FDA

By Brian Dolan 06:00 am May 1, 2009
Tunstall's RTX3371 Wireless Telehealth Monitor follows the trend of many of the telemedicine solutions we saw on display at the American Telemedicine Association event earlier this week: 2G radios. If a device is simply transmitting biometric data into the cloud en route to online portals for physicians and other caregivers, who needs high-speed 3G networks? Most telemedicine companies seem to...
By Brian Dolan 06:50 am April 21, 2009
According to a report by Ben Lorca over at O'Reilly Radar, out of the 20 categories of iPhone applications, the "Medical" category has added the third most new applications in the past three months. The number of medical applications for the iPhone grew almost 133 percent during the period. The "Books" and "Travel" categories took the first and second places for most new apps added during the...
By Brian Dolan 02:04 pm March 25, 2009
John Maschenic, Associate Director, Vertical Data Sales, Verizon Wireless has been responsible for the company's enterprise data sales organization for the last seven years and has focused on healthcare since 2005. Since much of the discussion currently underway in the mHealth industry has been focused on application development, hospital uptake of mHealth services, and mobile phone capabilities...
By Brian Dolan 01:04 pm March 20, 2009
After this week's big announcement from Apple that the iPhone will soon be able to connect to medical devices via Bluetooth, we thought it'd be a good idea to check-in with the Continua Health Alliance, which is working to ensure interoperability for connected personal medical devices. Earlier today, mobihealthnews caught up with Continua Health Alliance President David Whitlinger to discuss the...
By Brian Dolan 07:21 am March 12, 2009
John Halamka, MD, MS, the CIO of CareGroup Health System and Dean for Technology at Harvard Medical School, has cut the cord and no longer has a landline phone. Halamka wrote a post about going all mobile over at his blog Life as a Healthcare CIO. Halamka is also Chair of the US Healthcare Information Technology Standards Panel (HITSP), and a practicing Emergency Physician. This is a puff piece,...
By Brian Dolan 09:16 am March 10, 2009
Sicel Technologies, a developer of wireless implantable sensors, has received clearance from the FDA to begin marketing DVS-HFT, the next-gen of its wireless implantable dosimeter that measures radiation dose at the tumor site. Health & Beauty Care Executive magazine and Good Housekeeping magazine each gave awards to A&D's Wellness Connected services, according to the company. The devices...
By Brian Dolan 11:36 am February 18, 2009
Even though the FDA recently began an open dialog with the wireless medical device community over mHealth regulation, enforcement of federal quality regulations at labs that develop medical devices has been scaled back by the FDA, according to a recent report by the Project on Government Oversight. FDA inspections of "good laboratory practices" at facilities that do early testing of medical...
By Brian Dolan 09:34 am February 13, 2009
Maybe it's because of the new billing codes for cardiac telemetry devices, but the newscycle is brimming with announcements from wireless implantable cardiac monitoring devices this week. We just wrote about Medtronic's Reveal XT, now the FDA announced approval for Transoma Medical's Sleuth AT, which is also an implantable wireless cardiac monitor that communicates with a personal device the...
By Brian Dolan 04:48 am February 12, 2009
One of the last and liveliest sessions at TEPR+ last week was a presentation and Q&A with Don Witters from the FDA Center for Devices and Radiological Health. Witters repeated multiple times that he attended the show in order to begin a dialog with the mHealth industry to establish clear pathways and regulations that ensure wireless quality of service, coexistence with other medical systems,...