Edap (NSDQ:EDAP) said yesterday it won FDA 510(k) clearance for its Focal One device designed for prostate tissue ablation procedures. The French company’s Focal One device uses both magnetic resonance and 3D biopsy data, alongside real-time ultrasound imaging, to allow urologists to view 3D images of the prostate while using high intensity ultrasound to ablate the […]
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Edap submits new FDA 510(k) for Focal One HIFU
Edap (NSDQ:EDAP) said today it submitted a new FDA 510(k) application for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer after withdrawing its previous application in July. The new application alllowed the France-based company to include a new set of clinical data, which it had decided to include following “advanced discussions” with […]
EDAP submits FDA 510(k) for Ablatherm Fusion HIFU device
Edap (NSDQ:EDAP) said this week it submitted an FDA 510(k) application for its next-gen Ablaterm Fusion device. The Lyon, France-based company’s next-generation Ablatherm Fusion is a robotic high-intensity focused ultrasound device designed to allow urologists to import pre-treatment diagnostic info, including MRI images and 3D biopsy maps, and merge them with live ultrasound images during prostate […]
EDAP pulls FDA bid for Focal One, plans to resubmit with new data
Edap (NSDQ:EDAP) said today it withdrew the FDA 510(k) application for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer. The French company said that following “advanced discussions” with the federal watchdog, it plans to submit a new 510(k) application which includes new clinical data. “As mentioned during our last quarterly call, a […]
EDAP touts CMS reimbursement win for HIFU prostate ablation
Edap (NSDQ:EDAP) today touted that the Centers for Medicare & Medicaid Services established reimbursement billing codes for high intensity focused ultrasound ablation procedures for prostate tissue. The French company said that the new CMS C-code covering HIFU ablation of prostate tissue procedures will take effect July 1. The code will cover procedures performed by its HIFU […]
Edap looks to raise $11m in direct placement round
Edap (NSDQ:EDAP) said today it inked an agreement with institutional investors for the placement of 3.3 million shares at $3.50 a piece, bringing in an estimated $11.5 million for the company. Investors in the round will receive warrants to purchase up to 3.3 million shares at an exercise price of $4.50 per share, exchangeable beginning 6 […]
Edap seeks FDA nod for Focal One HIFU
Edap (NSDQ:EDAP) said today it submitted an application for FDA 510(k) clearance for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer. The company said the new submission comes following the FDA 510(k) clearance of its Ablatherm Robotic HIFU designed for the ablation of prostate tissue, which it won last November. “We […]
Edap slips shareholders lawsuit
Edap (NSDQ:EDAP) said yesterday that the appeal deadline lapsed for a shareholders lawsuit filed after an FDA advisory panel recommended against approval for its its Ablatherm device for treating prostate cancer. EDAP shares plunged last year after the FDA’s Gastroenterology & Urology Devices panel voted that the device did not appear to be effective or safe. Ablatherm, which won […]
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 […]
Edap revives Ablatherm HIFU FDA approval bid
EDAP (NSDQ:EDAP) said today it hopes to renew the de novo application for its Ablatherm HIFU prostate cancer device after responding to a “deficiency list” letter it received in July. The letter detailed a 4-item list of issues and put the de novo process for Ablatherm, a computer-controlled high-intensity focused ultrasound device designed to ablate the entire prostate gland, […]
