Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Medtronic, Opti Medical Systems.
Hydrocephalus involves the buildup of excess fluid in the brain. It affects more than 1 million people in the U.S. – most of them children – and can result in brain damage and related neurological impairments. Shunt implants are the standard treatment to drain that fluid, but more than half of them fail within the first couple of years of placement.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb, Roche, Synedgen, Transit Scientific.
The implementation date for the EU’s new med-tech regulatory framework has been pushed back a year, giving device makers much-needed breathing room for compliance work. At the same time, the International Organization for Standardization (ISO) has not fulfilled the planned May update of its device clinical investigations standard, ISO 14155.
The latest U.S. FDA town hall for testing for the COVID-19 included a few updates on serological testing, but perhaps the most important take-away was when Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiology, advised attendees that performance expectations regarding next-generation sequence (NGS) testing for the SARS-CoV-2 virus will closely resemble those of conventional molecular testing.
As more COVID-19 antibody testing becomes available, one question has been on everybody’s mind: Does the presence of antibodies to SARS-CoV-2, the virus responsible for the global pandemic, mean that people are protected from future infection? To that end, Genscript Biotech Corp., of Piscataway, N.J., has applied for emergency use authorization (EUA) with the U.S. FDA to market a test that specifically recognizes neutralizing antibodies to SARS-CoV-2.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Fractyl, Surgical Information Sciences.
LONDON – After eight years in development, Memed Diagnostics Ltd. has secured CE marking for its point-of-care blood test, which is able to distinguish between bacterial and viral infections in 15 minutes.
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