Regulatory: Page 25

FDA debuts website for patient-reported cancer outcomes
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has unveiled Project Patient Voice, a new pilot program for communicating patient-reported outcomes from cancer clinical trials.
June 23, 2020
2016 09 02 09 36 05 93 Fda Logo V2 400
Ziosoft lands FDA clearance for dual-energy CT software
By AuntMinnie.com staff writers
Advanced visualization and artificial intelligence (AI) software developer Ziosoft has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its CT Dual kV image analysis software for dual-energy CT studies.
June 15, 2020
2020 02 20 00 48 1332 Approved Stamp 400
Medo.ai gets FDA nod for hip dysplasia AI software
By AuntMinnie.com staff writers
Artificial intelligence (AI) software developer Medo.ai has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Automated Real-time Intelligent Assistant, an AI software application for detecting hip dysplasia on ultrasound exams in infants.
June 15, 2020
2020 02 20 00 48 1332 Approved Stamp 400
Groups ask NRC to allow virtual radiotracer training
By AuntMinnie.com staff writers
A group of medical specialty societies has sent a letter to the U.S. Nuclear Regulatory Commission (NRC) asking the agency to allow healthcare personnel to fulfill requirements for radiotracer handling through virtual training programs.
June 11, 2020
2018 12 11 00 02 7009 Atom Nuclear Lab 400
CDRH now taking radiation safety reports by email
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) is now accepting radiation safety reports by email.
June 10, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
Medtronic recalls StealthStation DBS software
By AuntMinnie.com staff writers
Device manufacturer Medtronic has recalled the autoregistration feature on its StealthStation DBS software used in deep brain stimulation (DBS) procedures due to inaccuracies that could lead to serious harm to patients, according to a summary published June 1 by the U.S. Food and Drug and Administration (FDA).
May 31, 2020
2016 09 02 09 28 19 895 Fda Logo 400
4DMedical gets FDA clearance for lung analysis software
By AuntMinnie.com staff writers
Medical image analysis software developer 4DMedical (formerly 4Dx) has received U.S. Food and Drug Administration (FDA) clearance for XV Technology, a software application that provides 4D analysis of functional lung impairment from a fluoroscopy exam.
May 26, 2020
2020 05 27 17 38 9776 4 D Medical Xv Technology 20200527171811
Guerbet brings Vectorio to Canadian market
By AuntMinnie.com staff writers
Contrast developer Guerbet has received approval to market its Vectorio contrast media kit in Canada for imaging of hepatocellular carcinoma.
May 18, 2020
2019 12 18 19 15 2524 Guerbet Rsna 2019 400
FDA sends warning letters to breast implant manufacturers
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has sent warning letters to two breast implant manufacturers for failing to comply with federal regulations.
May 14, 2020
2016 09 02 09 36 05 93 Fda Logo V2 400
Senator's letter prompts VA probe of Ill. hospital
By AuntMinnie.com staff writers
A letter from U.S. Senator Tammy Duckworth (D-IL) sparked an investigation into four radiology errors by a single radiologist -- who was later dismissed -- at a U.S. Department of Veterans Affairs (VA) hospital in Illinois.
May 6, 2020
2018 02 14 21 21 4230 United States Flag 400
FDA updates mammo facility guidance for COVID-19
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) on April 27 updated its guidance for mammography facilities amid the ongoing COVID-19 pandemic.
April 28, 2020
2016 09 02 09 36 05 93 Fda Logo V2 400
FDA relaxes rules on imaging modifications for COVID-19
By Brian Casey
In an effort to make medical imaging more available to COVID-19 patients, the U.S. Food and Drug Administration (FDA) is relaxing its rules on modification of radiology equipment. Modifications will not need the agency's imprimatur before being used on patients during the crisis.
April 23, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
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