Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Bevel, Haemonetics, Neuro42, Personalis, Tempus AI.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agendia, Aptargroup.
Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler.
Otsuka Precision Health Inc. and Click Therapeutics Inc. pondered the signature question of cognitive behavioral therapy when setting the market approach for their jointly developed prescription digital therapeutic for major depressive disorder, Rejoyn.
Stereotaxis Inc. Genesisx received the greenlight from the EU authorities for its next generation robotic system, which it says builds on the benefits and performance of the previous Genesis while greatly reducing its barriers to adoption.
Device makers and physicians alike were less than enthused about several features of the draft Medicare inpatient rule for fiscal year 2025, but thanks in part to support from the device industry, the final rule provides a new code that encompasses both left atrial appendage closure and ablation, a change that may reduce spending without dinging sales of these devices.
In an earnings call, Asensus Surgical Inc. told shareholders it will have to file for bankruptcy if they do not approve the previously reported merger with Karl Storz Se & Co. KG.
In Ciconia Medical Inc.’s first patenting, the company’s founder and CEO, Roni Cantor-Balan, describes the development of a cervical measurement device for childbirth progress monitoring that replaces the manual vaginal examinations undertaken during labor.