Press Releases
Roche today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for the cobas® Respiratory 4-flex. This is the first FDA-cleared assay utilizing Roche's innovative TAGS (Temperature-Activated Generation of Signal) technology, designed to streamline respiratory testing, and to ensure timely and accurate diagnoses for patients. The new test provides accurate PCR results for the four most common respiratory viruses: SARS-CoV-2, influenza A, influenza B and re
Read more...1 August 2025
SetPoint Medical, a company dedicated to developing therapies for people living with chronic autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s SetPoint System, a breakthrough innovation for people with rheumatoid arthritis (RA). The SetPoint System is a first-of-its-kind neuroimmune modulation device for the treatment of adults living with moderate-to-severe RA who are not adequately managed by—or cannot tolerate&mdash
Read more...Ultromics, a pioneer in AI-driven cardiology solutions, today announced it has raised $55 million in Series C financing. The round was co-led by L&G, Allegis Capital and Lightrock, with continued support from Oxford Science Enterprises, GV, Blue Venture Fund and Oxford University. Major U.S. health systems, including UChicago Medicine's venture investment vehicle, UCM Ventures, and UPMC Enterprises also participated in the round. Built on years of clinical study and hundreds
Read more...31 July 2025
Life Backup Plan by Galacxia, Inc, redefining how individuals and care systems manage everything from emergencies to healthcare communication, today announced $45,000 in new funding. The investment will support the app’s national rollout and fuel development of features aimed at improving emergency response, streamlining care coordination, and lowering healthcare costs. “Life Backup Plan began as a safety net for people alone during vulnerable moments—seniors, solo
Read more...BD, a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Veritor™ System for SARS-CoV-2, a digital test designed to detect COVID-19 antigens in symptomatic individuals in about 15 minutes at doctors' offices, urgent care centers, retail clinics and other convenient points of care. The BD Veritor™ System for SARS-CoV-2 has been available under Emergency Use Authorization (EUA)
Read more...30 July 2025
Monogram Technologies Inc. an AI-driven robotics company revolutionizing orthopedic surgery, today announced that on Saturday, July 26, 2025, Monogram completed the first ever fully autonomous saw-based robotic knee replacement procedure on a live patient. The procedure was performed at the Krishna Shalby Hospital in Ahmedabad India, as part of Monogram’s multi-center clinical trial in India for the Monogram TKA System. As previously announced, Monogram and Shalby pa
Read more...30 July 2025
SUPERWISE, a trusted Enterprise AI Governance and Operations Platform, today announced the successful implementation of its cutting-edge AI solutions with Renova Health, a leader in chronic care management. This strategic deployment by SUPERWISE leverages its advanced AI capabilities to transform patient engagement at Renova Health through real-time data, intelligent automation, and personalized care, all integrated within Renova's RCare platform. SUPERWISE's strategic deplo
Read more...Matrix Medical Network (Matrix), a leader in delivering high quality, home-based health and care services, announced a new strategic partnership with CareNexa, LLC dba Molecular Testing Labs (MTL), a CLIA- and New York state-certified, CAP-accredited laboratory renowned for its innovation and quality in molecular diagnostics. The collaboration represents an additional step in Matrix's mission to improve health outcomes for patients and deliver greater value to clients. Matrix se
Read more...Stereotaxis a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its groundbreaking MAGiC Sweep™ catheter. MAGiC Sweep is the world’s first robotically navigated high-density electrophysiology (EP) mapping catheter, representing a significant advancement in the technology available to diagnose and treat complex arrhythmia patients.
Read more...Innovaccer Inc., a leading healthcare AI company, today announced a strategic partnership with the American Medical Group Association (AMGA), a trusted trade association representing more than 400 of the nation’s leading health systems and medical groups. Through this collaboration, Innovaccer will support AMGA’s mission by enabling its members to access cutting-edge innovation, influence the adoption of emerging technologies, and shape the future of care delivery for both patient
Read more...