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Achieving marketing authorization under FDA rules includes submitting your device under the correct classification — and companies can struggle to determine which class a new medical device falls into.
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).
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.