510(k) for Clarus Medical Systems' spinal surgery system:
This article was originally published in Clinica
Clarus Medical Systems of Minneapolis, Minnesota, has received 510(k) clearance from the FDA for its SITEtrac minimally invasive spinal surgery system. Designed as an alternative to open lumbar spine surgery, the system consists of tubular dilators, retractors and a high-resolution endoscope. The system is reusable and does not require any specialised instruments.
You may also be interested in...
Office of New Drugs Director Peter Stein said in an interview that a large amount of coronavirus-related work is arriving at the FDA, but so far staff are keeping up.
Akero’s FGF21 analog yields 63%-72% relative hepatic fat reduction in Phase IIa study; the company awaits biopsy data hoping to see a fibrotic benefit. Also, Genfit says COVID-19 pandemic should not significantly delay its Phase III NASH readout.
US Vice President Mike Pence and Medicare administrator Seema Verma want academic and university hospital laboratories to send their de-identified COVID-19 test data results, daily, to the Department of Health and Human Services. Commercial and private labs are exempt from the request, as they already share their coronavirus test results with the government.