FDA grants breakthrough device designation for Renovos’ bone graft gel
Renovite BMP-2 is made from a synthetic nanoclay gel, designed to be safer and more effective than current bone graft materials. UK-based Renovos Biologics has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for Renovite... Read More →
Nanowear Announces FDA 510(k) Clearance for AI-enabled Continuous Blood Pressure Monitoring and Hypertension Diagnostic Management: SimpleSense-BP
NEW YORK–(BUSINESS WIRE)–Nanowear, a leader in healthcare-at-home remote diagnostics, announced that its nanotechnology-enabled wearable and software platform, SimpleSenseTM, has received FDA 510(k) clearance for a novel AI-enabled Software-as-a-Medical Device (SaMD). As the first non-invasive, cuffless, continuous blood pressure monitor, and... Read More →
Bloomlife and PeriGen Partner to Improve Access to Critical Maternal and Fetal Health in the Face of Maternity Care Deserts
SAN FRANCISCO, Jan. 4, 2024 /PRNewswire/ — Bloomlife, an award-winning maternal health company, and PeriGen, the market leader in applying artificial intelligence to improve safety in childbirth, today announced a partnership to improve access to essential monitoring of high-risk pregnancies.... Read More →
Xcellerant Ventures Backs CRISPR QC in Series A and Commercial Expansion
SAN DIEGO–(BUSINESS WIRE)–CRISPR QC, a biotechnology start-up based in San Diego, is pleased to announce a major stride in its ongoing Series A funding round. Known for their CRISPR Analytics Platform, powered by the CRISPR-Chip, CRISPR QC analyzes and optimizes... Read More →
Enspectra Health Announces US FDA Clearance of VIO™ System, First of Its Kind Technology to Visualize Skin Cellular Structures in Real-Time
MOUNTAIN VIEW, Calif., Jan. 3, 2024 /PRNewswire/ — Enspectra Health, a health tech company, announces US FDA 510(k) clearance of the VIO System, launching a new era in noninvasive imaging. VIO, the first of its kind technology, combines reflectance confocal... Read More →
Medicare OK clears sales hurdle for heart surgery simulation software
Medicare will now reimburse nearly $1,000 per procedure for heart surgery planning software from an Ohio State University spinoff – clearing a hurdle for increasing sales to hospitals. Dasi Simulations LLC’s software – “3D predictive model generation for preplanning of... Read More →
Teijin Limited Signs Joint R&D Agreement with Garwood Medical Devices
Electrochemical therapeutic technology BioPrax™ addresses the high failure rate of joint implants due to infection BUFFALO, NY, UNITED STATES, January 3, 2024 /EINPresswire.com/ — Garwood Medical Devices, a breakthrough New York medtech company, and Teijin Limited, a leading Japanese conglomerate... Read More →
Galway medtech breakthrough firm SymPhysis raises €1.5m
SymPhysis Medical has received €1.5m in funding and is seeking an additional €4.5m-plus early next year to support the continued development of its breakthrough medical device, FDA approval and the creation of new jobs. The Galway business is developing a... Read More →
Sentante Secures €6 Million in New Funding to Revolutionize Endovascular Care
Sentante, a pioneering medical device company headquartered in Lithuania, announces the closing of a €6 Million seed funding round led by Practica Capital with participation of EIC fund. The company will use the proceeds from the financing for the planned... Read More →
GT Medical enhances GammaTile Therapy with Cesium-131 seed business acquisition from Isoray Medical
USA —GT Medical Technologies, a US-based medical equipment manufacturer, has agreed to acquire the radioactive Cesium-131 seed business and its infrastructure from Isoray Medical, a subsidiary of Perspective Therapeutics. This acquisition aims to fortify GT Medical’s position in the market,... Read More →