Abbott (NYSE:ABT) announced today that the FDA approved its new Proclaim Plus spinal cord stimulation (SCS) system with FlexBurst360. The FlexBurst360 therapy is the next generation of Abbott’s proprietary BurstDR stimulation. Abbott designed it to provide pain coverage across up to six areas of the trunk and/or limbs. It has programming that adjusts as a […]
FDA
Thermedical wins FDA nod for clinical trial of ablation tech
Thermedical announced today that it received FDA approval for a clinical trial to evaluate its SERF ablation system. Waltham, Massachusetts-based Thermedical will conduct an open-label, single-arm interventional clinical trial to evaluate the safety and efficacy of the Thermedical SERF ablation system with the Durablate catheter in people with ventricular tachycardia (VT) resistant to conventional treatment. […]
FDA clears Insulet Omnipod 5 for children two years and older
Insulet (Nasdaq:PODD) announced today that the FDA cleared its Omnipod 5 for individuals aged two years and older with type 1 diabetes. Acton, Massachusetts-based Insulet’s Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals six years of age and older. In June, the company […]
FDA clears expanded labeling for Preceptis Medical’s ear tube system
Preceptis Medical announced earlier this week that the FDA cleared expanded indications for its Hummingbird tympanostomy tube system (TTS). New labeling for the Hummingbird system for office-based pediatric ear tube procedures allows for in-office procedures in all children 6 months and older. Previous FDA clearance allowed for the use in children between 6 months old […]
FDA says 44 more deaths have been reported in Philips ventilator recall
The FDA has received reports of 44 more deaths associated with Philips Respironics’ massive respiratory device recall. FDA’s update, posted yesterday, brings the death total to 168, with 69,000 medical device reports (MDRs) filed related to the recall. The news comes amid Philips’ announcement that CEO Frans van Houten and the company’s supervisory board agreed […]
New FDA ruling may lower costs for over-the-counter hearing aids
The FDA today issued a final rule that may improve access to hearing aids by potentially lowering costs for the devices. By establishing a new category of over-the-counter (OTC) hearing aids, consumers with perceived mild to moderate hearing impairment may purchase hearing aids directly from stores or online retailers without the need for a medical […]
Medtronic has Class I recall for low-shock risk in ICDs
Medtronic (NYSE: MDT) is recalling 22,110 Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) in the U.S. The Class I recall — the most serious classification from the FDA — is due to the potential for reduced shock energy during high-voltage therapy for Cobalt and Crome ICDs and CRT-Ds, according […]
Dexcom to update next-gen G7 software, delaying FDA clearance, launch timelines
The CEO of Dexcom (Nasdaq:DXCM) said today that the company’s regulatory path for the next-generation G7 has been slightly delayed. Speaking on the continuous glucose monitor (CGM) maker’s second-quarter earnings call, Dexcom Chair, President and CEO Kevin Sayer explained that the company has — based on feedback from the FDA — been tweaking the software of its next-generation […]
FDA clears Rapid Medical’s small, adjustable thrombectomy device
Rapid Medical announced that it received FDA 510(k) clearance for its Tigertriever 13 device for treating large vessel occlusions. Yokneam, Israel-based Rapid Medical designed Tigertriever 13 to remove thrombus from delicate brain blood vessels during an ischemic stroke. Rapid Medical said in a news release that Tigertriever 13 is the smallest revascularization device in the […]
FDA approves Biotronik’s self-expanding stent system
Biotronik announced today that it received FDA approval for its Pulsar-18 T3 peripheral self-expanding stent system. Pulsar-18 T3 combines a 4-French low-profile delivery system with a tri-axial system with a braided shaft design and thin struts with low chronic outward force (COF), creating an improved implantation procedure for endovascular treatments. According to a news release, […]
FDA clears Neuronetics’ therapy for anxious depression
Neuronetics (Nasdaq:STIM) announced today that the FDA cleared a new indication for its transcranial magnetic stimulation (TMS) system. The new indication for the NeuroStar advanced therapy for mental health allows the system to treat anxiety symptoms for adult patients who suffer from major depressive disorder (MDD), also known as anxious depression. NeuroStar is a non-drug, […]