No matter how you look at it, guiding percutaneous coronary interventions to treat complex lesions with optical coherence tomography (OCT) or intravascular ultrasound (IVUS) produces similar results in patients with complex lesions, a study presented Oct. 23 at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco indicated. Read More

The U.S. FDA recently released a guidance for non-invasive remote monitoring devices, which were granted tremendous leniency during the COVID-19 pandemic as a means of reducing the demands on hospitals and doctor’s offices. That policy has been extended for the non-COVID era as part of the agency’s strategic plan to improve health equity by ensuring that access to digital health technologies is enjoyed by diverse American populations in a variety of health care access-challenged geographical areas. Read More

Phasev Inc. has raised $15 million in a funding round that will allow the company to further develop its machine learning (ML) technology that aims to revolutionize clinical trial design, execution and analysis. The funding round was led by Viola Ventures and Exor Ventures and included participation from Lionbird and a group of prominent angel investors. Read More

Burning Rock Biotech Ltd. wants to significantly change the way cancers are detected and the biotech is sailing ahead with the latest breakthrough device designation received from China’s NMPA for its multi-cancer detection blood test (MCDBT), Overc. Read More

The U.S. FDA, Health Canada, and the U.K. Medicines and Healthcare Products Regulatory Agency have once again sidestepped the usual mechanisms for international regulatory cooperation to strike a blow for harmonization. Read More

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New hires and promotions in the med-tech industry, including: Day Zero, J&J, Olympus, Pulse Biosciences, Radiaction, Theragent. Read More

Med-tech firms raising money in public or private financings, including: Orbimed. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Boston Scientific, Electrocore, Implicity. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aktiia, Axosim, Vyant Bio, Butterfly Network, Forest Neurotech, Inspira Technologies, Xtant Medical, RTI Surgical. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Bifurcation Systmes, Life Molecular Imaging, Sintau Intl., Medinol, MTF Biologics, Think Surgical. Read More