Devices
FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued
Devices
Devices
BMC Medical has recalled (Class 1) its Luna G3 APAP (Model LG3600), an auto-adjusting positive airway pressure machine for treating obstructive sleep apnea, due to a firmware defect. If affected devices operate simultaneously under high pressure, high respiratory rate, and high peak flow, an "Error" message on
Devices
FDA’s recent discussion paper (see earlier story) on regulating generative AI (GenAI) medical devices could increase regulatory scrutiny for user-facing GenAI-enabled devices, according to an analysis by law firm Crowell & Moring, which says the agency may need to rethink traditional approaches to evaluating medical software. FDA
Devices
FDA has granted Heartvue.ai a 510(k) clearance (K260811) for its Heartvue.Proton, a machine learning–powered software for viewing, post-processing, and quantitative evaluation of cardiovascular magnetic resonance images (MRI). Cardiac MRI is the gold standard for assessing cardiac structure and function, but manual analysis can take up
Devices
Boston Scientific has recalled (Class 1) all unused spinal cord stimulator Infinion CX Leads after determining that the lead body may experience mechanical stress at the anchor site, which may result in high impedance measurements or lead fractures. “Abnormal impedance measurement may lead to inadequate stimulation and/or additional intervention,
Devices
FDA has released two guidance documents on dental-related medical devices. The one guidance, Dental Curing Lights – Premarket Notification (510(k)) Submissions, provides recommendations for 510(k) submissions for dental curing lights that emit non-ionizing optical radiation intended to photopolymerize dental restorative resins. FDA is issuing this guidance to
Devices
FDA has added a new frequently asked questions section to its Web page on PFAS (per- and polyfluoroalkyl substances) in medical devices, saying it has found no evidence that certain PFAS materials widely used in medical equipment are harming patients. The agency said its review of scientific literature and post-
Devices
FDA has issued an Early Alert after becoming aware that Boston Scientific sent a letter to customers recommending all Imager II Angiographic Catheters be removed from where they are used or sold because of a manufacturing issue affecting the catheter tip. The devices are used to create images of specific
Devices
A MasterControl analysis of the first months of medical device inspections under the new FDA Quality Management System Regulation (QMSR) found that agency investigators are “uncovering interconnected problems that span a company’s entire quality system.” A MasterControl statement says the investigators are increasingly finding that complaint-handling deficiencies, corrective
Devices
FDA says the Boston Scientific 7/9 recall of its ENROUTE Transcarotid Neuroprotection System is Class 1. An agency notice says the company notified customers that the affected devices should be removed from where they are used or sold. The ENROUTE Transcarotid System reportedly is designed to transport emboli away
Devices
CDRH is issuing an early alert to notify the public about an Abiomed action recommending that all Automated Impella Controllers (AIC) be removed from where they are used or sold. The removal is due to “purge cassette recognition issues resulting from failures of the purge flag component within the purge
Devices
FDA has granted Abbott Diabetes Care a de novo authorization for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged two years and older living with diabetes. The agency says the device is the first wearable in the U.S. to continuously monitor both ketones
Drugs
The Sedgwick Recall Index covering the first half of 2026 shows that the number of medical device recalls fell from 487 to 462 (down 5.1%), while the number of units recalled increased 516.8% from 50.7 million units in the first half of 2025 to 313.07 million
Devices
FDA has cleared Roche/Eli Lilly’s Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test as a single blood-based option to aid in identifying amyloid pathology associated with Alzheimer's disease in individuals 55 years and older with signs, symptoms, or complaints of cognitive decline. The companies say
Devices
FDA has issued an early alert about a potentially high-risk problem involving certain CooperSurgical INCA neonatal and infant nasal continuous positive airway pressure (CPAP) sets that may develop a loose connection between the tubing and nasal cannula. Earlier this month, the company sent affected customers a letter recommending that
Devices
CDRH is issuing an Early Alert after becoming aware that GE HealthCare issued a letter alerting affected customers of updated use instructions for Portrait Mobile Monitoring Solutions devices operating on certain version of Portrait Core Services software. The alert recommends that users ensure “appropriate alternative monitoring is established for patients
Devices
Boston Scientific has recalled its ENROUTE Transcarotid Neuroprotection System Plus, a single-use percutaneous catheter kit used during transcarotid artery revascularization. The device is intended to provide direct carotid access and dynamic blood flow reversal to capture loose plaque debris, protecting the brain from strokes during carotid stenting. An FDA
Devices
Medline has issued a device correction (Class 1 recall) for convenience kits containing B. Braun’s bupivacaine hydrochloride components. An FDA notice says Medline issued a letter to affected customers recommending that certain Medline convenience kits be corrected prior to continued use by removing components affected by the B. Braun
Devices
FDA Digital Health Center of Excellence director Rick Abramson says that digital health technologies (DHTs), especially those enabled by artificial intelligence, can continuously capture information about a person’s health in real time and in the context of their everyday life. Writing in an FDA Voices column, Abramson says DHTs
Devices
FDA has granted Vitestro a de novo authorization for Aletta, the first standalone robotic device designed to draw blood from a patient’s arm without hands-on intervention by a phlebotomist. The device is authorized for use in adults in outpatient settings and must operate under the supervision of a
Devices
A systematic analysis conducted by university researchers around the world of all FDA-cleared artificial intelligence/machine learning-enabled medical devices through 12/5/2025 highlights a “profound validation gap” and the need for evidence standards capable of keeping pace with the speed of regulatory clearance. Writing in the open-