Boston-based eye tracking company SyncThink has made major changes to its marketing materials since the FDA objected to its labeling in a warning letter. The letter is dated July 31st; MedCityNews first spotted the missive.
"Specifically, the EYE-SYNC device was cleared as a prescription device under K152915 with the following indications for use: recording, viewing, and analyzing eye movements...
23andMe's app.
In a public letter dated November 22, the Food and Drug Administration has instructed personal genome startup 23andMe to immediately stop selling its testing service until the offering receives de novo 510(k) clearance. Regulatory Focus first spotted the letter.
"[M]onths after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not...
