Fractyl Health CEO Harith Rajagopalan envisions a scenario in which those with type 2 diabetes don’t have to rely on insulin injections. Insulin has long been a staple of treatment for type 2 diabetes patients who need to manage their blood sugar levels, but Rajagopalan’s aim is to go beyond that temporary fix. Trained as […]
Diabetes
DarioHealth acquires PsyInnovations for $30M
DarioHealth announced that it entered into an agreement to acquire digital health company PsyInnovations for up to $30 million. PsyInnovations develops the wayForward behavioral digital health platform with AI-enabled screening to triage and navigate members to specific interventions, digital cognitive behavioral therapy (CBT), self-directed care, expert coaching and access to in-person and telehealth provider visits, according […]
FDA issues draft clinical trial guidelines for neurostim, other devices to treat diabetes
The FDA today issued a draft guidance with recommendations for clinical trials for certain devices intended for treating diabetes. Included in the guidance are recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with type 2 diabetes mellitus, independent of medication delivery. Among the […]
Neurodon prepping IND application for type 1 diabetes treatment
Neurodon announced today that it initiated studies to prepare an FDA Investigational New Drug (IND) application for its type 1 diabetes treatment. Crown Point, Ind.-based Neurodon’s NDC-0009 novel molecule targets endoplasmic reticulum (ER) stress, a pathway triggered by factors arising from disease that features in type 2 and type 2 diabetes, as well as inflammation […]
Senseonics stock up on Street-beating Q1
Senseonics (NYSE:SENS) shares rose today on first-quarter results that beat the consensus forecast. The Germantown, Md.-based diabetes management technology developer posted losses of -$249.5 million, or -68¢ per share, on sales of $2.8 million for the three months ended March 31, 2021, registering a massive bottom-line slide from losses of -$42.6 million this time one […]
Insulet sues Roche over diabetes tech patent
Insulet (NSDQ:PODD) is suing Roche Diabetes Care in the U.K., claiming that Roche prematurely began selling tubeless insulin pumps covered by an Insulet patent three years before that patent expires. The trial for the lawsuit, filed in August 2020, began this week in the U.K. High Court. Insulet claims that Roche has been infringing the […]
Virta Health touts one-year outcomes for diabetes reversal tech in Native American tribal nation
Virta Health announced today that one-year outcomes for its diabetes reversal tech proved successful on a number of levels. San Francisco-based Virta’s results came from its multi-year partnership with the Mashantucket Pequot Tribal Nation. Native Americans suffer from the highest rates of type 2 diabetes compared to any other ethnic group in the country, with […]
Bigfoot Biomedical wins FDA clearance for smart insulin pen cap system
Bigfoot Biomedical announced today that it received FDA 510(k) clearance for its Bigfoot Unity diabetes management system. Milpitas, Calif.-based Bigfoot’s first-of-its-kind Bigfoot Unity system features connected smart pen caps designed to recommend insulin doses for diabetes patients using multiple daily injection (MDI) therapy, according to a news release. Bigfoot Unity smart pen caps offer on-demand […]
Insulet shares down after Q1 miss
Insulet (NSDQ:PODD) stock is down today — a day after the wearable insulin delivery system developer posted break-even Q1 results that were lower than analysts’ expectations. The company, however, yesterday evening raised the low end of its revenue guidance range to 16–20%. The range was previously 15–20%. The Acton, Mass.-based company a net loss of […]
Tandem Diabetes Care beats The Street in Q1, raises guidance
Tandem Diabetes Care (NSDQ:TNDM) narrowed its losses year-over-year in Q1, with results beating the consensus forecast on Wall Street. The San Diego-based company yesterday evening posted losses of –$5 million, or –8¢ per share, on sales of $141 million for the three months ended March 31, 2021, reducing losses by nearly two-thirds on sales growth […]