FDA 510(k) clearance

By Dave Muoio 11:45 am August 29, 2019
Tel Aviv, Israel-based Biobeat has been granted 510(k) clearance for a remote monitoring device capable of measuring the wearer’s blood pressure, oxygenation and heart rate. Designed for use in the hospital or at home, the device is available as either a wristwatch or adhesive patch. Of particular note, the products differentiate themselves from other remote monitoring devices through a...
By Dave Muoio 03:11 pm July 30, 2019
PhysIQ has received 510(k) clearance for an algorithm facilitating cloud-based analysis of patients’ continuous ambulatory respiration rates, according to an update to the FDA’s device clearance database that was confirmed by the company to MobiHealthNews. This regulatory clearance is the company’s third, and like its predecessors uses artificial intelligence to characterize raw sensor data as...
By Dave Muoio 02:31 pm April 2, 2019
The Loop System, a continuous remote monitor developed by Palo Alto-based startup Spry Health, received 510(k) clearance from the FDA last Friday, according to an update to the agency’s database that was confirmed by the company. Designed for management of COPD and other chronic conditions, the wristband wearable collects and monitors a user’s pulse-oximetry, respiration, heart rate and blood...
By Dave Muoio 03:39 pm November 8, 2018
Clinical diagnostic and workflow software maker MaxQ AI has received FDA 510(k) marketing clearance for Accipio Ix, an artificial intelligence workflow tool designed to help clinicians prioritize adults patients likely presenting with acute intracranial hemorrhage. The company received notification from the FDA of its decision in late October. Results generated by the algorithm-based software are...
By Dave Muoio 04:13 pm October 6, 2017
New York-based Peerbridge Health announced that its wireless device, dubbed the Peerbridge Cor System, is the latest ECG device to receive 510(k) clearance from the FDA. According to the company, the device has the smaller on-body footprint of any wearable, multi-channel ECG with water-resistant electrodes. “The 510(k) clearance of our Peerbridge Cor ECG monitor is an exciting milestone and the...
By Dave Muoio 03:04 pm October 4, 2017
Redwood City, California-based Carrot has received FDA 510(k) clearance for its Carbon Monoxide Breath Sensor System, an over-the-counter, Bluetooth-enabled device that pairs with a smartphone app and is intended for commercial use in smoking cessation programs. “Smoking is the number one cause of preventable illness and death worldwide,” Dr. David S. Utley, founder and CEO of Carrot, said in a...
By Heather Mack 02:22 pm February 6, 2017
Figuring out what is causing an irregular heartbeat typically means an invasive procedure: most often, electrophysiologists insert a catheter to the heart via an artery or vein to get a cardiac “map” and identify the origin of the arrhythmia. But a new device from Medtronic takes the process outside, in the form of a sensor-enabled vest. Dubbed the CardioInsight Noninvasive 3D Mapping System, the...
By Heather Mack 05:10 pm January 25, 2017
While most wearable baby monitors are designed with the intention to give parents peace of mind, some experts warn they may do just the opposite. In a recent JAMA article, researchers outlined how the proliferation of baby wearables that monitor vital signs and alert parents of abnormalities via a companion app can cause undue alarm to parents. Moreover, the researchers point out, the devices...
By Heather Mack 01:51 pm December 15, 2016
Vancouver, BC-based Clarius Mobile Health has received FDA 510 (k) clearance for its app-based, wireless, handheld ultrasound scanners. The devices, which are designed for clinicians to quickly conduct scans and guide short procedures at the bedside, are compatible with the latest smartphones and tables both for iOS and Android and are now available for medical professionals on Clarius’s website...
By Heather Mack 12:32 am December 6, 2016
Paris, France and Cambridge, Massachusetts-based Voluntis, which makes companion software for medical devices or medications, has received both FDA clearance and the CE Mark for a type 2 diabetes management app called Insulia. The app, which is designed for people treated with basal insulin, is classified as a prescription-only medical device and will be available to patients and healthcare...