Edap (NSDQ:EDAP) today said the FDA wants more on its bid for de novo approval of its Ablatherm HIFU prostate cancer device, saying it needs to address 4 points raised by the federal safety watchdog before the process can resume. The news, following the French firm’s March announcement that it would abandon its pre-market approval application, […]
Prostate
Augmenix wins FDA nod for SpaceOar prostate treatment
FDA clearance in hand, Augmenix is formulating U.S. commercial sales and insurance reimbursement plans for a medical gel designed to help protect the rectum during prostate cancer radiotherapy, CEP John Pedersen told MassDevice.com today.
Edap shares jump on Health Canada nod for prostate device
FDA: Edap’s Ablatherm prostate cancer device ‘not approvable’
Shareholders sue Edap following FDA slip
Study: Prostate cancer screening saves lives, but dangers remain | MassDevice.com On Call
MASSDEVICE ON CALL — The prostate cancer screening debate rages on as a new study published in the journal Lancet vindicates the life-saving potential of testing but cautions against introducing routine screening programs.
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.
FDA panel votes against EDAP’s ultrasound prostate cancer ablation
Study: Robot prostatectomy looks good at 10 years
Robot-assisted radical prostatectomy (RARP) proved just as good as open surgery in keeping the prostate cancer under control for 10 years following the procedure, according to a new study from researchers at the Henry Ford Hospital.
Nearly 99% of the RARP patients enrolled in the study survived cancer for a decade following surgery and about 73% were recurrence-free and 97.5% of the group was metastasis-free, according to the report.
Press Release: EDAP completes FDA inspection of manufacturing site
LYON, France — EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that the U.S. Food and Drug Administration (FDA) concluded its routine inspection of EDAP’s manufacturing site with no findings nor issuance of Form 483 observations.
EDAP creeps toward FDA approval with clean inspection
