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. […]
FDA
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 […]
FDA clears Carescape Canvas patient monitoring platform from GE HealthCare
GE HealthCare (Nasdaq:GEHC) announced today that it received FDA 510(k) clearance for its Carescape Canvas patient monitoring platform. Carescape Canvas offers precise, flexible patient care. Together with Carescape One, it makes up part of an adaptable ecosystem set for scaling up and scaling down monitoring capabilities. This comes based on the acuity of each individual […]
FDA clears reader for next-gen Abbott FreeStyle Libre 3
Abbott (NYSE:ABT) announced today that the FDA cleared a reader device for its FreeStyle Libre 3 continuous glucose monitoring (CGM) system. The FDA cleared Abbott’s next-generation FreeStyle Libre 3 in May 2022. Abbott designed FreeStyle Libre 3 as the smallest and thinnest CGM sensor in the world. The system constitutes the size of two stacked […]
FDA clears iTrack Advance canaloplasty device from Nova Eye Medical
Nova Eye Medical announced today that it received FDA 510(k) clearance for its new iTrack Advance canaloplasty device. The FDA cleared iTrack Advance for microcatheterization and viscodilation to reduce intraocular pressure (IOP). It treats adult patients with primary open-angle glaucoma. Fremont, California-based Nova Eye designed its newest canaloplasty device to leverage the proprietary features of […]
Moximed wins FDA nod for implantable shock absorber for knee osteoarthritis
Moximed announced that the FDA granted de novo marketing authorization for its Misha knee system for treating knee osteoarthritis (OA). Misha, an implantable shock absorber, treats people with medial knee OA. These patients failed to find relief from non-surgical or surgical treatment. This population continues to experience pain that interferes with daily activities. Due to […]