FDA: Page 7

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
InSightec submits PMA for ExAblate Neuro
By AuntMinnie.com staff writers
MR-guided focused ultrasound developer InSightec has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration for its ExAblate Neuro device for treating essential tremor.
October 21, 2015
Seno wraps up study for Imagio optoacoustic breast system
By AuntMinnie.com staff writers
Optoacoustic breast imaging developer Seno Medical Instruments has finished the final phase of a pivotal study to evaluate its Imagio breast imaging system.
September 28, 2015
Acertara reaches 510(k) milestone
By AuntMinnie.com staff writers
Ultrasound acoustic measurement and testing firm Acertara Acoustic Laboratories recently reached the milestone of 900 successful submissions for 510(k) clearance.
September 22, 2015
Delphinus wins $39.5M in venture capital
By AuntMinnie.com staff writers
Tomographic ultrasound developer Delphinus Medical Technologies has received $39.5 million in venture capital funding.
September 9, 2015
Fuji files PMA module for digital tomo
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has submitted the first module of its premarket approval (PMA) application to the U.S. Food and Drug Administration for digital breast tomosynthesis.
July 15, 2015
VuCOMP submits PMA for breast tomo CAD
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer VuCOMP has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration for its CAD software for digital breast tomosynthesis.
April 22, 2015
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