The U.S. Medicare program has a notorious problem with regard to coverage of digital products and software as a service, but the agency is dependent on Congress to add new benefit categories via legislation.
The U.S. FDA granted Momentis Surgical Ltd. 510(k) clearance for its Anovo robotic surgical platform for use in single site, abdominal access ventral hernia repairs. The U.S. regulatory agency also gave the greenlight to CMR Surgical Ltd.’s Versius system for use in cholecystectomy, in a sign of the growing market for smaller, more portable robotic devices to assist in minimally invasive procedures.
With confidence dropping in doing business with China-affiliated life sciences companies due to the Biosecure Act, one of the companies explicitly named in the U.S. legislation is fighting back. Raising the possibility of a constitutional challenge to the bill, Rade Drmanac, co-founder and chief scientific officer of Complete Genomics Inc., wrote to congressional leaders to urge them to remove the California-based subsidiary of MGI from the bill.
Third-party litigation funding has been a source of controversy in the U.S. over the past decade, but the practice drew little national scrutiny up to now.
Hologic Inc. signed an agreement to acquire Gynesonics Inc. for $350 million. The acquisition will significantly boost Hologic’s revenues from surgical gynecology and provide an option not met by the company’s current portfolio of products.
The U.S. FDA’s device center disclosed its guidance ambitions for this new fiscal year – a list that includes the usual A and B lists for draft and final guidances. However, the agency now has an “under construction” list of guidance ambitions, the status of which is entirely reliant on the agency’s resources.
Ceribell Inc. launched its initial public offering of more than 10.6 million shares of common stock at $17 and steadily saw the trading value rise, before closing just over $25 on Oct. 11 per share. Ceribell, which developed a portable electroencephalogram for use in intensive care and emergency department settings, expected to gross $180.3 million from the IPO excluding any exercise of the underwriters’ option to purchase additional shares. The IPO will close on Oct. 15.
Glooko Inc. secured a $100 million series F financing to support expansion of its diabetes ecosystem platform, which integrates information from more than 200 devices on a centralized, digital data platform that simplifies care for patients and clinicians. At the same time, the company reported the appointment of Mike Alvarez as CEO.
Abbott Laboratories reported it achieved new major milestones to support the company's growing suite of pulsed field ablation (PFA) solutions in electrophysiology: early completion of enrollment in the VOLT-AF IDE study supporting the Volt PFA system, and the launch of the Focalflex trial to assess the company's Tactiflex Duo ablation catheter, sensor enabled, which will be used in the treatment of patients with paroxysmal atrial fibrillation.
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