FDA

"The FDA's clearance of our IND application to initiate clinical evaluation of AHB-137 in CHB patients in the United States brings us one step closer to introducing a potential functional cure for people living with HBV." said AusperBio CEO and Co-founder Dr. Guofeng Cheng, "This milestone is a pivotal juncture for AusperBio, underscoring our consistent and outstanding execution in driving innovative therapies towards a functional cure for CHB."

"PAPILLON is the first randomized Phase 3 study in patients with NSCLC with EGFR exon 20 insertion mutations to show clinically meaningful results. This creates an opportunity to make a significant improvement to the standard of care for this patient population with high unmet medical need," said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. "We look forward to working with the FDA through the RTOR pathway in pursuit of an approval for RYBREVANT plus chemotherapy as we simultaneously progress the development of this novel bispecific antibody in additional patient populations."

The Levita MARS system is a first-of-its-kind minimally invasive surgical platform aimed at the high-volume abdominal surgery market. Harnessing the power of both magnets and machines, MARS reduces the number of incisions and enables surgeons to have complete control during laparoscopic procedures, all in a compact footprint designed to fit into existing operating rooms.

"From the outset, our vision for Evie has been to develop a consumer wearable that is beautiful, accessible and personalized, as well as be cleared by the FDA as a medical device. This first submission to the FDA marks a momentous milestone for our team and sets the stage for future FDA filings," said John Mastrototaro, CEO of Movano Health. 

This novel technology is designed for patients with aortic valvular disease. Aortic regurgitation is a common condition that can lead to heart failure. The J-Valve™ transcatheter aortic valve replacement procedure is performed through a minimally invasive transvascular approach, without the need for open-heart procedure or extracorporeal circulation.

New AI guidance software will allow more medical professionals to conduct cardiac ultrasound in multiple care settings expanding patient access to cardiac imaging.