iRhythm Technologies announced it has received another FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) System that works with a wearable to monitor patients with atrial fibrillation, an irregular heart rhythm.
Developed in partnership with Alphabet life science subsidiary Verily, the ZEUS System is a platform that works with the Zio Watch to detect AFib, characterize the amount...
Smart stethoscope company Eko last week announced it has received FDA 510(k) clearance for an algorithm that detects and characterizes heart murmurs in adult and pediatric patients.
Eko Murmur Analysis Software, which officially received the green light in late June, is a machine learning algorithm that uses heart sounds, phonocardiograms and ECG signals (when available) to detect murmurs and...
Smartphone urinalysis and wound-care company Healthy.io received FDA 510(k) clearance for home use of its Minuteful kidney-damage test.
The test is used to determine the increased presence of a protein called albumin in the urine, which can be an early sign of chronic kidney disease. The kit includes a testing strip, a sample cup and color board. Patients dip the test strip into their urine...
LiveMetric announced it has received FDA 510(k) clearance for its watch-like blood pressure monitor, LiveOne.
The cuffless device uses a sensor array placed over the radial artery to produce a pressure waveform. The waveform is then analyzed by an algorithm to determine systolic and diastolic blood pressure and pulse rate. According to the FDA's 510(k) database, LiveOne is intended to be used in...
Online searches for abortion medications soared after a Supreme Court draft decision overturning Roe v. Wade leaked in early May, according to an analysis published in JAMA Internal Medicine.
Researchers analyzed Google searches originating in the U.S. that mentioned terms like "abortion pill" or the medications "mifepristone/mifeprex" or "misoprostol/cytotec." They pulled data from January 1,...
Many venture-backed digital health startups aren't clinically robust, as measured by the number of regulatory filings and clinical trials, according to a study published in JMIR.
The analysis examined digital health companies using the Rock Health Digital Health Venture Funding Database, FDA data on 510(k), De Novo and premarket approval filings, and the number and type of clinical trials listed...
Digital mental health company Cerebral is under investigation by the Federal Trade Commission, according to a letter sent by the agency and reviewed by the Wall Street Journal.
According to WSJ, the FTC is investigating whether Cerebral was involved in deceptive or unfair marketing or advertising practices, including raising questions about programs where the virtual mental health company...
Brain data startup Rune Labs announced Tuesday it received FDA 510(k) clearance to use its StrivePD app to monitor Parkinson's disease patients' symptoms through the Apple Watch.
The StrivePD system uses Apple's Movement Disorder API to track tremors and dyskinesia, or uncontrolled, involuntary body movement. Patients can also use the app to log their medications, side effects and other symptoms...
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