Apyx Medical (APYX) FDA Approvals $4.19 +0.40 (+10.58%) As of 01:56 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Apyx Medical's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Apyx Medical (APYX). Over the past two years, Apyx Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Renuvion. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Renuvion FDA Regulatory Timeline and Events Renuvion is a drug developed by Apyx Medical for the following indication: Contracting subcutaneous soft tissue following liposuction in multiple areas of the body. 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. Publication - May 14,2026Publication Drug: RenuvionAnnounced Date: May 14, 2026Indication: Contracting subcutaneous soft tissue following liposuction in multiple areas of the bodyAnnouncementApyx Medical Corporation announced the publication of a new retrospective investigator-initiated study in Plastic and Reconstructive Surgery - Global Open1.AI SummaryApyx Medical Corporation announced that a new retrospective investigator-initiated study was published in Plastic and Reconstructive Surgery - Global Open. The 113-patient study looked at long-term results after liposuction, including patient satisfaction, safety, and the need for more surgery. It found that adding Renuvion to power-assisted liposuction led to better patient-reported satisfaction with abdominal appearance, skin quality, and excess skin. The Renuvion group also had lower rates of abdominoplasty and surgical revisions. Importantly, these benefits were achieved without raising complication rates compared with liposuction alone. The study suggests that Renuvion may help improve body contouring results while keeping safety similar. Apyx said the findings add to the clinical evidence supporting its technology and its newer AYON Body Contouring System.Read AnnouncementProvided Update - October 13,2025Provided Update Drug: RenuvionAnnounced Date: October 13, 2025Indication: Contracting subcutaneous soft tissue following liposuction in multiple areas of the bodyAnnouncementApyx Medical Corporation announced the submission of a new 510(k) premarket notification to the U.S. Food and Drug Administration (the "FDA") for the label expansion of the AYON Body Contouring System ("AYON") to include power liposuction.AI SummaryApyx Medical Corporation submitted a 510(k) premarket notification to the U.S. Food and Drug Administration to expand the label of its AYON Body Contouring System to include power liposuction. This could make AYON the first fully integrated contouring platform cleared for powered fat removal in one device. If cleared, surgeons will be able to treat all aspects of body contouring with a single system. The power liposuction feature uses a reciprocating cannula that removes fat more efficiently, reducing manual effort and improving procedure speed. Apyx plans to activate the new functionality remotely in AYON systems already installed at surgical centers nationwide. Following a nationwide commercial launch in September, Apyx is hosting a virtual key opinion leader event on October 14, 2025, to discuss AYON’s rollout and collect feedback from aesthetic surgeons.Read AnnouncementProvided Update - January 6,2025Provided Update Drug: RenuvionAnnounced Date: January 6, 2025Indication: Contracting subcutaneous soft tissue following liposuction in multiple areas of the bodyAnnouncementApyx® Medical announce it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (the "FDA") for the AYON Body Contouring System.AI SummaryApyx Medical Corporation has announced that it submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its new AYON Body Contouring System. This announcement highlights the company’s efforts toward innovation in the field of aesthetic surgery. The AYON system is designed to be an all-in-one solution, offering surgeons the versatility needed for comprehensive body contouring procedures. The device integrates multiple advanced technologies to remove unwanted fat, enhance tissue contraction, and address a range of patient needs including skin tightening. Key features include ultrasound-assisted liposuction, dual aspiration, electrocoagulation, and volume enhancement, along with the use of Renuvion treatment for loose skin. Apyx Medical views the AYON Body Contouring System as a breakthrough that could broaden treatment capabilities for surgeons.Read Announcement Apyx Medical FDA Events - Frequently Asked Questions Has Apyx Medical received FDA approval? As of now, Apyx Medical (APYX) has not received any FDA approvals for its therapy in the last two years. What drugs has Apyx Medical submitted to the FDA? In the past two years, Apyx Medical (APYX) has reported FDA regulatory activity for Renuvion. What is the most recent FDA event for Apyx Medical? The most recent FDA-related event for Apyx Medical occurred on May 14, 2026, involving Renuvion. The update was categorized as "Publication," with the company reporting: "Apyx Medical Corporation announced the publication of a new retrospective investigator-initiated study in Plastic and Reconstructive Surgery - Global Open1." What conditions do Apyx Medical's current drugs treat? Currently, Apyx Medical has one therapy (Renuvion) targeting the following condition: Contracting subcutaneous soft tissue following liposuction in multiple areas of the body. