FDA clears Gillette's CranioCap:
This article was originally published in Clinica
US hospital Gillette Children's Speciality Healthcare has received FDA 510(k) clearance to market its CranioCap cranial brace for the treatment of deformational plagiocephaly (a miss-shapen head) in infants. The custom-made device works by applying passive pressure to prominent regions of the cranium, redirecting its growth to recessed areas in the brace to improve cranial symmetry and/or shape. The CranioCap is worn for three to four hours at a time and it takes three to four months for adequate change to take place, said the St Paul, Minnesota hospital.