Abbott (NYSE:ABT) won a regulatory green light from the FDA for its FreeStyle Precision Pro system, designed to monitor blood glucose and β–Ketone in hospital settings and featuring wireless data collection.
Abbott says the FreeStyle Precision Pro is the only clinic-based system of its kind to use individually wrapped test strips, designed to help prevent cross contamination and mix-ups in hospital settings. In addition to its wireless data capacity, the new FreeStyle system can also be used with a docking station or a data upload cable to gather test results, Abbott reported.
FreeStyle was cleared as a Class II device, meaning it was exempt from pre-market notification but is still subject to other controls and post-market surveillance.
The company’s FreeStyle InsuLinx was recently the subject of the FDA’s highest-risk recall status, but Abbott has said it has patched through a software update to fix a potentially dangerous tech glitch.