MALVERN, Pa. — Siemens Healthcare has announced that it recently submitted to the U.S. Food and Drug Administration (FDA) its premarket approval application (PMA) for the MAMMOMAT Inspiration® with Breast Tomosynthesis option.
Imaging
Siemens seeks FDA approval for next-gen mammograms with tomosynthesis
Anticipating autism through functional neuroimaging
Is 9-month-old Mila Goshgarian at risk for developing autism spectrum disorder (ASD)? Her 4-year-old twin brothers are both on the spectrum, so statistically her chances are at least 20 percent.
Press Release: VuCOMP Announces FDA Approval of M-Vu Computer-Aided Detection (CAD) for Mammography Version 3.1
VuCOMP lands FDA nod for updated M-Vu mammography system
Cancer detections systems maker VuCOMP announced this week that it won FDA approval for new computer-aided detection software, launching version 3.1 of its M-Vu CAD for mammography.
Press Release: GE Healthcare Announces FDA Approval of Invenia Automated Breast Ultrasound System
GE Healthcare wins FDA approval for dense-breast mammograms
GE Healthcare (NYSE:GE) announced this week that it won FDA approval for its Invenia Automated Breast Ultrasound system, indicated to help doctors identify cancers in women with dense breast tissue.
EDAP outlines road to FDA approval for prostate cancer ultrasound therapy
Press Release: EDAP’s Ablatherm-HIFU FDA Panel Meeting Confirmed for July 30, 2014
Prostate cancer: EDAP lands FDA date for therapeutic ultrasound
France-based EDAP TMS SA will get its day with the FDA next month, when the agency’s expert advisors will review EDAP’s Ablatherm-HIFU therapeutic ultrasound technology for treatment of prostate cancer.