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The agency revised its earlier policy on COVID-19 antibody tests to cut down on false and inappropriate marketing claims that have cropped up. In March it was critical for FDA to provide regulatory flexibility for serology test developers, given the nature of this public health emergency. But officials said this week that flexibility never meant they would allow fraud.
Pulmonx was poised to go public but the global pandemic forced the company to switch gears. Still, Pulmonx managed to raise $66 million to support the commercialization of its minimally invasive treatment for severe emphysema.
The large-scale study, intended to validate the use of Fitbit's wearable technology for atrial fibrillation detection, is expected to enroll hundreds of thousands of people. The company said its wearables have the potential to accelerate AFib detection thanks to 24/7 heart rate tracking powered by a long battery life.