Category:
FDA
Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
FDA Clears First Major Imaging Device Advancement for Computed Tomography in Nearly a Decade
The new diagnostic imaging device, called Siemens NAEOTOM Alpha, is designed to transform the information from X-ray photons that pass through a patient's body, and are received by a detector, into a detailed 3-dimensional image.
Nanox to Announce Zebra Medical Vision Secures 8th 510K FDA Clearance for its Coronary Artery Calcium (CAC) Solution as Part of Its Population Health...
On August 10th, 2021 Nanox announced that it had entered into an acquisition agreement via merger with Zebra Medical Vision LTD.
NGMedical GmbH Receives FDA Clearance for Its AM Titanium Lumbar Interbody BEE® PLIF
The BEE® PLIF cage has been created to benefit from additive manufacturing features. The purposefully designed honeycomb endplate design reduces the risk of subsidence, while allowing fusion.
Kleiner Device Labs Receives FDA Market Clearance for KG2 Surge Flow-Thru Interbody System
The system maximizes total bone graft delivery volume, better distributes graft bilaterally into the intervertebral disc space, and streamlines the implant delivery, positioning, and grafting process for TLIF and PLIF spinal fusion procedures.
FDA Authorizes Software that Can Help Identify Prostate Cancer
The software is called Paige Prostate and is compatible for use with slide images that have been digitized using a scanner.
Zebra Medical Vision Secures 8th FDA Clearance for its Coronary Artery Calcium Solution as Part of Its Population Health Offering
The CAC solution will empower clinicians to report findings and recommend preventative treatments before a coronary event occurs, subsequently saving lives while lowering costs for the healthcare systems.
Gynesonics Announces FDA Clearance of Next Generation Sonata System
“This clearance brings significant system improvements that expand the location of fibroids that can be treated while allowing the physician to control all aspects of the treatment from within the sterile field,” said Jiayu Chen, Ph.D. Vice President, Engineering and Advanced Technologies at Gynesonics.
SOLOPASS® System (Bedside Neuro-Navigation Device) Receives FDA 510(k) Clearance
inTRAvent’s SOLOPASS® system brings simple, portable, bedside neuro-navigation into the intensive care unit.
Nyxoah Announces U.S. FDA Breakthrough Device Designation Granted for the Genio® System for Obstructive Sleep Apnea and Complete Concentric Collapse
Under the Program, the FDA will provide the Genio® system with priority review & interaction with FDA’s experts throughout the premarket review phase until the product is commercialized in the US.
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