FDA: Page 6

FDA hits firm with thermography warning letter
By AuntMinnie.com staff writers
A California provider of natural health products has been hit with a warning letter from the U.S. Food and Drug Administration (FDA) for a variety of alleged infractions, including using marketing claims for a breast thermography system that the FDA said have not been approved by the agency.
May 1, 2017
2016 09 02 09 36 05 93 Fda Logo V2 400
GE submits 510(k) for wide-bore MRI scanner
By AuntMinnie.com staff writers
GE Healthcare said its 3-tesla wide-bore MRI system, Signa Premier, is pending 510(k) clearance by the U.S. Food and Drug Administration.
April 27, 2017
2017 04 28 11 12 37 891 Signa Premier
FDA OK's iCAD tomosynthesis software
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer iCAD said its PowerLook Tomo Detection software has received premarket approval from the U.S. Food and Drug Administration (FDA).
March 26, 2017
FDA OK's Fuji's breast tomo upgrade
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA said its digital breast tomosynthesis optional software upgrade has received premarket approval from the U.S. Food and Drug Administration (FDA).
January 23, 2017
Medicrea files 510(k) for 3D-printed spinal implant
By AuntMinnie.com staff writers
French implant developer Medicrea has filed a 510(k) submission for U.S. Food and Drug Administration clearance of its 3D-printed titanium patient-specific spinal implant.
January 8, 2017
QView lands FDA nod for ABUS CAD software
By AuntMinnie.com staff writers
Computer-aided detection (CAD) software developer QView Medical said the U.S. Food and Drug Administration (FDA) has approved its premarket approval application for QVCAD, a CAD software package for automated breast ultrasound (ABUS) studies.
November 22, 2016
FDA OKs Medtronic's defibrillator
By AuntMinnie.com staff writers
Device manufacturer Medtronic has received U.S. Food and Drug Administration (FDA) approval for its Claria MRI Quad cardiac resynchronization therapy defibrillator SureScan device for patients with heart failure.
November 13, 2016
FDA publishes 510(k) guidelines for digital detectors
By Brian Casey
The U.S. Food and Drug Administration (FDA) has published new guidelines for companies submitting 510(k) applications to the agency for solid-state digital detectors to be used in digital radiography systems.
September 1, 2016
2016 09 02 09 36 05 93 Fda Logo V2 400
Fuji applies for DBT software upgrade
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has submitted the final module of its premarket approval (PMA) application for digital breast tomosynthesis (DBT) to the U.S. Food and Drug Administration.
August 24, 2016
FDA issues draft update for medical device changes
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) said it has issued updated draft recommendations on new 510(k) filings for medical device modifications.
August 4, 2016
Carestream submits 510(k) for conebeam CT scanner
By AuntMinnie.com staff writers
Carestream Health has filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for clearance of its Carestream OnSight 3D extremity imaging system.
March 23, 2016
Fuji readies new DR products for RSNA
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA plans to unveil two new digital radiography (DR) products at RSNA 2015 in Chicago.
November 26, 2015
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