SonaCare Medical said today that it won 510(k) approval from the FDA for the latest version of its high intensity focused ultrasound prostate tissue ablation device. The Sonablate device was the 1st of its kind to receive regulatory approval for the focused ablation of prostate tissue, according to SonaCare. The next-gen version features a tool […]
SonaCare inks marketing deal with Philips’ Invivo biz for its UroNav software
SonaCare Medical said today it inked a marketing alliance deal with Royal Philips (NYSE:PHG) business Invivo to license its UroNav fusion software with its Sonablate planning system. The new deal will allow clinicians to use the UroNav device to annotate and biopsy targeted prostate tissue and localize the tissue appropriate for ablation directly with its […]
FDA clears Edap’s Ablatherm prostate device
Edap (NSDQ:EDAP) said today that it won 510(k) clearance from the FDA for its Ablatherm, less than a month after a similar device from rival SonaCare won a nod from the federal safety watchdog. The Ablatherm device, like SonaCare’s Sonablate 450, is designed to ablate prostate tissue using high-intensity focused ultrasound. After a years-long dance with the FDA that […]
FDA clears SonaCare HIFU prostate device, prompts Edap to yank de novo, go for 510k
SonaCare said it won FDA pre market approval for its high intensity focused ultrasound device designed to treat prostate cancer, causing competitor EDAP (NSDQ:EDAP) to yank the de novo application for its Ablatherm HIFU. SonaCare said its Sonablate 450 will be available in the U.S. this October. “The FDA regulatory authorization to market Sonablate in the […]
Prostate cancer: FDA panel recommends against approval for SonaCare’s Sonablate
SonaCare Medical said it will reposition its Sonablate prostate cancer device to treat a more aggressive stage of the disease after an FDA panel last week failed to recommend approval for the device.
SonaCare lands a date with the FDA for prostate cancer therapy
North Carolina-based SonaCare Medical is getting a day with the FDA, but the company’s prospects are murky given that it’s going before an advisory panel that just rejected a technology similar to SonaCare’s Sonablate 450 prostate cancer therapy.
Cardiovascular Systems prices $33M offering | Wall Street Beat
Cardiovascular Systems (NSDQ:CSII) priced a public offering of some 2 million shares of CSII stock at $17.60 apiece, saying it expects to net about $33 million from the deal.
