Landmark Case Highlights Legal Risks for Medical AI Device Makers

A recent legal case may shape future liability risk for manufacturers of AI-enabled medical devices, including those using imaging AI.

Key Details

• Dickson v. Dexcom Inc. is the first case to hold that federal law can preempt state personal injury lawsuits for certain FDA-authorized devices.
• The case involves Class II devices cleared via the FDA’s De Novo pathway, frequently used by AI/ML-enabled device manufacturers.
• Manufacturers using the De Novo pathway for AI/ML devices do so over three times more than other device manufacturers.
• The authors suggest this case could impact future court handling of injury claims involving AI/ML medical devices.

Why It Matters

Legal precedents on product liability directly affect how AI imaging tools are developed, cleared, marketed, and insured. Understanding potential liability exposure is critical for radiology AI startups, manufacturers, and investors.

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