Regulatory: Page 87

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
FDA OKs HeartFlow FFR-CT software
By AuntMinnie.com staff writers
HeartFlow has received U.S. Food and Drug Administration clearance for its FFR-CT software, which noninvasively estimates fractional flow reserve (FFR) from cardiac CT studies.
November 26, 2014
IRadimed submits 510(k) at FDA request
By AuntMinnie.com staff writers
MRI accessories company IRadimed has submitted a 510(k) application to the U.S Food and Drug Administration (FDA) for its MRidium 3860+ MRI IV infusion pump.
November 26, 2014
Calgary Scientific brings ResolutionMD to Australia
By AuntMinnie.com staff writers
Calgary Scientific has received certification from the Australian Therapeutic Goods Administration for its ResolutionMD image viewing software.
November 25, 2014
Philips lands FDA nod for IQon
By AuntMinnie.com staff writers
Philips Healthcare has received U.S. Food and Drug Administration 510(k) clearance for its IQon spectral CT scanner.
November 25, 2014
InSightec set to bring ExAblate to Japan
By AuntMinnie.com staff writers
MR-guided focused ultrasound (MRgFUS) developer InSightec has received approval from Japan's Ministry of Health, Labor, and Welfare for its ExAblate MRgFUS system.
November 24, 2014
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