Regulation
The Visibly Digital Acuity Product uses a touchscreen mobile device paired with a computer to test how sharp a user's vision is at a distance.
The Cardiac Scale monitors patients with fluid management conditions like heart failure and kidney disease.
He's concerned that the acquisition would "provide Amazon with access to enormous tranches of patient data."
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.
Of the 224 companies analyzed, 98 received a clinical robustness score of zero.