October 12, 2021 By Jim Hammerand International Biophysics rebrands as Movair, launches Luisa portable ventilator in U.S.
October 12, 2021 By Sean Whooley Insulet CEO Shacey Petrovic touts Omnipod 5, expects device launch this year
September 28, 2021 By Chris Newmarker CDRH’s Shuren says they’re ‘starting to turn the corner’ from COVID-19
September 24, 2021 By Brian Buntz A closer look at a microrobot that could treat a rare brain malformation
September 16, 2021 By Jim Hammerand CMS aborts launch of MCIT payment program for breakthrough devices
September 9, 2021 By Sean Whooley Novocure wins FDA breakthough designation for liver tumor treatment device
September 9, 2021 By Danielle Kirsh Madorra wins FDA breakthrough nod for home vulvovaginal atrophy treatment device
August 12, 2021 By Sean Whooley ProPublica report raises questions about FDA’s handling of Medtronic’s HVAD
