The use of dermal fillers has spiked in recent years for a number of reasons, but so have the associated adverse events. An FDA advisory committee made several associated recommendations, including that a patient’s vision be prospectively evaluated prior to any peri-ocular treatment with fillers, but this could be a simple count-the-fingers check, something that should not appreciably increase procedure times or affect the volume of procedures.
Fluxergy Inc. said Thursday that it has won CE-IVD marking for its one-hour COVID-19 real-time polymerase chain reaction (RT-PCR) test. The automated, sample-to-action Fluxergy diagnostic testing system can run multiple assay types – such as molecular, immunochemistry, chemistry and cytometry – simultaneously on the same cartridge. The SARS-CoV2 RT-PCR test is the first CE-marked product for the Fluxergy diagnostic platform.
PARIS – Implanet SA won approval from its founding shareholders to acquire a majority stake in spinal implant manufacturer Orthopaedic & Spine Development SAS (OSD). Implanet’s bid is aimed at acquiring majority control, and potentially the entire share capital, of Avignon, France-based OSD, valued at $5 million. OSD’s founding shareholders, representing 71.5% of the capital, have already committed to respond favorably to the bid, thus confirming the principles behind this merger.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA seeks nominations for blood products advisory panel; Massachusetts hospital hit for HIPAA access non-compliance; No reports recorded for Medtronic recall; Tillis, Cotton eye patent examiner practice for Section 101 problem.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurora Spine, Fluxergy, Rapid Medical, Tiger Tech.
Genetron Holdings Ltd. said its blood-based, early screening test for hepatocellular carcinoma (HCC) demonstrated 88% sensitivity and 93% specificity in 1,615 subjects in China vs. 71% sensitivity and 95% specificity with the use of ultrasound plus alpha-fetoprotein (AFP). The primary outcome, unveiled on March 25, came from a multicenter prospective trial that Beijing-based Genetron initiated together with The National Cancer Center China in 2019.
Keeping you up to date on recent developments in diagnostics, including: Review highlights differences in accuracy of COVID-19 rapid tests; Likelihood of disease from hidden genetic defects; Confocal PET enables color differentiation of PET tracers in preclinical imaging.
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