Cognixion announced today that it received FDA breakthrough device designation for its flagship brain-computer interface (BCI) technology. Santa Barbara, California-based Cognixion designed the Cognixion One Axon as an assisted reality device. It utilizes bionic combination or AI, augmented reality and assistive technology. The company designed the system to help people with severe motor impairments communicate […]
FDA
FDA clears smart toilet seat for home heart monitoring from Casana
Casana announced today that it received FDA clearance for its Heart Seat — a smart toilet seat that measures certain vital signs. Heart Seat measures heart rate and oxygen saturation (SpO2). Casana also has partnerships with researchers to conduct validation studies for further clinical measurements. The company plans to file for future indications this year, […]
Medtronic wins FDA nod for next-gen Micra leadless pacemaker
Medtronic announced today that it received FDA approval for its Micra AV2 and Micra VR2 leadless pacemakers. The next-generation, miniaturized, leadless pacemakers offer longer battery life and easier programming compared to previous versions. Medtronic said they also continue to deliver the established benefits of leadless pacing, such as reduced complications compared to traditional pacemakers. According […]
FDA clears Intuitive da Vinci surgical robot for prostatectomy
Intuitive Surgical announced today that the FDA cleared its da Vinci SP surgical robot for simple prostatectomy. The clearance, which includes prostatectomy as a representative procedure, expands da Vinci SP’s (single-port) available urologic surgical procedures. Sunnyvale, California-based Intuitive’s surgical robot now offers the removal of an enlarged prostate blocking urine flow with this procedure. In […]
MiniMed 780G a ‘monumental improvement,’ Medtronic Diabetes head says
It’s been a long road for the Medtronic (NYSE:MDT) Diabetes unit to get its next-generation technology to market. For years, clinical data backed up the MiniMed 780G insulin pump with Guardian 4 sensor technology. Over the last year alone, The company hit an initial hiccup with an FDA warning letter related to its California Diabetes facility in 2021. […]
Medtronic Diabetes unit fully resolves FDA warning letter
Medtronic (NYSE:MDT) announced today that the FDA lifted the warning letter related to its Diabetes business unit headquarters. In December 2021, the FDA issued a warning letter to Medtronic’s Northridge, California, Diabetes headquarters. The letter centered around the inadequacy of specific medical device quality system requirements at the Northridge facility. It scrutinized the areas of […]
Abbott wins duo of FDA clearances for CentriMag life support system
Abbott announced today that it received two FDA clearances for its CentriMag system for life support. The agency cleared the CentriMag blood pump for longer-term use in adults using the CentriMag system. These adults require extracorporeal membrane oxygenation (ECMO) to save their life. Longer-term support provides physicians more time to assess the next steps and […]
FDA clears basal-only insulin pod for type 2 diabetes from Insulet
Insulet (Nasdaq:PODD) announced today that it received FDA clearance for its Omnipod GO long-acting insulin delivery device. Omnipod GO, which received clearance for people with type 2 diabetes aged 18 or older, covers the basal-only insulin population. The target population typically takes daily injections of long-acting insulin. The first-of-its-kind, standalone, wearable insulin delivery system provides […]
FDA approves next-gen MiniMed 780G insulin pump from Medtronic
Medtronic announced that it received FDA approval for its MiniMed 780G system with the Guardian 4 sensor. The news — posted in the evening on April 21 — has MDT shares up more than 4% to $89.36 apiece in afternoon trading today. (MassDevice’s MedTech 100 Index is up slightly.) The positive news for the business […]
Avanos Medical has a serious recall of airway access device for young children
The FDA today issued a notice labeling a recall by Avanos Medical (NYSE:AVNS) as Class I, the most serious kind. Avanos’ recall regards its Ballard Access closed suction system for neonates and pediatrics. These affected devices feature the Y-manifold or elbow manifold. Avanos reported four injuries and one death related to the issue with the […]
UroMems picks up FDA STeP designation for smart implant that treats urinary incontinence
UroMems announced that it received Safer Technologies Program (STeP) designation from the FDA for its UroActive smart continence therapy. STeP, a collaborative program, helps reduce the time needed to develop and obtain marketing authorization for eligible devices. FDA launched STeP in 2021, modeling the program on its breakthrough devices designation program. STeP covers devices that […]