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Adagio Medical FDA EventsBioCardia FDA EventsCognition Therapeutics FDA EventsCorbus Pharmaceuticals FDA EventsPrecision BioSciences FDA EventsHUTCHMED FDA EventsEli Lilly and Company FDA EventsTeleflex FDA EventsBioMarin Pharmaceutical FDA EventsDiaMedica Therapeutics FDA EventsDyne Therapeutics FDA EventsGuardant Health FDA EventsLigand Pharmaceuticals FDA EventsMadrigal Pharmaceuticals FDA EventsMetaVia 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 Tactile Systems Technology FDA Events NeuroPace FDA Events Delcath Systems FDA Events ClearPoint Neuro FDA Events Sight Sciences FDA Events Profound Medical FDA Events Orchestra BioMed FDA Events KORU Medical Systems FDA Events Sanara MedTech FDA Events Microbot Medical FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:APYX last updated on 5/14/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. 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Publication - May 14,2026Publication Drug: RenuvionAnnounced Date: May 14, 2026Indication: Contracting subcutaneous soft tissue following liposuction in multiple areas of the bodyAnnouncementApyx Medical Corporation announced the publication of a new retrospective investigator-initiated study in Plastic and Reconstructive Surgery - Global Open1.AI SummaryApyx Medical Corporation announced that a new retrospective investigator-initiated study was published in Plastic and Reconstructive Surgery - Global Open. The 113-patient study looked at long-term results after liposuction, including patient satisfaction, safety, and the need for more surgery. It found that adding Renuvion to power-assisted liposuction led to better patient-reported satisfaction with abdominal appearance, skin quality, and excess skin. The Renuvion group also had lower rates of abdominoplasty and surgical revisions. Importantly, these benefits were achieved without raising complication rates compared with liposuction alone. The study suggests that Renuvion may help improve body contouring results while keeping safety similar. Apyx said the findings add to the clinical evidence supporting its technology and its newer AYON Body Contouring System.Read Announcement
Provided Update - October 13,2025Provided Update Drug: RenuvionAnnounced Date: October 13, 2025Indication: Contracting subcutaneous soft tissue following liposuction in multiple areas of the bodyAnnouncementApyx Medical Corporation announced the submission of a new 510(k) premarket notification to the U.S. Food and Drug Administration (the "FDA") for the label expansion of the AYON Body Contouring System ("AYON") to include power liposuction.AI SummaryApyx Medical Corporation submitted a 510(k) premarket notification to the U.S. Food and Drug Administration to expand the label of its AYON Body Contouring System to include power liposuction. This could make AYON the first fully integrated contouring platform cleared for powered fat removal in one device. If cleared, surgeons will be able to treat all aspects of body contouring with a single system. The power liposuction feature uses a reciprocating cannula that removes fat more efficiently, reducing manual effort and improving procedure speed. Apyx plans to activate the new functionality remotely in AYON systems already installed at surgical centers nationwide. Following a nationwide commercial launch in September, Apyx is hosting a virtual key opinion leader event on October 14, 2025, to discuss AYON’s rollout and collect feedback from aesthetic surgeons.Read Announcement
Provided Update - January 6,2025Provided Update Drug: RenuvionAnnounced Date: January 6, 2025Indication: Contracting subcutaneous soft tissue following liposuction in multiple areas of the bodyAnnouncementApyx® Medical announce it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (the "FDA") for the AYON Body Contouring System.AI SummaryApyx Medical Corporation has announced that it submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its new AYON Body Contouring System. This announcement highlights the company’s efforts toward innovation in the field of aesthetic surgery. The AYON system is designed to be an all-in-one solution, offering surgeons the versatility needed for comprehensive body contouring procedures. The device integrates multiple advanced technologies to remove unwanted fat, enhance tissue contraction, and address a range of patient needs including skin tightening. Key features include ultrasound-assisted liposuction, dual aspiration, electrocoagulation, and volume enhancement, along with the use of Renuvion treatment for loose skin. Apyx Medical views the AYON Body Contouring System as a breakthrough that could broaden treatment capabilities for surgeons.Read Announcement
