Regulation

By Jonah Comstock 10:22 am July 20, 2015
Palo Alto-based novel blood test company Theranos was granted a waiver from the FDA allowing the company to offer its first FDA-cleared blood test, its herpes simplex 1 virus IgG (HSV IgG) test, outside of a lab setting. According to the company, it's the first HSV test to receive the waiver, called a CLIA waiver (CLIA stands for the Clinical Laboratory Improvement Amendments of 1988). The move...
By Jonah Comstock 09:10 am July 16, 2015
MedWatcher, a tool for adverse event reporting, that the FDA worked on with Epidemico. Google met with the FDA last month to discuss the possibility of the FDA using Google search data to learn about drug side effects, according to a report in Bloomberg, which spotted a public record of the meeting and secured additional information from an FDA spokesperson. The talk appears to have been an...
By Aditi Pai 09:06 am July 16, 2015
St. Jude Medical has announced that it received FDA 510(k) clearance for the St. Jude Medical Invisible Trial System, which is a mobile-enabled discreet spinal cord stimulation (SCS) trial system. Patients who need spinal cord stimulation therapy, which helps them manage chronic pain, can have small device implanted in their body. The implant connects to thin wires, called leads, which deliver...
By Aditi Pai 10:32 am July 15, 2015
AmeriHealth Caritas, a Medicaid managed care organization, has partnered with Palo Alto-based Theranos, which is working on a smaller, cheaper, alternative to common lab blood tests, to offer Theranos' services to its Medicaid members. AmeriHealth Caritas operates in 16 states and DC. It serves more than 6.6 million members. Theranos uses a lab-on-a-chip technology to run multiple blood tests on...
By Jonah Comstock 09:29 am July 14, 2015
President Obama addresses the White House Conference on Aging. Yesterday, celebrating 50 years of Medicare and 80 years of Social Security, the White House hosted its Conference on Aging. At a panel during the summit, experts discussed how to make technology accessible to seniors. A study on that same topic was released by AARP today. "We choose to do big things here in America," President...
By Jonah Comstock 09:04 am July 9, 2015
Jawbone's beef with competitor Fitbit is heating up, according to a report from Bloomberg. Jawbone is apparently trying to get the US International Trade Commission to block Fitbit's imports into the US based on the same complaints that form the basis of its two recent lawsuits against Fitbit. "Complainants seek relief from the Commission in the form of a limited exclusion order excluding from...
By Brian Dolan 10:22 am July 8, 2015
Rep. Mike Thompson (D-CA) Yesterday the state of Delaware became the 29th among these United States to have a telehealth parity law hit its books. Coincidentally, a few representatives in Congress also re-introduced a nationwide telehealth parity law similar to one the group put forward last year. Delaware Gov. Jack Markell signed the bill into law after it unanimously passed both houses of...
By Brian Dolan 11:30 am July 7, 2015
HHS appoints Susannah Fox as CTO: Just two weeks after our last hiring roundup, the Department of Health and Human Services announced that it had appointed longtime patient advocate and Pew Research alum Susannah Fox as its new CTO. Fox has also been an early and important voice in the emerging mobile and digital health. Her team's work at Pew helped ground the mobile health discussion with...
By Jonah Comstock 10:20 am July 7, 2015
Fitbit Surge It looks like the NIH may be the next big stakeholder to look to mobile tools for data collection in clinical research, joining the likes of Apple and Google. As part of the White House's Precision Medicine Initiative (PMI), announced in January during the State of the Union address, the NIH is considering using smartphones and wearables for data collection, according to a new...
By Jonah Comstock 08:03 am July 6, 2015
Theranos, the 12-year-old Palo Alto-based company working on a smaller, cheaper, alternative to common lab blood tests, has received its first voluntary FDA 510(k) clearance, for its herpes simplex 1 virus IgG (HSV IgG) test. Using a (still largely secretive) lab-on-a-chip technology, Theranos is able to run multiple blood tests on just a few drops of blood, whereas traditional labs need to draw...