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Results For "FDA-clearance"

54 News Found

a2z wins FDA nod for groundbreaking abdomen-pelvis CT AI Triage system
News | November 30, 2025

a2z wins FDA nod for groundbreaking abdomen-pelvis CT AI Triage system

Abdomen-pelvis CT is the nation’s highest-volume CT category


Transmural Systems wins breakthrough FDA nod for coronary-saving TAVR device
Medical Device | November 27, 2025

Transmural Systems wins breakthrough FDA nod for coronary-saving TAVR device

The clearance for TELLTALE positions Transmural Systems at the forefront of next-generation electrosurgical solutions for structural heart interventions


Meduloc wins FDA green light for new class of bone-fracture fixation system
Medical Device | November 19, 2025

Meduloc wins FDA green light for new class of bone-fracture fixation system

The cleared system pairs a flexible nitinol implant with a deployable prong-locking mechanism, delivering rotational and length stability


Roche’s Elecsys pTau181 becomes first FDA-cleared blood test to rule out Alzheimer’s pathology in primary care
R&D | October 14, 2025

Roche’s Elecsys pTau181 becomes first FDA-cleared blood test to rule out Alzheimer’s pathology in primary care

New test expands access to early Alzheimer’s assessment, streamlining diagnostic pathways and improving referral efficiency


Heuron gets FDA green light for stroke triage and notification solution
News | May 25, 2024

Heuron gets FDA green light for stroke triage and notification solution

This marks the first FDA approval of an AI-based brain disorder analysis solution from Korea


Qure.ai adds new FDA breakthrough device status for qSpot-TB
Digitisation | February 09, 2024

Qure.ai adds new FDA breakthrough device status for qSpot-TB

4 FDA clearances & 61 EU MDR CE tags achieved for AI in 18 months


SigTuple’s AI100 with Shonit receives USFDA 510(k) clearance
Startup | October 03, 2023

SigTuple’s AI100 with Shonit receives USFDA 510(k) clearance

SigTuple’s AI100 with Shonit is the premier solution for AI assisted digital pathology


Philips and Masimo introduce advanced monitoring capabilities to Philips high acuity patient monitors
News | June 02, 2023

Philips and Masimo introduce advanced monitoring capabilities to Philips high acuity patient monitors

The latest extension of Masimo and Philips’ ongoing collaboration will help enable clinicians to make quick and informed decisions without the need for additional monitoring equipment


USFDA clears Abbott’s test to detect four sexually transmitted infections simultaneously
Drug Approval | May 06, 2022

USFDA clears Abbott’s test to detect four sexually transmitted infections simultaneously

Abbott's multiplex test runs on its most advanced molecular PCR platform, the Alinity m system, which provides fast results in high volumes – detecting four infections simultaneously


USFDA clears Franklin Mountain Medical's new dual catheter
Biotech | April 26, 2022

USFDA clears Franklin Mountain Medical's new dual catheter

It enables precise visualization and treatment access to the left heart