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At La Vie Clinic, our co-founder Nagwa Attalla, office manager Rawan Batal, and physician Dr

Whilst most people obtain adequate B12 through a balanced diet containing animal products, certain groupsincluding vegans, older adults, and those with malabsorption conditionsmay need additional attention to their B12 status

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Under this alternative pathway, devices that are granted an FDA Breakthrough Device designation are not evaluated in terms of the current substantial clinical improvement criterion at 419.66(c)(2) for the purposes of determining device pass-through payment status, but do need to meet the other requirements for pass-through payment status in our regulation at 419.66

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