▾ G11 Media Network: | ChannelCity | ImpresaCity | SecurityOpenLab | GreenCity | Italian Channel Awards | Italian Project Awards | ...
InnovationOpenLab

CLEW Medical Secures FDA Clearance for Second-Generation AI Models

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)...

Business Wire

Advancing Predictive Patient Deterioration Technology with Superior Accuracy

BOSTON: 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.

Fonte: Business Wire

If you liked this article and want to stay up to date with news from InnovationOpenLab.com subscribe to ours Free newsletter.

Related news

Last News

Gyala: a new "Made in Italy" cybersecurity

With a proven track record in the defence field, Gyala now also brings its cybersecurity technologies to the wider enterprise audience

ITALIAN PROJECT AWARDS 2023: the best IT projects of the year, awarded

Now in its third edition, the initiative is targeted at the ICT professional world and honours projects based on innovative ideas and technologies, realised…

I3P launches the Cybersecurity Incubation Program

The I3P's initiative is promoted together with the National Cybersecurity Agency in collaboration with Leonardo and C*Sparks.

iVis Technologies enables remotely-controlled corneal telesurgery

It's based on Italian technologies the first successful intercontinental telesurgery intervention for keratoconus carried out remotely, connecting Bari…

Most read

NukuDo, a Global Leader in Cybersecurity Workforce Development, Launches…

Today, NukuDo, a global leader in cybersecurity workforce development and staffing, proudly announces the launch of its North American headquarters in…

AmerisourceBergen Specialty Group Provides Substitute Notice of Data Incident…

AmerisourceBergen Specialty Group, LLC (ABSG) is issuing notice to individuals who may have been impacted by a data security incident. ABSG’s parent company…

Latin America Data Center Market Landscape Report 2024-2029 Featuring…

The "Latin America Data Center Market Landscape 2024-2029" report has been added to ResearchAndMarkets.com's offering. The Latin American data center…

TruBridge Announces Participation in the Stifel Cross Sector Insight Conference

TruBridge, Inc. (NASDAQ:TBRG), a healthcare solutions company, today announced that management will participate in the Stifel Cross Sector Insight Conference…

Newsletter signup

Join our mailing list to get weekly updates delivered to your inbox.

Sign me up!