FDA

By Brian Dolan January 14, 2010
By Bradley Merrill Thompson, MBA, JD (I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s and should not be attributed to the commenter’s.) At the risk of insulting my new friends in Silicon Valley, I submit that traditionally-unregulated IT companies...
By Brian Dolan January 13, 2010
The FDA recently approved MediSens Wireless' wireless body monitoring system, which assesses muscle and neuromotor functions in the upper extremities, for its first phase of clinical trials. MediSens' Clinical Movement Assessment System (CMAS) could be used by health care professionals working in physical medicine and rehabilitation, neurology, orthopedics and physical and occupational therapy....
By Brian Dolan January 4, 2010
Wireless remote monitoring company MedApps announced that it has received ISO 13485:2003 and ISO 9001:2008 certification from Underwriters Laboratories (UL), which subsequently led to a CE Mark certification and CMDCAS approval, enabling the company to market its products throughout Europe and Canada. To date, MedApps has secured two FDA clearances, various FCC certifications, AT&T and...
By Brian Dolan December 31, 2009
While our year-end report is a solid snapshot of the state of the industry at the end of 2009, we noticed that a good number of our most popular news posts from the past year did not find their place in the overall narrative. As expected the iPhone was a dominant theme for our most popular posts of 2009, which were picked based on which ones accumulated the greatest number of views during the...
By Brian Dolan December 1, 2009
By Bradley Merrill Thompson, Partner, Epstein Becker & Green (I would like to thank John Murray of FDA, Scott Thiel of Roche Diagnostics and Russ Gray of the Anson Group for their comments on a draft. The views expressed -- right or wrong -- are only the author’s and should not be attributed to the commenters.) Most people in the wireless health industry have heard by now that FDA has...
By Brian Dolan November 24, 2009
Intel announced a whole slew of new customers for its Intel Health Guide in the U.S., including the Veterans Affairs (VA) Rural Resource Center Western Region, Memorial Hospital and Health System in South Bend, Indiana; Nightingale Home Healthcare of Indiana; and all seven independently owned offices of the Home Care Group. The Intel Health Guide is an FDA-cleared remote patient monitoring system...
By Brian Dolan November 19, 2009
Back in February we reported that the Food & Drug Administration (FDA) had just begun its conversation with the mobile health industry and that the ways in which it would regulate this emerging industry would come out of that conversation. It's now November and those working on wireless health are getting antsy. When will the FDA weigh-in? For the past few months, Bradley Merrill Thompson,...
By Brian Dolan November 18, 2009
While it has been pushing antimicrobial cases for smartphones used in healthcare settings for the past few months, start-up RidRx's device offering received a lot more attention: iStetho Adapter enables users to connect old stethoscopes to an iPhone or iPod Touch. The company also developed an iPhone app, iStethoscope Pro, and suggests that users look to iPhone apps iMurmur or iAuscultate to...
By Brian Dolan October 21, 2009
During a wireless health-focused session at the Connected Health Symposium in Boston this week, the panelists from Verizon, WellDoc, GenerationOne and Sensei had some memorable quotes and bits of wisdom that often stood out as best practices or interesting comments. Below is a rundown of some of the more helpful aphorisms from the event: Carriers eye connected health at home and on-the-go "We...
By Brian Dolan October 15, 2009
Tim Gee, Principal, Medical Connectivity Consulting, was kind enough to write-up the first sessions at our Everywhere Healthcare event last week at CTIA Wireless I.T. & Entertainment event in San Diego. What follows is Tim's notes from the session (including some commentary from him in parenthetical asides.) Brian Dolan, co-founder and editor of MobiHealthNews kicked off the event by...

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