NATIONAL HARBOR, Md. – Cardiovalve Ltd., of Or Yehuda, Israel, scored a double hit with the U.S. FDA, winning a breakthrough device designation for its transcatheter tricuspid valve replacement system, as well as approval to conduct an early feasibility study in tricuspid regurgitation (TR). Read More

Asuragen Inc., an Austin, Texas-based molecular diagnostics company, has received good news from the U.S. FDA. The agency gave the green light for the company’s Amplidex Fragile X Dx and Carrier Screen Kit, which aims to detect a genetic condition known as Fragile X syndrome. The diagnostic kit determines the number of cytosine-guanine-guanine (CGG) repeats in the FMR1 gene to aid in the diagnosis of Fragile X syndrome and associated disorders, including Fragile X-associated tremor/ataxia syndrome and Fragile X-associated primary ovarian insufficiency. Read More

LONDON – The COVID-19 outbreak appears to be sliding toward pandemic status, with the virus spreading to four more countries and confirmed cases and deaths mounting in infection hotspots in Italy, Iran and South Korea. Read More

Artificial intelligence still has a lot to prove when it comes to its relevance in improving health care. But one bright spot was a deal last July between Dublin-based Medtronic plc and San Francisco-based startup Viz.ai Inc. to use the latter’s AI system that’s designed to spot a large vessel occlusion automatically in CT angiogram images. Read More

U.S.-based device makers have been grappling with FDA cybersecurity requirements for some time, but now the European Union (EU) is working on cybersecurity regulations as well. Throw in privacy requirements by the state of California and the EU’s General Data Protection Regulation (GDPR), and device makers are facing an increasingly complicated world of enforcement and litigation. Read More

New hires and promotions in the med-tech industry, including: Alydia Health, Earlysense, Neuroone Medical Technologies. Read More

Med-tech firms raising money in public or private financings, including: Arima Genomics, Endologix, Karius. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Medtronic, Senseonics. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aiforia Technologies, Eurofins Discoverx, Innovative Forensic DNA, Intermed Group, Intermountain Forensics, Labcorp, Nanalysis Scientific, Perkinelmer, Proteostasis Therapeutic, Resolution Bioscience, RS2D, Shuwen Biotech, Sigma Imaging Technologies, Smith+Nephew, Spineovations, Velalabs. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Deka, Fresenius, Teva, United Therapeutics. Read More

The latest global regulatory news, changes and updates affecting medical devices and technologies. Read More

Keeping you up to date on recent developments in cardiology, including: Using AI to predict heart attacks, stroke; Startup focuses on nano-capsules derived from milk to deliver heart drug; Biotronik sees positive results with ultrathin strut DES. Read More