With this in mind, the FDA is issuing today's draft guidance to help clarify whether activities performed on medical devices are likely remanufacturing as well as a discussion paper on cybersecurity servicing of devices.
As a Breakthrough Device, NIVA|HF will receive pre-market developmental assistance and prioritized regulatory review from FDA. NIVA|HF is the first application of VoluMetrix's proprietary venous waveform technology.
The FDA has requested additional Chemistry, Manufacturing, and Control ("CMC") related information. The Company is confident in its ability to address and provide the FDA with the required information and testing data over the coming four to six weeks.
Medtronic's decision to stop the sale and distribution of the HVAD follows the company's voluntary recall of a subset of the HVAD pumps in December 2020. The FDA will continue to monitor adverse events associated with the HVAD System and keep health care providers and the public informed as new or additional information becomes available.
The Cognoa ASD Diagnosis Aid is a software as a medical device that uses a machine learning algorithm to receive input from parents or caregivers, video analysts and health care providers to assist physicians evaluate a patient at risk of ASD.
MID develops proprietary Transcatheter Cardiac Repair (TCR) technologies addressing unmet needs in the treatment of structural heart disease. The company's products are designed to achieve surgical efficacy with percutaneous safety.
Varian, a Siemens Healthineers company, announced today that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its cardiac radioablation (CRA) system, currently in development as a noninvasive therapy for select patients with refractory ventricular tachycardia.