The FDA’s operations have been badly hampered by the COVID-19 pandemic, but Jeff Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH), said review times for most non-COVID product categories should resume their normal clip by the end of 2021. However, he acknowledged that the lag for in vitro diagnostics (IVDs) may not be fully resolved until 2022 because of the resources needed to review emergency use authorizations for tests for the SARS-CoV-2 virus.
LONDON – Neogenomics Inc. reported it plans to acquire Inivata Ltd., taking up a $390 million fixed price option to purchase the liquid biopsy specialist eight months early. The option was agreed to in May 2020, when Neogenomics made a $25 million minority equity investment in Inivata and was granted the right to acquire the rest of the company by the end of 2021.
My01 Inc. has received FDA clearance for its My01 Continuous Compartmental Pressure Monitor with full Bluetooth capabilities. The device is intended to help doctors diagnose and avert the risks of developing compartment syndrome, a potentially devastating complication of certain fractures and trauma injuries.
TORONTO – Audioptics Medical Inc. has raised a C$1.9 million (US$1.5 million) seed investment round for development of a device that visualizes and assesses the structures of the middle ear to help patients avoid surgery for conductive hearing loss. Audioptics Medical CEO Dan MacDougall told BioWorld the investment marks a major step in his company’s path towards commercial development of its flagship product, the Ossiview Middle Ear Imaging system.
The Biden administration’s May 5 about-face on the proposed TRIPS waiver of intellectual property (IP) protections for COVID-19-related medical products is not playing well with U.S. industry, EU trading partners and others concerned about the long-term unintended consequences.
PERTH, Australia – Imagion Biosystems Ltd. has entered a collaborative research program with therapeutic antibody development company Patrys Ltd. to combine their technologies to target brain tumor imaging and diagnosis.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amt, My01, Renovacare, Viome.
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