PROCEPT BioRobotics (PRCT) FDA Approvals $19.03 -0.19 (-0.98%) As of 12:43 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock PROCEPT BioRobotics' Drug in the FDA Approval ProcessThis 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 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. Provided Update - March 12,2026Provided Update Drug: HYDROS™ Robotic SystemAnnounced Date: March 12, 2026Indication: For Aquablation® TherapyAnnouncementPROCEPT BioRobotics announced the international expansion of the HYDROS Robotic System, the company's next-generation platform for delivering Aquablation therapy to treat benign prostatic hyperplasia (BPH).AI SummaryPROCEPT BioRobotics announced the international expansion of the HYDROS Robotic System, its next-generation platform for delivering Aquablation therapy to treat benign prostatic hyperplasia (BPH). HYDROS is designed to provide a surgical solution that removes prostate tissue using a precision waterjet guided by robotics, aiming to improve procedure consistency and patient outcomes as the company brings the technology to more markets outside the U.S. Clinical evidence supporting Aquablation shows it can provide durable relief from BPH symptoms while preserving sexual and urinary function—outcomes that matter a great deal to patients. The company highlights Aquablation as a complete therapy option for men with BPH, backed by data that emphasize symptom improvement and quality-of-life benefits. All surgical treatments carry risks and side effects. For details on potential complications and safety information, visit https://aquablation.com/safety-information/.Read AnnouncementFDA Clearance - August 21,2024Fda Clearance Drug: HYDROS™ Robotic SystemAnnounced Date: August 21, 2024Indication: For Aquablation® TherapyAnnouncementPROCEPT 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 SummaryPROCEPT 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 Has PROCEPT BioRobotics received FDA approval? As of now, PROCEPT BioRobotics (PRCT) has not received any FDA approvals for its therapy in the last two years. What drugs has PROCEPT BioRobotics submitted to the FDA? In the past two years, PROCEPT BioRobotics (PRCT) has reported FDA regulatory activity for HYDROS™ Robotic System. What is the most recent FDA event for PROCEPT BioRobotics? The most recent FDA-related event for PROCEPT BioRobotics occurred on March 12, 2026, involving HYDROS™ Robotic System. The update was categorized as "Provided Update," with the company reporting: "PROCEPT BioRobotics announced the international expansion of the HYDROS Robotic System, the company's next-generation platform for delivering Aquablation therapy to treat benign prostatic hyperplasia (BPH)." What conditions do PROCEPT BioRobotics' current drugs treat? Currently, PROCEPT BioRobotics has one therapy (HYDROS™ Robotic System) targeting the following condition: For Aquablation® Therapy. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events ACADIA Pharmaceuticals FDA EventsBelite Bio FDA EventsDogwood Therapeutics FDA EventsDyne Therapeutics FDA EventsEikon Therapeutics FDA EventsGreenwich LifeSciences FDA EventsHarrow FDA EventsImmunome FDA EventsOncolytics Biotech FDA EventsOric Pharmaceuticals FDA EventsScholar Rock FDA EventsBiohaven FDA EventsNuvation Bio FDA Events4D Molecular Therapeutics FDA EventsREGENXBIO FDA Events 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 Related Companies MiniMed Group FDA Events TransMedics Group FDA Events AxoGen FDA Events NovoCure FDA Events Pulse Biosciences FDA Events Inspire Medical Systems FDA Events Artivion FDA Events Alpha Tau Medical FDA Events Bioventus FDA Events SS Innovations International FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:PRCT last updated on 3/16/2026 by MarketBeat.com Staff. 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Provided Update - March 12,2026Provided Update Drug: HYDROS™ Robotic SystemAnnounced Date: March 12, 2026Indication: For Aquablation® TherapyAnnouncementPROCEPT BioRobotics announced the international expansion of the HYDROS Robotic System, the company's next-generation platform for delivering Aquablation therapy to treat benign prostatic hyperplasia (BPH).AI SummaryPROCEPT BioRobotics announced the international expansion of the HYDROS Robotic System, its next-generation platform for delivering Aquablation therapy to treat benign prostatic hyperplasia (BPH). HYDROS is designed to provide a surgical solution that removes prostate tissue using a precision waterjet guided by robotics, aiming to improve procedure consistency and patient outcomes as the company brings the technology to more markets outside the U.S. Clinical evidence supporting Aquablation shows it can provide durable relief from BPH symptoms while preserving sexual and urinary function—outcomes that matter a great deal to patients. The company highlights Aquablation as a complete therapy option for men with BPH, backed by data that emphasize symptom improvement and quality-of-life benefits. All surgical treatments carry risks and side effects. For details on potential complications and safety information, visit https://aquablation.com/safety-information/.Read Announcement
FDA Clearance - August 21,2024Fda Clearance Drug: HYDROS™ Robotic SystemAnnounced Date: August 21, 2024Indication: For Aquablation® TherapyAnnouncementPROCEPT 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 SummaryPROCEPT 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
