The regulatory decision comes just a few weeks after the FDA cleared the company’s pulmonary embolism product.
Highlighting the company’s rapid progress in the radiology space, Israeli startup Aidoc has received its third FDA clearance for its AI-based algorithm to help highlight potential instances of cervical spinal fractures.
The regulatory decision comes just a few weeks after the FDA cleared the company’s pulmonary embolism product. Aidoc also has approval for its algorithm for the detection of intracranial hemorrhages through CT scans.
The company’s cervical spinal fracture product already received approval from European regulators.
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Delayed diagnosis of cervical spinal fracture is a common problem in emergency rooms and can lead to potential major neurological issues including quadriplegia. The incidence of delayed or missed diagnosis of cervical spinal injuries has been tagged at between 5 and 20 percent.
Aidoc’s technology functions as a triage tool for radiologists and runs continuously on hospital systems, automatically ingesting radiological images. By surfacing patients with potential issues, Aidoc’s algorithms serves as workflow optimization tool so clinicians can prioritize high-need and high-risk individuals.
CEO Elan Walach previously told me that that Aidoc has eight other products in clinical trials and has the overarching ambition of creating a “full-body comprehensive suite” of AI-based algorithms, applicable across different use cases.
Since its founding in 2016, Aidoc has raised more than $40 million, including a $27 million Series B early this year led by Square Peg Capital.
Recently, the company said it had reached a milestone by analyzing its 1 millionth CT patient scan and has a stated intention to reach 500 hospital partners in the next two years and build out its comprehensive full body coverage suite.
AiDoc currently lists the University of Rochester Medical Center, Cedars-Sinai and AZ Maria Middelares General Hospital in Belgium as a few of its roughly 100 commercial clients.
Competitors in the space include Dutch company Quantib, Cambridge, Massachusetts-based EnvoyAI and fellow Israeli startup Zebra Medical Vision.
Date: June 19, 2019
Source: MedCityNews
