Dexcom Inc. appears poised for a very strong year with multiple new products, including the long-awaited G7, having recently received regulatory green lights in the U.S. and Europe. In addition, recommendations to expand coverage of continuous glucose monitors (CGMs) for individuals with type 2 diabetes promise to open the market to millions of new patients. Dexcom CEO Kevin Sayer provided new details and updated guidance at the J.P. Morgan Healthcare Conference in San Francsico earlier this week and the company released preliminary results for the fourth quarter and full year of 2022. Read More
Hinge Health Inc., a company offering online and virtual musculoskeletal (MSK) care, is expanding its digital platform to include in-person care. The new House Calls service will initially kick off in Chicago, followed by a nationwide rollout. Read More
At a time when Chat GPT is making waves in the world of artificial intelligence (AI), new legislation is making the rounds in Washington that would allow an AI algorithm to write prescriptions for pharmaceuticals. Rep. David Schweikert (R-Ariz.) introduced H.R. 206 to the House Energy and Commerce (E&C) Committee Jan. 9, although at present the bill enjoys the backing of no other members of the House, suggesting that this legislation has a steep climb in front of it. Read More
Act Genomics (Hong Kong) Ltd. won U.S. FDA approval for its genomic profiling test for solid tumors, Actonco. This marks the first time an Asia-based company has received FDA clearance for a comprehensive genomic profiling test. Read More
A study in a mouse model of tau protein build-up in the brain, similar to that seen in later stage Alzheimer’s disease (AD), shows that changes to the microbiome in these animals can impact the degree and progression of neurodegeneration observed. As reported in the Jan. 12, 2023, study published in Science, the researchers found that mice that were germ free and those given antibiotics to change their gut microbiome early in life had significant reductions in brain atrophy compared with those with a standard microbiome. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Autolomous, Center for Breakthrough Medicines, Cone Health, Dawn Health, Gradient Health, Hip Innovation Technology. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medcura. Read More
