Devices
Smiths Medical ASD is recalling (Class 1) its Medfusion model 4000 syringe pump due to issues associated with earlier software versions. According to a recall notice, the issues may affect the alarm system, the pump, the control screen, and other parts of the pump. “If undetected issues are present in
Devices
FDA has cleared a Nanox AI 510(k) for HealthFLD, an artificial intelligence (AI) software that provides automated qualitative and quantitative analysis of liver attenuation from routine contrast and non-contrast chest and abdomen computed tomography scans in patients between the ages of 18 to 75. The company says HealthFLD
Devices
Given an FDA increased emphasis on cybersecurity, medical device manufacturers must prioritize compliance with regulatory standards. That’s the view of Mecrypt vice president Naomi Schwartz, a former FDAer, writing in an online Medical Design & Outsourcing post. “The transition from leniency to strict enforcement,” Schwartz writes, “signals a new
Devices
FDA has cleared a Masimo 510(k) for its MightySat Medical, an over-the-counter fingertip pulse oximeter. The company says it uses the same technology “relied on by hospitals and clinics around the world to monitor more than 200 million patients every year, and shown to have no clinically
Devices
FDA is convening a 2/13 advisory committee meeting to discuss the clinical significance of Abbott Medical’s TRILUMINATE pivotal trial that evaluated the company’s TriClip G4 System (TriClip) for improving health status in patients with symptomatic, severe tricuspid regurgitation (TR), whose symptoms and TR severity persist despite optimal
Devices
FDA has cleared a Proscia 510(k) for its Concentriq AP-Dx, a comprehensive diagnostic software for pathologists for viewing, interpreting, and managing whole slide images. The clearance was based on data from a clinical study demonstrating that diagnoses made on Concentriq AP-Dx are non-inferior to traditional glass
Devices
FDA has granted Samsung Electronics a de novo authorization for a sleep apnea feature using a compatible Samsung Galaxy Watch and phone. The sleep apnea feature enables users over age 22 years who have not been diagnosed with sleep apnea to detect signs of moderate to severe obstructive sleep apnea
Devices
Researchers from universities in three countries say the FDA medical device de novo pathway “holds significant potential for innovators seeking to define new categories of novel medical devices, as well as for FDA to modernize the 510(k) pathway by promoting reliance on modern device predicates that represent a more
Devices
Philips North America has recalled (Class 1) its BrightView computed tomography gamma camera system because of the risk of the detector unexpectedly falling due to a component failure. “If the detector is positioned below center of the gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to
Devices
Four Hogan Lovells attorneys say medical device companies should begin performing gap assessments of their quality systems now to assure compliance with the 2/2/2026 compliance date for the new FDA Quality Management System Regulation (QMSR). Writing in an online post, the attorneys say the agency originally intended to
Devices
FDA has granted Orthoson a breakthrough device designation for its Bio-Structural Gel and its use to alleviate back pain due to degenerative disc disease. “The patented pNIPAM-DMAc co-polymer is designed to mimic the body’s own natural tissue in the nucleus pulposus, while restoring mechanical function of
Devices
Percussionaire is recalling its High Frequency Transport Phasitron Breathing Circuit Kits due to a product defect that causes over-pressurization. “There are two parts of the Phasitron kit that must be pressed together during manufacturing,” a recall notice explains. “If one part is angled incorrectly and pressed, the part can
Devices
FDA has approved an expanded indication for Boston Scientific’s WaveWriter Spinal Cord Stimulator (SCS) for treating chronic low back and leg pain in people without prior back surgery (non-surgical back pain). SCS therapy uses an implanted device that delivers mild electrical impulses to interrupt pain signaling that travel
Devices
In response to an earlier Nurse Assist, LLC product recall, Cardinal Health is recalling products supplied to it for use in Covidien and Cardinal Health brand urology and operating room-specific kits and trays. The products contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP supplied
Devices
FDA has cleared a Hologic 510(k) for its Genius Digital Diagnostics System with the Genius Cervical AI algorithm, a digital cytology system that the company says combines deep-learning-based artificial intelligence with volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells. Traditional screenings for
Devices
FDA has approved Edwards Lifesciences’ Evoque tricuspid valve replacement system for treating tricuspid regurgitation (TR). The device is indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is deemed appropriate by a heart team, according to
Devices
Cardinal Health is recalling all sizes of its Monoject sterile Syringe Luer-Lock Tip Soft Packs (1, 3, 6, 12, 20, 35, and 60 mL) and Monoject sterile Enteral Syringes with ENFit connection (1, 3, 6, 12, 35, and 60 mL), which are color-coded purple to denote enteral feeding
Devices
JDRF (formerly the Juvenile Diabetes Research Foundation) says it applauds FDA for providing important and needed clarity on the agency’s views on the topic of digital health technologies (DHTs) for detecting prediabetes and undiagnosed Type 2 diabetes. Responding to the agency’s request for comment on the topic, JDRF
Devices
FDA has cleared a GE HealthCare 510(k) for its Novii+ Wireless Patch, an antepartum and intrapartum maternal and fetal monitor that measures and displays in real time fetal heart rate, maternal heart rate and uterine activity. “Novii+ allows moms to move around and stay active during labor while providing
Devices
FDA has published a final rule, Quality Management System Regulation Final Rule, to amend the current Quality System Regulation good manufacturing practice (CGMP) requirements to harmonize with an international standard. The document will take effect on 2/2/26, giving medical device manufacturers and importers two years to modify their
Drugs
The House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations will hold a 2/6 public hearing on “Protecting American Health Security: Oversight of Shortcomings in FDA’s Foreign Inspection Program.” In a statement, committee chair Rep. Cathy Morris Rodgers (R-WA) and subcommittee chair Morgan Griffith (R-
Drugs
The Biotechnology Innovation Organization (BIO) says it is committed to enhancing clinical trial diversity as part of its BIOEquality Agenda. In a response to an FDA 11/29-11/30/2023workshop on clinical trial diversity, BIO notes that under the FDA Omnibus Reform Act of 2022, the agency was required