Within two weeks of MiniMed’s initial public offering in March, the Medtronic spinoff received FDA clearance for its latest-generation MiniMed Flex automated insulin delivery system. The smaller, screenless pump system is a major milestone for one of the world’s largest diabetes businesses. “We have a long history with durable pumps,” MiniMed EVP, Chief Product and Technology Officer, Ali Dianaty said in […]
Food & Drug Administration (FDA)
MiniMed flexes with next-gen insulin pump after spinning off from Medtronic
FDA labels MiniMed insulin pump recall Class II
The FDA recently published a Class II recall related to insulin pump systems made by MiniMed (Nasdaq:MMED). Class II recalls constitute a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. MiniMed is […]
InVera wins FDA clearance for non-thermal infusion catheter
InVera Medical announced today that it received FDA 510(k) clearance for its InVera Infusion Device. Galway, Ireland-based InVera designed its minimally invasive device to help physicians deliver treatment more effectively to diseased leg veins, including varicose veins. It aims to treat chronic venous disease (CVD), which currently faces a significant gap in care, the company […]
Glucotrack to submit continuous blood glucose monitor for FDA IDE in early Q2
Glucotrack (Nasdaq:GCTK) today provided an update on the planned regulatory timeline for its continuous blood glucose monitor (CBGM). The Glucotrack device features no on-body external component. The company designed it for three years of continuous, accurate blood glucose monitoring for a more convenient, less intrusive solution. Unlike traditional CGMs that measure glucose in interstitial fluid, […]
Novo Nordisk gets FDA nod for Awiqli once-weekly basal insulin for type 2 diabetes
Novo Nordisk announced today that it received FDA approval for Awiqli, the first and only once-weekly, long-acting basal insulin. Awiqli (insulin icodec-abae) injection 700 units/mL, is indicated as an adjunct to diet and exercise to improve glycemic control (blood sugar) in adults living with type 2 diabetes. Approval grants people with type 2 diabetes a […]
MiniMed wins FDA clearance for next-gen Flex insulin pump
MiniMed (Nasdaq:MMED) announced today that it received FDA clearance for the MiniMed Flex next-generation insulin pump. Flex, a discreet, smartphone-controlled insulin pump, was designed by the company — which just went public as part of its separation from Medtronic — to seamlessly fit into everyday life. Clearance covers individuals aged 7 and older with type […]
Insulet issues warning on certain Omnipod 5 pumps due to manufacturing issue
Insulet (Nasdaq:PODD) today initiated a voluntary medical device correction for specific lots of Omnipod 5 insulin pump pods. Omnipod 5 — the world’s first available tubeless, wearable, automated insulin delivery system — is a patch-based pump system designed to proactively correct for glucose highs every five minutes and protect against lows with insulin dosing. Acton, […]
Airiver Medical wins FDA breakthrough nod for drug-coated balloon, treats first patient
Airiver Medical announced today that it received FDA breakthrough device designation for its pulmonary drug-coated balloon (DCB). Additionally, Airiver announced the first treated patients in a clinical trial for the DCB. The Brooklyn Park, Minnesota-based company designed its DCB to treat central airway stenosis. Central airway stenosis (airway narrowing) can lead to prolonged intubation, tracheostomy, […]
Senseonics earns FDA IDE for next-gen Gemini CGM, posts Q4 revenue beat
Senseonics (NYSE:SENS) posted fourth-quarter results that proved mixed compared to Wall Street forecasts alongside a major pipeline announcement. Along with its fourth-quarter results, the company shared that it secured FDA investigational device exemption (IDE) for its self-powered, battery-enabled Gemini sensor. It enrolled the first patients in the IDE trial and expects to complete that in […]
ICU Medical resolves Smiths Medical warning letter, posts mixed Q4
ICU Medical (Nasdaq:ICUI) shares dipped slightly today on fourth-quarter results that were mixed compared to the consensus forecast. Shares of ICUI fell 1.25% to $149.74 apiece in early-morning trading today. The San Clemente, California-based infusion technology and critical care product provider reported losses of $15.7 million. That equals 64¢ per share on sales of $540.7 […]
