Adam Stone writes on technology trends from Annapolis, Md., with a focus on government IT, military and first-responder technologies. Internet-connected medical devices represent a fast-growing ...

U.S. health officials said Monday they plan to overhaul the nation's decades-old system for approving most medical devices, which has long been criticized by experts for failing to catch problems with ...

There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...

Late last month, India’s drug regulator came out with a draft guidance document to regulate “medical device software” — this move, the medical device industry agrees, could not have come sooner. The ...

A popular medical monitor is the latest device produced in China to receive scrutiny for its potential cyber risks. However, it is not the only health device we should be concerned about. Experts say ...

FDA is making an example out of Abiomed, which Johnson & Johnson bought last year for $16.6 billion. In a warning letter that comes about a year after the agency issued guidance on its regulation of ...

Real-time operating systems (RTOSes) allow medical device manufacturers to improve the performance of their medical devices and ensure they meet regulatory requirements. But choosing whether to use an ...

Anna Baluch is a freelance writer from Cleveland, Ohio. She enjoys writing about a variety of health and personal finance topics. When she's away from her laptop, she can be found working out, trying ...

Profound Medical shares rose after the company said it has regained distribution rights for its medical device system used to destroy prostate cancer tissue previous licensed out. Shares traded 9.1% ...

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