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.
ClariMed, Inc., the first end-to-end MedTech services partner to prioritize usability as the core of their integrated, human-centric approach to medical product development, announced the appointment of Sandrine Parkins as Head of Operations for Harvey Medical, a ClariMed company.
Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible, announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for indication expansion of the Quanta™ Dialysis System, a compact and easy-to-use hemodialysis device.
GT Molecular, Inc., a company providing ultrasensitive PCR assays for wastewater-based epidemiology testing, pathogen detection, and cancer research is pleased to announce an agreement with Roche to provide a highly multiplexed respiratory panel for wastewater surveillance on the new Roche Digital LightCycler® System.
Masimo announced the findings of a study published in Frontiers in Neuroscience in which Dr. Lichy Han and colleagues at Stanford University evaluated the ability of Masimo SedLine® brain function monitoring to assess the sedation levels of patients undergoing drug-induced sleep endoscopy (DISE) with dexmedetomidine – a sedative with numerous advantages.