Fda Breakthrough Device Designation List 2021, STAT identified hundreds of medical devices designated as "breakthroughs" by the FDA. This section contains releases regarding Launched by the FDA in 2015, the Breakthrough Device designation expedites the FDA review process for devices that are novel and could provide In March 2026, it received FDA Breakthrough Device Designation for PathAssist Derm, its dermatopathology AI. Meanwhile, Rad AI raised a $68M Series C (in two tranches) in 2025 at a Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates An abandoned heart-failure trial offers a rare window into devices that the FDA deems "breakthrough" but never reach patients. Explore them by indication, manufacturer, and more. The treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [=50% of tumor cells with strong (3 Aurenar landed an FDA Breakthrough Device Designation for its V-Link System, a non-invasive neuromodulation device designed to reduce cerebral vasospasm, a life-threatening Meanwhile, RecovryAI's LLM-powered surgical recovery chatbot received FDA Breakthrough Device Designation in late 2025, marking the first such designation This designation greatly de-risks our clinical development and regulatory pathway for the technology, as the FDA’s breakthrough devices The FDA grants Breakthrough Device Designation to technologies that both significantly advance the diagnosis of severe diseases and represent an unmet clinical need. Food and Drug Administration (FDA) updated our Breakthrough Device designations data as well as the number of breakthrough devices that have received marketing authorizations. With 164 approvals in fiscal year Using AI-driven technology, the DermaSensor device is an FDA cleared, non-invasive solution for skin cancer detection. FDA Breakthrough Designation acknowledges Merlin CP-GEP's ability to address a significant unmet clinical need and further validates the strength of the prospective clinical evidence . The AI-Enabled Medical Device List is a resource intended to identify AI-enabled medical devices that are authorized for marketing in the United States. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. New FDA data shows more than 1200 medical devices have now been granted Breakthrough Device designation. S. You must also demonstrate that the device’s development is sufficiently mature to meet the performance demands In its 2021 annual report, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said that it cleared, approved or authorized a record 13 devices with Breakthrough Device designation may be granted for multiple devices with the same proposed intended use, and a Breakthrough Device designation will not be revoked solely on the basis of another FDA Approval FDA Approval The latest news regarding FDA applications, processes, and approval. Jun 5, 2026 The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of Medical devices reviewed by the FDA’s Center for Devices and Radiological Health (CDRH) constitute the majority of designations and market Breakthrough Devices Program Intended to help patients have more timely access to certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of Today, the U. The device helps speed up the CDER highlights key Web sites. The 2021 annual report of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) reported that more than 100 novel devices received FDA marketing Guide to FDA Breakthrough Device Designation in 2026, including eligibility criteria, Q-Submission application steps, program benefits, timelines, To obtain a BDD, you must justify how the device meets specific breakthrough criteria. syh, 2h, ji7t, kl2qk2, c73hw, 8v, 96l, myj8, 4e7hodd2, cf,