Regulation

By Brian Dolan 08:43 am October 27, 2015
Fitbit Surge The Consumer Electronics Association (CEA), which puts on the massive CES event in Las Vegas every January, just published a set of voluntary guidelines for how technology companies should approach privacy and security for personal wellness data collected by wearable devices and other connected wellness devices. The CEA said the guidelines represent a consensus among its member...
By Aditi Pai 11:23 am October 22, 2015
Almost two years after the FDA first told 23andMe to halt sales on its mail-order direct-to-consumer genetic testing service for disease risks, the company has relaunched a version of its new Personal Genome Service (PGS), which now meets FDA standards. “We’ve worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing," 23andMe CEO Anne Wojcicki...
By Jonah Comstock 10:49 am October 22, 2015
The FDA has cleared SmartLinx Vitals Plus, a mobile-connected in-hospital patient monitoring system from Qualcomm Life subsidiary Capsule. It received FDA 510(k) clearance for prescription use as a class II medical device. Qualcomm Life completed the acquisition of the French company just last month. On its website, Capsule describes Vitals Plus as "an innovative patient monitoring system that...
By MHN Staff 05:57 am October 15, 2015
By the MobiHealthNews team This morning a number of big name medical institutions launched new studies using Apple's ResearchKit, iPhones and, in at least one case, the Apple Watch. As more ResearchKit study apps become available on Apple's app store, it appears that many of them are laying the groundwork for future FDA-cleared medical apps. It not only seems to be the case, the medical...
By Aditi Pai 09:39 am October 14, 2015
Hands Up Therapy, app from NHS library The National Health Service in England will complete its two-year pilot of the NHS health app library this week, on October 16th, and the organization plans to relaunch the offering as a series of "app stores" that focus on specific diseases and conditions. When NHS's pilot first began, in March 2013, the company said in a post that a key focus for the...
By Jonah Comstock 11:04 am October 12, 2015
A smart baby bottle, which uses sensors to measure a baby's tongue strength and sends the data to a provider's mobile device, has received FDA clearance. Atlanta, Georgia-based NFANT Labs, formerly known as CCB Research Group, has been working on the system for about a little under two years. "Many infants in the NICU have trouble transitioning from tube feeding to bottle or breast feeding and...
By Jonah Comstock 07:39 am October 12, 2015
Belfast, Northern Ireland-based Intelesens has received FDA 510(k) clearance for its wearable vital signs monitor, called zensor, designed for monitoring patients outside the hospital. “This is a significant milestone for Intelesens and zensor," Intelesens Commercial Manager Stephen Henderson said in a statement. "...Not only does FDA clearance give the company access to the world’s biggest...
By MHN Staff 10:09 am October 8, 2015
By Bradley Merrill Thompson If I invented an unprecedented mobile technology for treating tennis elbow, the law would require me to do substantial and expensive clinical trials before bringing it to market. In my last post, I argued that the FDA regulatory system is structurally biased against new technology, including novel software, even if it is low risk.  By law, any medical device that is...
By Jonah Comstock 11:47 am September 28, 2015
The Texas office of the Attorney General weighed in on a motion to dismiss Teladoc's antitrust suit against the Texas State Medical Board on the grounds that there is, in fact, state supervision of the medical board which would make it a state agency under law and therefore immune to suit. Politico first spotted the news. In April, Teladoc sued the Texas Medical Board, alleging that a recently...
By Brian Dolan 11:48 am September 21, 2015
The Federal Trade Commission (FTC) has charged the marketers of a vision improvement app, called UltimEyes, with deceptively claiming they their program was scientifically proven to improve the user's eye sight. The company behind the app, Carrot Neurotechnology, and its co-owners Adam Goldberg and Aaron Seitz have agreed to pay $150,000 and to stop citing the claims. Notably, the $5.99 app is...