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

Edwards Lifesciences Lowers Tariff Impact Forecast, Keeps Gross Margin Guidance Intact

 
• By 

The company reaffirmed its guidance for adjusted gross profit margin for the full year 2025 to remain within the original range of 78% to 79%. Chief financial officer Scott Ullem attributed this to currency and tariff dynamics.

Olympus, Revival Co-Found Swan In $458M Deal, Face Tech and Regulatory Hurdles

 
• By 

Olympus and Revival Healthcare Capital have launched Swan Endosurgical in a $458m milestone-based joint venture to develop a robotic platform for endoluminal surgery. The deal combines Olympus’ GI expertise with Revival’s start-up model, but will face technical and regulatory hurdles.

Alternative Funding Sources Emerge Amid Biotech Industry Challenges

 
• By 

The biotech funding landscape is undergoing a fundamental shift. With traditional VC becoming increasingly cautious and selective, industry executives are exploring new avenues for capital. Conversely, this evolution may ultimately benefit the sector's long-term sustainability.

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 

The NHS England chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

More from Medtech Insight

EU/US Trade Deal Raises Questions For Medtech

 

There is still no clarity on how life sciences will be treated in the final agreement.

NICE To Consult On UK Late-Stage Healthtech Assessments

 
• By 

NICE’s three-pronged lifecycle approach to healthtech evaluations includes late-stage assessments (LSA), which will be the focus of a short consultation in August.

Roche Diagnostics Growth Flattens As China Reforms Bite; Bets On US Manufacturing, CGM For Growth

 
• By 

Roche has taken steps to mitigate potential tariff exposure that include shifting inventories and increasing US production of medicines. The company also initiated a tech transfer for one of its most exposed products to a US manufacturing site.