CLEW Medical, a clinical surveillance and predictive analytics company, today announced that its second-generation, AI/machine-learning models for predicting patient deterioration have received 510(k) clearance from the Food & Drug Administration (FDA). This marks a significant milestone for CLEW, following its pioneering 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.”

Obtaining this FDA 510(k) clearance required CLEW to fulfill all standard prerequisites applicable to medical devices. This involves a thorough assessment of safety and performance data, along with extensive experimentation. The FDA also approved the company’s proposed PCCP (pre-authorized change control plan) to allow certain future changes to the system input data set without needing to file a new 510(k).

Built upon proprietary, machine-learning derived prediction models and rules-based best practices, the CLEW platform offers health systems an early identification of a patient’s risk of deterioration. A recent peer-reviewed study published in CHEST Journal notably found that predictions from the CLEW platform were at least five times more accurate than alerts from the leading telemedicine system and generated 50 times fewer alarms than other monitoring systems.

Source: Company Press Release