MedTech News
BD Receives FDA 510(k) Clearance for Rapid Point-of-Care COVID-19 Test
FRANKLIN LAKES, N.J., July 30, 2025 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), 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.
Gnosis Launches EdenDx, the First Non-Invasive Liquid-Based Cytology U.S. Test for Early Endometrial Cancer Detection
ORANGE, Calif., July 30, 2025 /PRNewswire/ — Gnosis, a Southern California-based diagnostic lab advancing women’s health through molecular innovation, today announced the national launch of EdenDx, which stands for Early Detection for Endometrial Neoplasia, the first commercially available non-invasive liquid-based cytology test in the United States for early-stage endometrial cancer detection.
Trial Evaluating Blood Test for 10 Cancers Reaches Major Milestone
SOUTHAMPTON, England, July 30, 2025 /PRNewswire/ — MODERNISED (NIHR207538), a multi-site UK clinical study has passed a key milestone: over 450 participants have joined the trial evaluating ENLIGHTEN®, a first-of-its-kind blood test, registered with the MHRA, and designed to spot signals of up to 10 cancers at their earliest, most treatable stages
Mapping cells in time and space: New tool reveals a detailed history of tumor growth
Researchers developed a tool to recreate cells’ family trees. Comparing cells’ lineages and locations within a tumor provided insights into factors shaping tumor growth.
Alafair Biosciences Earns Dual FDA 510(k) Clearances for VersaCoat™ Flowable Hydrogel
VersaCoat, a syringe-deliverable soft-tissue protector, brings Alafair’s proven hyaluronic acid and alginate formula to complex surgical sites—expanding its impact in orthopedic, trauma, and sports medicine procedures.
Labcorp Achieves IVDR CE-Marking for PGDx elio™ tissue complete in the EU
BURLINGTON, N.C., July 29, 2025 /PRNewswire/ — Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today PGDx elio™ tissue complete has been CE-marked under the European Union’s (EU) new In Vitro Diagnostic Regulation (IVDR).
Body Vision Medical Receives Regulatory Approval for LungVision® in Brazil, Expanding Access to AI-Driven Advanced Imaging for Lung Cancer Diagnosis
WALTHAM, Mass., July 29, 2025 /PRNewswire/ — Body Vision Medical, a global leader in AI-powered intraoperative imaging, is proud to announce that its LungVision advanced imaging system has received regulatory approval from ANVISA, Brazil’s National Health Surveillance Agency. This approval marks another significant step forward in the company’s mission to improve early and accurate lung cancer diagnosis around the world.
Artificial biosensor can better measure the body’s cortisol stress hormone
Cortisol is a crucial hormone that regulates many important bodily functions like blood pressure and metabolism, and imbalances of this stress hormone can lead to health problems.