Devices
Draeger has expanded a 10/2024 device correction (Class 1 recall) to include additional Atlan A350 and A350XL anesthesia workstations used in operating rooms and other procedural settings. The devices are used to deliver inhaled anesthesia and provide both automatic and manual ventilation for adult, pediatric, and neonatal patients. According
Devices
A 2/27-4/5/2025 FDA inspection at the Zoll Medical facility in Chelmsford, ME, found Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of an automated external defibrillator, ventilator, and electrodes and sensors. A just-released 4/30 Warning Letter says the specific
Devices
CDRH associate director for compliance and quality Keisha Thomas told the RAPS Quality Conference that medical device companies need to treat risk management as an ever-evolving responsibility. Her presentation covered FDA’s new compliance program under the new Quality Management System Regulation, according to a RAPS online post. “Our
Devices
FDA has issued an early alert regarding a potentially high-risk issue affecting certain patient circuits used with Baxter's Volara System, a positive pressure therapy device used to mobilize lung secretions and deliver aerosolized medications. According to the agency, Baxter has initiated an urgent medical device correction involving
Drugs
Three Akin Gump attorneys say that while a 2026 FDA draft guidance on how drug companies may communicate healthcare economic information with payors, formulary committees, and similar entities doesn’t break significant new ground, there are some differences between it and the 2018 final guidance it will replace when it
Devices
FDA has issued an early alert warning healthcare providers about a potentially high-risk defect affecting certain infant resuscitation systems manufactured by GE HealthCare, citing concerns that the devices may deliver incorrect oxygen concentrations to newborn patients. The alert follows a company notice advising users to inspect and, if necessary,
Devices
FDA says its breakthrough devices program has surpassed 1,280 designations since its launch, highlighting the growing use of the expedited pathway by medical device developers seeking to bring innovative technologies to patients with serious or life-threatening diseases. According to updated figures released by FDA, the agency had granted
Devices
FDA has issued a guidance document outlining its intent to exempt several low-risk, unclassified medical devices from premarket notification requirements, a move aimed at reducing regulatory burdens on manufacturers while maintaining existing safety and quality controls. Under the guidance, FDA said it does not intend to enforce compliance with
Devices
FDA has issued an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with the company’s Impella heart pump system, citing concerns about blood clot formation that could lead to serious vascular complications. The agency said it is aware that Abiomed has advised
Drugs
FDA has published a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities: Questions and Answers, with answers to common questions about firms’ communication of health care economic information (HCEI) about their prescription drugs and medical devices to payors, formulary committees, or other similar entities
Devices
DexCom says it has identified two lots of stolen Dexcom G7 continuous glucose monitoring sensors that were diverted into the commercial market after being designated for destruction, prompting the company to notify users and coordinate with FDA and law enforcement authorities. The company disclosed that the affected sensors were originally
Devices
FDA has published a final guidance, Content of Human Factors Information in Medical Device Marketing Submissions, to provide a risk-based framework to guide manufacturers on the human factors information that should be included in marketing submissions to CDRH, including 510(k)s, de novo requests, PMAs, and HDEs. The
Devices
FDA this week marked the 50th anniversary of the 1976 Medical Device Amendments by highlighting the law’s lasting role in shaping the modern oversight of medical devices. In a new FDA Voices commentary, CDRH director Michelle Tarver said the amendments created the regulatory framework that continues to govern how
Devices
FDA has issued an update on a Philips Respironics device correction involving its Trilogy Evo platform ventilators, citing risks that could cause serious injury or death if the devices are not updated. The action affects several ventilator models in the Trilogy Evo platform, including the Trilogy Evo, Trilogy EV300, Trilogy
Devices
Researchers from several universities say that low use of predetermined change control plans (PCCPs) for AI-enabled medical devices could be a missed opportunity for improving device performance. The researchers report on a cross-sectional study describing PCCP use among AI-enabled medical devices and the comprehensiveness of public reporting
Devices
FDA and federal prosecutors are signaling a tougher stance on failures to report patient safety issues to regulators, according to a new legal analysis from Cooley LLP examining the recent criminal enforcement action against medical device maker ExThera Medical Corporation and one of its former executives (see earlier story). Former
Devices
Senator Tom Cotton (R-AR) is pressing FDA and government cybersecurity officials to review Chinese-made medical devices cleared before updated cybersecurity requirements took effect, citing concerns that vulnerable devices could expose Americans to espionage, fraud and potentially dangerous remote manipulation. In a 5/26 letter to acting FDA commissioner
FDA Policy/General
The long-term impact of the Supreme Court’s Loper Bright decision in the health landscape remains unclear, according to an article in the Yale Journal on Regulation. Immediately after the decision was announced, many commentators warned of a coming “seismic” impact. Written by staff and a student at the
Devices
FDA has issued an early alert about a potentially high-risk software problem involving certain heart pump controllers manufactured by Abiomed that could temporarily stop circulatory support during treatment. The agency says Abiomed has initiated an urgent medical device correction affecting all Automated Impella Controllers used with left ventricular Impella
Devices
React Health is recalling (Class 1) certain VOCSN V+Pro ventilators due to a manufacturing issue that could lead to undetected oxygen leaks and potentially cause serious injury or death, according to an FDA notice. The recall affects VOCSN V+Pro Package devices with catalog number PRT-01198-000 and
Devices
FDA says the Bolton Medical 8/23 recall (correction) notice, with updated use instructions for all RelayPro Thoracic Stent Graft Systems, is a Class 1 recall, the most serious type of medical device recall. An agency notice says the company also recommended that customers use alternative stent-graft options before
Devices
Implantica says it has submitted the final response to FDA on its PMA for RefluxStop that addresses the agency’s remaining questions tied to Module 3 of the submission and includes additional testing that followed a previously disclosed 100-Day Meeting. Implantica said the FDA has now completed reviews of