Medtronic (NYSE:MDT) said today that its Envision Pro continuous glucose monitoring system received CE Mark approval and will be commercialized in Europe and the Middle East this fall. The Envision Pro CGM is designed to provide blinded glucose levels, track events and compile reports for physicians to assess therapies. The CGM collects glucose data to generate […]
Abbott wins FreeStyle Libre reimbursement in Ontario, Quebec
Abbott (NYSE:ABT) said today that it has won public reimbursement in Ontario and Quebec for its FreeStyle Libre sensor-based glucose monitoring system — the first of its kind listed by any provincial health plan in Canada. FreeStyle Libre is designed to monitor glucose levels with a small sensor on the back of the upper arm […]
FDA approves ready-to-use liquid glucagon from Xeris
Xeris Pharmaceuticals (NSDQ:XERS) said yesterday that the FDA has approved its Gvoke glucagon injection for the treatment of hypoglycemia. Gvoke is a ready-to-use, room-temperature, stable liquid glucagon designed to treat severe hypoglycemia in pediatric and adult patients with Type 1 diabetes aged two years old or above. Chicago-based Xeris’ Gvoke may be administered with a pre-filled […]
Dance Biopharm, DarioHealth partner up on smart inhaler
Dance Biopharm said today that it has partnered with DarioHealth (NSDQ:DRIO) to integrate Dance’s smart inhaler into DarioHealth’s digital therapeutics program. Durham, N.C.-based Dance Biopharm’s smart inhaler includes vibrating mesh designed to create a soft mist that improves medication coverage in the lung. In clinical trials, the device delivered insulin in mist form with a faster […]
Frequency Therapeutics registers $100m IPO
Frequency Therapeutics has registered an initial public offering of common stock worth $100 million. Woburn, Mass.-based Frequency Therapeutics did not disclose the number of shares it seeks to sell or the price range of the offered units. The company applied to the Securities and Exchange Commission have its common stock listed on The Nasdaq Global […]
Medtronic’s In.Pact AV DCB meets endpoints in trial
Medtronic (NYSE:MDT) said last week that its clinical study comparing the In.Pact AV drug-coated balloon to percutaneous transluminal angioplasty (PTA) met primary safety and effectiveness endpoints. The study pitted the In.Pact AV DCB against PTA in patients with de novo or non-stented restenotic arteriovenous fistulae lesions. Results were presented at the Cardiovascular and Interventional Radiology Society […]
Clearside Biomedical, Regenxbio ink sales deal for gene therapy microinjector
Clearside Biomedical (NSDQ:CLSD) has agreed to grant Regenxbio (NSDQ:RGNX) the option to an exclusive worldwide license to sell Clearside’s SCS gene therapy microinjector. The option and licensing deal is potentially worth more than $130 million, the companies said. The SCS microinjector is designed to deliver adeno-associated virus (AAV) gene therapies to treat wet age-related macular […]
Flowonix warns on software anomaly with Prometra pump
Flowonix earlier this month warned about a software anomaly with its Prometra infusion pump that could unexpectedly shut down the device. The Budd Lake, N.J.-based company won FDA approval in February for updated software included in the Prometra system, which is indicated for intrathecal infusion of drug therapy, including infumorph, saline and baclofen. Flowonix warned […]
Concept Medical wins FDA breakthrough nod for MagicTouch AVF drug-coated balloon
Concept Medical said yesterday that it won breakthrough designation from the FDA for its MagicTouch AVF drug-coated balloon. MagicTouch AVF is designed to treat stenotic lesions of arteriovenous fistulae or arteriovenous graft in hemodialysis treatment of renal failure. India-based Concept Medical’s device is indicated for use in percutaneous transluminal angioplasty. The PTA procedure, using Concept […]
Eitan taps InfuSystem for Sapphire pump maintenance deal
Eitan Group said today that it inked a deal with InfuSystem (NYSE:INFU) for repair services on its fleet of Sapphire infusion pumps. Madison Heights, Mich.-based InfuSystem plans to offer flat and al-la-carte options for Sapphire service and repair, citing a three-business-day turnaround goal on repairs. “Our partnership with Eitan Group will create savings and improve […]
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