FDA 510(k)

By Jonah Comstock 11:04 am 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 08:51 am 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 11:28 am 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 08:03 am 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 07:19 am 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 11:09 am 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...
By Jonah Comstock 07:44 am June 5, 2015
Medtronic has received FDA 510(k) clearance for its MiniMed Connect device, which allows users of Medtronic's continuous glucose monitor (CGM) and insulin pump to view data from those devices on their smartphone. At the same time, Medtronic announced a partnership with Samsung to optimize the viewing of this CGM and pump data. The MiniMed Connect device is a keychain-sized device that users of...
By Jonah Comstock 11:07 am March 25, 2015
Vital Art and Science, developers of myVisionTrack, a vision test service for patients with age-related macular degeneration or diabetic eye disease, has received a second FDA clearance for their platform, which includes an app and a provider dashboard. They will also soon launch a major clinical trial in partnership with the Scripps Translational Science Institute and Roche, according to the...
By Jonah Comstock 04:02 am January 29, 2015
AliveCor's AF detection algorithm San Francisco-based AliveCor has received FDA clearance for two new algorithms for its smartphone-connected ECG: one that detects normality and one that detects interference. These follow up on AliveCor's atrial fibrillation detection algorithm that received clearance last fall. The Normal Detector assures patients that their ECG is free of abnormalities. If...
By Jonah Comstock 09:15 am December 1, 2014
South Korean technology company LG Electronics has received an FDA 510(k) clearance for something called "LG Smarthealth". The move indicates that LG might be playing catch-up with electronics competitor Samsung, which received a similar clearance for its S Health app last year. While there is no reference to LG Smarthealth on the company's website, several of LG's G3 smartphones do sport LG...