Vivasure submits PerQSeal for FDA approval, expands indications in Europe
June 24, 2025
Vivasure Medical announced today that it submitted its PerQSeal Elite vascular closure system to the FDA for premarket approval (PMA).
Vivasure Medical announced today that it submitted its PerQSeal Elite vascular closure system to the FDA for premarket approval (PMA).
A new point of care test for pre-eclampsia is set to revolutionise testing for suspected pre-eclampsia in maternity units across the UK, aiding early detection and prognosis in pregnant women between 20-37 weeks of gestation.
CAESAREA, Israel, June 24, 2025 /PRNewswire/ — Nitinotes, developer of the EndoZip™ System, a fully automated suturing platform for endoscopic sleeve gastroplasty (ESG), today announced it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial under an Investigational Device Exemption (IDE).
Opioids like fentanyl, morphine and oxycodone are the drugs most linked to overdoses in the U.S. Typical screening methods for drug usage involve collection of blood, saliva or urine samples. Now, in Analytical Chemistry, researchers demonstrate a pen-like tool that can quickly and non-invasively collect molecules from the skin’s surface to be screened for opioids with mass spectrometry.
Using stem cells from patients with ALS (amyotrophic lateral sclerosis), Cedars-Sinai has created a lifelike model of the mysterious and fatal disease that could help identify a cause of the illness as well as effective treatments.
A multinational team of researchers, co-led by the Garvan Institute of Medical Research, has developed and tested a new AI tool to better characterize the diversity of individual cells within tumors, opening doors for more targeted therapies for patients.
For those living with diabetes, MannKind offers a very different alternative to the current methods of insulin delivery.
IRVINE, Calif. and ABU DHABI, UAE, June 24, 2025 /PRNewswire/ — Ocutrx Technologies Inc. (“Ocutrx”), through its R&D division Genius Labs, today unveiled a major surgical innovation: the ability to render blood translucent in real time during surgery. This patent-pending advancement enables surgeons to see through pooled blood without the need for suction or irrigation—a world first. The technology, called HemoLucence™, will be a feature of the OR-Bot™ 3D Surgical Microscope System, which is scheduled to enter clinical trials in 2025 or 2026.
WESTMINSTER, Colo., June 23, 2025 /PRNewswire/ — Cerapedics Inc., a global, commercial-stage orthopedics company dedicated to redefining the path to bone repair, today announced the U.S. Food and Drug Administration (FDA) premarket approval (PMA) of PearlMatrix™ P-15 Peptide Enhanced Bone Graft as a Class III drug-device combination product for use in single-level transforaminal lumbar interbody fusion (TLIF) surgery in adult patients with degenerative disc disease (DDD). Despite the availability of over 350+ spinal bone grafts, none have demonstrated a substantial improvement in fusion speed until now. Powered by a proprietary P-15 Osteogenic Cell Binding Peptide, PearlMatrix Bone Graft is the first and only bone growth accelerator (BGA) proven to accelerate lumbar fusion.
New imaging innovation enhances wound assessment by combining fluorescence and thermal data for improved diagnostic precision and patient care