We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Devicemakers may need to consult with their legal counsel during an FDA inspection so they know what the agency may legally request, according to inspection expert David Chesney, principal of DL Chesney Consulting.
Israel-based Medasense Biometrics has received de novo marketing authorization from the FDA for its PMD 200 device that monitors a patient’s pain level while under anesthesia, using artificial intelligence (AI) algorithms to convert data into a patient’s “signature of pain.”
After filing a Special 501(k) requesting a change to its existing device clearance, Signifier Medical Technologies received FDA’s approval to remove a contraindication for its eXciteOSA daytime therapy for obstructive sleep apnea (OSA).
The FDA explains the types of modifications to a diagnostic ultrasound device for which the agency does not intend to enforce the requirement for a new 510(k) filing, in a final guidance released yesterday — one of six newly released guidances from the agency related to imaging solutions and lasers.
The U.S. Supreme Court has refused to review a $302 million judgment levied against Johnson & Johnson (J&J) by California for misrepresenting the risk of its pelvic mesh products in marketing materials.
President Biden has upheld the U.S. International Trade Commission’s final determination that Apple infringed on AliveCor’s wearable electrocardiogram device, keeping alive a limited exclusion order and a cease and desist order on Apple to cease importing certain versions of its watches.
BD’s Onclarity HPV Assay — the only FDA approved test that looks for multiple types of human papillomavirus virus (HPV) individually — can now be marketed for use with two different pap tests, Hologic ThinPrep and BD SurePath Liquid.