FDA Medical Devices

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FDA Medical Devices

FDA Medical Devices

@FDADeviceInfo

Official FDA - device recalls, safety, authorizations, radiation-emitting products. Contact us [email protected] or 800-638-2041 https://t.co/hfXZUjyZz5

Silver Spring, Maryland, USA Katılım Mayıs 2010
404 Takip Edilen97.1K Takipçiler
FDA Medical Devices retweetledi
U.S. FDA
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 fda.gov/news-events/pr…
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FDA Medical Devices@FDADeviceInfo·
AI isn’t being slowed, it’s being cleared forward with guardrails.
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FDA Medical Devices
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.
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FDA Medical Devices@FDADeviceInfo·
AI isn’t being slowed, it’s being cleared forward with guardrails.
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FDA Medical Devices
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. fda.gov/medical-device…
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FDA Medical Devices
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. fda.gov/news-events/fd…
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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. fda.gov/regulatory-inf…
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FDA Medical Devices retweetledi
U.S. FDA
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. fda.gov/regulatory-inf…
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U.S. FDA
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. fda.gov/news-events/pr…
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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: fda.gov/media/190779/d…
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FDA Medical Devices retweetledi
U.S. FDA
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. fda.gov/news-events/pr…   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.
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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. fda.gov/advisory-commi…
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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: regulations.gov/document/FDA-2…
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FDA Medical Devices
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: fda.gov/advisory-commi…
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FDA Medical Devices retweetledi
U.S. FDA
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. fda.gov/medical-device…
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U.S. FDA
U.S. FDA@US_FDA·
Today, we authorized the marketing of the first eyeglass lenses to slow the progression of nearsightedness in children 6 to 12 years old at the initiation of treatment. fda.gov/news-events/pr…
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FDA Medical Devices@FDADeviceInfo·
We’re also establishing a docket for public comment for the scheduled Nov. 6 virtual Digital Health Advisory Committee meeting. Learn how to submit written comments: Regulations.gov
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FDA Medical Devices@FDADeviceInfo·
The FDA is scheduled to host a virtual Digital Health Advisory Committee meeting Nov. 6 to discuss generative AI-enabled digital mental health medical devices. Learn more: fda.gov/advisory-commi…
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FDA Medical Devices
FDA Medical Devices@FDADeviceInfo·
While some per- & polyfluoroalkyl substances (PFAS) chemicals are linked to health concerns, the materials used in medical devices are not the same. FDA’s evaluation is currently there is no reason to consider restricting their continued use in devices. fda.gov/medical-device…
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FDA Medical Devices@FDADeviceInfo·
Reminder: Monday, August 4, the @US_FDA will host a public meeting to discuss recommendations for the reauthorization of the Medical Device User Fee Amendments for fiscal years 2028 through 2032 (MDUFA VI). Find out more and register today. fda.gov/medical-device…
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