article thumbnail

Enable Injections Receives First U.S. Food and Drug Administration (FDA) Approval

Legacy MEDSearch

Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse ® ) for the subcutaneous delivery of EMPAVELI ® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. “Enable’s purpose is to redefine drug delivery for the benefit of patients. .

article thumbnail

PolarisAR Receives Clearance from the U.S. Food and Drug Administration for Stellar Knee

Legacy MEDSearch

Food and Drug Administration (FDA). STELLAR Knee not only impacts the surgeon and the patient, but also empowers healthcare providers to change the standard of care.” Food and Drug Administration for Stellar Knee appeared first on Legacy MedSearch | Medical Device Recruiters.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

What do future healthcare CEOs look like?

World of DTC Marketing

American healthcare is in trouble. I have to laugh when I hear that a pharma company is patient-centric because that’s become a slogan to make employees feel good about themselves while the costs of prescription drugs increase every year. Highest-paid CEOs in 2019: Who made the list from healthcare. This has to end.

article thumbnail

Medinol Receives FDA Approval for Next Generation EluNIR-PERL™ Drug-Eluting Coronary Stent System

Legacy MEDSearch

Medinol today announced United States Food and Drug Administration (FDA) approval for the EluNIR-PERL drug-eluting stent (DES) for the treatment of coronary artery disease. EluNIR-PERL builds upon the proven performance and clinical data of the EluNIR DES system. For more information, see www.medinol.com.

article thumbnail

FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor

Legacy MEDSearch

Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. On March 5, the U.S. Following this announcement, Dexcom’s shares experienced a 2.2% increase in extended trading.

article thumbnail

Xironetic Receives FDA Clearance for Augmented Reality Surgical Software

Legacy MEDSearch

Xironetic, an early-stage healthcare technology company, today announced its IntraOpVSP augmented reality (AR) visualization software for complex surgeries has received clearance from the U.S. Food and Drug Administration (FDA). Food and Drug Administration cleared the software for use in 2022.

article thumbnail

Advanced Bifurcation Systems Inc. Receives FDA Breakthrough Device Designation

Legacy MEDSearch

Food and Drug Administration (FDA) for its novel coronary artery bifurcation stenting technology. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Receives FDA Breakthrough Device Designation appeared first on Legacy MedSearch | Medical Device Recruiters.

FDA 52