In what represents the first patenting from Cerathrive Ltd., its co-founder and CEO, Sarah Turner, describes their development of the Cera system, which they claim to be the first and only U.S. FDA-cleared red-light device that targets the gut-brain axis to improve focus and energy levels.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Angiodynamics, Cvrx, Endospan, Heartflow, Hemosonics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Roche, Thermo Fisher Scientific.
The speculation as to the status of Michelle Tarver, the acting director of the U.S. FDA’s device center, is officially over despite disclaimers at. The outgoing director, Jeff Shuren, said Tarver “will make a great center director” in remarks during an Oct. 17 public appearance, thus cementing Tarver’s role at FDA.
Nowdiagnostics Inc. established an exclusive agreement with Labcorp Holdings Inc. for distribution of its First To Know syphilis test in the U.S. The test provides results in 15 minutes with as little as a single drop of blood. The test will be available to hospitals and clinicians by the end of 2024 and offered to patients directly through Labcorp Ondemand in 2025.
China’s Tencent Technology Co. Ltd. has invested S30 million in Insighta Ltd., an early cancer detection company that was set up as a $200 million joint venture by Prenetics Global Ltd. and inventor Dennis Lo to revolutionize multi-cancer detection.
According to World Health Organization data, endometriosis affects about 10% of reproductive-age females globally. That already makes endometriosis a wildly underresearched and underfunded disease in relation to its prevalence. Plus, Rama Kommagani thinks even 10% is an underestimation. “Diagnosis is very underreported, particularly in low- and middle-income countries,” Kommagani, who is an associate professor of pathology at Baylor College of Medicine, told BioWorld.
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