Endocare submits CryoGuide for US clearance:
This article was originally published in Clinica
Endocare has submitted to the US FDA for marketing clearance its ultrasound planning and mapping system used to guide its targeted cryoablation procedure for treating cancer. The CryoGuide system allows doctors to visualise the target tumour in three dimensions, allowing them to place the probes used to freeze and destroy the tumour more precisely. Endocare's cryoablation system is already used to treat prostate and liver tumours and the Irvine, California company is also developing the device to treat other cancers, such as those in the kidney and breast.
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.