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FDA accepts Sibel Health’s Aria sensor for COA qualification

FDA accepts Sibel Health’s Aria sensor for COA qualification

Breath Diagnostics receives FDA Breakthrough Device Designation for OneBreath platform

Breath Diagnostics receives FDA Breakthrough Device Designation for OneBreath platform

Biomendex receives FDA 510(k) clearance for Adaptos Fuse

Biomendex receives FDA 510(k) clearance for Adaptos Fuse Bone Graft

Medtronic wins FDA nod for surgical robot for spine procedures

Medtronic wins FDA nod for surgical robot for spine procedures

Sonorous Neurovascular earns FDA breakthrough mark for novel stent

Sonorous Neurovascular earns FDA breakthrough mark for novel stent

Median Technologies receives FDA 510(k) clearance for eyonis LCS, an AI-based detection and diagnosis device for lung cancer screening

Median Technologies receives FDA 510(k) clearance for eyonis LCS, an AI-based...

FDA clears RevealDX’s AI lung nodule diagnostic

FDA clears RevealDX’s AI lung nodule diagnostic

Aidoc secures FDA clearance for healthcare’s first comprehensive foundation model AI

Aidoc secures FDA clearance for healthcare’s first comprehensive foundation model AI

FDA clears eMurmur’s next-gen AI heart murmur detection software

FDA clears eMurmur’s next-gen AI heart murmur detection software

Bridge to Life wins FDA De Novo for transplant liver perfusion system

Bridge to Life wins FDA De Novo for transplant liver perfusion...

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