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Prostate

FDA wants more from Edap on Ablatherm de novo bid

July 21, 2015 By Brad Perriello

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, […]

Filed Under: Food & Drug Administration (FDA), Urology Tagged With: EDAP TMS SA, Prostate

Augmenix wins FDA nod for SpaceOar prostate treatment

April 3, 2015 By Mark Hollmer

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.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Urology Tagged With: Augmenix Inc., De Novo Clearance, Prostate

Edap shares jump on Health Canada nod for prostate device

January 9, 2015 By Brad Perriello Leave a Comment

Edap shares jump on Health Canada nod for prostate device

Filed Under: News Well, Regulatory/Compliance, Urology Tagged With: EDAP TMS SA, Health Canada, Prostate

FDA: Edap’s Ablatherm prostate cancer device ‘not approvable’

November 6, 2014 By Brad Perriello Leave a Comment

FDA: Edap's Ablatherm prostate cancer device 'not approvable'

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Urology Tagged With: EDAP TMS SA, Prostate

Shareholders sue Edap following FDA slip

August 27, 2014 By Arezu Sarvestani

Shareholders sue Edap following FDA slip

A law firm is gathering support for a class action lawsuit against Edap TMS (NSDQ:EDAP), accusing leadership of misleading investors after an FDA expert panel panned the company’s flagship ablation technology.

Filed Under: Legal News, News Well, Oncology Tagged With: Ablation, EDAP TMS SA, Prostate

Study: Prostate cancer screening saves lives, but dangers remain | MassDevice.com On Call

August 7, 2014 By Arezu Sarvestani Leave a Comment

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.

Filed Under: Diagnostics, News Well, Research & Development Tagged With: On Call, Prostate

SonaCare lands a date with the FDA for prostate cancer therapy

August 6, 2014 By Arezu Sarvestani Leave a Comment

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.

Filed Under: News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Urology Tagged With: Ablation, Prostate, SonaCare Medical

FDA panel votes against EDAP’s ultrasound prostate cancer ablation

July 31, 2014 By Ingrid Mezo Leave a Comment

FDA panel rejects EDAP's ultrasound prostate cancer ablation

The FDA’s Gastroenterology & Urology Devices panel today voted against recommending approval of EDAP’s (NSDQ:EDAP) Ablatherm system for thermal ablation of the prostate gland to treat low-risk, localized prostate cancer.

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Ablation, EDAP TMS SA, Prostate

Study: Robot prostatectomy looks good at 10 years

July 17, 2014 By Arezu Sarvestani Leave a Comment

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.

Filed Under: News Well, Oncology, Robotics, Surgical Tagged With: Clinical Trials, Intuitive Surgical, Prostate

Press Release: EDAP completes FDA inspection of manufacturing site

June 30, 2014 By MassDevice Leave a Comment

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.

Filed Under: Food & Drug Administration (FDA), News Well, Oncology, Pre-Market Approval (PMA), Regulatory/Compliance, Ultrasound Tagged With: EDAP TMS SA, Press Release, Prostate

EDAP creeps toward FDA approval with clean inspection

June 30, 2014 By Arezu Sarvestani Leave a Comment

EDAP creeps toward FDA approval with clean inspection

Filed Under: News Well, Oncology, Pre-Market Approval (PMA), Regulatory/Compliance, Ultrasound Tagged With: EDAP TMS SA, Prostate

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