Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 6

Results For "FDA-clearance"

62 News Found

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


SonoScape receives USFDA 510(k) clearance for HD-550 Endoscopy system
Drug Approval | April 18, 2022

SonoScape receives USFDA 510(k) clearance for HD-550 Endoscopy system

The HD-550 endoscopy system has been available outside of the USA since 2019


USFDA clears Niramai's breast thermography device
News | March 14, 2022

USFDA clears Niramai's breast thermography device

The SMILE-100 System is a breast thermography device that helps healthcare personnel review, measure and analyze thermally significant indications in the breast region