510(k) for Medic-Aid's new inhaler:
This article was originally published in Clinica
Executive Summary
UK company Medic-Aid has received clearance from the US FDA for its HaloLite inhaled drug delivery system. The device uses an adaptive aerosol delivery technology which closely monitors the patient's breathing pattern and delivers the drug only during inspiration - shutting down after the pre-set dose has been administered. This way, the company says, HaloLite consistently delivers a precise dose to the lung. The product has been CE-marked and US clinical studies are to begin in the first half of this year.
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