regulation

The technology lets researchers and clinicians continuously stream a patient’s ECG rhythm, respiratory rate, heart rate, RR interval and three axis acceleration. 

Representatives from cardio monitoring device maker Eko and the FDA offer advice for medical device startups gearing up for their first approval.

The new guidances are intended to provide clarity on which products are or are not subject to regulatory enforcement, and to bring the agency’s efforts into compliance with provisions of the 21st Century Cures Act.

The third issue of the global eBook was launched at HIMSS19.