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EDAP TMS (EDAP) FDA Events

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FDA Events for EDAP TMS (EDAP)

This section highlights FDA-related milestones and regulatory updates for drugs developed by EDAP TMS (EDAP). Over the past two years, EDAP TMS has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Focal and High. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

EDAP TMS's Drugs in FDA Review

Focal One - FDA Regulatory Timeline and Events

Focal One is a drug developed by EDAP TMS for the following indication: For the Treatment of Benign Prostatic Hyperplasia (BPH). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

High Intensity Focused Ultrasound - FDA Regulatory Timeline and Events

High Intensity Focused Ultrasound is a drug developed by EDAP TMS for the following indication: For the treatment of pancreatic tumors. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

EDAP TMS FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, EDAP TMS (EDAP) has reported FDA regulatory activity for the following drugs: Focal One and High Intensity Focused Ultrasound.

The most recent FDA-related event for EDAP TMS occurred on January 8, 2025, involving High Intensity Focused Ultrasound. The update was categorized as "Provided Update," with the company reporting: "EDAP TMS SA announced that the first patient has been treated in a phase I/II PULS Trial sponsored by the Centre Léon Bérard, Lyon, France, evaluating proprietary High Intensity Focused Ultrasound (HIFU) technology for the treatment of pancreatic tumors."

Current therapies from EDAP TMS in review with the FDA target conditions such as:

  • For the Treatment of Benign Prostatic Hyperplasia (BPH) - Focal One
  • For the treatment of pancreatic tumors. - High Intensity Focused Ultrasound

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:EDAP) was last updated on 7/10/2025 by MarketBeat.com Staff
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