The European Health Data Space (EHDS) proposal is designed to standardize practices for transmission and other sharing of health information, but this proposal is far from the only significant development coming out of Brussels.
While still pending clearance in the U.S., Medtronic plc’s Minimed 780G advanced hybrid closed loop (AHCL) system continues to post strong results in clinical trials. Results of two studies presented at the 2023 Advanced Technologies & Treatments for Diabetes Conference in Berlin on Feb. 27 demonstrated that patients with type 1 diabetes (T1D) who used the device for one year maintained a 26.7% increase in time in range for adults and a 14% increase in time in range for children aged 7 to 17 compared to their baseline using multiple daily injections with a continuous glucose monitor (CGM).
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Lucira Health, Milestone Scientific.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: GE Healthcare, Iradimed, Macrogen, Monopar Therapeutics, Northstar Medical Radioisotopes, Orthoventions, Singleron, Sonde, Sonothera.
Manufacturers of contact lenses may or may not want prescribers to be agnostic as to brand, but the U.S. Federal Trade Commission’s (FTC) contact lens rule requires that prescribers give the prescription to the customer when the eye exam is complete.