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FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

With this in mind, the FDA is issuing today's draft guidance to help clarify whether activities performed on medical devices are likely remanufacturing as well as a discussion paper on cybersecurity servicing of devices.

Irrimax Receives FDA Clearance for Irrisept

"This new clearance from the FDA further solidifies Irrisept as the market leader in wound irrigation," said Mark Alvarez, CEO of Irrimax.

NeuraLace Medical Receives FDA 510(k) Clearance and U.S. Launch of Axon Therapy® Peripheral Nerve Stimulation System

Axon Therapy® is a non-invasively stimulate peripheral nerves and provide chronic nerve pain relief

FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns

The FDA granted StrataGraft regenerative medicine advanced therapy (RMAT), Priority Review and Orphan Drug designations for this indication.

VoluMetrix Reports NIVA|HF for Heart Failure Patients Designated as Breakthrough Device by U.S. FDA

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.

Ibex Granted FDA Breakthrough Device Designation

Ibex's Galen™ AI-powered platform is recognized by the FDA as breakthrough technology with the potential to more effectively diagnose cancer

Ortho Regenerative Technologies Receives Clinical Hold Letter From the U.S. FDA

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.

FDA Alerts Health Care Providers to Stop New Implants of Certain Ventricular Assist Device System

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.

FDA Authorizes Marketing of Diagnostic Aid for Autism Spectrum Disorder

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.

Micro Interventional Devices Receives FDA Breakthrough Device Designation for the MIA™-T Percutaneous Tricuspid Annuloplasty System

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 Receives FDA “Breakthrough Device Designation” for its Cardiac Radioablation System

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.

Spinal Stabilization Technologies Earned the CE Mark & the FDA’s “Breakthrough Designation” for its PerQdisc™ Nucleus Replacement System

The PerQdisc device replaces the nucleus pulposus of the intervertebral disc in the L1 - S1 spinal region in patients with single-level discogenic pain.

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