Tag: medical devices

Charlotte surgical institute launches as US hub for robotic, minimally invasive training

Editor's Note A new medical training institute in Charlotte, North Carolina, is positioning itself as a major national destination for robotic and minimally invasive surgery education, Axios Charlotte October 29 reports. The North American headquarters of IRCAD (Institut de Recherche contre les Cancers de l’Appareil Digestif, or Research Institute Against…

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By: Tarsilla Moura
November 3, 2025
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FDA recalls affect surgical staplers, OR procedure kits, ultrasound systems used in hospitals

Editor's Note The Food and Drug Administration (FDA) has announced three new recalls between October 14 and 16 that may affect OR inventory and perioperative workflows across multiple service lines. Each recall targets a commonly used product in surgical or imaging settings, prompting leaders to review supplies and coordinate with…

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By: Tarsilla Moura
October 20, 2025
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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…

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By: Tarsilla Moura
October 10, 2025
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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…

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By: Tarsilla Moura
October 10, 2025
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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…

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By: Susan Klacik
October 10, 2025
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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…

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By: Tarsilla Moura
October 9, 2025
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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…

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By: Tarsilla Moura
October 8, 2025
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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…

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By: Tarsilla Moura
October 2, 2025
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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…

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By: Tarsilla Moura
September 30, 2025
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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…

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By: Tarsilla Moura
September 26, 2025
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