FDA clearance

By Jonah Comstock August 23, 2016
The FDA has granted de novo clearance to two concussion assessment software products from ImPACT Applications. The Pittsburgh-based company developed its original software in the 90s for computers, though the clearance also includes ImPACT Pediatric, a newer version of the tests for children that runs on an iPad. "ImPACT's FDA clearance is a huge step forward for the industry, for athletes and...
By Brian Dolan June 29, 2016
Redwood City, California-based smartphone-connected breast pump startup Naya Health has received FDA clearance for its first pump system. Naya Health's device is called The Smart Pump, and it uses a hydraulic system instead of air to collect breastmilk. As a result, the pump is more comfortable and quieter, according to the company.  Some data from the system, including how often a mother pumps,...
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 August 25, 2015
The FDA has approved San Diego, California-based Dexcom for a Bluetooth-enabled continuous glucose monitor (CGM), called the G5 Mobile CGM system. Correction: A previous version of this article incorrectly stated the device had a 510(k) clearance when in fact it had a PMA approval. Unlike the company's previous connected CGM devices, the G5 Mobile CGM System has Bluetooth built right in to the...
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 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 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 Jonah Comstock 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...