FDA Medical Devices

Official FDA - device recalls, safety, authorizations, radiation-emitting products. Contact us [email protected] or 800-638-2041

[FDA Medical Devices @FDADeviceInfo]

Today, we celebrate Fifty Years of the Medical Device Amendments and the incredible work of CDRH. Here's to the next 50!
https://t.co/8IlV8w8wQY

[FDA Medical Devices @FDADeviceInfo]

50 years ago today, the Medical Device Amendments were signed into law — giving @US_FDA authority to ensure the safety & effectiveness of medical devices.

[FDA Medical Devices @FDADeviceInfo]

This marketing authorization is part of the FDA’s ongoing commitment to delivering innovative solutions that support improvements in patient outcomes.

[FDA Medical Devices @FDADeviceInfo]

The FDA authorized marketing of the DeepView AI System to detect deep burn tissue and flag specific skin areas unlikely to heal within 21 days. The DeepView AI System utilizes hardware and AI-driven software to analyze images obtained from the burn. https://t.co/p5rnK9NDWd

[FDA Medical Devices @FDADeviceInfo]

It is intended for prescription use by healthcare providers in conjunction with clinical assessment and not as a stand-alone diagnostic device.

[U.S. FDA @US_FDA]

Today FDA approved the first-ever gene therapy for the treatment of genetic hearing loss under the National Priority Voucher Program.
✅6th approval under the National Priority Voucher Program
✅Approved 61 days after filing

https://t.co/Modecu7S50

[FDA Medical Devices @FDADeviceInfo]

AI isn’t being slowed, it’s being cleared forward with guardrails.

[FDA Medical Devices @FDADeviceInfo]

The FDA’s AI stance in action!

The agency just cleared an AI ultrasound tool that estimates gestational age in under 2 minutes.

This is the model: support innovation that expands access and improves speed, while holding firm on safety and effectiveness.

[FDA Medical Devices @FDADeviceInfo]

AI isn’t being slowed, it’s being cleared forward with guardrails.

[FDA Medical Devices @FDADeviceInfo]

The FDA's Home as a Health Care Hub Initiative launches the "READI-Home: Reducing Readmissions through Device Innovation for the Home” innovation challenge to accelerate patient access to at-home medical technologies aimed at reducing hospital readmission. https://t.co/qltFtPWux0

[FDA Medical Devices @FDADeviceInfo]

The @US_FDA continues to advance the use of Real-World Evidence (RWE) to support smarter, more efficient regulatory decision-making for medical  devices.

Explore how RWE is driving real-world impact in our latest FDA Voices blog. https://t.co/eO9ctDl5Sr

[FDA Medical Devices @FDADeviceInfo]

Today, @US_FDA issued final guidance on collecting and submitting patient preference information, strengthening the agency’s commitment to patient engagement and advancing safe, effective medical devices. https://t.co/jOkYJPzwaj

[U.S. FDA @US_FDA]

Today, FDA issued final guidance for medical devices with indications for use associated with weight loss as part of the FDA’s ongoing efforts to support the development of safe and effective medical devices that can improve health outcomes and reduce the burden of chronic disease in the U.S. https://t.co/pJ1xcpgwad

[U.S. FDA @US_FDA]

The FDA approved a first-of-its-kind device to treat locally advanced pancreatic cancer, reflecting the agency’s unwavering commitment to advancing safe and effective medical devices that address chronic diseases and improve the lives of Americans. https://t.co/XHDntiu83w

[FDA Medical Devices @FDADeviceInfo]

Anchored on the pillars of safety & innovation, the CDRH 2025 annual report highlights the Center’s resilience and sustained performance this past year. Check out CDRH’s 2025 Annual Report to learn more about their work to protect & promote public health: https://t.co/iqdcNVQoXs

[U.S. FDA @US_FDA]

Today, the FDA announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a first-of-its-kind digital health pilot to expand access to chronic disease technologies. https://t.co/7kvzX5vJRi

The voluntary pilot is designed to promote access to certain digital health devices while safeguarding patient safety and marks a major step in the agency’s plan to support technology-enabled care, strengthen chronic disease management, and expand health care access for patients nationwide.

[FDA Medical Devices @FDADeviceInfo]

Reminder: submit written comments on generative AI-enabled digital mental health medical devices to docket number FDA-2025-N-2338 by Dec. 8 for review and consideration by the FDA. https://t.co/GzYFxyNyGm

[FDA Medical Devices @FDADeviceInfo]

The FDA Digital Health Advisory Committee will discuss generative AI-enabled digital mental health medical devices at its Nov. 6 virtual meeting. Learn how to submit written public comments on the meeting: https://t.co/ZWNG34rEyq

[FDA Medical Devices @FDADeviceInfo]

The FDA has posted materials for the virtual Digital Health Advisory Committee meeting on Nov. 6. Access the meeting materials and webcast link, and learn more about the meeting:
https://t.co/GzYFxyNyGm

[U.S. FDA @US_FDA]

The FDA announced a request for public comment by Dec. 1 on measuring and evaluating the performance of AI-enabled medical devices in the real-world. https://t.co/5QQS8EjGBb