Agamatrix

By Brian Dolan November 24, 2015
Considering recent events, big name consumer brands are more likely than ever to move into regulated medical devices. Two weeks ago Apple CEO Tim Cook told a newspaper that while his company wouldn't put the Apple Watch through the motions of an FDA clearance process, Cook "wouldn't mind putting something adjacent to the watch through it." He said that before adding maybe that'd be an app or...
By Brian Dolan September 16, 2014
Burlingame, California-based Misfit, formerly Misft Wearables, today launched Misfit Flash, its second wearable device that tracks various activities and sleep. The sub-$50 Flash's pricepoint isn't the only difference between it and Misfit's original device, Shine. Flash is made out of "soft-touch" plastic instead of the Shine's stainless steel body. Flash comes in a variety of colors including "...
By Aditi Pai August 20, 2014
New York City-based medical device maker Philosys received FDA 510(k) clearance this week for its smartphone-connected glucose meter, Gmate Smart. To use the Gmate Smart glucometer, users launch the device's connected app, plug in their Gmate glucometer through the audio jack, insert a test strip into the glucometer, add a blood sample, and view results on the app. Gmate Smart's app is only...
By Jonah Comstock July 18, 2014
Israel-based HelpAround, which makes an app that connects people with diabetes in the same immediate area, has raised $550,000 from Windham Venture Partners and angel investors Walter Winshall, Robert Oringer and former Harmonix COO Michael Dornbrook. Windham and the angel investors co-led the round. MobiHealthNews wrote about HelpAround earlier this year at HIMSS, where the company positioned...
By Jonah Comstock March 24, 2014
Health and fitness app app maker Azumio currently leads the diabetes app market with 17.8 percent market share, according to a new report from Research2Guidance. The company tracked iOS and Android downloads of more than 1,000 diabetes apps between 2008 and 2013 with the help of Priori Data, a Berlin-based company that collects publicly available metadata on apps. According to Research2Guidance's...
By Brian Dolan February 27, 2014
"Here at HIMSS it's all about hospital-to-patient, doctor-to-patient, nurse-to-patient. Why is no one talking about patient-to-patient?" HelpAround Co-founder and CEO Yishai Knobel said during an interview at HIMSS 2014 in Orlando this week. "Especially when research has shown that peer support drives medical outcomes." Knobel's startup Israel-based HelpAround is poised to be one of the first to...
By Jonah Comstock December 16, 2013
AgaMatrix's Jazz meter connecting to an iPhone application that may or may not be Health Manager. AgaMatrix, the medical device maker that launched the first iPhone-connected blood glucometer in the United States, has received FDA 510(k) clearance for a cloud-connected app called AgaMatrix Health Manager, according to an FDA clearance document. "The big differentiation with this version is it...
By Aditi Pai September 23, 2013
Israel-based LabStyle Innovations announced CE mark certification for its smartphone-based glucose monitor Dario, according to a press release. In the coming months, the company will plan a soft launch of Dario in Europe to collect customer feedback and refine its roll-out strategy. In May, LabStyle raised $10 million by common stock and planned to use the money to develop, market and manufacture...
By Neil Versel July 31, 2013
Aging in place and disease management technology developer Ambio Health has gained FDA 510(k) regulatory clearance for its flagship Ambio Remote Health Monitoring System. The system, first introduced at the Consumer Electronics Show in January, essentially adds wireless capability to standard home health monitors and automates data collection. Stamford, Connecticut-based Ambio is now free to sell...
By Brian Dolan May 8, 2013
Last month the US Food and Drug Administration gave three medical devices 510(k) Class II clearances that aim to help people with diabetes better manage their condition via glucose meters that connect to apps on smartphones and tablet devices. Palo Alto, California-based Glooko received its second 510(k) clearance for glucose monitoring logbook app and cable that connects various off-the-shelf...