FDA 510(k)

By Jonah Comstock February 10, 2016
BioGaming, an Israel-based startup, has received FDA clearance for its YuGo Microsoft Kinect-based physical therapy system. Calls to the company for comment went unanswered and its website appears to be down.  Physiotherapists can use the system to create personalized gameified routines for patients which patients can then complete at home using an Xbox or a computer connected to a Kinect device...
By Aditi Pai December 15, 2015
China-based Viatom Technologies has received FDA 510(k) clearance for Checkme Pro, a connected medical device that tracks a number of vital signs, according to Medgadget. The small Checkme Pro device includes an ECG that tracks heart rate, QRS duration, ST segment, and rhythm analysis, a pulse oximeter, an activity tracker, a thermometer, and a sleep monitor. The device can be set to a hospital...
By Aditi Pai December 2, 2015
Philosys has received an FDA 510(k) clearance for the Android version of its smart glucometer companion app, called Gmate Smart. The device now works with Samsung Galaxy S3, S4, and S5 devices that have an Android operating system 4.0 or higher as well as Apple iPhone, iPod Touch, and iPad with iOS version 5.0 or higher. Philosys received an FDA clearance for the iOS app last year, in August, but...
By Jonah Comstock November 17, 2015
Visible Patient, a French company that makes 3D models of human organs to assist surgeons, has received FDA 510(k) clearance for its VP Planning Software Suite. The software suite has had a CE Mark for six months and has been commercially available in Europe for a year. Via the software, surgeons send radiological data like CT and MRI scans to Visible Patient. In-house designers create 3D models...
By Jonah Comstock October 12, 2015
A smart baby bottle, which uses sensors to measure a baby's tongue strength and sends the data to a provider's mobile device, has received FDA clearance. Atlanta, Georgia-based NFANT Labs, formerly known as CCB Research Group, has been working on the system for about a little under two years. "Many infants in the NICU have trouble transitioning from tube feeding to bottle or breast feeding and...
By Jonah Comstock August 17, 2015
Israeli medical device company Integrity Applications has begun the process with the FDA to bring its noninvasive glucose monitoring device, GlucoTrack, to the United States. GlucoTrack allows users to monitor their blood glucose level without drawing blood. The user wears a clip on his or her ear, and GlucoTrack uses a combination of sensors to determine blood glucose level, then sends the data...
By Jonah Comstock July 8, 2015
Last month, Roche quietly launched its Accu-Chek Connect app, a diabetes management app which contains, among other things, an unprecented feature: a prescription insulin bolus calculator called Bolus Advisor. Roche has been selling the app in other countries for a little while, even issuing a brief recall in April in some of those countries. It received FDA clearance for the Android version of...
By Jonah Comstock July 6, 2015
Theranos, the 12-year-old Palo Alto-based company working on a smaller, cheaper, alternative to common lab blood tests, has received its first voluntary FDA 510(k) clearance, for its herpes simplex 1 virus IgG (HSV IgG) test. Using a (still largely secretive) lab-on-a-chip technology, Theranos is able to run multiple blood tests on just a few drops of blood, whereas traditional labs need to draw...
By Jonah Comstock June 25, 2015
An oral appliance for treating sleep apnea, with an embedded wireless compliance sensor, has received FDA clearance. The device is from Australian company SomnoMed and the tracker is from Braebon Medical Corporation, a company based in Ontario, Canada. The tracker, called DentiTrac, can be embedded in a number of different oral appliances to track compliance with continuous open airway therapy (...
By Aditi Pai June 17, 2015
Australia-based Analytica has received FDA 510(k) clearance for PeriCoach, its smartphone-connected device that helps women monitor their pelvic floor exercises. The goal of PeriCoach is to reduce or stop urinary incontinence. It will commercially launch in the US next week. According to the company's website, one in three women experience a bladder leak at some point in their lives. And although...

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