In what represents the first patenting to emerge in the name of Durvena Inc., co-founder and CEO John Ashley describes the development of a treatment for vein grafts that strengthens the graft and reduces the occurrence of intimal hyperplasia that commonly leads to graft failure.

The U.S. FDA’s January 2025 draft guidance for AI-enabled device software functions has not fared well in terms of industry response. Two major trade associations argue that the draft is at least somewhat redundant with existing agency guidance.

The U.S. FDA gave the green light to Nanosonics Ltd.’s Coris system via de novo clearance for reducing infection risk by delivering improved cleaning outcomes for flexible endoscopes, especially the complex channels of endoscopes that are prone to biofilm build up.

In the first patenting from Lent Innovations LLC, the company’s founder, Anne Lent – an allergist and immunologist – describes their invention of an epinephrine auto-injector tailored to the specific needs of children to reduce the risk of use errors and incorrect injection technique.

Researchers from the University of Southern California filed for protection of a thin film electrode array they developed to be implanted using endovascular methods for minimally invasive, high-resolution electrical recording and stimulation of the nervous system and other electrogenic tissue.

Researchers from Arizona State University and Mayo Clinic have filed for protection of wireless, battery-free brain implants which may be used in the monitoring, stimulation, and treatment of epilepsy, tumors, neurodegenerative disorders, neuroinflammatory conditions and trauma.

Embattled Masimo Corp. disclosed it received a non-binding term sheet offering $850 million to $950 million for a potential joint venture that would include its consumer health products and the Sound United business. In an 8-K filing with the U.S. Securities and Exchange Commission, Masimo said it intends to negotiate for a higher price.

The years’ long effort by activist investor Politan Capital Management LP to take control of the Masimo Corp. board of directors and oust Masimo CEO and founder Joe Kiani took a turn for the weird this week as news emerged that Masimo Chief Operating Officer Bilal Muhsin notified the board that he would step down if Kiani were pushed out.

In just its second PCT filing, Ykrita Lifesciences Private Ltd. (YLS) continues to assemble intellectual property for its development of an extracorporeal bioengineered dual-cell liver regeneration (EBDLR) system which serves as a lightweight, portable, ectopic liver device to aid in the rejuvenation of the body’s own liver and treat acute liver failure without the need for surgery.