May 4, 2017
OCR settles HIPAA complaint with CardioNet. CardioNet, one of the oldest companies in the mobile cardiac arrhythmia monitoring space, has agreed to pay the Office of Civil Rights $2.5 million and enter into a corrective action plan in the end result of a HIPAA breach investigation that's been going on since 2012. The judgment is significant, writes law firm Morgan Lewis in a blog post, because it...
April 7, 2017
In a true first, the Food and Drug Administration is allowing 23andMe to sell its direct-to-consumer genetic test kits that provide information about an individual’s risk to certain diseases such as Alzheimer’s or Parkinson’s disease.
23andMe’s $199 genetic tests are available with the FDA’s blessing nearly three and a half years after the agency first ordered 23andMe to immediately stop selling...
January 11, 2017
Toolbox Genomics, a company that will soon begin to offer actionable health insights based on customers' sequenced genomes, has raised a small round of seed funding, the company told MobiHealthNews. The exact amount of the funding was not disclosed. The company's product will launch in mid-February for $49, CEO Didier Perez told MobiHealthNews.
"Basically what we do is based on a user's own DNA...
November 23, 2016
More than a decade ago, when most people were still using not-so-smart mobile phones, the first human genome was sequenced. It cost $3 billion. In the time it took for smartphones to become the essential consumer technology, DNA sequencing rapidly evolved from a costly, uncommonly used process into a quick, reliable, relatively cheap and widely used predictive tool to give insight on disease risk...
November 17, 2016
Telemedicine provider MDLive has hired Scott Decker as the company’s new chief executive officer. The company’s current CEO and founder, Randy Parker, will now be MDLive’s chief business development officer and also serve on the board of directors.
Decker comes to MDLive from HealthSparq, where he was also CEO and where he built a cloud-based healthcare shopping and price transparency platform...
November 3, 2016
Digital nutrition platform Zipongo has raised $18 million in new funding and will use the funding to continue to move more deeply into the healthcare space. The round was led by Mayfield (whose other health investments include Basis Science, HealthTap, Lantern, Brighter, and Finrise), with participation from existing investors including Excel Venture Management.
Zipongo's platform consists of a...
October 27, 2016
Personal genomics startup Helix, which is developing a digital hub for all things related to DNA testing ranging from direct-to-consumer to doctor-ordered, has announced several partnerships: the Icahn School of Medicine at Mount Sinai, National Geographic and ExploraGen will collaborate to deploy Helix’s genetic-testing service, which is powered by DNA sequencing giant Illumina. Additionally,...
March 21, 2016
At the same time as it announced CareKit, Apple announced in a press release that ResearchKit would be updated to more easily make use of users' genetic data, via a module designed by consumer genetics company 23andMe. Apple also added other modules for common medical tests to ResearchKit.
“The response to ResearchKit has been fantastic. Virtually overnight, many ResearchKit studies became the...
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...
October 15, 2015
Mail-order personal genetics service and research company 23andMe has completed a $115 million in a round led by Fidelity Management and Research Company with participation from Casdin Capital, WuXi Healthcare Ventures, and Xfund, as well as existing investors Illumina, New Enterprise Associates, MPM Capital, and Google Ventures.
Part of this funding round was disclosed earlier this year when...