Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion® Cosmetic Technology in Dermal Resurfacing Procedures
Apyx Medical Corporation, a manufacturer of medical devices and supplies and the innovator of Helium Plasma Technology, marketed and sold as Renuvion® and J-Plasma® in surgical markets, today announced it has received 510(k) clearance from the U.S. Food and Drug...
FDA Hits Verrica With Third CRL For Lead Drug Candidate VP-102
Verrica Pharmaceuticals has obtained its third Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its New Drug Application for its molluscum contagiosum treatment candidate VP-102. The first CRL was distributed in July 2020 as the FDA...
Inaugural Patient Injected with Vaxinia, Cancer-Killing Oncolytic Virus
Imugene and City of Hope announced this week that the first patient has initiated treatment in a revolutionary Phase I clinical trial, which will evaluate the safety and efficacy of CF33-hNIS (Vaxinia), a cancer-killing virus, in adults with advanced tumors. The...
Altamira Therapeutics Receives Philippines’ FDA Approval of Bentrio Nasal Spray
Altamira Therapeutics Ltd., a company committed to developing therapeutics that address unmet medical needs, announced that Bentrio™ has been approved by the Philippines' Food and Drug Administration (FDA) and is now cleared for commercialization. The product will be...
Trinity Biotech Announces CE Mark of its 10-Minute Covid-19 Antigen Test
Trinity Biotech PLC has achieved a CE Mark for its 10-minute Covid-19 antigen test. Health professionals and trained users can utilize the CE mark as the company intends to launch the test throughout the European Union. The test not only displayed efficiency and...
XACT Robotics® Receives FDA Clearance for Ablation Procedures
XACT Robotics has received US Food and Drug Administration (FDA) clearance for a modification to its XACT ACE ® Robotic System, which is designed to support robotic insertion and steering of ablation probes during ablation clinical procedures. This clearance expands...
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