Cybersecurity
Cybersecurity

Preparing for the PATCH Act and RTA

By MedTech Intelligence Staff
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The FDA announced that on October 1, 2023, it would begin to Refuse to Accept (RTA) medical device premarket submissions that do not comply with PATCH Act requirements. Erez Kaminski, former head of AI with Amgen and founder of  Ketryx, and Paul Jones, former FDA official and Executive Vice President of Ketryx, provide an overview of challenges companies face as they work to comply with the new cybersecurity regulations and standards.

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David Goldman
David Goldman
Soapbox

Revolutionizing Healthcare: Augmented Reality’s Unprecedented Impact

By David Goldman
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Augmented reality (AR), with the help of artificial intelligence (AI), is providing healthcare professionals with the means to offer patients an unprecedented level of care and personalized treatments, and assisting MedTech and life sciences companies in product design and development. Yet, the potential of AR with AI in health care is still far from fully explored.

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Patient on ventilator
Patient on ventilator
MEDdesign

MD PnP Presents Remote Control Care Testing and Verification Method

By MedTech Intelligence Staff
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For “Systematic Testing of a Ventilator Remote Control System Towards Safe Use in Tele-Critical Care and Prolonged Care,” researchers developed a prototype system for network-based far remote-control of the NKV-550 critical care ventilator, with the goals of identifying and implementing foundational remote-control capabilities, and exploring essential performance, interoperability, and cybersecurity requirements.

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