Trisalus Life Sciences Inc., of Westminster, Colo., reported the start of a clinical trial assessing a treatment that combines its intravascular, tumor-directed proprietary Pressure-Enabled Drug Delivery (PEDD) approach with standard-of-care systemic chemotherapy. Read More
The 2.3% medical device tax is a thing of the past, and now Medicare coverage is one of the issues that is front and center for the Medical Device Manufacturers Association. MDMA President and CEO Mark Leahey told BioWorld also that while member companies are keen on regulatory harmonization, the struggles in standing up the new European regulatory framework is a far more pressing concern. Read More
HONG KONG – India’s central government has finally placed most med-tech devices into the category of ‘drugs,’ subjecting them to control under the Drugs and Cosmetics Act, 1940. Read More
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has issued a draft guidance to help sponsors better understand the evidence requirements for market authorizations for medical devices, including in vitro diagnostics (IVDs) and software as a medical device (SaMD). Read More
Medical device companies are seeking to reduce product defects and increase patient safety with an industry-managed program that focuses on final product quality via oversight of the most critical manufacturing processes. Modeled on a 30-year-old aerospace industry program called Nadcap, Medaccred brings device manufacturers and suppliers together to define accreditation for special processes. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott, Ablative Solutions, Daxor, Purplesun, Oxford Immunotec, Tandem Diabetes Care. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alivecor, Companion Medical, Cardiovalve, Denmat, Merit Medical, Reddress, Synaptive Medical. Read More
Keeping you up to date on recent developments in diagnostics, including: Detailed mapping of breast tumors sheds light on role of genetic variations; Leveraging AI in breast cancer diagnosis; T cell population is biomarker for β-cell function; Oligodendrocyte-neural connections not just about myelin. Read More
