Deep Reasoning AI—a company founded by Cornell University (Ithaca, USA) artificial intelligence (AI) professors—has announced that the US Food and Drug Administration has granted 510(k) clearance for NeuroDR, an AI-enabled software for visualising the arteries of the head and neck from computed tomography angiography (CTA) scans.
NeuroDR was developed in collaboration with 3DR Labs, which conducted performance studies, while medical device software and regulatory consultancy Innolitics designed these studies, prepared the submission, and managed the US FDA review from regulatory strategy through clearance.
NeuroDR runs automatically in the background once a scan is complete, as stated in a Deep Reasoning AI press release. The software removes bone, soft tissue and veins, then returns 3D maximum intensity projections, volume renderings, and curved planar reformats of the left and right internal carotid and vertebral arteries, to the hospital’s picture archiving and communication system (PACS) as digital imaging and communications in medicine (DICOM) images. It also separates the anterior and posterior circulation into their own views, so physicians can review each without overlapping anatomy.
According to Deep Reasoning AI, NeuroDR supports healthcare professionals in confirming the presence or absence of physician-identified lesions as well as in their evaluation, documentation, follow-up, and treatment planning.
“NeuroDR is Deep Reasoning AI’s first FDA-cleared product and a first step toward complete, patient-specific 3D anatomy from routine scans,” said Mike Beck, the company’s president and chief executive officer (CEO). “Innolitics guided us from strategy to clearance and answered every FDA question on a tight clock. We are ready to bring NeuroDR to hospitals.”
“Deep Reasoning AI brought rigorous AI software and a team willing to do the work FDA asks for. Clearing a fully automated neurovascular device 105 days after submission reflects that. We are proud to celebrate it with them,” added Yujan Shrestha, partner at Innolitics.
Deep Reasoning AI and 3DR Labs are now planning to bring NeuroDR to US hospitals and imaging centres, the release notes.
