Abiomed’s cardiopulmonary bypass system was cleared by the U.S. Food and Drug Administration (FDA) today (10/27) proceeding their April acquisition of Breethe. The effects of COVID-19 have created an increased need for heart recovery in cardiogenic shock patients....
According to an analysis published in JAMA Internal Medicine, almost half of the Medical Device Reports (MDRs) were directly from the Medical Device Safety Communications (MDSC) sent by the U.S. Food and Drug Administration (FDA). From this report, it was more clear...
The FDA is implementing a body of accredited testing facilities to streamline the medical device testing process internationally. The agency has released final guidelines for the program today (9/25) outlining the steps medical device companies must take in order to...
The medical device industry is one of the most complex and rapidly evolving sectors of the health sciences field. Dynamic innovation in medical devices has helped better healthcare both in terms of people’s quality of life and their longevity; however, while the value...
With thoughts of the latest pandemic on so many of our minds, it can be useful to look to history for context and reassurance as we try to understand our current predicament. Often, it is easy to become lost in a vague picture of the developing world as the sole...
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