San Diego-based Dexcom Inc., is the target of a class action lawsuit in U.S. district court over the company’s G7 continuous glucose monitors, an action which follows a U.S. FDA warning letter by a mere seven months and a recall announced in July, suggesting that litigation often follows other sources of bad news for firms in the med-tech business.
Pomdoctor Ltd. raised $20 million through a Nasdaq IPO on Oct. 8, with the funds geared to expand its mobile health platform for chronic diseases in China.
Like the federal district court before it, the U.S. Court of Appeals for the Third Circuit said it lacks jurisdiction to rule on the merits of Novo Nordisk A/S’ claim that the CMS violated the Inflation Reduction Act (IRA) when it treated six of the company’s insulin aspart products as one negotiation-eligible single-source drug.
Among severe insulin-deficient diabetes patients, 12 weeks of 100-mg, once-daily dosing of Biomea Fusion Inc.’s icovamenib lowered hemoglobin A1c by 1.8% from placebo at the 52-week timepoint, an increased benefit over and above what was seen at 26 weeks.
Although type 2 diabetes tends to get more airtime, type 1 diabetes also had drawn a number of the developers to the table. Recently winning the attention of Wall Street is SAB Biotherapeutics Inc., which offered data during the European Association for the Study of Diabetes annual meeting. Vertex Pharmaceuticals Inc. and Biomea Fusion Inc. are among the other players.
With a new drug available to slow the progression of type 1 diabetes, Sanofi SA is partnering with two med-tech companies to increase screening for early-stage type 1 diabetes and identify eligible patients.
Ernst & Young LLP didn't quite declare the patient cured but saw signs of a strong med-tech recovery after a few years on life support in its annual Pulse of the MedTech Industry report. The global accounting giant particularly called out strength in the cardiovascular, diabetes, robotics and orthopedics segments.
Convatec Group plc secured CE mark and UKCA approvals for Convamatrix, its porcine placenta-based wound dressing designed for hard-to-heal wounds. The single use, skin substitute product is intended to cover, protect and provide a moist wound environment to support the body’s natural healing process.
Roche Holdings AG received CE mark approval for the integration of its AI-enabled continuous glucose monitoring system, Accu-Chek Smartguide, with the Mysugr diabetes management app. The integrated solution, which combines predictive CGM technology with therapy data in one place, will simplify the daily decision-making for users managing their diabetes.
Goodpath Inc., a virtual provider of whole-person care for chronic conditions, raised $18 million in series A financing, led by Massmutual Ventures with participation from Healthy Ventures and current investors.