Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainlab, Piccolo Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: BD, Brainstorm Cell Therapeutics, Gala Therapeutics, Integral Diagnostics, Lightdeck Diagnostics, Lucid Diagnostics, Medica, Mediwound, Nuprobe, Paragonix, Pavmed, Pre Diagnostics, Scanwell Health, Seaspine, Solys Diagnostics, Spineway, Tsunami Medical.
Keeping you up to date on recent developments in cardiology, including: Algorithm can make echocardiography a breeze for the inexperienced; Algorithm suppresses CT scan time in chest imaging studies; Study shows distal radial access better for occlusion.
TORONTO – Puzzle Medical Devices Inc. has been granted a U.S. FDA breakthrough device designation for a transcatheter heart pump designed for fragile patients with few minimally invasive options for treating advanced heart failure.
PERTH, Australia – About seven years ago, Australia’s George Institute for Global Health conducted a study to find out how many people require dialysis for end-stage kidney failure compared to how many people receive treatment.
Patensee Ltd. initiated a first-in-human trial of its machine vision-based surveillance system for stenosis in hemodialysis patients. The trial will evaluate the imaging system's ability to perform contact-free surveillance of the access points or fistulas essential for dialysis, which nearly all narrow or become blocked over time. The surveillance system aims to mimic the central components of a dialysis nurse's exam using technology.
The Washington Legal Foundation’s (WLF) webinar on False Claims Act (FCA) litigation highlighted several developments in case law, including that non-relator FCA cases were up significantly in fiscal year 2020. However, Jay Stephens, an attorney with Kirkland & Ellis LLP, noted that Sen. Chuck Grassley (R-Iowa) has taken aim yet again at the materiality standard for false claims as spelled out in the Supreme Court’s Escobar, a move which if successful could amplify the federal enforcement focus on life science companies.
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