FDA 510(k) clearance

By  Aditi Pai 06:37 am September 2, 2015
Berkeley, California-based Eko Devices has received FDA 510(k) clearance for its smartphone-enabled stethoscope, called Eko Core as well as the companion smartphone app. Eko Devices, which describes itself as a "Shazam for heartbeats", has previously received an investment from two Shazam cofounders, as well as Founder.org, Stanford StartX, former HHS advisor John Noonan. The company has raised...
By  Aditi Pai 09:21 am August 4, 2015
Naperville, Illinois-based PhysIQ has received an FDA 510(k) clearance for its personalized physiology analytics system. The offering is categorized as a Class II device for patient monitoring under the product code: automated calculation of a summary index based on several individual measured vital sign inputs. PhysIQ's offering is an early warning detection platform that analyzes a user's...
By  Jonah Comstock 07:52 am July 31, 2015
The US Department of Defense may soon start using smartphone-based diagnosis tools to detect traumatic brain injuries in soldiers on the battlefield. According to a post on its "Armed with Science" blog, the DoD is working with Bethesda, Maryland-based BrainScope to put its FDA-cleared Ahead 200 device into action. Currently, it takes a CT scan to definitively establish the presence of a...
By  Jonah Comstock 04:00 am July 2, 2015
Proteus Digital Health has received an update to its FDA 510(k) clearance for its digital medicine platform, adding a new indication to the clearance. The system is now, to the company’s knowledge, the first technology to have an indication in its FDA clearance for measuring medication adherence. “We are delighted that our collaborative work with the FDA continues to enable positive progress,”...
By  Jonah Comstock 09:59 am June 2, 2015
New York City-based Cohero Health has received FDA 510(k) clearance for its mobile connected spirometer. The Bluetooth-connected device measures critical lung function with comparable accuracy to clinical-grade spirometers, and sends the data to a smartphone or tablet. Cohero Health has already been using the spirometer as part of its medication adherence tracking platform in a pilot at Mount...
By  Jonah Comstock 11:03 am May 27, 2015
In the last two months, the FDA has cleared a number of clinically-focused mobile health devices. Some are first-time clearances for companies that have been waiting on their 510(k) for a while, including a few MobiHealthNews has been keeping an eye on over the years. Others are incremental clearances for slight hardware or algorithm updates. Here's five mobile health clearances that came through...
By  Jonah Comstock 08:56 am April 9, 2015
In March, Roche received FDA clearance for its Accu-Chek Connect companion app, and, less than a month later, issued a recall of that app. App recalls, which are becoming more common as more and more apps receive FDA clearance, are less severe than device recalls because they can often be ameliorated with a quick software patch. The app, available only on Android at present, helps patients track...
By  Aditi Pai 08:52 am April 9, 2015
Rochester, Minnesota-based Mayo Clinic spin-off Ambient Clinical Analytics has received FDA 510(k) clearance for a software-based decision support tool, called AWARE. AWARE stands for Ambient Warning and Response Evaluation. It’s an interface for EMR data that prioritizes and organizes a patient’s medical information in three ways: by organ, chronologically as a timeline, or as a customized...
By  Jonah Comstock 10:05 am April 1, 2015
Sense4Baby, the maternal and fetal monitoring product developed by West Health and then acquired by AirStrip Technologies, has received a second FDA 510(k) clearance, which will allow pregnant mothers to perform non-stress tests in their homes. The technology was previously only cleared for use by providers in clinical settings. The Sense4Baby offering is a packaged kit that includes the wearable...
By  Jonah Comstock 11:03 am December 3, 2014
A California hospital has begun requiring certain patients use a wearable remote patient monitoring device in order to comply with internal patient safety protocols. Chino Valley Medical Center is employing the Leaf Patient Monitoring System from Pleasanton-based Leaf Healthcare. The sensor monitors patient movement in bed, then uses that data to calculate when the patient needs to be turned to...