A medical device can be designated for the De Novo pathway when it offers novel technology with a reasonable assurance of ...

View offers 2D and 3D visualisation, along with AI-based tools, to assist in clinical decision making.

Bayer today announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for expanded capabilities of ...

View streamlines imaging analysis and visualization by using a suite of AI-enabled tools intended to aid clinical decision making.

GE HealthCare Technologies Inc. GEHC recently announced that the FDA has granted 510(k) clearance for View, a next-generation diagnostic imaging viewer within its Genesis Radiology Workspace. For ...

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...

The Millipede88 aspiration catheter. [Image courtesy of Perfuze] Perfuze announced today that it received FDA 510(k) ...

Xenocor, Inc., a developer of advanced surgical visualization and minimally invasive surgery technologies, today announced the appointment of David McNally as Chief Executive Officer. McNally brings ...

Detailed price information for Kane Biotech Inc (KNE-X) from The Globe and Mail including charting and trades.

The MEVION S250-FIT is the first and only proton therapy system designed to fit into a standard radiation therapy vault. By enabling cancer centers to use their existing infrastructure, the MEVION ...

Risk-off sentiment dragged the ASX healthcare sector lower this week, headlined by Immutep’s plunge after scrapping a Phase III trial ... Read More The post Scott Power: ASX healthcare sector reels ...