that wearable technology such as an Apple Watch can safely identify heart rate irregularities that were eventually confirmed to be atrial fibrillation. The study, conducted by the Stanford University School of Medicine and Apple (NSDQ:AAPL) was published in the New England Journal of Medicine today. The Apple Heart Study has […]
iRhythm Technologies won’t file 10-Q, citing material weaknesses
iRhythm Technologies (NSDQ:IRTC) this week said it would not be filing its quarterly report on Form 10-Q, citing previously disclosed material weaknesses, according to an SEC filing. The San Francisco-based company said it identified errors that affected prior periods while preparing the quarterly report for the period ended Sept. 30, 2019. The errors could affect the […]
FDA aims to publicly report information on Watchman-related deaths
This article has been updated with comments from the American College of Cardiology. The FDA said Thursday that it plans to make public information on four patient deaths linked to Boston Scientific’s (NYSE:BSX) Watchman heart implant once it receives that information from the company. The agency said it has asked the sponsor of a Watchman […]
Shockwave Medical prices $75 million offering
Shockwave Medical (NSDQ:SWAV) filed a common stock equity offering with the SEC priced at $75 million. The Santa Clara, Calif.–based company said in yesterday’s filing that at the assumed public offering price of $36.14 that was reported on Nov. 11, it expects to offer nearly 2.1 million shares of common stock. Shockwave said it anticipates approximately […]
Report: FDA still hiding reports of patient deaths
This article has been updated with a response from Boston Scientific. The FDA is apparently allowing medtech companies to submit incomplete reports of device-related deaths, according to a new report by the StarTribune of Minneapolis. The news article says that the agency accepted one summary report covering four deaths related to Boston Scientific’s (NYSE:BSX) Watchman […]
InCarda Therapeutics raises $35 million
InCarda Therapeutics — which is developing an inhaled paroxysmal atrial fibrillation drug — filed an SEC Form D confirming the sale of more than $35 million in equity. The Newark, Calif.–based drug-device combo company sold nearly $35.3 million since the first sale of the offering occurred on Oct. 20, 2017, according to yesterday’s filing. InCarda […]
Edwards’ Sapien 3 TAVI wins expanded approval in Europe
Edwards Lifesciences (NYSE:EW) said today that it received CE Mark approval for expanded use of its Sapien 3 transcatheter aortic valve implantation (TAVI) system. The expanded use if for treatment of patients with aortic stenosis who are at low risk for open-heart surgery. The Sapien 3 TAVI is the first transcatheter heart valve system to win […]
Okami Medical wins FDA clearance for vascular occlusion system
Okami Medical yesterday said it won FDA 510(k) clearance for its LOBO Vascular Occlusion System. The Low-Profile Braided Occluder (LOBO) system helps patients and physicians with the occlusion of peripheral blood vessels. The system uses HDBraid technology to give physicians a minimally invasive platform for rapid and focal occlusion of a wide range of arterial […]
Abbott recall of CentriMag circulatory support system designated as Class I
Updated Nov. 6 after FDA edited its notice to update on injury and fatality numbers. The U.S. FDA today issued a Class I designation — its most serious — over Abbott’s recall of its CentriMag circulatory support system. By the time Abbott (NYSE:ABT) initiated a recall in August 2019, there were already reports 44 injuries related […]
Boston Sci fires back at judge who imposed sanctions
Boston Scientific (NYSE:BSX) has angrily responded to a judge’s recent sanctions in a whistleblower lawsuit lodged over two of its cardiac rhythm management devices. In an Oct. 16 ruling, Judge Steven Rau lambasted the company for using “shenanigans” in slow-rolling the discovery process. The lawsuit accuses Boston Scientific of defrauding the FDA by not reporting […]
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