The CEO of Dexcom (Nasdaq:DXCM) said today that the company’s regulatory path for the next-generation G7 has been slightly delayed. Speaking on the continuous glucose monitor (CGM) maker’s second-quarter earnings call, Dexcom Chair, President and CEO Kevin Sayer explained that the company has — based on feedback from the FDA — been tweaking the software […]
Food & Drug Administration (FDA)
ICU Medical’s Smiths Medical has a Class I infusion pump recall
The FDA has issued a notice classifying a recall of infusion pumps from Smiths Medical as Class I, the most serious kind. Smiths Medical — which was acquired by ICU Medical in January for $2.35 billion — earlier this month issued a warning in Europe for the same reason: eight potential issues with its Medfusion […]
6 drug delivery innovations you need to know
From wearable insulin delivery devices to drug-eluting implants and everything in between, drug delivery innovation never stops. Vaccines, life-saving therapeutics, vision-correcting drugs and more are being developed and marketed for delivery with all kinds of technologies. More than a year ago, we compiled a list of eight drug delivery innovations you need to know. With […]
FDA lifts hold on Vertex’s insulin-producing cell therapy for diabetes
Vertex Pharmaceuticals (Nasdaq:VRTX) announced today that the FDA lifted the clinical hold placed on the Phase 1/2 trial of VX-880. Boston-based Vertex designed VX-880 as a stem cell-derived fully differentiated pancreatic islet cell replacement therapy for people with type 1 diabetes with impaired hypoglycemic awareness and severe hypoglycemia. It could potentially restore the body’s ability […]
Virpax to pursue over-the-counter pathway for topical spray treatment for osteoarthritis pain
Virpax Pharmaceuticals (Nasdaq:VRPX) announced today that it will pursue a direct to over-the-counter (OTC) regular pathway for Epoladerm. Berwyn, Pennsylvania–based Virpax designed the Epoladerm investigational pre-filled topical spray analgesic product for the non-addictive management of chronic pain associated with osteoarthritis (OA) of the knee. According to a news release, the company expects the direct to […]
FDA grants breakthrough nod for Carthera’s SonoCloud-9
Carthera announced today that it received FDA breakthrough device designation for its SonoCloud-9 system. Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin. Once in place, the device becomes invisible. When activated for a few minutes using a transdermal needle connected to an external control unit, it uses low-intensity pulsed ultrasound to […]
First patient enrolled in MedAlliance’s drug-eluting balloon trial
MedAlliance announced today that the first patient was enrolled in a trial of its Selution SLR sirolimus-eluting balloon. Last month, the company received FDA investigational device exemption (IDE) for the Selution SLR drug-eluting balloon, which it designed to provide a controlled sustained drug release, similar to a drug-eluting stent. The FDA IDE BTK (below-the-knee) Selution4BTK […]
Dexcom CEO expects ‘science boom’ with CGM, automated insulin delivery
With the G7 nearing FDA clearance, Dexcom leadership foresees major innovations for integrated automated insulin delivery down the line. Kevin Sayer began thinking about automated insulin delivery all the way back in 1994 when he was working at MiniMed. Nearly 30 years later, as CEO of Dexcom (Nasdaq:DXCM), that space continues to pique his interest. […]
Real-world data backs Medtronic’s next-gen MiniMed 780G insulin pump
Medtronic (NYSE:MDT) announced positive real-world data supporting its next-generation MiniMed 780G insulin pump system. Results from real-world analyses in Europe and Chile, along with clinical data, were presented by Medtronic at the American Diabetes Association (ADA) 82nd Scientific Sessions in New Orleans. According to a news release, the MiniMed 780G advanced hybrid closed loop system, […]
Abbott to develop biowearable for continuous monitoring of glucose, ketone levels
Abbott (NYSE:ABT) announced today that it is developing a new biowearable for continuously monitoring both glucose and ketone levels. The all-in-one sensor has already garnered FDA breakthrough device designation and will be used in pivotal trials in 2023, with regulatory submissions to follow thereafter. Abbott Park, Illinois-based Abbott said in a news release that the […]
