Insulet data shows Omnipod 5's superiority to regular pump therapy
WEBMar 8, 2024 — Results demonstrated significantly lower mean glucose and time above 180 mg/dL in the Omnipod 5 group. That group also spent significantly less time below 70 mg/dL. Mean time decreased from 1.66% to 1.18% with Omnipod 5, compared to an increase from 1.66% to 1.75% in the control group. Time below 54 mg/dL proved non-inferior between groups.
Know Labs unveils wearable, non-invasive CGM set to go to FDA
WEBFeb 27, 2024 — A rendering of the KnowU non-invasive glucose monitor. [Image courtesy of Know Labs] Know Labs (NYSE:KNW) today unveiled KnowU, its wearable, non-invasive continuous glucose monitor (CGM) system. Seattle-based Know Labs first announced its initial prototype last June.It says KnowU is the result of an accelerated development process over the past eight months.
Insulet fully launches Omnipod 5 with Dexcom G7 in the U.S.
WEBJun 20, 2024 — Omnipod 5, the first FDA-cleared tubeless automated insulin delivery system, communicates with a CGM. It proactively corrects for highs and protects against lows with insulin dosing. The waterproof device features mobile app control for ease of use. Acton, Massachusetts-based Insulet began a limited rollout of Omnipod 5 …
The company behind Narcan looks toward a treatment for fentanyl ...
WEBMar 13, 2018 — A nasal spray designed to reverse opioid overdoses called Narcan has become a life-saving tool used by police departments and communities around the country. Now, the company that created Narcan – Opiant Pharmaceuticals (NSDQ: OPNT) – is hoping that its latest drug-device combination can …
FDA clears Dexcom G7 next-gen CGM - Drug Delivery Business
WEBDec 8, 2022 — Dexcom (Nasdaq:DXCM) announced today that the FDA cleared the next-generation Dexcom G7 continuous glucose monitoring (CGM) system. FDA clearance for the highly anticipated device covers people with all types of diabetes aged 2 years and older. San Diego-based Dexcom’s device features a 60% size reduction from the previous generation, the G6.
FDA clears automated insulin pump from Beta Bionics
WEBMay 19, 2023 — The FDA announced today that it cleared the Beta Bionics iLet ACE automated insulin pump and iLet dosing decision software. FDA clearance covers the devices for people 6 years of age and older with type 1 diabetes. Combined with a compatible, FDA-cleared integrated continuous glucose monitor (iCGM), they form the iLet Bionic Pancreas.
Dexcom CEO explains plans for Stelo CGM, G7 and beyond
WEBJun 23, 2024 — The Stelo glucose monitor. [Image courtesy of Dexcom] Dexcom (Nasdaq:DXCM) CEO Kevin Sayer says the prospect of an over-the-counter CGM made him and other company leaders uneasy. When the company first began planning a glucose monitor for the type 2 diabetes population not using insulin, there were questions about reimbursement, the impact of GLP-1 drugs and other causes for concern.
Lilly partners with four companies on insulin pen tech
WEBMay 6, 2021 By Nancy Crotti. Eli Lilly (NYSE:LLY) today announced deals with four companies whose diabetes management tech will work with Lilly’s latest insulin pen. The Tempo Pen is a modified version of Lilly’s existing prefilled, disposable insulin pen to which the Tempo Smart Button — in late-stage development – attaches. Through ...
FDA submission for 365-day CGM from Senseonics is ‘imminent’
WEBFeb 29, 2024 — Senseonics (NYSE:SENS) shares dipped after hours on fourth-quarter results that came in ahead of the consensus forecast. The company also reported an “imminent” submission of its latest, longest-lasting continuous glucose monitoring (CGM) technology. Shares of SENS fell 3.5% to 69¢ apiece after the market closed today.
AMF Medical wins breakthrough nod for insulin management …
WEBNov 30, 2021 — AMF Medical announced today that it received FDA breakthrough device designation for its Sigi insulin management system. Ecublens, Switzerland-based AMF Medical’s Sigi (for diabetes mellitus treatment) can be programmed to deliver basal and bolus insulin at both set and variable rates. Sigi, an …