Clinical updates, including trial initiations, enrollment status and data readouts and publications: Berlin Heals, Monteris Medical, Proteotype Diagnostics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocardia, Cvrx, Guardant, Histosonics, Imperative Care, Innovative Renal Care, Proximie, Vantive.
Carlsmed Inc. launched its IPO at a price of $14 to $16 per share for 6.7 million shares, which would raise just over $100.5 million at the midpoint. The spinal surgery technology company could well pull in more money, if recent history provides guidance. Most med-tech IPOs this year have settled at the upper end of their price range, with Caris Life Sciences Inc. notably raising its price twice before going public at $21, a dollar more than the top of its initial range.
Synchrony Medical Ltd. received the greenlight from the U.S. FDA for its Libairty airway clearance system which is expected to transform the lives of people with chronic lung diseases. The company is now looking to raise $5 million in series A funding to support the launch of the product in the U.S. later this year.
The U.S. Centers for Medicare & Medicaid Services (CMS) has pulled off the gloves when it comes to spending on skin substitutes in the draft Medicare physician fee schedule for 2026, proposing a payment methodology that would slash spending by 90%. However, the doc fee draft also proposes to simplify the process by which telehealth coverage is provided for a physician service, a move that may significantly expand the types of services that can be handled without an in-office visit.
To the surprise of no one in the device industry, the Medicare national coverage analysis for renal denervation (RDN) includes both radiofrequency and ultrasound technologies, but the agency has listed a range of specialists to be part of the patient’s care team, including but not limited to an endocrinologist.