The U.S. Supreme Court has heard two cases this year regarding the False Claims Act (FCA), including the Shutte v. Supervalu case, which the court has remanded to the Court of Appeals for the Seventh Circuit. However, even though the case has not come to a close, Jay Stephens of Kirkland & Ellis LLP, believes that the Supreme Court’s handling of Supervalu creates an environment in which the process of discovery will become much more burdensome for all involved.
Medtech Europe has on several occasions given voice to concerns about the drawn-out overhaul of the European Union’s medical device regulation but has come up with a new set of recommendations to break the regulatory logjam.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Enovis, Limacorporate, Orion Health, Pieces Technologies, Veradigm, Vicarious Surgical.
The co-founders of Zero Candida Ltd. described, in the company’s first PCT filing, their development of a drug-free solution for treating vaginal fungal infections using an intravaginal light-based treatment device (ILTD) that projects light at predefined intervals and intensities to treat infection.
An artificial intelligence (AI) tool developed by Annalise.ai Pty Ltd. was able to improve radiologists’ accuracy in detecting abnormalities on non-contrast computed tomography brain (CTB) scans. According to a study published in European Radiology, the Annalise Enterprise CTB module improved radiologists' accuracy by 32% and reduced their overall reading time by 11%.
Light therapy during sleep helps increase resistance to Alzheimer’s disease (AD) progression, a study in Frontiers of Optoelectronics suggests. The researchers found that photobiomodulation (PBM) during deep sleep improved the ability of the lymphatic system to flush beta-amyloid from the brains of mice, demonstrating the importance of sleep in fending off the neurodegenerative disease and opening a possible new therapy for prevention and treatment of Alzheimer’s.
The U.S. FDA’s Sept. 6 hearing of the Patient Engagement Advisory Committee (PEAC) tackled the question of health equity, a discussion that touched on several issues such as accessibility. One of the committee’s recommendations was that the FDA assist the Centers for Medicare & Medicaid Services (CMS) with the latter’s task of developing codes for payment, not the kind of task to which the FDA is typically assigned.
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