FDA Events for Apyx Medical (APYX)
This 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.
- Drug:
- Renuvion
- Announced Date:
- January 6, 2025
- Indication:
- Contracting subcutaneous soft tissue following liposuction in multiple areas of the body
Announcement
Apyx® 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 Summary
Apyx 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- Drug:
- Renuvion
- Announced Date:
- April 11, 2024
- Indication:
- Contracting subcutaneous soft tissue following liposuction in multiple areas of the body
Announcement
Apyx® Medical Corporation announce the Renuvion Users' Summit is taking place in Las Vegas from April 12-13, 2024.
AI Summary
Apyx Medical Corporation, the maker of Renuvion—a cutting-edge helium plasma and radiofrequency technology—has announced that the Renuvion Users' Summit will be held in Las Vegas from April 12-13, 2024. The summit is set to gather cosmetic and plastic surgery professionals from 13 countries, providing a unique forum for sharing new research, clinical data, and user experiences related to this innovative technology.
During the two-day event, 27 leading experts will present insights on advancements in body contouring, tissue contraction, and other aesthetic treatments using Renuvion. The summit will focus on the latest trends in clinical practices, helping surgeons improve outcomes for patients dealing with loose skin and related issues. This meeting represents Apyx Medical’s ongoing commitment to fostering educational and scientific exchanges that enhance patient care in the field of cosmetic surgery.
Read Announcement
Apyx Medical FDA Events - Frequently Asked Questions
As of now, Apyx Medical (APYX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Apyx Medical (APYX) has reported FDA regulatory activity for Renuvion.
The most recent FDA-related event for Apyx Medical occurred on January 6, 2025, involving Renuvion. The update was categorized as "Provided Update," with the company reporting: "Apyx® 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."
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 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:APYX) was last updated on 7/12/2025 by MarketBeat.com Staff
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