Preparing for the PATCH Act and RTA

By MedTech Intelligence Staff

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.

• Engage with MedTech executives and regulators in Washington DC for an in-depth look at trends in advanced manufacturing and supply chain intelligence.
• Trends in Advance Manufacturing Technology for quality improvement & management, speeding time to market, mitigating labor resource issues, and more.
• Supply Chain Intelligence technologies and strategies for building sustainable, resilient supply chains.

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Precision Medicine Meets AI:
Advances in Cough Monitoring

By Carlos Chaccour, M.D., Ph.D., Hyfe AI

Recent developments, specifically artificial intelligence and the ubiquity of smart devices, enable us to monitor cough unobtrusively and continuously for periods of time. Objective cough quantification can be combined with patients’ perceptions to better determine diagnosis, treatment response and prognosis.

FDA Issues Final Guidance on Cybersecurity in Medical Devices

By MedTech Intelligence Staff

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions provides recommendations on what information to include in premarket submissions and emphasizes that cybersecurity is a component of quality system regulation.

Bringing More Patients Home

By By MedTech Intelligence Staff

Hospital at Home models are expanding capacity for overcrowded hospitals and emergency departments and providing comfort to a growing range of patients. Dave Kerwar, co-founder of Inbound Health, discusses the best candidates for hospital at home care and opportunities for MedTech providers to enhance this model of care, as payers and CMS look at long-term adoption.

Featured Quote

Manufacturers often struggle against the more intensive challenge of keeping pace with emerging risks to already-active devices. As a result, only a fraction of known vulnerabilities actually receive manufacturer patches.

— Shankar Somasundaram, Asimily

How redesign can help meet sustainability demands
for medical devices

Redesign using Design for Environment principles can help medtech companies meet sustainability demands for their devices. See how to analyze and use eco-smart designs that account for sustainable materials, product durability, and improved energy efficiency.

Download to learn more

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2023 MedTech Regulatory Performance Report