Cook Regentec spinout Sexton Biotechnologies said today that it raised $5 million for the cell and gene therapy bioproduction tools it’s developing. The company is Cook’s first to pick up outside investment capital and spin out as an independent biotechnology company, according to a news release. Sexton is made up of a 17-person team from Cook […]
FDA clears Insulet’s OmniPod Dash as insulin pump alternative
Insulet (NSDQ:PODD) said today that it won FDA clearance to market its Omnipod Dash alternate controller-enabled (ACE) infusion pump as an integrated insulin pump. The Acton, Mass.-based company received FDA 510(k) clearance for the Omnipod Dash in June 2018 and launched the device earlier this year. The latest indication states that the pump can reliably and […]
Ambrosia app links Abbott’s FreeStyle Libre with Fitbit wearable
Ambrosia Systems said today that it launched its LinkBlueCon application on the Fitbit and Abbott (NYSE:ABT) FreeStyle Libre smartwatch platforms for glucose monitoring. San Fransisco-based Ambrosia’s LinkBlueCon app is designed to monitor glucose levels and receive notifications when glucose readings are outside the target range, all without the need to go to a clinic. Ambrosia said […]
Tandem Diabetes Care touts real-world t:slim X2 insulin pump data
Tandem Diabetes Care (NSDQ:TNDM) yesterday touted real-world data from users of the t:slim X2 insulin pump. The data, from more than 8,000 users, was published in the medical journal Diabetes Technology & Therapeutics. San Diego-based Tandem said the study showed a 45% relative risk reduction in hypoglycemia and a 71% relative risk reduction in hypoglycemic events, […]
Pulmatrix doses first patient in Pulmazole trial
Pulmatrix (NSDQ:PULM) said yesterday that it dosed the first patient in its Phase II trial of Pulmazole for the treatment of allergic bronchopulmonary aspergillosis asthmatics. The 64-patient study is a randomized, double-blinded, placebo-controlled trial to evaluate the safety and efficacy of three dose levels of the anti-fungal drug itraconazole formulation Pulmazole. The multi-center, four-arm trial will […]
Senzer Pharmaceuticals wins CE Mark for cannabinoid inhaler
Senzer Pharmaceuticals said yesterday that it has received the CE Mark for its cannabinoid inhaler. London-based Senzer said the Class IIa medical device approval, obtained in a joint project with manufacturing partner Europlaz, is the first-ever granted in the cannabinoid space and will allow the company to accelerate its plans to launch in the UK […]
Orchestra BioMed wins breakthrough nod for Virtue SEB
Orchestra BioMed said today that it received breakthrough device designation from the FDA for its Virtue sirolimus-eluting balloon for the treatment of below-the-knee peripheral artery disease. The Virtue SEB is the first and only non-coated below-the-knee sirolimus-eluting angioplasty balloon system to receive a breakthrough nod, Orchestra BioMed said in a release. The New Hope, Pa.-based […]
Medtronic launches Envision Pro CGM in Europe
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 […]
