Digital Diagnostics is a startup that is primarily engaged in medical imaging technology, specifically through its AI diagnostic platform LumineticsCore™. The company has received FDA clearance for this platform, making it the first AI diagnostic system to make a diagnosis without physician input.
iCAD is a startup that offers AI-powered solutions for breast cancer detection and risk evaluation, which falls under medical imaging technology. Additionally, their solutions are FDA cleared, meeting the criteria for FDA approval.
QT Imaging is a startup that is primarily engaged in medical imaging technology, specifically breast imaging. The company has received FDA 510(k) clearance for its Breast Acoustic CT™ Scanner, which qualifies as FDA approval for its product.
Synaptive Medical is a startup engaged in medical imaging technology, and its Modus X robotic exoscope has received FDA 510(k) clearance for Near-Infrared fluorescence visualization.
Eyenuk is a startup specializing in AI for eye screening, specifically through its EyeArt system, which is FDA cleared for autonomous detection of diabetic retinopathy. This matches the criteria of being a medical imaging startup with FDA approval.
Koning is a startup that is primarily engaged in medical imaging technology, specifically breast imaging. The company has received FDA approval for its Koning Vera Breast CT device for both diagnostic imaging and 3D-guided biopsy.
AlgoSurg Inc is a startup that develops medical imaging technology, specifically cloud-based software for 3D surgery planning and patient-specific instrument design. Additionally, the company has FDA approval for its Deftfix cloud-software for planning surgeries with Hexapod fixator.
Genetesis is a startup founded in 2013, primarily engaged in medical imaging technology through its CardioFlux MCG platform. The company has received FDA 510(k) clearance for its CardioFlux cardiac imaging platform and has been granted Breakthrough Device Designation by the FDA.
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