All articles by Sdebbarma Sdebbarma
Sdebbarma Sdebbarma
GE HealthCare secures FDA 510(k) clearance for diagnostic viewer
View offers 2D and 3D visualisation, along with AI-based tools, to assist in clinical decision making.
Francis Medical concludes first commercial procedures with Vanquish system
Vanquish uses ultrasound, transurethral and electromagnetically guided thermotherapy to ablate prostate tissue.
LifeVac receives FDA De Novo classification for anti-choking device
LifeVac is approved for use as a single-use, non-powered, non-invasive airway clearance device.
Neuspera reports positive data in urinary urge incontinence device trial
Key findings included 94% of test-phase responders experienced at least a 50% decrease in episodes of UUI.
Cognita secures FDA breakthrough device designation for CXR
Mosaic expects the collaboration with the FDA will help address diagnostic capacity constraints in the US healthcare system.
Philips launches Rembra CT system for acute imaging
Rembra facilitates rapid diagnosis, streamlines workflows, and ensures operational consistency in frontline healthcare settings.
Airiver Medical receives FDA breakthrough device status for DCB
The FDA’s Center for Devices and Radiological Health granted the status for the DCB.
Droplet improves genomic analysis speed using NVIDIA Parabricks software
The adoption of GPU-accelerated software now enables significant time savings.
BD secures FDA clearance for antimicrobial irrigation system
Surgiphor 1,000mL allows clinicians to remove debris and microorganisms from wounds during powered irrigation procedures.
FDA grants breakthrough designation to PathAI for pathology solution
The latest milestone follows PathAI’s 510(k) clearance for AISight Dx, the first FDA-approved digital pathology system.