Another Set Of Eyes: US FDA Authorizes AI Software To Spot Prostate Cancer

The Paige Prostate is a first-of-its-kind digital prostate imaging analysis software that can act as an extra pair of eyes to help pathologists spot cancer cells.

The Paige Prostrate software can be used by pathologists to find cancerous cells that otherwise would go undetected
The Paige Prostrate software can be used by pathologists to find cancerous cells that otherwise would go undetected • Source: Paige.AI.

The US Food and Drug Administration has granted de novo authorization to Paige.AI.’s Paige Prostate medical software to aid pathologists in finding prostate cancer. According to the agency, clinical data shows it significantly improved the detection of cancerous cells that otherwise would have gone unnoticed.

Paige, spun off from New York’s Memorial Sloan Kettering Cancer Center, develops artificial intelligence medical software to analyze diagnostic imaging...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Business

Waters’ Purchase Of BD Biosciences & Dx Brings Growth Potential Alongside Trade-Offs

 
• By 

Waters Corp. will acquire Becton Dickinson’s Biosciences and Diagnostics business for $17.5bn, doubling its TAM to $40B. Analysts praise the flow cytometry addition but see weaker growth in diagnostics.

Medtronic, Philips Cement New Pact To Embed Next-Gen Tech In Monitoring Platforms

 
• By 

Under the terms of the new agreement, Philips will also begin bundling essential supplies – including ECG, noninvasive blood pressure (NIBP) components, and batteries – with its Medtronic-enabled monitors.

Deals Shaping The Medtech And Diagnostics Industries, June 2025

 
• By 

An interactive look at medtech and diagnostics deals made during June 2025. Data courtesy of Biomedtracker.

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

More from Medtech Insight

Medtronic, Philips Cement New Pact To Embed Next-Gen Tech In Monitoring Platforms

 
• By 

Under the terms of the new agreement, Philips will also begin bundling essential supplies – including ECG, noninvasive blood pressure (NIBP) components, and batteries – with its Medtronic-enabled monitors.

Bivacor Rotary Heart Could Upend The Artificial Heart Market, If It Reaches Its Destination

 
• By 

Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.

Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

 
• By 

Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.