Medical Device Legal News with Sam Bernstein: Episode 16

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A cardiac imaging company and its founder pay $85.48M and enter into a 5 year CIA to resolve allegations that it overpaid referring physicians to supervise PET scans, despite having obtained a fair market value assessment; the president of a laboratory company is sentenced to 8 years in prison and ordered to pay $24M for defrauding investors in a manner similar to the Theranos case and for paying kickbacks to facilitate billing Medicare and other payors for medically unnecessary allergy testing; the FDA updates its enforcement policy See more +
A cardiac imaging company and its founder pay $85.48M and enter into a 5 year CIA to resolve allegations that it overpaid referring physicians to supervise PET scans, despite having obtained a fair market value assessment; the president of a laboratory company is sentenced to 8 years in prison and ordered to pay $24M for defrauding investors in a manner similar to the Theranos case and for paying kickbacks to facilitate billing Medicare and other payors for medically unnecessary allergy testing; the FDA updates its enforcement policy regarding non-invasive remote monitoring devices and issues updated guidance regarding premarket notifications for magnetic resonance diagnostic devices as well as for the testing and labeling of medical devices for safety in the MRI environment. See less -
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