Sunrise Labs rebrands as Suntra Medtech Solutions with a strategic repositioning to meet the demands of a rapidly ...

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A recent project conducted by Northeastern graduate students looked at device recalls over the past five years and some of the common threads. In 2018, the top causes of recalls were software, ...

An increasing number of medical devices incorporate artificial intelligence (AI) capabilities to support therapeutic and diagnostic applications. In spite of the risks connected with this innovative ...

The application of AI in telehealth to allow doctors to make real-time, data-driven rich choices is a key component in generating a better patient experience and improved health outcomes. Artificial ...

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 ...

Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s ...

Orthogonal worked with Brian Binkowski, to gain a clearer picture of the state of SaMD approvals in the U.S. Following is what they learned about the rate of FDA approvals and clearances and which ...

Infographics can propel MedTech research and campaigns and enhance the user experience. Here Fabricio Pamplona, co-founder of online infographic maker for scientists Mind the Graph, explores the power ...

The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry’s ability to make technology a ...

nsuring the safety and efficacy of medical devices/IVDs is paramount in the healthcare industry. This critical objective is achieved through comprehensive risk management practices, and two key ...

An explanation of these principles and the actions that must be addressed in compliance with 21 CFR 820, ISO 13485 and the EU MDR. When a nonconformance is identified, two things should be done ...