CLEW Medical Secures FDA Clearance for Second-Generation AI Models
13 Mayo 2024 - 7:30AM
Business Wire
Advancing Predictive Patient Deterioration
Technology with Superior Accuracy
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. For more information about that study, click
here.
For more information about the CLEW system, contact the CLEW
team.
About CLEW Medical, Inc.
CLEW offers the first FDA-cleared, class II medical device,
AI/ML-based clinical predictive models for critical care as a part
of its intelligent clinical surveillance platform. Its ability to
offer accurate, predictive insights around patient deterioration
allows health systems to optimize patient interventions, decreasing
mortality and reducing complications & readmissions. Its
proprietary models offer an optimal balance of precision and
sensitivity, which results in fewer high-risk notifications,
reducing alarm fatigue amongst providers and clinicians. For more
information, visit clewmed.com.
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Media Matter Health for CLEW Medical Matt Robbins T:
617.874.5203 clew@matternow.com