Online eyewear and vision care company Visibly announced it had received FDA 510(k) clearance for its at-home vision test.
The Visibly Digital Acuity Product uses a touchscreen mobile device, like a smartphone, paired with a computer to test visual acuity, or how sharp a user's vision is at a distance.
The computer screen displays optotypes, or specifically shaped symbols or letters for vision...
Bodyport announced it has received the FDA green light for its connected scale that remotely monitors patients with fluid management conditions such as heart failure and kidney disease.
The Cardiac Scale, which is intended for people 21 and over who weigh less than 397 pounds, can be used to track body weight, pulse rate, center of pressure and peripheral impedance, which can signal changes in...
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...
.jpeg?itok=HF3iI7dj "Person answering their front door and getting a delivery from another person")
_0.jpg?itok=tyyYywlQ "A medical visit")
