What You Should Know:
– CLEW Medical, a provider of AI-driven clinical surveillance and predictive analytics, has achieved a breakthrough with FDA 510(k) clearance for its second-generation AI models for predicting patient deterioration.
– The FDA clearance builds upon their pioneering achievement of being the first FDA-cleared Class II medical device for this purpose in 2021.
Rigorous Testing for FDA Approval
Obtaining FDA clearance signifies that CLEW’s AI models have undergone rigorous evaluation. The process involved a comprehensive assessment of safety and performance data, along with extensive testing. The FDA also approved CLEW’s proposed pre-authorized change control plan (PCCP), allowing specific future modifications to the system’s input data without requiring a new 510(k) application.
Early Warning System for Patient Care
CLEW’s platform leverages a combination of cutting-edge machine-learning models and established best practices to identify patients at risk of deterioration early on. This empowers healthcare systems to intervene proactively, potentially improving patient outcomes.
Clinically Validated Performance
A recent study published in the prestigious CHEST Journal demonstrated the effectiveness of CLEW’s platform. The study found that CLEW’s predictions were at least five times more accurate than alerts from a leading telemedicine system, and generated 50 times fewer alarms compared to other monitoring systems. This translates to fewer false positives and more actionable insights for healthcare providers.
“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.”
