NeuroOne (Nasdaq:NMTC) announced today that it accelerated the anticipated timeline of the FDA submission for its nerve ablation tech. Eden Prairie, Minnesota-based NeuroOne now expects to submit the trigeminal nerve ablation for FDA 510(k) clearance in May. It previously projected a submission by the end of June. Trigeminal nerve ablation, a minimally invasive procedure, uses […]
Food & Drug Administration (FDA)
Sooma wins FDA IDE for neuromod tech that treats depression
Sooma Medical announced today that it received FDA investigational device exemption (IDE) for its transcranial direct current stimulation (tDCS) device. The company can now begin a pivotal study of the medical device with the IDE. Helsinki, Finland-based Sooma designed the tDCS device to treat depression through portable neuromodulation. Worn as a cap, the device uses a […]
Miach Orthopaedics wins expanded FDA nod for Bear implant
Miach Orthopaedics announced today that the FDA cleared an expanded indication for the company’s Bear implant for ACL tears. The Bear implant previously won novo approval to treat skeletally mature patients at least 14 years of age with complete ACL tears. Now, the FDA granted 510(k) clearance to expand the indication to include children and […]
Lungpacer wins FDA IDE for AeroNova system
Lungpacer Medical announced today that it received FDA investigational device exemption (IDE) to begin a trial for its AeroNova system. The STARI (stimulation to activate respiration) trial evaluates the feasibility of the investigational AeroNova system. It looks at the system in patients suffering from moderate to severe Acute Hypoxemic Respiratory Failure (AHRF). AeroNova, a novel, […]
Dexcom receives FDA warning letter
Dexcom faces regulatory scrutiny in the U.S. following inspections of sites in California and Arizona. Our sister site, Drug Delivery Business News, reports today that the company received a warning letter from the FDA. The letter followed inspections of the company’s plants in San Diego and Mesa, Arizona. San Diego is where Dexcom’s headquarters is located, […]
Smiths Medical warns on potentially too small endotracheal tubes
ICU Medical‘s Smiths Medical today announced that it warned of a potential issue with certain sizes of its endotracheal tubes. The company issued an urgent medical device correction to notify affected global customers last month. It outlines a potential issue with the 2.0, 2.5, 3.0 and 3.5 mm sizes of intubation oral/nasal endotracheal tube products […]
Philips discontinues Tack endovascular system sales after serious recall
The FDA has deemed a recall of the Philips Tack endovascular system Class I, the most serious kind. This recall involves removing devices from use and sale. According to the FDA notice, the device may cause serious injury of death if customers continue to use it. As a result of the recall, Philips plans to […]
Stereotaxis submits pair of catheters for FDA clearance
Stereotaxis today announced it submitted its EMAGIN 5F and MAGiC catheters for FDA clearance. EMAGIN 5F, short for Endovascular Magnetic Intervention, is a 5-French diameter that navigates tortuous venous and arterial vasculature. Stereotaxis designed it to enable efficient and safe navigation to access difficult-to-reach vascular anatomy. The company said EMAGIN 5F expands the established benefits […]
Olympus has a serious endoscope guide sheath recall
The FDA today issued a notice warning of the removal of certain single-use guide sheath kits for endoscope instruments by Olympus. This recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type of recall, as it may cause serious injury or death. Olympus warned […]
FDA clears Tandem Diabetes Care’s next-gen automated insulin delivery algorithm for type 2 diabetes
Tandem Diabetes Care (Nasdaq:TNDM) today announced a major regulatory win that brings its diabetes technology to more patients. Our sister site, Drug Delivery Business News, reports today that the FDA cleared Tandem’s Control-IQ+ automated insulin delivery algorithm for people with type 2 diabetes. Control IQ+ builds on the company’s proven Control-IQ algorithm. It also includes […]
FDA asks some fired employees to return
The FDA is working to rehire some of the employees it recently dismissed, including scientists reviewing Elon Musk’s Neuralink brain implant, multiple sources familiar with the matter told Reuters. The rehiring effort, also reported by the New York Times, Associated Press and other media outlets, follows a series of mass terminations initiated by President Donald […]
