FDA

By Brian Dolan 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 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 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 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 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 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 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,...