FDA 510(k) clearance

By Jonah Comstock January 13, 2016
Neurometrix has received FDA clearance for a new smartphone-controlled version of Quell, its wearable for pain relief, the company announced last week. Like its predecessor, the device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids. It's worn around the calf. “This 510(k) further advances Quell technology by allowing the...
By Jonah Comstock December 21, 2015
GI Logic has received FDA 510(k) clearance for a novel device that noninvasively monitors the digestive system after patients have surgery. The device, called AbStats, consists of two disposable sensors, a telemetry monitor, and a tablet app. “Cardiology has this portable Holter monitor that can measure heart attacks in realtime, find out if someone’s having an arrhythmia, and phone up their...
By Jonah Comstock September 15, 2015
The ACT device paired with a previous phone. LifeWatch, a Swiss remote cardiac monitoring company that has been connecting to mobile phones since 2009, has received FDA clearance for a new version of its Ambulatory Cardiac Telemetry (ACT) system that will run on Android devices. Currently, the system runs on Microsoft Windows phones. Patients use the mobile software to answer a couple...
By MHN Staff September 10, 2015
by Bradley Merrill Thompson Let’s say no one had ever invented the tongue depressor, but this year, in a flash of inspiration, I came up with the idea. Indeed, let’s say there’s nothing else like it. To bring the first tongue depressor to market, it’s quite likely I would have to spend years conducting clinical trials, to be followed up by perhaps a year of FDA review. For a tongue depressor. Why...
By Aditi Pai 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 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 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 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 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 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...

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