The US Food and Drug Administration (FDA) has granted 510(k) clearance (K262134) for Deep Reasoning AI’s NeuroDR, an AI software tool designed for neurovascular computed tomography angiography scans.
The software visualises head and neck arteries using these scans.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
It was created alongside medical imaging post-processing provider 3DR Labs and regulatory consultancy Innolitics.
The clearance was secured 105 days after submission, with Deep Reasoning AI and 3DR Labs now planning to supply the platform to US hospitals and imaging centres.
NeuroDR operates automatically in the background after a scan finishes.
The software strips away soft tissue, bone and veins to produce 3D maximum intensity projections, curved planar reformats, and volume renderings of the left and right internal carotid and vertebral arteries.
It then delivers these visualisations directly into hospital picture archiving and communication systems as digital imaging and communications in medicine (DICOM) images.
The platform also divides anterior and posterior circulations into distinct displays, allowing doctors to inspect each section without anatomical overlap.
Clinicians utilise the system to assist in verifying whether physician-identified lesions are present, as well as to aid in evaluating, documenting, monitoring, and planning treatment.
Innolitics managed the entire regulatory pathway, handling cybersecurity and software documentation alongside regulatory interactions, which included a live demonstration during an early orientation meeting.
Because of familiarity with regulator expectations from earlier cleared technologies, the team bypassed a formal pre-submission meeting. 3DR Labs conducted the performance studies, which Innolitics designed.
Deep Reasoning AI president and CEO Mike Beck said: “NeuroDR is Deep Reasoning AI’s first FDA-cleared product and a first step toward complete, patient-specific 3D anatomy from routine scans.
“Innolitics guided us from strategy to clearance and answered every FDA question on a tight clock. We are ready to bring NeuroDR to hospitals.”
Founded by Cornell University AI professors, Deep Reasoning AI builds imaging technology that merges deep learning with anatomical reasoning to construct patient-specific 3D models despite anatomical variations, imaging artefacts, or metal implants.
Innolitics is a regulatory and medical device software consultancy while 3DR Labs provides radiologic post-processing services, workflow orchestration, and AI integration.
