GE HealthCare has launched new editions of its three invasive cardiac software solutions, which secured FDA clearance in December 2024.

Hyperfine is collaborating with NVIDIA to advance the AI capabilities of the Swoop Portable magnetic resonance imaging (MRI) ...

A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...

Diagnos Inc. (“ DIAGNOS ” or the “ Corporation ”) (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a pioneer in early detection of critical health issues through the use of its FLAIRE platform based on ...

Medical device recalls are essential to patient safety, addressing critical issues in devices that may pose health risks. Here are some of the latest recalls reported to the FDA: ...

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Johnson & Johnson (J&J) MedTech’s Monarch Quest ...

Getting FDA approval was a long process – an ... according to Reuters. The 5th Medical Device Software Development Summit is your must-attend opportunity to gain actionable strategies, real ...

The US FDA has recently proposed a new draft framework ... with the General Data Protection Regulation. The 5th Medical Device Software Development Summit is your must-attend opportunity to ...

We report everything from clinical trial updates to product launches, FDA announcements ... improving their quality of life. A medical device is any apparatus, implement, machine, appliance, software, ...

Using Nvidia and GE Healthcare technology, the robotic surgery system is intended to help doctors detect lung cancer earlier.

Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug Administration’s (FDA) required 30-day window across a three-year period ...