gains seven new 510(k) clearances for brain and chest imaging solutions

3536 has received US Food and Drug Administration (FDA) 510(k) clearances covering an additional seven findings as part of the company’s innovative artificial intelligence (AI)-assisted triage and notification solutions. The clearances, which include a suite of time-sensitive stroke findings and an expansion of findings for chest X-ray, build on Annalise’s momentum and growth strategy in the US market, as per a company press release.

Annalise Triage uses deep learning to identify the suspected presence of time-sensitive pathologies and flag priority cases within the radiology worklist, assisting the care team in treating patients with the most critical conditions first, the release adds.

All FDA-cleared Annalise chest X-ray (CXR) and computed tomography (CT) Brain findings are a subset of a comprehensive group of solutions, field-tested and available outside the USA, with clinical studies showing improvements in detection accuracy, diagnostic decision-making, and reporting speed.

The latest 510(k)-cleared findings for use in triage and notification for CT Brain are acute subdural/epidural haematoma; acute subarachnoid haemorrhage; intra-axial haemorrhage; and intraventricular haemorrhage.

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

Annalise has also expanded its portfolio of FDA 510(k)-cleared findings for triage and notification on CXR to a total of five, and—the company claims—now offers the highest number of findings for triage and notification on chest X-ray in the US market. The findings include pneumothorax; tension pneumothorax; pleural effusion; pneumoperitoneum; and vertebral compression fracture.

As with head CT, quickly identifying imaging findings via CXR can help expedite diagnosis, guide treatment decisions, and improve patient outcomes, the release details.

“AI-assisted triage is becoming increasingly important in healthcare,” said Rick Abramson, Annalise’s chief medical officer. “Triage solutions drive quality improvement by enabling earlier detection and intervention for our most critically ill patients. And, by prioritising the radiology worklist, these solutions also help address some of the burnout issues that have affected our specialty since the pandemic.”


Please enter your comment!
Please enter your name here