The FDA has gone after Biosense, a health startup that makes uCheck, an automated urine analyzer sold directly to end customers. You pee on a strip then use the uChek iPhone app to take a picture and analyze the contents of your urine for health info like glucose. Biosense claims that it can help detect up to 25 diseases, like diabetes, pre-clampsia, and urinary tract infection.
A letter has been sent to Biosense from FDA about its home kit + iPhone app product asking why Biosense hasn’t gotten uCheck officially sanctioned by the government.
AliveCor’s Veterinary Heart Monitor for the iPhone helps vets diagnose heart disease in dogs, cats, and horses.
What do you do if you’re a medical technology startup while waiting for the FDA to approve your flagship iPhone-based product?
If you’re AliveCor, you launch a veterinary version of it.
The product in question is AliveCor’s iPhone ECG heart monitor, which the company showed off nearly two years ago, at the CES in 2011. The device allows a medical professional to assess a patient’s heart rhythm, providing more data than a stethoscope or manual check of their pulse. Although the device has broad potential, it has yet to be approved by the FDA.