The FDA today labeled Abbott’s recall of some HeartMate II and HeartMate 3 left ventricular assist systems (LVAS) as Class I, the most serious kind. Abbott issued the recall of the HeartMate II and HeartMate 3 LVAS due to an issue known as extrinsic outflow graft obstruction (EOGO). The issue happens when biological material builds […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
ICU Medical’s Smiths Medical has a serious ventilators recall
The FDA recently labeled Smiths Medical’s recall of some ventilators as Class I, the most serious kind. ICU Medical’s Smiths Medical initiated a recall of some ASD PneuPac paraPAC Plus 300 and 310 Ventilator kits on February 7. The company said the ventilators may intermittently provide continuous positive gas flow instead of the intended cycling […]
Raydiant Oximetry wins FDA IDE nod for fetal pulse oximeter
Raydiant Oximetry announced that the FDA granted investigational device exemption (IDE) to its Lumerah technology. IDE enables an early feasibility study evaluating the technology for pregnant women during labor and delivery. The company designed Lumerah to improve the detection of fetal distress during labor and delivery. A non-invasive, transabdominal fetal pulse oximeter, it measures the […]
Biotronik unveils new AI-powered insertable cardiac monitor
Biotronik announced that it received CE mark approval and completed the first European implant of its latest insertable cardiac monitor (ICM). The BioMonitor IV features AI capabilities for false positive reduction. The AI cuts false positives for AFib, bradycardia, tachycardia and pause. According to Biotronik, its SmartECG reduces 86% of false detections across all major […]
Philips comes to consent decree agreement with DOJ, FDA over Respironics recall
Philips today announced a final agreement on a consent decree with the FDA and U.S. Dept. of Justice (DOJ). The consent decree primarily focuses on its Philips’ Pennsylvania-based Respironics business — the subject of a major recall over the past several years. That includes manufacturing facilities in Murrysville and New Kensington, a service center in […]
Onkos Surgical wins FDA de novo nod for antibacterial-coated orthopedic implants
Onkos Surgical this week announced it received FDA de novo approval for its antibacterial coated implants. According to the Parsippany, N.J.-based company, bacterial contamination of a permanent implant could have devastating effects in orthopedic oncology and revision arthroplasty. “Implant contamination is a growing concern to the orthopaedic surgical community,” Dr. Steven Gitelis, chief medical officer, […]
Outset Medical stock soars on optimistic analyst outlook
Outset Medical shares are on the rise after BTIG analysts initiated coverage with a “Buy” rating for the home hemodialysis company. Shares of OM rose by more than 25% to $2.58 apiece in late-afternoon trading today. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose slightly. The optimistic outlook […]
Orthobond wins FDA de novo approval for antibacterial technology that could have vast device applications
Orthobond has secured FDA de novo approval for its Ostaguard antibacterial technology that could one day be used for a wide range of medical devices — and beyond medtech. The Monmouth Junction, New Jersey-based device developer says it’s the first time the FDA has granted a de novo request for a non-eluting coating designed to […]
FDA approves Symani surgical robot platform from Medical Microinstruments
Medical Microinstruments announced today that the FDA granted de novo clearance for its Symani surgical robot platform. Clearance covers soft tissue manipulation to perform microsurgery. This technique involves reconnecting tiny vessels to restore blood flow or redirect fluid during reconstruction or repair. FDA authorization makes Symani the only commercially available platform in the U.S. for […]
Neurovalens wins FDA nod for anxiety-treating neuromod device, raises $2.65M
Neurovalens announced today that it received FDA clearance for its Modius Stress device for treating anxiety and raised $2.65 million. Belfast, Northern Ireland–based Neurovalens designed Modius Stress to deliver non-invasive electrical stimulation. It stimulates key areas of the brain and nervous system without the need for surgically implanted electrodes. Modius Stress treats anxiety with a […]
Synchron launches BCI registry with eyes on larger study, approval
Synchron announced today that it launched a community-centered registry to evaluate its brain-computer interface (BCI) technology. The company said its study aims to bring patients, carers and clinicians together to learn about BCI design and its benefits for people with limited mobility. Synchron designed its BCI technology to decipher the neural code of the brain, […]