The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Neovasc snares second patent term extension; CMS drops CT image quality proposal; TGA opens docket for nanomaterials regulation; ATA supports OIG statement on telehealth.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aquarius Surgical Technologies, Healthmode, Htg Molecular Diagnostics, Inventiva, Materials and Machines, Medi-Tate, Mesa Biotech, Mind Medicine, Olympus, Picnichealth, Sirtex Medical, Surgical Lasers, Thermo Fisher, Vela Diagnostics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fusion Robotics, Roche.
Keeping you up to date on recent developments in neurology, including: Preventing seizures after brain injury could slow or stop the onset of dementia, Researchers find new signaling pathway in neurons, Developing a cost effective, less invasive method to diagnose potential for Alzheimer’s disease.
If Marvel’s Peter Parker had chosen to apply his graduate work in biochemistry and his web-shooters to medicine, he might have created something like Nanomedic Technologies Ltd.’s Spincare system. The system uses a hand-held medical gun that prints a flexible, transparent layer of artificial skin directly on a wound or burn. The Electrospun Healing Fiber (EHF) technology creates a waterproof, protective nano polymer matrix.
Test developers and the U.S. FDA are scrambling to meet the testing needs of the American public, however, it's somewhat unclear what the agency's priorities are for the emergency use authorization (EUA) program. Jeffrey Shapiro, of Hyman Phelps & McNamara, made the case that the FDA’s Center for Devices and Radiological Health (CDRH) should be more transparent about its priorities for EUA review.
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