What happened
In a triple-blinded, multisite, independent study, researchers have found that only one third of commercially available FDA-cleared blood glucose meters in the United States could consistently perform to an accuracy standard close to, but actually more lenient than, the FDA’s. Of the 18 BCGs tested, only six were consistently accurate in each of three test sites. Five were compliant...
New York-based One Drop has received FDA clearance for its mobile blood glucose monitoring system, One Drop Chrome. The system consists of the Chrome Meter lancing device, test strips and a companion app, and is also now officially available with a monthly subscription service called One Drop Premium. People in the United States, UK and European Union can start ordering the $39.95 subscription...
Diabetes tracking company Glooko, which offers a cloud-based logbook app and a cable that connects the iPhone to commercially available blood glucose monitors, has launched -- and received FDA 510(k) clearance for -- a new app and cable for Android phones.
Glooko's new app will connect to the same cloud-based web dashboard as the company's iPhone app. That platform was FDA cleared in May and...
According to an FDA filing, wireless-enabled blood glucose meter developer Telcare just received 510(k) clearance for its device, Telcare BGM. The company submitted its device for FDA review at the beginning of March.
Telcare has largely eschewed the glucometer-smartphone pairing model currently pursued by a number of other device makers in favor of a wireless meter "that requires no additional...
French pharmaceutical company Sanofi Aventis announced that it has tapped medical device maker Agamatrix to create blood glucose meter plug-in for Apple's iPhone called iBGStar, during a presentation at the European(Association for the Study of Diabetes conference. According to the companies, the meter could be the first medical device plugin to connect to Apple's iPhone.
While Johnson &...
Wireless-enabled blood glucose meter developer Telcare has raised $2.5 million of a targeted $4 million equity offering, according to a regulatory filing. Telcare plans to offer its blood glucose meter offering (pending FDA clearance) to its customers at the same pricepoint of "disconnected" devices that are already on the market.
According to the company: "[The] Telcare blood glucose meter...
Bayer is bringing the Nintendo DS enabled blood glucose meter, Didget, to the US next month, according to a report in BusinessWeek.
Inventor and entrepreneur Paul Wessel wanted his diabetic 4-year-old son, Luke, to stop hiding his glucose meter, so he found a way to pair one of Luke's treasured possessions, his Nintendo DS, with his least favorite. German healthcare company Bayer purchased Wessel...
Ever since Johnson & Johnson company Lifescan demonstrated a prototype iPhone app and Bluetooth-enabled glucometer at Apple's World Wide Developers Conference last year, the personal medical device market has buzzed about connecting blood glucose meters to smartphones. Lifescan's was a prototype that Apple asked them to whip up in a few weeks, and a similar product offering from the company...
Entra Health Systems, an applied healthcare technology developer, is powering a mobile phone-based diabetes management service recently launched on Australian wireless operator Telstra's network. The service is called the Telstra Diabetes Management Online Service in Australia, and it includes Entra's MyGlucoHealth Wireless meter, Bluetooth technology and the user's mobile phone. Entra is calling...
The New York Times' David Pogue and the Wall Street Journal's Walt Mossberg both published connected health device reviews in their respective newspapers yesterday: Pogue turned in a double header review for Fitbit and Philips' DirectLife devices, while Mossberg tested Bayer's just unveiled Contour USB meter for diabetes management. Each of the devices managed to make it through the reviews with...
