FDA clearance

By Brian Dolan January 13, 2014
This month the FDA cleared the second generation of Waltham, Massachusetts-based EarlySense's passive and contactless bedside monitor, which continuous measures respiration rate, heart rate and motion. Among the changes to the system are more sophisticated management tools to help administrators better measure and track quality goals. "One of the very strong attributes of our technology and...
By Brian Dolan December 3, 2013
The FDA has granted 510(k) class II clearance to La Jolla, California-based Sense4Baby's cellular-enabled maternal and fetal monitoring system. The company has also secured a CE Mark for the European market and other countries where that approval is recognized. The regulators cleared Sense4Baby's "model B+" system for healthcare providers to use to monitor expectant mothers and their fetuses...
By Jonah Comstock September 9, 2013
iSonea, the Maryland-based startup working on smartphone-based asthma monitoring, says it will launch its AirSonea connected hardware device in Australia prior to launching in the US. The company's AirSonea product, which builds on the company's previous device, the Wheezometer, uses a proprietary sensing method the company calls Acoustic Respiratory Monitoring to monitor an asthma patient's...
By Brian Dolan August 13, 2013
Last week AliveCor, which offers the FDA-cleared iPhone-enabled Heart Monitor (formerly called the iPhoneECG), appointed board member and Khosla Ventures operating partner Euan Thomson as interim CEO. Just five months ago the San Francisco-based company announced the appointment of its previous CEO Dan Sullivan, a longtime medical device industry executive and entrepreneur, who has now left the...
By Brian Dolan August 7, 2013
Ideal Life's Blood Pressure Cuff Verizon Wireless' plans for an FDA-cleared mobile health platform focused on chronic disease management and other health conditions has been in the works for some time. The software platform, officially called The Verizon Wireless Converged Health Management (CHM) Device has just secured Class II 510(k) clearance from the FDA this month. Once it commercially...
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 July 23, 2013
Mountain View, California-based Biosense Technologies, maker of the uChek smartphone-enabled urine analysis system, has already had a busy year. Its cofounder appeared onstage at TED. Its uChek system was held up as an example of FDA's lack of enforcement in a Congressional hearing in March. The FDA subsequently took the rare action of sending the company a warning letter about uChek that...
By Aditi Pai June 21, 2013
Last week, Withings commercially launched Pulse, an activity tracker, which the company first announced at CES in January. The tracker is available for pre-order at $99.95 from the company's website. Pulse is unique among activity trackers in that it can auto-detect when you start running and as the name suggests it can measure your pulse. Nike+ FuelBand is rumored to get a similar pulse...
By Brian Dolan March 12, 2013
After almost exactly four years, Johnson & Johnson company LifeScan has announced the launch of a Bluetooth-enabled glucose meter and companion iPhone app similar to the one the company showed off on-stage at an Apple World Wide Developer's Conference in 2009 for the launch of iPhone 3.0. As MobiHealthNews exclusively reported following the Apple presentation, the LifeScan demonstration was...
By Brian Dolan January 17, 2013
Silicon Valley-based startup Glooko announced two new executive hires this week and that its MeterSync Cable and Logbook iOS app received Class II FDA Clearance 510(k). The company appointed Rick Atlinger, who previously served as a vice president at Intuit Health, as its first CEO. Glooko co-founder Yogen Dalal filled in as interim CEO since the startup's founding. Altinger launched Intuit's...