Call it a case of good intentions.
The California startup Theranos Inc. has set out to revolutionize the blood-testing industry, but they hit a little snag.
The FDA "considers the “nanotainers” made and used by the company to collect finger-pricked blood an unapproved medical device," The Wall Street Journal reported, citing a person familiar with the matter.
Inspectors recently visited the firm after Theranos voluntarily submitted data to the agency in an effort to gain approval for its testing method.
Of the 100 Theranos proprietary tests submitted to the FDA, only one has been approved, a test that detects herpes.
Citing the same person, The Wall Street Journal wrote, "to resume broader use of the tiny vials, Theranos must have them vetted and officially approved by the FDA."