Huma.AI Adds Post-Market Surveillance Capacity to its Unique AI-Based Healthcare Data Knowledge Platform

Huma.AI has announced that it has secured $9.5 million in funding to expand its team, technology, and products to meet the needs of its fast-growing customer base. 

With this financial support, Huma.AI has expanded its self-service Business Intelligence platform to include a Post-Market Surveillance (PMS) solution specifically designed to help medical device and in vitro diagnostic (IVD) manufacturers meet stringent new compliance and oversight requirements required by the European Union (EU). 

Lana Feng, Ph.D., CEO and co-founder of Huma.AI 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.”

Launching a Post-Market Surveillance Solution for EU MDR and IVDR

To ensure the safety and efficacy of all medical and in vitro diagnostics devices sold in the EU, the European Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR) now require Device and IVD manufacturers to meet a new compliance and oversight requirements.

One specific regulation is the requirement for a Post-Market Surveillance (PMS) system. The PMS system must actively and systematically gather, record, and analyze relevant data on the quality, performance, and safety of a device throughout its entire lifetime.

Dr. Feng continued, saying that, “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. MDR and IVDR have changed all that. Put simply, that status quo approach is suddenly obsolete,” Dr. Feng said. 

To counter the difficulties in PMS, Huma.AI’s solution is a faster, more precise, and scalable approach that leverages the latest Machine Learning (ML) and Natural Language Processing (NLP) technologies. This solution has been validated by customers to shorten the time spent on literature searches from weeks to minutes with a 10x increase in accuracy. In addition, the platform connects multiple data sources meeting regulatory requirements to help ensure compliance.

Rapid Growth and Expansion

In 2021, Huma.AI’s annual revenue tripled, even in the midst of the pandemic. The company currently serves 10 global pharmaceutical and medical device companies, and is continuing to expand as customer awareness grows across the life science industry. Its unique, human-centered AI technology allows rapid development of new use cases.

Dr. Feng explained that Huma.AI’s transformative ML and NLP platform makes the interrogation of healthcare data “as easy as using Google.” She noted the platform is especially advantageous for exploring the 80 percent of data that are unstructured. “The Huma.AI platform enables users to extract key insights across millions of documents or billions of rows of unorganized texts more accurately in minutes rather than months,” said Dr. Feng.

Huma.AI's Post-Market Intelligence platform uses Machine Learning to streamline time-consuming workflows and ease the documentation burden on regulatory teams.