December 3, 2013
The FDA has granted 510(k) class II clearance to La Jolla, California-based Sense4Baby's cellular-enabled maternal and fetal monitoring system. The company has also secured a CE Mark for the European market and other countries where that approval is recognized. The regulators cleared Sense4Baby's "model B+" system for healthcare providers to use to monitor expectant mothers and their fetuses...
November 21, 2013
Rep. Joseph Pitts (R-PA)
This week the US House of Representatives' Energy and Commerce Committee's subcommittee on Health held a hearing to discuss the "Federal Regulation of Mobile Medical Apps and Other Health Software", which ended up being a partial re-run of the committee's FDA-apps hearings back in March. This time around, however, the committee stacked the witness table with supporters...
November 11, 2013
By Bradley Merrill Thompson
More than three years have passed since I wrote the first edition of this e-book for MobiHealthNews, and much has changed. Among other things, FDA at last has published its final guidance on mobile medical apps. Further, the mHealth industry has morphed several times over the last couple years. Consequently, in this second edition, more than 80 percent of the content...
September 23, 2013
PillPhone: One of the first patient-facing mobile apps to get FDA clearance.
Last week when departing ONC chief Dr. Farzad Mostashari told MobiHealthNews that he thought the FDA should release its final guidance document for mobile medical apps without delay, he might have known something we didn't.
After more than two years since the FDA first published its draft guidance on how it regulates...
September 4, 2013
By Dan Haley, VP of Government Affairs, athenahealth
In 2011 the Food and Drug Administration (FDA) released draft guidance seeking to clarify its intentions with regard to regulation of mobile health information technology (“mhealth IT”). The Agency solicited and received public comment. Thereafter began a nearly two-year waiting game that continues to this day and has more than a few mobile...
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...
June 18, 2013
Last month the medical journal of Diabetes Science and Technology published the results of a small efficacy study conducted at George Washington University Medical Center that used Vocel's PillPhone application. MobiHealthNews covered the results of the study in-depth back in early 2011 when they were first made public, but last month's medical journal was the first to officially publish the...
May 22, 2013
The pre-FDA clearance version of MobileCT
Nephosity, a San Francisco-based startup, has joined the swelling ranks of companies to receive Food and Drug Administration (FDA) 510(k) clearance for a mobile medical imaging app.
The FDA has approved Nephosity's MobileCT Viewer iPad app for remote diagnostic viewing of CT, MRI and X-ray images when a fixed workstation is not readily available,...
April 24, 2013
Last month Germany-based research firm Research2Guidance predicted that the overall, worldwide mobile health market would generate about $26 billion in revenues by 2017, but this month it broke out a 2017 revenue prediction for mobile health sensors that connect to a mobile health app: $5.6 billion. The firm believes that this segment of the market will grow at a compound annual growth rate of 69...
April 24, 2013
By Bradley Merrill Thompson
Some technology companies are sitting on the sidelines, or just dipping their toes in the mHealth waters, out of fear of the unknown. Will FDA regulate this space? If we get into healthcare, will we get sued if someone breaks a finger nail using our app? Will the FTC come after us if we don’t have a bunch of clinical trials to support every claim we make? Will a...