medical devices

By Jonah Comstock 09:54 am May 6, 2015
Indianapolis-based pharma giant Eli Lilly is opening a new drug delivery and innovation center in Kendall Square in Cambridge, Massachusetts. Construction will begin immediately, with the center opening by the end of the year for a planned staff of 30 scientists and engineers. Eli Lilly Senior Director of Global Corporate Communications Edward Sagebiel said one Eli Lilly executive will move to...
By Jonah Comstock 08:39 am March 12, 2015
Lack of medical device connectivity and interoperability are big contributors to preventable medical errors, according to a recent survey of nurses. According to the 526 registered nurses who participated in the survey, which was commissioned by the Gary and Mary West Health Institute and conducted by Harris Poll, nurses end up shouldering a lot of the burden of medical devices and electronic...
By Jonah Comstock 05:00 am December 23, 2013
Parks Associates predicts unit sales of networked medical devices will exceed 14 million units by 2018, more than five times the sales from 2012, according to a new report. The firm also looked at what connected medical devices consumers had in their homes. "The addressable market for networked medical devices includes 68 million Americans with hypertension and 26 million with diabetes," Harry...
By Aditi Pai 04:49 am December 11, 2013
To drive medical interoperability, all parties will need to push policy to get things done, Galileo Analytics Cofounder Anna McCollister-Slipp said at the mHealth Summit near Washington DC. McCollister-Slipp was recently appointed to serve on the FDA/ONC HIT Policy Committee’s FDASIA Working Group. "There's some piecemeal policy things that are ongoing that are really critical," McCollister-Slipp...
By Neil Versel 04:00 am September 19, 2013
Departing national health IT coordinator Dr. Farzad Mostashari would prefer that the Food and Drug Administration unilaterally issue a long-anticipated final guidance on mobile medical apps rather than waiting for inter-agency consensus with the Federal Communications Commission and Mostashari's own Office of the National Coordinator for Health Information Technology. "I testified before Congress...
By Neil Versel 04:44 am August 22, 2013
A startup company is looking to raise $650,000 on Indiegogo to test and eventually bring to market a wireless sensor meant to aid in the early detection of breast cancer and the tracking of patients being treated for the disease that kills 40,000 U.S. women each year. Eclipse Breast Health Technologies, of La Mesa, California, launched its crowdfunding campaign Monday and hopes to reach its goal...
By Brian Dolan 06:29 am August 7, 2013
Ideal Life's Blood Pressure Cuff Verizon Wireless' plans for an FDA-cleared mobile health platform focused on chronic disease management and other health conditions has been in the works for some time. The software platform, officially called The Verizon Wireless Converged Health Management (CHM) Device has just secured Class II 510(k) clearance from the FDA this month. Once it commercially...
By Neil Versel 12:16 pm July 31, 2013
Aging in place and disease management technology developer Ambio Health has gained FDA 510(k) regulatory clearance for its flagship Ambio Remote Health Monitoring System. The system, first introduced at the Consumer Electronics Show in January, essentially adds wireless capability to standard home health monitors and automates data collection. Stamford, Connecticut-based Ambio is now free to sell...
By Neil Versel 04:34 am July 30, 2013
Data liberation advocate Hugo Campos has scored a small victory in his ongoing battle to gain access to potentially life-saving data generated from the implantable cardioverter-defibrillator in his chest. Campos now gets XML files of reports from his defibrillator after device manufacturer Medtronic agreed to supply Campos' doctors at Stanford Hospital & Clinics with a script to run in...
By Brian Dolan 04:30 am October 2, 2012
In an editorial published in The Wall Street Journal last week, former Senator Evan Bayh, a Democrat from Indiana, argued that at least one provision in the Affordable Care Act "threatens thousands of American jobs and our global competitiveness". Bayh was pointing to the 2.3 percent tax that the law requires medical device companies to tack on to each sale starting in January. For the first half...