Devices
Former FDAer Daniel McMullen, who most recently was director of the CDRH Office of Neurological and Physical Medicine Devices, the agency unit responsible for the total lifecycle review of medical devices such as Neuralink’s brain implant, has joined Neuralink to lead its medical affairs division. The appointment was reported
Devices
A 6/24-7/2 FDA inspection at Envoy Medical in Saint Paul, MN, found Quality System regulation violations in the firm’s manufacturing of the Esteem II implantable hearing system. A just-released 11/11 Warning Letter says the specific violations were: * failure to adequately establish and maintain procedures
Devices
Draeger has recalled (Class 1) its ErgoStar CM 60 (catheter mount 60), an airway connector/catheter mount, after receiving multiple complaints reporting that cracks were forming in the hose of specific catheter mounts. The device is used in respiratory care to link a patient's breathing tube (e.g.
Devices
An FDA advisory committee has voted unanimously against recommending approval of Johnson & Johnson’s V-Wave heart shunt for patients with advanced heart failure who have not responded to medication, citing insufficient evidence that the implant works. The FDA’s circulatory system devices advisory panel voted 15-0 that
Devices
FDA has published a guidance, eCopy Program for Medical Device Submissions, describing how the agency is implementing the eCopy program under the FDA Reauthorization Act of 2017. The document says the eSTAR program is the current program for submissions solely in electronic format. But until eSTAR is implemented for each
Devices
FDA and the Center for Medicare and Medicaid Services’ Center for Medicare and Medicaid Innovation (CMMI) are launching the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices pilot. An FDA Digital Health Center of Excellence announcement says FDA will work with CMMI’s Advancing Chronic Care with Effective
Drugs
The Sedgwick Recall Index for the third quarter of 2025 shows that while the total 97 drug recalls was the same as in the second quarter, the number of recalled units increased 137% to 44.56 million. The report says the average recall size more than doubled between the second
Devices
FDA has issued a device correction alert after Olympus recalled (Class 1) the instructions for its Single Use Ligating Device PolyLoop, warning that improper use could lead to serious injury or death. The alert directs clinicians to follow newly reinforced instructions and supplemental safety guidance. Olympus notified customers of the
Devices
The American Hospital Association (AHA) says it generally supports artificial intelligence (AI) policy frameworks that balance flexibility to drive market-based innovations with appropriate safeguards to protect privacy and patient safety. The association stated its position in response to an FDA request for comment on the measurement and evaluation of
Devices
Glycar has recalled (Class 1) certain batches of the SJM Pericardial Patch because affected units may fail to meet required tensile-strength specifications, potentially leading to serious injury or death. The recall covers one lot of the cardiovascular surgical patch, used for pericardial closure and for the reconstruction or repair
Devices
Baxter has recalled (Class 1) its Life2000 Ventilation System after the company discovered a cybersecurity vulnerability that could allow unauthorized individuals to alter device settings. According to an FDA notice, internal testing revealed that if someone gains physical access to an unattended Life2000 device, they could potentially change therapy settings
Devices
A Massachusetts federal judge has sentenced three former Magellan Diagnostics executives for concealing a device malfunction that produced inaccurately low lead test results for thousands of children and other patients. A Department of Justice statement says the three pleaded guilty either to felony counts of introducing misbranded medical devices into
FDA Policy/General
FDA has issued a draft guidance, Cross-Center Master Files: Where to Submit, with recommendations for master file holders about to which Center a master file is to be submitted (1) that is referenced in and intended to support more than one regulatory submission for which the lead Center for
FDA Policy/General
National Center for Health Research president Diana Zuckerman says FDA commissioner Marty Makary’s plan to rely on “spontaneous [and] robust” expert panels rather than advisory committees misses the point on the value of advisory committees and undermines the credibility of agency decisions. Writing in a Medpage Today opinion column,
Devices
FDA has issued an early alert warning about a potentially high-risk defect in certain Fresenius Kabi Ivenix large volume pump (LVP) primary administration sets that could cause dangerous reverse fluid flow and delay critical medication delivery. The issue involves a misassembly in one lot of administration sets in which
Devices
Intersurgical has recalled (Class 1) its i-View Video Laryngoscope, citing serious safety risks that could potentially lead to severe injury or death. The recall affects devices with model number 8008000 and serial numbers 1240555 and 1240793. The recall was prompted by reports that the devices may fail to turn
Devices
FDA has issued a correction notice for NOxBOX Ltd.’s NOxBOXi Nitric Oxide Delivery System after reports of dosing fluctuations when the device is used with the Bunnell LifePulse High Frequency Jet Ventilator and possibly other conventional ventilators. The agency warned that the problem can interrupt nitric oxide therapy and
Devices
FDA says the 8/22 Medline recall of three models of sterile medicine convenience kits is Class 1. An agency notice says the company contacted five customers on 8/8, telling them to hold any kits in their possession. A formal recall notice followed on 8/22, the agency says.
Devices
Siemens Healthineers has issued an urgent safety correction (Class 1 recall) for dozens of its 3 Tesla MRI models after identifying a potentially catastrophic failure involving the systems’ magnet venting pathways. The alert covers many of the company’s high-field MRI systems, including MAGNETOM Verio, Skyra, Prisma, Vida, Lumina,
Devices
Aesculap Implant Systems has agreed to pay $38.5 million to resolve federal allegations under the False Claims Act that it knowingly sold defective knee replacement implants and provided unlawful kickbacks to a surgeon. The Pennsylvania-based medical device company also entered into a non-prosecution agreement for distributing two
Devices
FDA has denied a citizen petition requesting that it warn patients about whether surgical mesh implanted off-label during cosmetic mastopexy procedures may interfere with breast cancer detection using mammography or ultrasound. In an 11/14 denial letter, FDA said it has found no evidence of a safety signal linking
Drugs
NYU Grossman School of Medicine ethicist Arthur Caplan says he is concerned that reductions in force at FDA and HHS can adversely affect clinical trial oversight and participant protections. In a Medscape video, Caplan says, “I am extremely worried about what’s been taking place at FDA and at HHS