Orchestra BioMed (Nasdaq:OBIO) today announced the first patient enrollments in a study of its Virtue Sirolimus AngioInfusion Balloon (SAB). The FDA investigational device exemption (IDE) trial compares the Virtue SAB to the Boston Scientific Agent paclitaxel-coated balloon. Agent is currently the only FDA-approved drug-coated balloon (DCB) for coronary indication, picking up approval in March. New Hope, […]
Drug-Device Combinations
Vivani prices $15.7M offering
Vivani Medical (Nasdaq:VANI) announced that it priced a best efforts registered direct offering of 6 million shares of common stock. The Alameda, California-based company priced the shares at $1.62 apiece. It also announced a concurrent private placement of more than 3.7 million shares of common stock at the same price. Gregg Williams, the company’s board […]
Multiple studies back Cordis Selution SLR drug-eluting balloon
Cordis today announced new findings from a duo of studies supporting the use of its Selution SLR drug-eluting balloon (DEB) system. Miami Lakes, Florida-based Cordis announced results from the SELUTION DeNovo and SELUTION 4ISR trials at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. Both randomized clinical trials demonstrated positive outcomes that met […]
Ypsomed launches YpsoLoop autoinjector platform designed for circularity
Ypsomed announced that it launched YpsoLoop, its first autoinjector platform designed for circularity. The Swiss drug delivery device maker says the two new 1 mL and 2.25 mL platforms enable material recovery. Their design enables automated disassembly and efficient recycling while offering the convenience of a pre-filled, two-step autoinjector. Ypsomed said the YpsoLoop platform integrates […]
Insulet adds JPMorgan veteran to its board of directors
Insulet (Nasdaq:PODD) announced today that it appointed Robert “Robbie” L. Huffines to its board of directors. Huffines, a former global chair of investment banking at JPMorgan Chase & Co., joins the automated insulin delivery technology maker’s board effective Oct. 31, 2025. He joins as an independent director and a member of the Insulet Audit Committee. […]
Abbott makes Lingo OTC CGM available for sale at Walmart
Abbott (NYSE:ABT) today shared that it made its Lingo biowearable device available for purchase at Walmart stores. This marks the first availability for the over-the-counter continuous glucose monitor (CGM) at a brick-and-morter retailer. It brings the Lingo device to more than 3,500 Walmart Supercenter locations (in their health and wellness sections) in the U.S. and […]
Glaukos picks up FDA approval for Epoxia incision-free keratoconus treatment
Glaukos (NYSE:GKOS) announced today that the FDA approved its Epoxia incision-free alternative to traditional corneal cross-linking procedures. Epoxia offers an advancement in corneal cross-linking for the treatment of keratoconus. Glaukos describes the rare, sight-threatening disease as “currently far too often undiagnosed and untreated.” Aliso Viejo, California-based Glaukos developed Epoxia to eliminate the need for the […]
Dexcom is facing a class action suit related to G7 CGM
A class action lawsuit has been filed against Dexcom (Nasdaq:DXCM) in the U.S. District Court for the Central District of California. The lawsuit, led by plaintiff Kelly Grisoli on behalf of all others similarly situated, demands a jury trial for claims that Dexcom’s representations for its latest-generation G7 continuous glucose monitor (CGM) were false, misleading, […]
Baxter faces investor lawsuit over infusion pumps
Investors have filed a lawsuit claiming Baxter (NYSE:BAX) violated federal securities laws as a result of issues with certain infusion pumps. Bloomberg Law first reported the filing of the lawsuit in Illinois. The class action suit seeks a trial by jury as investors hope to recover damages related to the rollout of its Novum IQ […]
Civica to launch affordable long-acting insulin in pre-filled pens in 2026
Civica announced today that it plans to launch an affordable long-acting insulin in pre-filled pens starting in January 2026. The company plans to launch insulin glargine-yfgn in pre-filled pens at the lowest list price in the current long-acting insulin market. It intends to make the offering available in the U.S. beginning on Jan. 1, 2026. […]
