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Decision Diagnostics falsely claimed that their nonexistent test would soon hit the market, leading to price surges and increased trading of the company’s stock, the SEC alleged. Read More
The FDA granted the designation based on pre-clinical data from its animal studies and clinical data collected in its first in-human feasibility trial. Read More
The company will now launch the test in Europe for use in healthcare settings, including clinics and emergency rooms, and will initiate trials evaluating its over-the-counter use. Read More
The authorization “provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year,” said Raquel Peat, director of the Center for Devices and Radiological Health’s Office of Orthopedic Devices. Read More