HeartWare International Inc. files a pre-market approval application with the Food & Drug Administration for a ventricular assist device designed as a bridge-to-transplant system.
HeartWare International Inc. (NSDQ:HTWR) filed a pre-market approval application with the Food & Drug Administration for its cardiac assist device.
The Framingham, Mass.-based company’s ventricular assist system is designed to provide a temporary “bridge” for heart transplant patients with “end-stage heart failure,” according to the company.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Patients implanted with the device in HeartWare’s Advance clinical trial had a 94 percent survival rate, according to the company.
The company closed a $143.8 million debt offering and investor Apple Tree Partners completed the sell-off of 1 million shares for more than $81 per share in December.
A PMA is a regulatory pathway to market medical devices that have no incumbent products with which the FDA can compare the safety.
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At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
