Announces FDA 510(k) Clearance for Four Non-contrast Head CT Findings

We are excited to share that we have received the first U.S. FDA 510(k) clearance for our triage and notification solution for non-contrast head CT in the U.S. Cleared findings include:

  • Acute subdural/epidural hematoma
  • Acute subarachnoid hemorrhage
  • Intra-axial hemorrhage
  • Intraventricular hemorrhage

Triaging specific subtypes of brain hemorrhage is important because each type has its own specific causes, symptoms, and treatments.

“Triage solutions drive quality improvement by enabling earlier detection and intervention for our most critically ill patients,” said Rick Abramson, MD, MHCDS, FACR, Chief Medical Officer at “And by prioritizing the radiology worklist, these solutions also help address some of the burnout issues that have affected our specialty since the pandemic.”

“We are thrilled to mark our entry into the U.S. neuroimaging space with this set of high-precision tools for prioritizing intracranial hemorrhage cases on non-contrast head CT,” said Lakshmi Gudapakkam, CEO of “ is committed to developing the highest quality tools for advancing patient care and patient care efficiency in the U.S.”

The additional findings build on our momentum in the U.S and bring FDA 510(k) cleared findings to a total of nine, include five total findings for triage and notification of chest X-rays.

Click here to read the full press release.

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