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The mandatory reporting requirements “have been essential during the COVID-19 pandemic,” the agency said, noting that the information received from hospitals enabled the agency to assess risks more quickly. Read More
According to CyMedica, the device is the only FDA-cleared pain management and patient engagement technology that delivers tailored muscle stimulation to reduce muscle weakness while keeping providers advised of patient progress. Read More
International Medical Development did not take adequate corrective and preventive actions for quality deficiencies at its Huntsville, Utah, plant, the FDA found in a Feb. 8-12 inspection. Read More