Huma.AI has added a post-market surveillance (PMS) solution to its AI-based business intelligence platform for the healthcare industry.

The PMS feature is specifically designed to help device and IVD manufacturers meet stringent new compliance and oversight requirements required by the European Union (EU).

In addition, the company has raised $9.5m in a Series A funding round to expand its team, technology and products to address the needs of its customer base.

Led by Excelerate Health Ventures, the financing round has seen participation from the company’s existing investors Fusion Fund and ShangBay Capital.

Also, the new investors Hatteras Venture Partners, Boston Millennia Partners, SteelSky Ventures, W Fund, King Fund and Human Longevity Venture Fund have also participated in the funding round.

Huma.AI CEO and co-founder Lana Feng said: “We’re thrilled to broaden the capacity of our platform so clients can more quickly and efficiently collect and process the data they need to bring life-saving, life-extending products to patients faster and help track and confirm post-market performance.

“Seeing the excitement on our clients’ faces when a critical insight is surfaced by the Huma.AI platform is priceless and makes all the hard work we put into the technology meaningful.”

To ensure the safety and efficacy of all medical devices and diagnostics sold in the EU, MDR and IVDR regulations now require new compliance and oversight, including the PMS system.

The PMS system is designed to actively and systematically gather, record and analyse data on the quality, performance and safety of a device throughout its lifetime.

Huma.AI said that its PMS solution is a rapid, more precise and scalable approach that leverages advanced ML and NLP technologies.

The solution has been validated to reduce the time spent on literature searches from weeks to minutes with a ten-fold increase in accuracy, said the company.

Feng added: “It’s practically impossible to keep up with the volume and velocity of scientific, analytical and performance data and meet the new obligations of Risk Management, Performance Evaluation and Post-Market Surveillance.

“Until recently, device and diagnostics manufacturers have been able to make do with a patchwork of tools and systems, and a largely manual and error-prone regulatory compliance process.”