FDA

Lifeward, previously known as ReWalk Robotics, declared today an agreement to sell ordinary shares amounting to $5 million in proceeds. The enterprise located in Marlborough, Massachusetts, has agreed to issue and sell over 1.8 million shares, each priced at $2.75. […]

Fire1 announced today the successful completion of a $120 million funding round aimed at accelerating the development of its heart failure management technology. A significant milestone was reached as the company received breakthrough device designation from the FDA. Additionally, its

Francis Medical announced today that it has successfully concluded an $80 million Series C equity financing that exceeded expectations. The round was jointly spearheaded by Arboretum Ventures and Solas BioVentures. New backers, including Orlando Health Ventures and two other strategic

Xeltis announced today the completion of participant enrollment in its EU pivotal trial for aXess, a pioneering vascular access conduit. The trial is focused on evaluating the conduit in adults suffering from end-stage renal disease. Based in Eindhoven, The Netherlands,

Endologix revealed today that Dr. Matt Thompson, the company’s President and CEO, plans to vacate his current position to assume the role of EVP and chief medical officer. This transition paves the way for Dr. John Liddicoat, who has been

Alleviant Medical has announced obtaining both FDA investigational device exemption (IDE) and breakthrough device designation for their innovative atrial shunt. Operating out of Austin, Texas, Alleviant has pioneered a unique no-implant atrial shunt designed to manage heart failure characterized by

AccurKardia has announced its recent acquisition of the FDA’s breakthrough device designation for its cutting-edge AI-based software designed to detect hyperkalemia using ECG data. The AK+ Guard platform utilizes Lead I ECG readings to identify and alert both patients and

Stryker has solidified a definitive agreement to acquire Inari Medical for $80 per share, a substantial markup valuing the transaction at $4.9 billion. Prior to the announcement, Inari Medical’s shares were trading at around $48. Endorsed by both Stryker’s board

Medtronic (NYSE: MDT) has announced that its Harmony transcatheter pulmonary valve (TPV) system has secured CE mark approval. According to Children’s HeartLink, a nonprofit from Minneapolis, approximately 1.3 million children worldwide are born annually with congenital heart defects. The Harmony

NanoVibronix (Nasdaq:NAOV) has announced the successful completion of the initial phase in a randomized controlled trial for its UroShield device. This study was conducted by researchers at the University of Michigan. UroShield, a compact ultrasonic therapeutic tool, implements innovative low-intensity