Public Policy
The latest clearance is for an algorithm that characterizes how much atrial fibrillation a patient is experiencing over time.
Eko Murmur Analysis Software is a machine learning algorithm that detects and characterizes heart murmurs in adult and pediatric patients.
This marks the urinalysis and wound-care company's third 510(k) clearance.
The cuffless device uses a sensor array over the radial artery to produce a pressure waveform that's used to determine systolic and diastolic blood pressure.
An analysis published in JAMA Internal Medicine found about 350,000 searches for abortion pill-related terms the first week in May.
The decision affects all providers, especially those working in ERs, says a law professor.
CMS did not explicitly concur with the OIG's recommendation to develop its own source of race and ethnicity data.
Of the 224 companies analyzed, 98 received a clinical robustness score of zero.
According to the Wall Street Journal's reporting, the Federal Trade Commission is investigating whether the startup was involved in deceptive or unfair marketing or advertising practices.
The StrivePD app uses Apple's Movement Disorder API to track tremors and uncontrolled body movement.