Globus Medical, a manufacturer of surgical robots, received an FDA Warning Letter after the company’s inadequate response failed to address findings regarding screws misplaced during surgeries, lack of correction and preventive action (CAPA) plans and failure to file medical device reports (MDR). Read More

The FDA outlines what goes into a De Novo device request filed using the electronic Submission Template and Resource (eSTAR), in a final guidance released Thursday. Read More

ICU Medical is updating the use instructions for the Plum 360, Plum A+ and Plum A+3 Infusion Systems due to a manufacturing defect of the batteries, which can substantially diminish the life of the batteries and could put patients at risk. Read More

The FDA outlined its proposed policy on predetermined change control plans (PCCPs) for medical devices in a new draft guidance. Read More

The FDA’s efforts to actively oversee the safety of medical devices after they’ve hit the market have begun to bear fruit, with the agency making strides toward setting up a postmarket surveillance system and planning to kick it into gear by the end of 2024, a Government Accountability Office (GAO) analysis finds, but two core challenges remain. Read More

Breas Medical has initiated a nationwide correction for 8,186 of its Vivo 45 LS ventilator devices after internal testing identified the potential for short term elevated levels of formaldehyde exposure to users under specific conditions. Read More

A recent FDA Warning Letter illustrates to sponsors the importance of properly managing monitoring responsibilities and having a thorough site activation process. In this article, we’ll examine the letter received by the sponsor of a multisite trial of a device for preventing recurrent ischemic stroke and discuss how problems could have been avoided in the first place. Read More

Abiomed has recalled certain Impella CP with SmartAssist heart pumps after nine devices in a single lot failed a company inspection — but were inadvertently released to customers — the FDA announced. Read More

This edition of Quick Notes features clearances for a mini robotic system, peripheral arterial disease and peripheral vascular disease testing devices, testing assays for the evaluation of monoclonal gammopathy and breakthrough device designation for a posterior cervical system for treatment of the cervical and upper thoracic spine. Read More

CMS has issued a final procedural notice outlining a Medicare coverage pathway — Transitional Coverage for Emerging Technologies (TCET) — for certain FDA Breakthrough Devices to be covered under Medicare. Read More

Serious issues with Medtronic’s nerve monitoring system and Smiths Medical’s ambulatory infusion pumps have prompted software corrections from the two devicemakers, with the FDA assigning the recalls the greatest level of concern. Read More

Sponsors of adaptive AI-enabled medical devices seeking FDA approval should consider submitting a predetermined change control plan (PCCP), according to regulatory attorney Eric Henry of King & Spalding. Read More