Clearances

Quanta Dialysis System Submitted to FDA for Clearance

Quanta Dialysis Technologies has submitted a 510(k) premarket notification to the FDA for indication expansion of the Quanta Dialysis System.

Clearances

Levita Mars Minimally Invasive Surgical Platform Cleared by FDA

Levita Magnetics has received FDA clearance for its Mars surgical platform which uses magnets for minimally invasive surgery.

Clearances

FDA OKs AccurKardia AccurECG Analysis System

AccurKardia’s AccurECG Analysis System, a cloud-based and fully automated ECG interpretation software platform, has received U.S. FDA 510(k) clearance, offering customizable outputs and integration with clinical workflows.

Clearances

Quanta Dialysis System Submitted to FDA for Clearance

Quanta Dialysis Technologies has submitted a 510(k) premarket notification to the FDA for indication expansion of the Quanta Dialysis System.

Nanox.ARC Imaging System Nabs FDA Clearance

May 9, 2023

Nanox.ARC is a stationary multi-source digital 3D tomosynthesis system that utilizes novel, cold cathode X-ray tubes.

FDA Clears Norlase ECHO Green Pattern Laser

May 8, 2023

Norlase, a global ophthalmic laser manufacturer developing next-generation laser solutions, has received both U.S. FDA 510(k) clearance and CE mark approval for the ECHO Green Pattern Laser photocoagulator.

FDA Clears Cumulus Neuroscience EEG Device for At-Home Use

May 5, 2023

The Cumulus EEG device is now FDA-cleared for use by adult and adolescent patients for remote acquisition, display, and storage of electroencephalograph data.