The Food and Drug Administration the week of Aug. 7 cleared for marketing the first sterilization system for 3D-printed devices in health care facilities. The V-PRO maX 2 Low Temperature Sterilization System has a specialty cycle that can sterilize surgical instruments such as patient-specific surgical guides and anatomical models fabricated via 3D printing processes and intended for single-use during operative procedures.

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The Food and Drug Administration is seeking public feedback on a discussion paper released today on potential regulatory approaches for generative artificial…
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The Food and Drug Administration has issued an early alert for all heart pump controllers by Abiomed, which sent a correction notice to all customers with…
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The Cybersecurity and Infrastructure Security Agency and other federal agencies released a joint guide yesterday for organizations to apply zero…
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A new tactical brief on technology-enabled care explores key trends, innovations and learnings, and provides considerations for how hospitals can…
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The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology released a request for information Jan. 29…
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The Food and Drug Administration announced Dec. 5 that it will launch the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, or…