When Dr. Fran Kaufman began her career in the late 1970s, diabetes management consisted of urine testing and animal insulin. At that point, it had not been proven that managing glucose actually mattered, according to Kaufman, and proof didn’t come until 1992 with the conclusion of the DCCT study. “I’ve seen a lot of innovation,” […]
FDA
FDA clears Insulet’s next-generation Omnipod 5 wearable insulin delivery pump
Insulet (NSDQ:PODD) announced today that it received FDA clearance for its Omnipod 5 automated insulin delivery system. FDA clearance for the next-generation version of the company’s wearable insulin delivery pump system covers individuals aged six years and older with type 1 diabetes. The platform provides easier glucose management, with no multiple daily injections, no tubes […]
FDA grants IDE approval for Capillary Biomedical’s 7-day-wear infusion set
Capillary Biomedical announced today that it received FDA investigational device exemption (IDE) for its SteadiFlow infusion technology. Irvine, California-based Capillary Biomedical designed its new SteadiFlow seven-day-wear infusion set technology to significantly extend patient wear time to a week and maintain insulin stability. The SteadiSet infusion set, powered by the SteadiFlow technology platform, features an integrated […]
FDA grants new drug approval to Glenmark’s rhinitis-treating nasal spray
Glenmark Pharmaceuticals announced today that it received FDA approval for a new drug application (NDA) for Ryaltrais. Ryaltris, a fixed-dosed, prescription drug product nasal spray treats symptoms of seasonal allergic rhinitis in adults and pediatric patients over 12 years of age in the U.S. Glenmark’s fully owned subsidiary, Glenmark Specialty S.A. (Switzerland), received the NDA […]
Dexcom CEO touts unprecedented performance of G7 in clinical trial, awaits FDA decision
Exciting new data for the next-generation Dexcom (NSDQ:DXCM) G7 continuous glucose monitor (CGM) surprised even the company’s leadership. Dexcom Chair, President & CEO Kevin Sayer, presenting clinical study results for the G7 at the 40th Annual J.P. Morgan Healthcare Conference, has previously lauded the expected impact of the wearable glucose monitor, and the new data […]
FDA clears Glaukos’ iPrime
Glaukos (NYSE:GKOS) announced that it received FDA 510(k) clearance for its iPrime viscodelivery system. San Clemente, California-based Glaukos designed the iPrime viscodelivery system as a sterile, single-use, minimally invasive device for delivering viscoelastic fluid during ophthalmic surgery. Glaukos develops medical devices and pharmaceuticals centered around novel therapies for treating glaucoma, corneal disorders and retinal diseases. […]
Senseonics expects FDA approval for next-gen 180-day CGM in ‘coming weeks’
Senseonics (NYSE:SENS) announced that it anticipates the FDA to decide within weeks on approval of its new CGM system. The company seeks a premarket approval supplement for the next-generation Eversense 180-day implantable continuous glucose monitoring (CGM) system. Data presented earlier this year demonstrated strong accuracy. The next-generation Eversense matched performance levels compared to the current […]
FDA approves injectable atopic dermatitis treatment from LEO Pharma
LEO Pharma announced today that it received FDA approval for its Adbry injection treatment for moderate-to-severe atopic dermatitis. Ballerup, Denmark-based LEO Pharma designed its Adbry injection for treating atopic dermatitis in adults aged 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. According […]
Medtronic Diabetes receives FDA warning over quality system requirement inadequacies
Medtronic (NYSE:MDT) announced today that it received an FDA warning letter after an inspection of its Diabetes Business. The company received the letter on Dec. 9 for its Northridge, California facility — the Medtronic Diabetes Business headquarters — following an inspection that concluded in July 2021. FDA’s warning letter to Medtronic focused on the inadequacy […]
Report: Insulet expects delays in FDA review for Omnipod 5 with launch pushed back
The highly anticipated launch of the Insulet (NSDQ:PODD) Omnipod 5 may not come as soon as thought as an FDA review drags on. SeekingAlpha reported that Insulet CEO Shacey Petrovic, speaking at the Nasdaq Investor Conference, said the regulatory agency will likely not complete its review of the next-generation Omnipod 5 before the end of […]