FDA clearance

By Brian Dolan 06:35 am February 11, 2014
San Francisco-based AliveCor announced that the FDA has granted its smartphone-enabled, single-channel ECG (electrocardiogram) recorder device over-the-counter (OTC) clearance. The company is now taking direct-to-consumer preorders for the device at a $199 pricepoint. It expects to begin shipping them in early March. Up until now the AliveCor device has only been made available to physicians and...
By Jonah Comstock 06:26 am February 10, 2014
A British company, Camntech, has received FDA clearance for a motion-tracking wristband and a wristworn electronic diary, likely for use in clinical trials. The devices are called the MotionWatch 8 and PRO-Diary. According to the filing, the devices "are intended for the acquisition and analysis of the physical activity of the body during daily living and sleep." The devices upload data to a PC...
By Brian Dolan 11:25 am January 13, 2014
Vocera Communications announced this week that it had acquired alarm management company mVisum for $3.5 million. Vocera has yet to respond to a request for additional comment. Notably, in April 2013 mVisum settled a lawsuit filed by competitor AirStrip Technologies, which alleged mVisum had infringed on its patents for remote monitoring of patient medical data on smartphones. As part of the...
By Brian Dolan 04:38 am 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 02:31 am 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 01:08 pm 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 05:31 am 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 06:29 am 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 12:16 pm 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 05:26 am 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...