January 16, 2015
As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing claims) crosses over into regulated medical device territory. As always the agency is seeking comment from the industry and the public on their new draft guidance for the next 90 days.
June 26, 2014
Image Source: Keller Sports' online store, which is showing the device as currently not for sale.
Adidas could soon add a new activity tracker to its product line, a wristworn wearable called the miCoach Fit Smart, according to a report from Engadget.
A letter Adidas wrote about the miCoach Fit Smart to the FCC in May 2014 explains that Adidas wants the device's external photographs, internal...
April 30, 2014
Three former Dexcom employees left the company last year to form a new venture, Glucovation, which is developing a direct-to-consumer, wearable device that continuously senses glucose for people trying to lose weight or improve their athletic performance. The Glucovation team is headed up by Dexcom's former senior technical director for R&D, Robert Boock, who was in charge of that company's...
June 7, 2013
By Aditi Pai, Jonah Comstock, & Brian Dolan
Mobile health has come a long way since the start of 2009 when Apple demonstrated on-stage at its World Wide Developer Conference how blood pressure monitors and blood glucose meters could connect to the iPhone 3G via cables or Bluetooth. MobiHealthNews has tracked health-related wearable devices from their infancy as research projects at university...
May 14, 2013
Last week a widely spread rumor made it's way to various tech blogs about the next generation Nike+ FuelBand: Reportedly, the second generation device is currently being tested by Nike employees who are wearing it out in the public because the prototype still has the form factor of the original. A report in gadget blog, Gear Live, claims that the next FuelBand will include Bluetooth 4.0 (aka...
May 13, 2013
An example of remote doctor visits: meVisit's app
Telehealth holds enormous potential for transforming healthcare, but, to telemedicine pioneer Dr. Jay Sanders, the primary barrier is not financial. Instead, physician and patient attitudes about healthcare and health itself must change, said Sanders, who often has been called the father of telemedicine.
"The critical issue is really not...
November 2, 2012
A new report from Juniper is the latest in a flurry of forecasts about the role that smart wearable devices, or wearables, are going to play in the mobile technology market over the next few years. Juniper says wearables will be a $1.5 billion market by 2014, up from just $800 million this year.
Some of that drive is from “multifunction” devices like Google’s Project Glass and a similar product...
November 1, 2012
ZephyrLife's Android App
Massachusetts General Hospital in Boston will conduct a clinical trial of wearable health monitoring devices from Zephyr Technology to monitor pregnant women as they give birth, then quickly roll the system out to a hospital in Uganda in an effort to stem high infant mortality.
Mass General's Center for Global Health is testing Annapolis, Md.-based Zephyr's BioHarness...
June 27, 2012
Psychologist Sherry Pagoto, UMass Medical School in Worcester
Annually since 2004, the president of the University of Massachusetts system has had discretionary funds to award to faculty research projects in science and technology. This year, President Robert L. Caret gave the largest of $750,000 in Science and Technology Initiatives Fund grants – a $185,000 award over two years – to support...
May 8, 2012
Recent months have brought a flurry of industry metrics, market predictions, investment rounds, research announcements and more that have fueled the rising trend of wearable health devices. This past February MobiHealthNews reported on market predictions made by ABI Research: In five years the number of wearable wireless health and fitness devices will hit 169.5 million. That’s up from almost 21...