Regulatory: Page 24

Radiology payments to be lower under 2021 MPFS, HOPPS
By Kate Madden Yee
The U.S. Centers for Medicare and Medicaid Services (CMS) has released proposed rules for the 2021 Medicare Physician Fee Schedule (MPFS) and the 2021 Hospital Outpatient Prospective Payment System (HOPPS) -- and they don't bring good news for radiology.
August 4, 2020
2019 07 31 17 01 7432 Medicare Puzzle 400
FDA document outlines new mammo appeals process
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has released a draft guidance document with new options for mammography facilities that want to appeal accreditation decisions.
July 19, 2020
2016 09 02 09 36 05 93 Fda Logo V2 400
Avicenna.ai lands FDA nod for Cina Head triage software
By AuntMinnie.com staff writers
Artificial intelligence (AI) software developer Avicenna.ai has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for its Cina Head AI computer-assisted triage software.
July 13, 2020
2020 07 14 18 12 7478 2020 07 14 Avicenna 20200714180323
Qubyx gets FDA clearance for software, iMac bundle
By AuntMinnie.com staff writers
Image display calibration firm Qubyx Software Technologies has received U.S. Food and Drug Administration 510(k) clearance for a bundle of its PerfectLum 4.0 display calibration and quality assurance software with an Apple iMac diagnostic medical display.
July 13, 2020
2019 12 17 23 59 6699 News Ball 400
ITM submits drug master file to FDA for GeGant
By AuntMinnie.com staff writers
German radiopharmaceutical group ITM Isotopen Technologien München said it has submitted a drug master file to the U.S. Food and Drug Administration (FDA) for its GeGant germanium-68/gallium-68 generator.
July 12, 2020
2019 12 17 23 59 6699 News Ball 400
Therapixel garners FDA clearance for mammo AI software
By AuntMinnie.com staff writers
French artificial intelligence (AI) software developer Therapixel has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its MammoScreen software for screening mammography exams.
July 8, 2020
2020 03 10 18 34 4441 New Product 400
MIM gets FDA clearance for autocontouring software
By AuntMinnie.com staff writers
Medical imaging software developer MIM Software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Contour ProtégéAI autocontouring software.
July 8, 2020
2020 07 09 20 52 8488 Mim Astro 2019 400
Quantib gets FDA nod for AI integration platform
By AuntMinnie.com staff writers
Artificial intelligence (AI) software developer Quantib has received U.S. Food and Drug Administration (FDA) clearance for its AI workflow integration platform.
July 8, 2020
2020 02 20 00 48 1332 Approved Stamp 400
RapidAI gets FDA clearance for stroke imaging AI
By AuntMinnie.com staff writers
Artificial intelligence (AI) software developer RapidAI has garnered U.S. Food and Drug Administration (FDA) clearance for its Rapid ASPECTS stroke imaging computer-aided diagnosis (CADx) software.
July 6, 2020
2020 02 20 00 48 1332 Approved Stamp 400
Telemedicine group asks U.S. Congress for permanent reform
By AuntMinnie.com staff writers
The American Telemedicine Association (ATA) has sent a letter to U.S. lawmakers, requesting they advance permanent telehealth reform.
June 30, 2020
2020 07 01 22 14 2802 Washington Dc Capitol 400
Okla. hospital resolves mammography issue
By AuntMinnie.com staff writers
A hospital in Oklahoma has resumed mammography screening services after having its accreditation revoked for failing to meet clinical standards for images.
June 29, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
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
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