Artificial Intelligence Graphic

Software and Artificial Intelligence as a Medical Device

By MedTech Intelligence Staff

Earlier this month, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) issued the guidance document, “Software and Artificial Intelligence as a Medical Device.” The guidance brings together current guidances,…

Earlier this month, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) issued the guidance document, “Software and Artificial Intelligence as a Medical Device.” The guidance brings together current guidances,…

Continue reading

Jonathan Ripley

Process and Planning Are Key to Successful EU MDR PMS Compliance

By Jonathan Ripley

…and sales will never promote or infer an off-label intended use, even if it is common practice. The good news is that if the manufacturer collects sufficient clinical, safety, and…

…and sales will never promote or infer an off-label intended use, even if it is common practice. The good news is that if the manufacturer collects sufficient clinical, safety, and…

Continue reading

Brad Jolly
MEDdesign

Five Critical Considerations for Connected Health Manufacturers

By Brad Jolly

…and monitoring patients. While these technologies have significantly improved the standard of care, they have also introduced a range of challenges for healthcare practitioners, administrators, and patients. The good news

…and monitoring patients. While these technologies have significantly improved the standard of care, they have also introduced a range of challenges for healthcare practitioners, administrators, and patients. The good news

Continue reading

3M logo

3M Health To Collaborate with Amazon To Accelerate AI in Clinical Documentation

By MedTech Intelligence Staff

3M Health Information Systems (HIS) has announced a collaboration with Amazon Web Services (AWS) to accelerate the innovation and advancement of 3M M*Modal ambient intelligence. As part of the collaboration,…

3M Health Information Systems (HIS) has announced a collaboration with Amazon Web Services (AWS) to accelerate the innovation and advancement of 3M M*Modal ambient intelligence. As part of the collaboration,…

Continue reading

FDA Logo

FDA Issues Draft Guidance on Predetermined Change Control Plans for AI/Machine Learning-Enabled Medical Devices

By MedTech Intelligence Staff

On March 30, the FDA’s Center for Devices and Radiological Health (CDRH) published a draft guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled…

On March 30, the FDA’s Center for Devices and Radiological Health (CDRH) published a draft guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled…

Continue reading

CardioMEMs sensor

Remote Monitoring Technology Improves Survival in Heart Failure Patients

By MedTech Intelligence Staff

…at two years. “These new findings are encouraging news for physicians and the millions of people living with a progressive disease for which there is no cure,” said Philip B….

…at two years. “These new findings are encouraging news for physicians and the millions of people living with a progressive disease for which there is no cure,” said Philip B….

Continue reading

European Union Flag

Clock Starts for New EU MDR Transition Dates

By MedTech Intelligence Staff

An extension to the EU MDR transition period, approved by the European Council on March 7, is now in force following its publication in the Official Journal of the European…

An extension to the EU MDR transition period, approved by the European Council on March 7, is now in force following its publication in the Official Journal of the European…

Continue reading

Philip Remedios and Irina Samkova

How a Comprehensive UX Approach Brings Value to the Design Process

By Irina Samkova, Philip Remedios

…much more simplistic interfaces to support the nonclinical end-user. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device…

…much more simplistic interfaces to support the nonclinical end-user. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device…

Continue reading

Cybersecurity

Managing Legacy Technology Security

By MedTech Intelligence Staff

To help address the cybersecurity risks of legacy devices used in healthcare environments, the Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) has published “Health Industry…

To help address the cybersecurity risks of legacy devices used in healthcare environments, the Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) has published “Health Industry…

Continue reading

Lorenzo Gutierrez, Starfish Medical

Integrating Games into Medical Devices To Improve Patient Outcomes

By Lorenzo Gutierrez

…make patients feel happier, more engaged with their treatment and motivate them to stick with their treatments, facilitating a speedier recovery. References: [1] https://www.med-technews.com/news/Digital-in-Healthcare-News/partnership-develops-video-game-style-technology-to-reduce-r/ [2] Drachen, A., Nacke, L. E.,…

…make patients feel happier, more engaged with their treatment and motivate them to stick with their treatments, facilitating a speedier recovery. References: [1] https://www.med-technews.com/news/Digital-in-Healthcare-News/partnership-develops-video-game-style-technology-to-reduce-r/ [2] Drachen, A., Nacke, L. E.,…

Continue reading