SPI Medical Imaging: Speed is the Key for AISAP’s FDA Approval

AISAP has received FDA clearance for its AI-powered AISAP CARDIO point-of-care ultrasound (POCUS) software platform. The new solution combines four computer-assisted diagnosis (CADx) modules of valvular pathologies and eight key measurements into a single software package that automatically generates analyses, interpretations and reports.

The vendor boasts that AISAP CARDIO empowers clinicians with basic scanning skills, to accurately diagnose up to 90% of the most common cardiac structural and functional parameters within minutes, all whilst at the bedside.

Why we are covering this topic

• Achieving FDA clearance is a significant milestone for AISAP in its planned expansion into the US market, and it has reached this point relatively quickly since its formation in 2022.
• This pace is particularly notable considering it obtained FDA approval for multiple solutions at once, both for diagnostics and measurements.

Why it matters

• Providers are demonstrating an increasing appetite for AI-based ultrasound solutions, and cardiology is a particular area of focus.
• Many OEMs will be interested in AISAP’s offering, however its intention to remain independent poses challenges.