FDA

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...
By Brian Dolan October 14, 2009
At the Body Computing Conference last week in Los Angeles, the Food and Drug Association's Brian Fitzgerald weighed in on a big question: Who owns your health data? According to a report in Fast Company, the typical answer most consumers would provide is "my body, my data." Fitzgerald, however, had an insightful and perhaps troubling reply. It made for a true regulatory monkey wrench: "These are...
By Brian Dolan October 12, 2009
"With the FDA recently saying too many [medical] devices are getting approved too easily and some other things they are articulating, it's frustrating," Montage Systems CEO Eric Collins said during a panel session at the CTIA Wireless IT & E event last week. Montage is still awaiting FDA approval of its Wireless Healthphone, which is meant to send patient data wirelessly to doctors and other...
By Brian Dolan September 30, 2009
"Everyone is going to look for solutions that not only improve care but also save healthcare dollars," MedApps CEO Kent Dicks told MobiHealthNews in a recent interview. "No one can dispute that." MedApps navigated the early years of wireless health, first as a mobile phone-based solution, which the FDA approved in 2007, before switching to a connected, dedicated device, called HealthPAL. It's a...
By Brian Dolan September 29, 2009
Charlotte, North Carolina-based Premier healthcare alliance inked a deal with mobile application developer AirStrip Technologies for AirStrip OB, which provides obstetricians and nurses with real-time, remote access to fetal and maternal waveform data, including fetal heart rate and maternal contractions. Premier began offering the application to its 2,200 hospital members about two weeks ago....
By Brian Dolan September 24, 2009
Changes for 510(k) in 2011? The AP reports that the Food and Drug Administration (FDA) has agreed to a review of its 510(k) review procedure, which has come under fire by both safety advocates and government watchdogs, the report said. The nonprofit Institute of Medicine will conduct the two-year review of the 510k procedure. More On managing de-centralized care: "There seems to exist almost an...
By Brian Dolan August 25, 2009
"The single fastest growing medical device we have in this country is probably the iPhone," Jon Linkous, CEO of the American Telemedicine Association told Mobihealthnews. "I have discussions about the iPhone every single day." Linkous also explained how the telemedicine industry has grown from "white labeled" (literally) corporate video conferencing solutions to the rapidly growing wireless...
By Brian Dolan August 24, 2009
By Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C. Last month I outlined the triggers that could cause an ordinary mobile phone to become an FDA-regulated medical mobile phone. This month, in the second of six planned articles, I will outline the FDA requirements that would apply to a mobile phone that crosses that line. To summarize the July 13 article on "FDA may regulate...
By Brian Dolan July 21, 2009
FDA OKs St. Jude wireless implant: The U.S. Food and Drug Administration (FDA) has granted St. Jude Medical approval for its its Accent RF pacemaker and Anthem RF CRT-P, which feature secure, wireless transmission of data that the clinician or a home monitor can track. St. Jude claims its system is unique as an "integrated system of pacing devices with wireless telemetry from implant through...

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