Medical Device Artificial Intelligence

Representative experience

Developed an innovative strategy for interacting with FDA allowing Viz.ai to gain a quick De Novo clearance for a novel Computer-Aided Triage and Notification Platform to identify Large Vessel Occlusion strokes in CTA imaging.

Successfully assisted IDx LLC to achieve De Novo reclassification from the FDA for the groundbreaking AI-based device IDx-DR, which autonomously analyzes images of the retina for signs of diabetic retinopathy.

Assisted CSD Labs in obtaining 510(k) clearance of eMurmur, an innovative, AI-based murmur detection software.

Advised Bay Labs in seeking 510(k) clearance for its EchoMD AutoEF software, which applies machine learning algorithms to process echocardiography images in order to calculate left ventricular ejection fraction.

Assisted numerous clients with novel medical devices featuring AI and machine learning algorithms in developing and gaining FDA alignment on creative regulatory strategies to bring these innovative products to market in the U.S.