Sam Brusco, Associate Editor05.13.24
CLEW Medical, a clinical surveillance and predictive analytics company, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its second-generation, artificial intelligence (AI)/machine learning models to predict patient deterioration.
The FDA also approved the company’s proposed PCCP (pre-authorized change control plan) to allow specific, future changes to the system’s input data set without having to file a new 510(k). CLEW said it’s a significant milestone, following its first FDA clearance as a Class II medical device in 2021.
“At CLEW, we understand the significance of using AI to enhance care for critically ill patients,” said Paul Roscoe, CLEW CEO. “We are committed to fostering trust among caregivers, while offering them the most sophisticated and accurate clinical predictions available on the market by adhering to the most stringent regulatory processes. AI and machine-learning technology in this space must undergo the same level of scrutiny and diligence in design, development, testing, and validation as other medical devices used by clinicians.”
CLEW’s platform is built on proprietary, machine-learning derived prediction models and rules-based best practices. It provides health systems with early identification of a patient’s deterioration risk.
The company said a recent peer-reviewed study in CHEST Journal showed predictions from the CLEW platform were at least five times more accurate than alerts from the leading telemedicine system. The platform also generated 50 times fewer alarms than other monitoring systems.
The FDA also approved the company’s proposed PCCP (pre-authorized change control plan) to allow specific, future changes to the system’s input data set without having to file a new 510(k). CLEW said it’s a significant milestone, following its first FDA clearance as a Class II medical device in 2021.
“At CLEW, we understand the significance of using AI to enhance care for critically ill patients,” said Paul Roscoe, CLEW CEO. “We are committed to fostering trust among caregivers, while offering them the most sophisticated and accurate clinical predictions available on the market by adhering to the most stringent regulatory processes. AI and machine-learning technology in this space must undergo the same level of scrutiny and diligence in design, development, testing, and validation as other medical devices used by clinicians.”
CLEW’s platform is built on proprietary, machine-learning derived prediction models and rules-based best practices. It provides health systems with early identification of a patient’s deterioration risk.
The company said a recent peer-reviewed study in CHEST Journal showed predictions from the CLEW platform were at least five times more accurate than alerts from the leading telemedicine system. The platform also generated 50 times fewer alarms than other monitoring systems.