Notable regulatory approvals of emerging technologies over the past 30 days

Along with AI in its various iterations, the list may include virtual and augmented reality, 3D printing, robotics and other technologies currently changing healthcare delivery.

Cognoa: FDA clearance for AI-driven autism diagnosis device (June 2)

DEARhealth: CE mark for AI-powered chronic disease management (June 9)

Ibex: FDA breakthrough designation for AI pathology cancer diagnostics (June 9)

Subtle Medical: CE mark for AI positron emission tomography (PET) image enhancement (June 9)

iCad: CE mark for AI analysis of 3D mammography (June 14)

Synopsys: FDA clearance for 3D medical/surgical printing (June 14)

VoluMetrix: FDA breakthrough designation for venous waveform monitoring (June 15)

Teleglobal Consulting: CE mark for AI chest abnormality detection (June 20)

Onkos Surgical: FDA clearance for porous 3D-printed bone-growth collars (June 22)

Interventional Systems: FDA clearance for miniature interventional-procedure robot (June 29)

Tissue Analytics (of Net Health): CE mark for mobile wound imaging & analytics (June 29)

CoreLink: FDA clearance for 3D-printed cervical spine implant (June 30)

Around the web

The AI approach may prove more effective than PET/CT, which can only diagnose N2 disease with 70-85% sensitivity, researchers reported Tuesday in Radiology.

The results could lead to expanded use of chest radiography in interstitial lung disease clinics, experts reported in the American Journal of Roentgenology.

Experts say this is the first study to assess how preprocessing techniques impact providers' ability to routinely extract similar quantitative imaging features from US scans.

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