Chester County News and Community Website
WEST CHESTER, PA — Centinel Spine®, LLC, a Chester County-based medical device company specializing in cervical and lumbar spinal disease solutions, has recently announced that the Food and Drug Administration …
Chester County-based Centinel Spine Files PMA Application for Innovative Cervical Total Disc Replacement System Read More
PLYMOUTH MEETING, PA — ECRI has named gaps with recalls of home-use medical devices as the nation’s most pressing health technology safety issue for 2023.
Recalls of Home-Use Medical Devices: Nation’s Top Health Technology Safety Issue for 2023 Read More
WASHINGTON, D.C. — On Monday, the U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may, in turn, lower costs for millions of …
New FDA Rules Lower Price for Hearing Aids Read More
WASHINGTON, D.C. — The Federal Trade Commission took action last week to protect patients who rely on medical instruments used in sinus procedures. The FTC’s order requires Medtronic, Inc. to …
FTC Acts to Protect Patients Who Rely on Medical Instruments Used in Sinus Procedures Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration this week approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common …
FDA Approves First Generic of Symbicort to Treat Asthma and COPD Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s June 14, 2021, recall …
FDA Orders Philips Respironics to Notify Patients Regarding Recall Read More
MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) recently announced that the U.S. Food and Drug Administration (FDA), at this time, has declined to issue an EUA for COVAXIN™ for active …
Ocugen Provides an Update on its COVAXI Pediatric (2-18) Emergency Use Authorization Request Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. …
FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse Read More