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

FDA Accepts Label Update for Plasma IQ, the First FDA-Cleared Handheld Plasma Energy Device

Plasma IQ: Suneva Medical, Inc. (“Suneva” or the “Company”), an innovative medical technology company using regenerative medicine to change the standard of care in aesthetic treatments, today announced that the U.S. Food and Drug Administration (FDA) accepted updates to the Plasma IQ label, including the removal of the product’s eye contraindication.

The removal of this specific contraindication was due in part to a compilation of literature provided to the FDA showing the safety and efficacy of the ablative device on skin tissue, particularly around the eye area. This label update allows Suneva to address treatment around the eye with patients in the United States.

“On the heels of our announcement of the planned merger with Viveon Health Acquisition Corp. to build on our leadership in the regenerative aesthetics sector, we are pleased with the FDA’s decision to update the Plasma IQ label,” said Pat Altavilla, Chief Executive Officer of Suneva. “We believe Suneva’s innovations have always been led by science and I look forward to working with our partner Neauvia to provide access of our Plasma IQ device to a larger patient population looking to improve their aesthetics through a focused energy treatment.”

Suneva has built its product portfolio to consist of several “only” and “first to market” products. Plasma IQ is the first handheld FDA-cleared plasma energy device indicated for the removal and destruction of skin lesions and coagulation of tissue. It is the latest advancement in aesthetics that delivers focused, controlled energy to effectively create microinjuries on the skin, renewing and restoring it. Plasma IQ is prescription only and should only be used by medically licensed and certified practitioners. Plasma IQ is owned and manufactured by Neauvia. Suneva is responsible for distribution of Plasma IQ within North America. For full product and safety information, visit here.

On January 12, 2022, Suneva Medical and Viveon Health Acquisition Corp. (NYSE American: VHAQ) (“Viveon Health” or “VHAQ”), a special purpose acquisition company, announced that they entered into a definitive merger agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on the NYSE under the symbol “RNEW.”

Medical Device News Magazine
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.


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. Receives FDA Clearance and Breakthrough Device Designation 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.

By using this website you agree to accept Medical Device News Magazine Privacy Policy