The U.S. FDA’s device center launched a new health care program designed to provide patients with a seamless home health care environment that stitches together various health care functions into an integrated system that eases the patient’s use of such technologies. The initiative, part of the agency’s health equity agenda, will rely on augmented and virtual reality and requires the development of a prototype that will be rolled out in underserved areas with several overarching objectives, including the democratization of clinical trial participation.
Owlstone Medical Ltd. received $6.5 million in funding from the Bill & Melinda Gates Foundation which will go towards expanding its Breath Biopsy platform as well as developing breath-based diagnostic tests to identify breath biomarkers for tuberculosis and HIV.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Curio Digital, Novartis, Pillar Biosciences, SAIL Fusion.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Blue Arbor, Cortechs.ai, Genembryomics, Progenesis, Scibase.
The EU has declared that it will investigate the anticompetitive practices of the People’s Republic of China where medical devices are concerned, a clear sign that device makers in the European Union succeeded in persuading Brussels that the Made in China 2025 initiative represents an intolerable form of economic adversarialism.
South Korean med-tech companies Nunaps Co. Ltd. and Share & Service are the latest to clear domestic approvals for digital therapeutics as the government ramps up R&D funding for artificial intelligence-based medical technologies.
Researchers have developed and validated a new technique that allows them to measure the lipid compounds in live cancer cells, one by one, according to a study published in the journal Analytical Chemistry. The new method paves the way for analyzing cells in greater detail to better understand infection, immunity and other phenomena, and could lead to the development of new, more targeted treatments.
The U.S. Federal Trade Commission’s final rule for noncompete clauses in employment contracts would seem to endanger life science patents and trade secrets, but there is a question of whether the agency stepped outside its statutory bounds in forming the rule. The U.S. Chamber of Commerce has already filed suit on the rule, but Joshua Rich of McDonnell Boehnen Hulbert & Berghoff LLP told BioWorld, that the Chamber is unlikely to be the last entity to file suit over the rule.
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