FDA grants emergency use authorization to COVID-19 ICU AI prediction software.
The FDA granted an emergency authorization to CLEW Medical’s remote data monitoring system to help predict and identify COVID-19 patients under intensive care who are most at risk for respiratory failure or insufficient blood flow.
The company’s CLEWICU artificial intelligence software ingests a large range of patient data by linking to electronic medical records, connected medical devices and vital sign monitors, with no need for additional data entry by ICU staff.
In addition to alerting providers to a patient’s potentially deteriorating condition as a diagnostic aid, the system’s real-time risk classification model also predicts which patients may not require any interventions within an eight-hour period.
The company previously submitted an application for a full 510(k) FDA clearance while the system undergoes testing at tele-ICU facilities at UMass Memorial Medical Center and the WakeMed health system in Raleigh, North Carolina.
Founded in 2014 and headquartered in Netanya, Israel, Clew developed a web platform and mobile app used for the early detection of life-threatening complications in patients in intensive care units.
IMDRF recommends UL 2900 compliance for medical device cybersecurity.
Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with the UL 2900 set of standards for network-connectable devices.
The guidance covers six key recommendations for cybersecurity best practices:
Company Name – Bedfont Scientific, Ltd. (UK, manufacturer of exhaled breath and gas monitoring instruments)
Subject: CGMP/QSR/Medical Devices/Adulterated
Violations included in the letter:
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