PARIS – At some point, scientists reported, it may be possible to quarantine viruses rather than humans. For the last two years, European research consortium Virofight has been working on a form of nanotechnology intended to neutralize viruses such as SARS-CoV-2, HIV, influenza and hepatitis viruses.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Realview Imaging.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Blackford, Breathtek, Evonik, Jenacell, Meridian Bioscience, Paramit, Provista Diagnostics, Sense Neuro Diagnostics, Sensyne, The Tecan Group, Todos Medical.
Bioventus Inc. reported plans to acquire Misonix Inc. in a cash and stock transaction valued at $518 million, which the companies expect to close in the fourth quarter of 2021. The transaction will create a total addressable market of $15 billion for the combined company across the wound care, orthopedics, lower extremity and neurosurgery market segments.
The FDA has posted a final rule for its intended use policy for devices, drugs and biologics, which formalizes the elimination of the totality-of-the-evidence approach to determining the manufacturer’s intended use. While the final rule says that mere knowledge of off-label use cannot be the sole determinant of the manufacturer’s intended use, the rule still allows the FDA to infer intended use by “any relevant source of evidence,” a term that may be sufficiently squishy to be functionally equivalent to the controversial totality-of-the-evidence standard.
Post-traumatic stress disorder (PTSD) affects about 8 million Americans a year, disrupting lives with nightmares, memory loss, feelings of isolation and other negative effects. Treatment typically involves psychotherapy, but many patients do not find relief. To that end, the FDA has granted breakthrough device designation to Evren Technologies Inc. for its noninvasive Phoenix earbud device for treating PTSD.