Harrison.ai has been awarded three FDA breakthrough device designations for its imaging AI solutions, including a tool for obstructive hydrocephalus triage.
Key Details
- 1Harrison.ai received three FDA breakthrough device designations.
- 2One designation is for a triage/prioritization AI solution for obstructive hydrocephalus.
- 3The solution is among only 13% of FDA breakthrough devices to achieve 510(k) marketing authorization.
- 4It is one of only two radiology FDA breakthrough devices to become eligible for Medicare’s NTAP.
- 5The FDA program aims to speed up innovation and clinical access to critical devices.
Why It Matters
FDA breakthrough status highlights a product's potential to address unmet clinical needs, and rapid regulatory pathways can accelerate adoption in radiology practice. Harrison.ai's achievement signals growing validation and support for advanced imaging AI in critical care.
Source
Radiology Business
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