The FDA said today that it plans to make public information on four patient deaths linked to Boston Scientific’s (NYSE:BSX) Watchman heart implant once it receives it from the company. The agency said it has asked the sponsor of a Watchman postmarket study for details on the deaths so it can include that information in […]
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 […]
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 […]
Abbott plans $38m Mitraclip plant in Indiana
Abbott (NYSE:ABT) announced yesterday that it plans to spend close to $38 million to open a manufacturing plant for its Mitraclip system in Westfield, Ind. The proposed 120,000-square-foot facility in Westfield’s NorthPoint Industrial Park could cost more than $37.6 million and is slated to employ as many as 477 people by the end of 2024, according […]
Abiomed touts real-world data on right-side heart failure with Impella RP
Abiomed (NSDQ:ABMD) said today that real-world data on its Impella RP heart pump showed a survival rate that matched that of its pre-approval study when following the FDA’s approved protocol for the device. The Impella RP is designed to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or […]
The top 10 medical disruptors of 2020
For the past 17 years, the Cleveland Clinic has predicted what the top 10 medical disruptors will be for the following year. The list of technologies, cultivated by a panel of physicians and scientists at the clinic, was led by Dr. Michael Roizen, emeritus chief wellness officer. “Healthcare is ever-changing and we anticipate that these […]
9 early medical devices that will horrify or amaze you
The movie Frankenstein inspired eight-year-old Earl Bakken to consider how electricity could restore life and health to the human body. Bakken went on to invent the first external cardiac pacemaker and to co-found medtech giant Medtronic in 1949. Bakken’s fascination with the effects of electricity on the human body continued throughout his career, and he amassed a collection of […]
Valfix Medical pulls in $1m for dual heart valve repair-replacement device
Valfix Medical this week filed an SEC Form D reporting that it sold more than $1 million in an equity offering. The Tel Aviv, Israel-based biotech company’s new notice completed its first sale on August 22 and does not intend for the equity offering to extend beyond one year, according to the filing. The total […]
Edwards Lifesciences to put $100m into Costa Rica expansion
Edwards Lifesciences (NYSE:EW) is slated to add a $100 million expansion and 500 new jobs by the end of 2020 in an effort to expand its operations in Costa Rica, according to the Costa Rican Investment Promotion Agency. The Irvine, Calif.-based company established cardiac device manufacturing facilities in Cartago in 2016, announcing a plan to add […]
FDA grants breakthrough nod for Corvia’s interatrial shunt
Corvia Medical said today that it won FDA breakthrough device designation for its interatrial shunt device for heart failure. The Tewksbury, Mass.-based company’s interatrial shunt is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria. It’s the world’s first transcatheter device indicated […]
Study: Abbott, Edwards may have mislabeled hundreds of patient deaths
This report has been updated with comments from Edwards Lifesciences, Madris Tomes and the FDA. Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA […]
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