FDA Seeks $60 Million in Funding to Improve Access to Safe and Effective Medical Products

The total $8.4 billion fiscal year 2023 budget request is 34% higher than the agency’s 2022 appropriated funding level.
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Baxter Issues Urgent Safety Notification for Potential Alarm Malfunction in Infusion Pumps

Thus far, the company has received 51 reports of serious injury and three reports of patient death over five years.
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Medtronic Recalls Atherectomy System due to Risk of Catheter Breakage

Medtronic Recalls Atherectomy System due to Risk of Catheter Breakage

The Class I recall affects more than 95,000 devices in the United States.
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CDRH Prepares to Take On 2022 While Managing Unprecedented Workload

The center is also hoping to move back into more normal review timelines next year.
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Five Years Later, Califf Nomination Still Controversial

President Biden intends to nominate former FDA Commissioner Robert Califf, M.D. as agency head, and the same opposition voiced during his previous nomination remains.
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FDA Reorg Establishes Office of Digital Transformation

The agency has realigned information technology, data management and cybersecurity functions, and established a new office reporting directly to the FDA commissioner.
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Medtronic Halts Sale of HVAD System, Urges Healthcare Providers to Stop Implantation

FDA also supports the removal of the HeartWare HVAD System from the market.
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FDA Introduces the Safer Technologies Program for Medical Devices

The program highlights the agency’s commitment to improving safety and supporting innovation, and is a welcome counterpart to the Breakthrough Devices Program.
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Medtronic Gets FDA Approval for the First Non-Surgical Valve for Patients with Congenital Heart Disease

The Harmony Transcatheter Pulmonary Valve is an alternative to open heart surgery.
The post Medtronic Gets FDA Approval for the First Non-Surgical Valve for Patients with Congenital Heart Disease appeared first on MedTech Intelligence. Source: MedTech Intelligence…

First At-Home, Molecular OTC Diagnostic Test for COVID-19 Wins FDA Authorization

The test generates results within 20 minutes and can be used by adults and children over the age of two years old.
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