Home FDA

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.”

Exit mobile version