FDA 510(k)

By Neil Versel 01:58 pm November 28, 2012
AFrame Digital, a Reston, Va.-based maker of telemonitoring technology, has received 510(k) clearance from the FDA to sell its MobileCare Monitor as a Class II medical device in the US. The company has had less-stringent Class I approval for its flagship monitoring product since 2009. MobileCare Monitor is a wristwatch-like device that offers continuous, real-time monitoring for seniors, people...
By Jonah Comstock 10:39 am November 16, 2012
A Beijing-based medical device company called Raiing has been granted 510(k) FDA clearance for the Raiing Wireless Thermometer, a peel-and-stick contact thermometer sensor that continuously transmits body temperature readings to a companion iPhone app, which is already available in the iOS AppStore. The app is called Vitals Monitor and is currently available for a free download, but the device...
By Brian Dolan 04:23 am September 11, 2012
Minneapolis-based Preventice announced this week that the FDA had cleared its remote monitoring device for patients with cardiac arrhythmias, the BodyGuardian Remote Monitoring System, with a 510(k) clearance. Preventice developed the system with its partner Mayo Clinic and licensed technology from Proteus Biomedical's partner Avery Dennison for the peel-and-stick sensor. BodyGuardian is a small...
By Brian Dolan 12:49 pm August 22, 2012
San Diego-based Sotera Wireless announced this week that the FDA had given its 510(k) clearance for the full version of its WiFi-enabled ViSi Mobile patient monitoring system, a part of which received an FDA clearance this past March. The full system enables care providers to review near real-time transmissions of patients vital signs no matter if their patients are in their beds or walking...
By Neil Versel 04:51 am July 2, 2012
The Beam Brush, a Bluetooth-enabled toothbrush from Louisville, Ky.-based startup Beam Technologies, and a companion app have received 510(k) clearance from the Food and Drug Administration. The FDA on June 21 cleared the product for sale as a Class I medical device on and the company announced the clearance Friday. Technically a manual toothbrush, the Beam Brush likely will go on sale this fall...
By Brian Dolan 03:39 am May 29, 2012
Photo Credit: Paul Savage Photography By Padma Nagappan One of the panels at the recently concluded WLSA Convergence Summit in San Diego focused on how things have changed within the last five years and whether the guidelines the FDA issued last year for devices helps provide clarity in navigating the choppy waters of clearance. The panel featured two companies that have received 510(k)...
By Brian Dolan 07:54 am August 2, 2011
Entra Health Systems, creator of MyGlucoHealth,  announced last week that it has received Health Canada's Therapeutic Products Directorate (TPD) clearance for the sale of its Bluetooth-enabled glucose meter in the country. MyGlucoHealth meters and test strips will be available for purchase in Canada immediately. The device secured FDA clearance and a CE Mark in 2009. MyGlucoHealth also launched...
By Brian Dolan 09:33 am August 1, 2011
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...
By Brian Dolan 07:24 am July 17, 2011
Last fall French pharmaceutical company Sanofi and Boston-area medical device maker Agamatrix announced plans to bring to market a glucose monitor, the iBGStar Jazz Nugget, which plugs into the iPhone. While the Nugget has yet to secure FDA clearance, it is already available in Europe and a US launch seems imminent. That's why it comes as something of a surprise that Agamatrix co-founder and...
By Brian Dolan 07:12 am June 20, 2011
Withings announced this week that they've received FDA clearance for their iOS-compatible blood pressure monitor, allowing for its immediate availability in the US for a $129.99 retail price. The release marks the first time an FDA-approved BP cuff includes direct connectivity with an iOS device. First announced at CES this year, the monitor runs on three AAA batteries and works in conjuction...