Regulatory: Page 86

FDA clears dBMEDx's bladder scanner
By AuntMinnie.com staff writers
Ultrasound technology developer dBMEDx has received clearance from the U.S. Food and Drug Administration for its new bladder scanner.
January 5, 2015
FDA approves Gadavist MR contrast for kids younger than 2
By AuntMinnie.com staff writers
Bayer HealthCare announced that the U.S. Food and Drug Administration approved its Gadavist (gadobutrol) injection for use with MRI in pediatric patients younger than 2 years old.
January 4, 2015
CMS to hold 2015 Medicare claims for 2 weeks
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) said it will put a two-week hold on claims for medical services submitted in 2015 under the Medicare Physician Fee Schedule.
December 30, 2014
AMIC resubmits Y-90 RadioGel to FDA
By AuntMinnie.com staff writers
Medical isotope producer Advanced Medical Isotope (AMIC) has filed a de novo submission with the U.S. Food and Drug Administration (FDA) for its yttrium-90 (Y-90) RadioGel brachytherapy cancer device.
December 22, 2014
China approves Elekta's Flexitron brachytherapy
By AuntMinnie.com staff writers
Elekta has received clearance for its Flexitron brachytherapy platform from the China Food and Drug Administration.
December 17, 2014
FDA warns against keepsake fetal US, heartbeat monitors
By Erik L. Ridley
The U.S. Food and Drug Administration has issued a consumer update to strongly discourage pregnant women from obtaining fetal keepsake ultrasound images and videos, as well as using over-the-counter Doppler fetal ultrasound heartbeat monitors.
December 15, 2014
2014 12 16 10 50 32 470 Pregnant Ultrasound 200
Vital Images gets FDA nod for stent planning
By AuntMinnie.com staff writers
Vital Images has received U.S. Food and Drug Administration 510(k) clearance for its fenestrated stent planning tool.
December 15, 2014
EOS gains FDA clearance for hipEOS
By AuntMinnie.com staff writers
EOS Imaging has received clearance from the U.S. Food and Drug Administration for its hipEOS 3D hip arthroplasty planning software.
December 15, 2014
Cianna nets FDA OK for SAVI Scout
By AuntMinnie.com staff writers
Cianna Medical has received clearance from the U.S. Food and Drug Administration for its Strut-Adjusted Volume Implant (SAVI) Scout surgical guidance system.
December 10, 2014
Siemens files 510(k) for CT lung cancer screening
By AuntMinnie.com staff writers
Siemens Healthcare has filed a 510(k) application with the U.S. Food and Drug Administration to market CT lung cancer screening on its entire line of CT scanners.
December 8, 2014
Delphinus gets additional FDA clearance for SoftVue
By AuntMinnie.com staff writers
Tomographic ultrasound developer Delphinus Medical Technologies has received another 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SoftVue system.
December 1, 2014
FDA clears SuperSonic probes
By AuntMinnie.com staff writers
SuperSonic Imagine has received U.S. Food and Drug Administration (FDA) 510(k) clearance for two new probes used with its Aixplorer ultrasound system.
November 30, 2014
Previous Page
Page 86 of 302
Next Page