Elutia (Nasdaq:ELUT) announced today that it submitted a 510(k) premarket notification to the FDA for its drug-eluting biomatrix. The company designed its next-generation CanGarooRM for use with cardiac implantable electronic devices like pacemakers and defibrillators. A bioenvelope, CanGarooRM stabilizes the implantable devices. Made from a natural biomaterial that promotes a regenerative healing response, the biomatrix […]
Drug-Device Combinations
B. Braun launches luer device for IV infusions
B. Braun Medical announced that it launched its new CareSite Micro luer access device designed to make IV access safer. Bethlehem, Pennsylvania-based B. Braun designed the device to reduce exposure to harmful chemicals. It aims to decrease infection risk in IV access for patients and healthcare providers. The company says its device is the only […]
Fresenius Kabi, Mayo Clinic ink deal on Ivenix infusion system
Fresenius Kabi announced that it signed a multi-year purchase agreement with Mayo Clinic centered around large-volume infusion pumps. The Lake Zurich, Illinois-based company expects Mayo Clinic to purchase 10,000 Ivenix pumps for hospitals and clinics in Minnesota, Arizona and Florida. It marks the largest contract for Ivenix pumps signed by the company to date. Ivenix, […]
FDA approves Glaukos iDose TR glaucoma-treating drug delivery implant
Glaukos (NYSE:GKOS) announced today that the FDA approved a New Drug Application (NDA) for its iDose TR implant. The approval allows for one administration per eye of iDose TR (travoprost intracameral implant) 75 mcg. The indication for the prostaglandin analog covers the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle […]
Encellin closes $9.9M financing to support implantable drug delivery pouch
Encellin announced today that it closed a $9.9 million financing round to support its cell encapsulation platform. The San Francisco-based company develops an encapsulated cell replacement therapy (EnCRT). It isolates therapeutic cells from the body’s immune system to help therapeutic cells survive in the body. Once implanted, cells within the EnCRT can exchange biomolecules with […]
Tandem Diabetes Care launches diabetes management platform for insulin pump users
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it launched Tandem Source, a diabetes management platform. The platform, for both insulin pump users and healthcare providers, brings together features of Tandem Diabetes Care’s legacy offerings. It combines t:connect, t:connect HCP and t:connect Portal with new, comprehensive data reporting in one central, scalable platform. All Tandem pump […]
Report: There’s still ‘mutual interest’ with EOFlow, Medtronic despite deal falling through
Business Korea reports that EOFlow CEO Kim Jae-jin is leaving the door open with regard to the company’s collapsed deal with Medtronic (NYSE:MDT). Medtronic announced this week that it terminated its $738 million agreement to acquire EOFlow, a maker of insulin patch pumps. The medtech giant cited “multiple breaches” of terms in the agreement as […]
Beta Bionics integrates iLet bionic pancreas with Dexcom G7
Beta Bionics announced today that it began the U.S. launch of its iLet bionic pancreas with the Dexcom G7 continuous glucose monitor (CGM). The launch marks the second G7-compatible automated insulin delivery system to hit the market in as many days. Yesterday, Tandem Diabetes Care became the first to launch an artificial pancreas using Dexcom’s […]
Medtronic nixes $738M deal for insulin patch pump maker EOFlow
Medtronic (NYSE:MDT) filed a Form 8K with the SEC today stating that it terminated its agreement to buy EOFlow. The medtech giant struck a $738 million deal to acquire the Seongnam, South Korea-based insulin patch pump maker in May. EOFlow develops the EOPatch — a tubeless, wearable and fully disposable insulin delivery device. Medtronic’s SEC filing […]
Tandem Diabetes Care launches first automated insulin pump integrated with Dexcom G7 CGM
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it launched its updated t:slim X2 insulin pump software with the Dexcom (Nasdaq:DXCM) G7. Integration makes Tandem the first to offer automated insulin delivery with the latest-generation Dexcom continuous glucose monitor (CGM). The FDA cleared the next-generation Dexcom G7 in December 2022. By February of this year, the […]