FDA issues Class I alert for Abiomed Impella heart device over cybersecurity risks
Editor's Note The Food and Drug Administration (FDA) on October 10 classified a cybersecurity correction involving Abiomed’s Automated Impella Controller as a Class I recall, the most serious type, according to the FDA Medical Device Recalls and Early Alerts database. While devices are not being removed from clinical settings, the…
FDA accelerates medical device safety alerts to reach public within days
Editor's Note The Food and Drug Administration (FDA) has expanded its early alert recall program to include all medical devices, speeding up how quickly the public learns about high-risk safety issues, Modern Healthcare October 9 reports. The initiative allows the FDA to post early alerts within days of manufacturers notifying…
Considerations for external transportation of processed medical devices
The centralization of medical device processing to one facility is becoming more prevalent. Centralizing sterile processing activities reduces expenses while concentrating expertise. However, this also introduces new concerns. When sterile processing is located within the same building where instrumentation is used, transport occurs over smooth floors in a controlled environment…
AI is turning medical devices into learning systems, Google Cloud exec says
Editor's Note Artificial intelligence (AI) is driving medical technology from reactive tools to adaptive learning systems, Medical Device Network October 6 reports. Shweta Maniar, Google Cloud’s global director of healthcare and life sciences, said that advances in agentic AI are enabling medtech devices to anticipate patient needs, simplify operations, and…
FDA has begun requiring electronic De Novo submissions for new medical devices
Editor's Note Beginning October 1, the Food and Drug Administration (FDA) is mandating that all De Novo classification requests be submitted electronically using its eSTAR system, according to a final rule and guidance issued by the agency. As detailed in the September 30 release, the shift marks a procedural change…
US launches tariff investigations into medical supplies and devices, raising stakes for healthcare supply chain
Editor's Note The US Department of Commerce has initiated national security investigations that could trigger new tariffs on a wide range of imported medical products, with potentially far-reaching effects for healthcare providers, Reuters September 24 reports. The probes, opened under Section 232 of the Trade Expansion Act of 1962, cover…
FDA posts four device safety communications, prompting inventory, workflow checks
Editor's Note The Food and Drug Administration (FDA) has issued four medical device recalls and early alerts between September 23 and 30, covering Automated Impella Controllers, Olympus ViziShot 2 FLEX (19G) endoscopic aspiration needles, 3M Ranger blood and irrigation fluid warming systems, and BD Alaris infusion pump sets. The notices…
Surgery, implantable devices offer new hope for drug-resistant epilepsy
Editor's Note Surgery and advanced implantable devices can give patients with drug-resistant epilepsy a far greater chance of seizure freedom than medication alone, UCSF News September 25 reports. While about 30 anti-seizure medications exist, one-third of patients do not achieve seizure control, and fewer than one in five seek care…
Remote monitoring speeds recovery, lowers complications after cancer surgery
Editor's Note Remote perioperative monitoring (RPM) accelerates recovery and reduces complications following major cancer surgery, according to a randomized trial published on August 28 by npj Digital Medicine and co-authored by researchers at the University of Miami Miller School of Medicine. The study enrolled 293 patients undergoing major abdominal or…
Surgical leaders urged to weigh risks, rewards of innovation with a critical eye
Editor's Note Innovation is transforming surgical care faster than most institutions can keep pace, but leaders must distinguish between investments that advance patient care and those that add cost without meaningful benefit. That is the central message from a September 8 Harvard Medical School article featuring insights from Jon O.…
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