FDA 510(k) clearance

By Heather Mack 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 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 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 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...
By Heather Mack October 31, 2016
Israel-based medical device maker TytoCare has received FDA 510(k) clearance for its digital stethoscope, joining the company's ecosystem of connected tools for remote medical examinations. The company also offers several FDA Class 1 devices –  a connected otoscope for ear examinations, a high-resolution camera, and a thermometer that uses the forehead to get a reading.  The stethoscope pairs...
By Jonah Comstock July 28, 2016
Companion Medical, a stealthy San Diego-based company that received funding last year from Eli Lilly and Company, has received FDA 510(k) clearance for its Bluetooth-connected smart insulin pen and associated mobile app, called InPen. "FDA clearance of the InPen and mobile app represents a significant advancement in diabetes care," CEO Sean Saint, a veteran engineer of Dexcom, Medtronic, and...
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...