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Medtronic is relaunching its Harmony Transcatheter Pulmonary Valve (TPV) system after a March 2022 recall following six reports of a failure of the capsule at the end of the delivery catheter.
At the end of the surgery, the surgeon removes the device with the needles stored safely inside, eliminating the potential for needle loss inside the patient.
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).