Toku, Inc., a commercial medical device company specializing in imaging technology and AI, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its patented CLAiR technology.
Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i announced new findings from the Q-FFICIENCY study were published in the Journal of Cardiovascular Electrophysiology demonstrating treatment with the QDOT MICRO™ Catheter significantly improved control of atrial fibrillation (AFib), relief of symptoms and overall quality of life.
QuantalX Neuroscience, a pioneering healthcare company dedicated to early detection of brain disorders, is pleased to announce that it has secured a US reimbursement code, 0858T, from the American Medical Association (AMA). This milestone achievement is a significant part of the company's pre-commercialization strategy in the US.
EyeCheq, a leading innovator in eye care technology with its fully autonomous eye screening platform, is pleased to announce the expansion of their Leadership Team. Dr. Ruwan Silva will serve as Chief Medical Officer and Christopher Grant as EVP of Operations to strengthen EyeCheq's scientific and operational expertise.
Genezen, a leading cell and gene therapy Contract Development and Manufacturing Organization (CDMO),announced the closing of an $18.5 million follow-on growth equity investment led by Ampersand Capital Partners.
Xēnix Medical, a surgical implant company focused on the development of novel science-based solutions for patients requiring spinal fusion surgery, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the SOLACE™️ Sacroiliac Fixation System with proprietary NANOACTIV™️ surface technology and compatibility with StealthStation® Navigation.
Medical device and technology company Lazurite® announced that its ArthroFree® Wireless Camera System will be available at the Arthroscopy Association of North America (AANA) Advanced Knee and Shoulder course on Oct. 20-22, and the Innovations in Hip Arthroscopy lab course on Nov. 3-4, at the AANA Orthopaedic Learning Center in Rosemont, Illinois.
-Wind River®, a global leader in delivering software for mission-critical intelligent systems, announced that RIVERFIELD Inc., is using VxWorks® to develop the Saroa Surgical System, a surgical assist robot.
Medical device company Linear Health Sciences announced it received an expanded indication from the U.S. Food & Drug Administration (FDA) for its Orchid SRV™ safety release valve. The expanded indication means that the Orchid SRV may now be used with all IV access methods.
American Regent announces the release and availability of Levocarnitine Injection, USP, FDA-approved, "AP" rated, and therapeutically equivalent to Carnitor®. Levocarnitine is indicated for the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency, and for the prevention and treatment of carnitine deficiency in patients with end-stage renal disease who are undergoing dialysis.