As device-makers, healthcare practitioners and people with diabetes convened at this year’s annual meeting of the American Diabetes Association, one major theme emerged: the industry is catching on to the potential of closed-loop insulin delivery systems. Major medical technology companies, including Medtronic and Insulet, touted data at this year’s meeting demonstrating the benefits of their […]
Valeritas touts positive results for V-Go wearable insulin delivery device
Valeritas (NSDQ:VLRX) shares jumped this morning after the company touted positive results from its Enable study, showing that patients who switched from insulin pens and syringes to the company’s wearable V-Go insulin delivery device experienced improved blood glucose levels and lowered their daily insulin dose. The company presented three posters at this year’s meeting of the […]
Sunovion looks to molecular clues, patient preferences to inform drug development
From discovery to commercial launch, drug development often takes years. New tools available to the industry, like the use of biomarkers and patient-reported outcomes, promise to help inform and speed up the process. “Being able to pick out the appropriate patients using the appropriate biomarkers and establishing a relationship between on-target pharmacology and any safety […]
Impel NeuroPharma readies trial for intranasal drug-device migraine treatment
Impel NeuroPharma said today that the FDA gave it the green light to proceed with its Phase III clinical trial of INP104 – a drug delivered by Impel’s intranasal delivery device for the treatment of acute migraine. The company expects to start enrolling patients in the pivotal trial in the second half of this year. […]
Tandem wins FDA nod for insulin pump with predictive low glucose suspend feature
The FDA this week approved Tandem Diabetes Care‘s (NSDQ:TNDM) t:slim X2 insulin pump with a predictive low glucose suspend feature designed to cut the frequency and duration of hypoglycemia. The San Diego, Calif.-based company said that upon launch, its new product will also feature Dexcom‘s (NSDQ:DXCM) G6 continuous glucose monitoring system. Tandem expects that the […]
FDA approves Senseonics’ implantable continuous glucose monitor
The FDA this week approved Senseonics‘ (NYSE:SENS) Eversense continuous glucose monitor for use in people ages 18 and older with diabetes. The device is the first CGM system to feature an implantable sensor that can be worn for up to 90 days. Senseonics’ Eversense device includes a small sensor that is implanted just below the […]
Mercator MedSystems raises $11m in Series D for micro-infusion catheter system
Mercator MedSystems said this week that it raised $11 million in a Series D equity round led by Shenzhen Salubris Pharmaceuticals, with participation from current Mercator investors and other unnamed new investors. The Emeryville, Calif.-based company plans to use its newly-acquired funds to support the clinical development of its micro-infusion catheter system, the Bullfrog device. […]
Medtronic’s MiniMed system wins FDA nod for pediatric indication
The FDA this week expanded its approval for Medtronic‘s (NYSE:MDT) MiniMed 670G hybrid closed-loop diabetes management device to include people ages 7 to 13 with Type I diabetes. The system, which automatically monitors blood sugar levels and doses basal insulin accordingly, was initially approved in the U.S. for people ages 14 and older. Medtronic’s MiniMed […]
Cerebral Therapeutics raises $3m for epilepsy drug-device therapy
Cerebral Therapeutics closed a $3 million Series A financing round this week to support the development of its drug-device therapy designed for patients with refractory epilepsy. The Aurora, Co.-based company’s product uses an implanted, refillable catheter system to deliver a continuous, intracerebroventricular dose of an anti-epileptic drug – valproic acid. Investors that contributed to Cerebral […]
Companion Medical launches data management system for smart insulin pen
Companion Medical launched today Insights by InPen, a diabetes management system that aggregates and analyzes data from Companion’s connected insulin injection pen. The company’s Insights by InPen system provides users with their average glucose, average total daily insulin dose, dose calculator usage, missed doses and more, according to Companion Medical. The system is available in […]
