FCA: 2020 Sees More False Claims Cases Than Ever While Recoveries Plummet
A report from the law firm Gibson Dunn found that the US government brought more new cases under the False Claims Act last year than ever before, which they partially attribute to COVID-19 enforcement actions.
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The US agency’s safety alert says the devices, which measure blood oxygen levels, may be less accurate in patients with darker skin tones.
The program will be open to roughly a hundred device firms with traditional 510(k)s under review between March and May of this year.