FDA Events for PROCEPT BioRobotics (PRCT)
This section highlights FDA-related milestones and regulatory updates for drugs developed by PROCEPT BioRobotics (PRCT).
Over the past two years, PROCEPT BioRobotics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
HYDROS™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
HYDROS™ Robotic System - FDA Regulatory Timeline and Events
HYDROS™ Robotic System is a drug developed by PROCEPT BioRobotics for the following indication: For Aquablation® Therapy.
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.
- Drug:
- HYDROS™ Robotic System
- Announced Date:
- August 21, 2024
- Indication:
- For Aquablation® Therapy
Announcement
PROCEPT BioRobotics® announced FDA 510(k) clearance of its next-generation platform, the HYDROS™ Robotic System. Leveraging insights from over 50,000 procedures, HYDROS features FirstAssist AI™ treatment planning, advanced image guidance, robotic resection, and a streamlined workflow.
AI Summary
PROCEPT BioRobotics® has received FDA 510(k) clearance for its next-generation HYDROS™ Robotic System, a major step forward in robotic-assisted Aquablation therapy. This innovative platform was developed using insights from more than 50,000 procedures to deliver improved precision and efficiency during surgeries. The HYDROS system harnesses FirstAssist AI™ for treatment planning by analyzing ultrasound images to identify critical anatomy and suggest optimal procedures. It also integrates advanced image guidance through next-generation ultrasound and digital cystoscopy, ensuring detailed visualization during surgery. In addition, robotic resection with a heat-free waterjet execution offers consistent and controlled tissue removal, while the streamlined workflow enhances the overall operating room experience. These features work together to provide a more accurate and efficient treatment plan, promising better clinical outcomes for patients and a smoother process for surgeons and staff.
Read Announcement
PROCEPT BioRobotics FDA Events - Frequently Asked Questions
As of now, PROCEPT BioRobotics (PRCT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, PROCEPT BioRobotics (PRCT) has reported FDA regulatory activity for HYDROS™ Robotic System.
The most recent FDA-related event for PROCEPT BioRobotics occurred on August 21, 2024, involving HYDROS™ Robotic System. The update was categorized as "FDA Clearance," with the company reporting: "PROCEPT BioRobotics® announced FDA 510(k) clearance of its next-generation platform, the HYDROS™ Robotic System. Leveraging insights from over 50,000 procedures, HYDROS features FirstAssist AI™ treatment planning, advanced image guidance, robotic resection, and a streamlined workflow."
Currently, PROCEPT BioRobotics has one therapy (HYDROS™ Robotic System) targeting the following condition: For Aquablation® Therapy.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- 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:PRCT) was last updated on 7/13/2025 by MarketBeat.com Staff
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