Category: Software as a Medical Device (SAMD) for early detection of prostate cancer

Overview: Nanostics, a precision diagnostics company, uses its AI-powered ClarityDX platform to predict disease. Its internationally validated lead test, ClarityDX Prostate, reduces unnecessary biopsies and improves patient outcomes. Commercially available across Canada, “the test puts patients in a leadership role [in their healthcare journey],” explained John Breen, Albertan patient.

System Benefits:

• Reduces 47% of unnecessary prostate biopsies, resulting in system savings of $258,250 per 1,000 men with elevated PSA levels
• Eliminates biopsy caused side effects like sepsis, incontinence, erectile dysfunction and anxiety
• Accelerates accurate diagnosis with AI-driven risk assessment
• Expands access through scalable lab/SaaS delivery models