Saturday, September 23, 2023
Saturday, September 23, 2023

Renuvion Dermal Handpiece for Wrinkle-Reduction Procedures Cleared by the FDA

Apyx Medical Corporation (NASDAQ: APYX), the manufacturer of Renuvion®, a proprietary helium plasma and radiofrequency technology, previously announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the use of the Renuvion Dermal handpiece for specific dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III.

Branded as Facial Renewal, this treatment for wrinkle-reduction provides patients with an effective and nonsurgical option for smoothing and contracting the skin in one procedure. Facial Renewal enables dermatologists, plastic surgeons and cosmetic physicians to achieve transformative results, without the patient needing invasive surgery or risking looking unnatural. Facial Renewal with Renuvion is the first major advancement in decades of skin treatments for the face, providing patients with dramatic and natural-looking results.

“Renuvion for facial procedures is groundbreaking. It’s a treatment that fulfills a big unmet need in cosmetic procedures,” said New York oculoplastic surgeon Tabasum Mir, MD. “I have been using the Renuvion technology on patients in my practice and I’ve seen the transformative results firsthand. With the new clearance for Facial Renewal, this opens a whole new treatment option for patients to achieve the youthful appearance they’re seeking.”

“We are very pleased to receive FDA clearance with a specific clinical indication that enables Apyx Medical to market and sell our Renuvion Technology to physicians and patients for use in dermal resurfacing procedures,” said Charlie Goodwin, President and Chief Executive Officer. “Facial Renewal with Renuvion offers patients a refreshed and more youthful look without having the unnatural ‘pulled’ appearance often associated with a facelift.”

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OTHER NEWS

FDA Grants Fast Track Designation to 9MW3011

9MW3011 has been approved to clinical study by NMPA and FDA, respectively. The first person has been dosed in the clinical study in China in March, 2023.

MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

"We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common and challenging infection", stated Dr Zhengyu Yuan, Chief Executive Officer at MicuRx. 

Via Nova Therapeutics Announces FDA clearance of Investigational New Drug (IND) Application for VNT-101

"We look forward to evaluating VNT-101 in the clinic," said Don Ganem MD, Co-Founder and CEO of Via Nova Therapeutics. "This is an important step to developing a flu antiviral with a novel mechanism of action, and a milestone for Via Nova Therapeutics as we advance our first compound into the clinic."

FDA OK’s ensoETM for Use in Cardiac Ablations to Reduce Risk of Esophageal Injury

Published studies that have examined the use of ensoETM for this purpose include the pilot eCOOL-AF study, the IMPACT study and a large multi-center analysis of over 25,000 patients (in press at the Journal of the American College of Cardiology: Clinical Electrophysiology). These studies have found up to an 83 percent reduction in esophageal injuries, and a significant reduction in risk of atrioesophageal fistula (AEF), one of the most dreaded complications of ablation procedures.

Annalise.ai Receives FDA Clearance and Breakthrough Device Designation

Annalise.ai has also received FDA Breakthrough Device Designation for its obstructive hydrocephalus software tool. This is the first radiology triage device to be granted Breakthrough status since the inception of the FDA Breakthrough Devices Program.

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