The FDA announced today that it authorized the Binx Health IO CT/NG assay at point-of-care settings to diagnose STIs. Point-of-care settings include physician offices, community-based clinics, urgent care settings, outpatient healthcare facilities and other patient care settings operating under a CLIA certificate of waiver, certificate of compliance or certificate of accreditation, according to a news […]
FDA
FDA committee to examine safety of endovascular stent grafts
FDA’s CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet later this year to examine the safety of endovascular stent grafts made by Endologix and other companies. Day one of the meeting will examine the benefit-risk profile of the Endologix AFX endovascular graft system regarding a potentially higher-than-expected risk of blood […]
Helius Medical wins FDA nod for tongue stimulator that improves MS patients’ gait
The FDA announced today that it authorized marketing for a stimulator device that treats gait deficit in those with multiple sclerosis (MS). Helius Medical’s portable neuromodulation stimulator (PoNS) is a neuromuscular tongue stimulator that uses a non-implantable apparatus to generate electrical pulses for stimulation of the trigeminal and facial nerves via the tongue to treat […]
FDA approves Medtronic’s Harmony transcatheter pulmonary valve system
FDA has approved a Medtronic device described as a first-in-the-world, non-surgical heart valve to treat severe pulmonary valve regurgitation — a condition often arising from congenital heart disease. The Harmony transcatheter pulmonary valve system could delay the time before someone with congenital heart disease might need additional open-heart surgery, FDA said today. The Harmony device […]
Medtronic recalls oxygenator used for cardiopulmonary bypass among kids
The FDA has designated a recall of a Medtronic oxygenator used on kids as Class I, its most serious level. The Affinity Pixie oxygenator and cardiotomy/venous reservoir with Balance biosurface is designed for treating newborns, infants and small pediatric patients requiring cardiopulmonary bypass. The system adds oxygen to the blood and removes carbon dioxide, while the […]
GE Healthcare 2D/3D imaging system wins FDA nod
GE Healthcare has announced FDA 510(k) clearance for a new surgical imaging system capable of 3D and 2D imaging. OEC 3D offers interoperative 3D imaging with precise volumetric images for spine and orthopedic procedures, according to GE Healthcare. It combines the benefits and familiarity of 2D imaging with OEC C-arms, delivering a familiar user experience with […]
FDA clears Optellum AI-based software system for early lung cancer diagnosis
Optellum announced today that it received FDA 510(k) clearance for its Virtual Nodule Clinic for early lung cancer diagnosis. Oxford, England-based Optellum’s product is an AI-powered clinical decision support software system for pulmonologists and radiologists managing patients with nodules (small lesions) in the lungs that could represent early-stage lung cancer, according to a news release. […]
Companies, docs alarmed by proposed 510(k) rollback
Medical associations and device companies have largely come out against a Trump administration proposal to permanently exempt certain medical devices and software from the FDA 510(k) clearance process. HHS used Trump’s waning days in office to propose permanently exempting 83 Class II devices and one unclassified device from the clearance review process. The list includes home ventilators, […]
FDA second-in-command to leave agency
Dr. Amy Abernethy, a top FDA official who was reportedly considered for the commissioner’s job, plans to leave the agency by the end of April. As principal deputy commissioner, Abernethy helps oversee the FDA’s day-to-day functioning and directs initiatives that cut across its regulatory centers covering drugs, medical devices, tobacco and food. She is also […]
Allergan must face breast implant class action
A federal judge in New Jersey has shut down part of a multi-district lawsuit against Allergan over its Biocell textured breast implants but kept most other parts of the litigation. Judge Brian Martinotti ruled on March 19 that some of the plaintiffs’ claims against Allergan (now part of AbbVie) were preempted by federal law while […]
FDA authorizes first machine learning-based screening device for COVID-19 biomarkers
The FDA announced that it authorized the first machine learning-based screening device for identifying COVID-19 biomarkers. Tiger Tech Solutions’ COVID Plus Monitor received emergency use authorization (EUA) as a non-diagnostic screening device to identify certain biomarkers that indicate some types of conditions, including hypercoagulation (which causes blood to clot more easily than normal), according to […]
