FDA

By Brian Dolan March 16, 2010
Within the healthcare chapter of the FCC's National Broadband Plan, which the agency published this morning, the FCC recommended that it work together with the FDA to clarify regulatory requirements and the approval processes for converged communications and health care devices. The FCC specifically pointed to mobile health apps, smartphone remote monitoring apps, point of care diagnostic...
By Brian Dolan March 15, 2010
"The iPhone has created a new direction for our company," Mark Cain, CTO, MIMvista said in June 2008. "We have taken a complex desktop application removed it from the realm of black art and placed it in the hands of physicians and patients. And we have only just scratched the surface." Cain's remarks were part of his presentation at Apple's World Wide Developer Conference in June 2008 -- the...
By Brian Dolan March 3, 2010
For the past two years, Microsoft's HealthVault group has been busily assembling a suite of personal medical devices that connect to its personal health information platform. Just this week the FDA's top medical device reviewer, Donna-Bea Tillman, announced her plans to step down in order to take a position with Microsoft's regulatory and policy group, according to a report from the Associated...
By Brian Dolan February 28, 2010
The Continua Health Alliance, a consortium of more than 220 organizations working to enable interoperability between personal medical devices, noted in a recent newsletter that the FDA believes new laws for connected health device regulations are neither likely nor needed. The revelation came after Continua hosted a pow-wow with industry folks at FDA head quarters last month -- MobiHealthNews...
By Brian Dolan February 26, 2010
By Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C. “Under the Federal, Food, Drug, and Cosmetic Act, HIT software is a medical device.” That’s according to Dr. Jeff Shuren, the new director of the Device Center within FDA. Yikes. Dr. Shuren testified yesterday at a hearing of the HIT Policy Committee, Adoption/Certification Workgroup. The workgroup invited numerous speakers...
By Brian Dolan February 8, 2010
Strategies for mHealth Companies Wishing to Avoid FDA Regulation By Bradley Merrill Thompson (I would like to thank Leah Kendall of EpsteinBeckerGreen 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 anyone else.) Most people know the difference between tax avoidance and tax evasion. Tax...
By Brian Dolan February 3, 2010
We reported earlier this week that Houston, TX-based wireless cardiac monitoring startup, eCardio had monitored about 20,000 patients to date. Today, CardioNet, one of the first wireless cardiac companies to go to market has announced that it just passed 300,000 patients monitored by its Mobile Cardiac Outpatient Telemetry (MCOT) service. “With 300,000 patients having now benefited from our MCOT...
By Brian Dolan February 3, 2010
During his keynote this morning at the mHI event in Washington D.C., the FCC's Digital Healthcare Director Dr. Mohit Kaushal pointed to Haiti earthquake survivor Dan Woolley's use of an iPhone first aid application to treat his own compound fractured leg and head wound: "This miraculous story would not have been possible a few years ago... but it's just the tip of the ice berg," Kaushal said....
By Brian Dolan January 19, 2010
Big news for the first startup shepherded by the West Wireless Health Institute: The FDA has greenlit Corventis' Nuvant system, a mobile cardiac telemetry system. The 510(k) clearance for Nuvant enables Corventis to begin marketing the service in the U.S. -- Corventis secured FDA clearance for its PiiX sensor (pictured), which is a part of the Nuvant system -- last April. According to the company...
By Brian Dolan January 19, 2010
Chilmark Research's John Moore set about reading the tea leaves on 2010 a few weeks into this already busy year, and came up with a list of top ten trends to for healthcare IT. Smartphone medical and health apps made it onto the trend list at number five: "Second Gen mHealth Apps Enter Market – Melding of Smartphones and Devices Remains Nascent: With literally thousands of mHealth apps now...