Understanding FDA’s Latest Rules on Medical Device Maintenance
The FDA’s new guidance distinguishes between servicing and remanufacturing of medical devices, urging vigilance and regulatory adherence.
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Top Experts Discuss Medical Device Cybersecurity Standards
Four medical device cybersecurity experts—Leon Lerman, CEO and co-founder of Cynerio; Scott Trevino, senior vice president of cybersecurity at TRIMEDX; Shankar Somasundaram, CEO of Asimily; and Ty Greenhalgh, industry principal of healthcare at Claroty—discuss how their platforms comply with various frameworks, offering real-time monitoring, encryption, and incident response to protect medical devices from emerging threats.
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WHO Introduces MeDevIS Platform for Medical Device Information
The WHO has launched MeDevIS, an online platform providing comprehensive information on medical devices to aid governments and regulators.
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FDA OKs AgileMD eCART Clinical Deterioration Suite
The FDA has granted 510(k) marketing clearance for AgileMD’s eCART Clinical Deterioration Suite for assessing patient condition.
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Masimo and Cleveland Clinic Launch Monitoring Partnership
Masimo and Cleveland Clinic have partnered to enhance hospital-based remote patient monitoring to improve situational awareness and outcomes.
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