CLEW Medical's Second-Generation AI Models Granted FDA Clearance

13 May 2024

CLEW Medical recently achieved a significant milestone as its second-generation AI/machine-learning models for predicting patient deterioration received 510(k) clearance from the FDA.

This clearance represents a noteworthy accomplishment for CLEW, following its initial FDA clearance as a class II medical device in 2021.

The company's dedication to improving care for critically ill patients through AI technology while maintaining trust among caregivers. He emphasized the necessity for stringent regulatory processes, asserting that AI and machine-learning technologies in healthcare must undergo rigorous scrutiny akin to other medical devices.

Obtaining FDA 510(k) clearance involved fulfilling standard prerequisites for medical devices, including thorough safety and performance assessments and extensive experimentation.

Additionally, the FDA approved CLEW's proposed PCCP (pre-authorized change control plan), enabling future updates to the system's input data set without requiring new 510(k) filings.

The CLEW platform, based on proprietary machine-learning derived prediction models and rules-based best practices, offers health systems early identification of patient deterioration risks.

A recent study published in the CHEST Journal highlighted the platform's effectiveness, showing predictions to be significantly more accurate than leading telemedicine alerts and generating fewer alarms compared to other monitoring systems.