Clinical updates, including trial initiations, enrollment status and data readouts and publications: Edwards Lifesciences, Jenavalve Technology, Theranica.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Curium, Diadem, Imeka, Johnson & Johnson, Magnus Medical, Memed, Piur, Quanterix, Quest, T2 Biosystems.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, RF Medical, Ventric Health.
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.
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.
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.
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.
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.
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