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Medical Devices News - Page 7

Import Nod on Hold Over False Positives, Tissue Detection: CDSCO Panel Seeks More Data on Medtronics PTeye Device

Medtronic gets USFDA nod for Simplera Sync sensor for MiniMed 780G System

Ruchika Sharma21 April 2025 11:30 AM IST
Medtronic plc has announced the U.S. Food and Drug Administration (FDA) has approved the Simplera Sync sensor for use with the MiniMed 780G...
Zydus

Zydus Medtech, Braile Biomedica of Brazil ink global licensing pact to commercialise TAVI technology

Ruchika Sharma20 April 2025 12:00 PM IST
Ahmedabad: Zydus MedTech Private Limited, a wholly owned subsidiary of Zydus Lifesciences Limited specializing in medical technology development, has...
Morepen Medtech, Bimedical FZE to form JV company in India

Morepen Medtech name changed to Morepen Medipath

Ruchika Sharma18 April 2025 2:15 PM IST
Gurugram: Morepen Labs has announced that the name of its subsidiary, 'Morepen Medtech Limited' has been changed to ‘Morepen Medipath...
JnJ Medtech bags USFDA nod for TRUFILL n-BCA Liquid Embolic System for Symptomatic Chronic Subdural Hematoma

Johnson & Johnson MedTech completes first cases with OTTAVA Robotic Surgical System

Ruchika Sharma15 April 2025 11:45 AM IST
Upon completion of the study, the company plans to submit the OTTAVA system for De Novo authorization in the United States.
CDSCO Launches Online Risk Classification Module for Non-IVD Medical Devices

India's Medical Device Exports to US Hit by 26% Reciprocal Tariff: AiMeD Raises Concerns

Farhat Nasim6 April 2025 11:15 AM IST
New Delhi: The imposition of a 26% reciprocal tariff by the United States on Indian medical device exports has raised serious concerns within the...
Gujarat Govt to Withdraw Dual Pricing Policy on Cardiac Stents, AiMeD Welcomes End to USFDA Bias

Gujarat Govt to Withdraw Dual Pricing Policy on Cardiac Stents, AiMeD Welcomes End to USFDA Bias

Farhat Nasim5 April 2025 4:33 PM IST
New Delhi: In a significant policy reversal, the Gujarat government has withdrawn a contentious dual pricing order for cardiac stents that offered...
JnJ Medtech bags USFDA nod for TRUFILL n-BCA Liquid Embolic System for Symptomatic Chronic Subdural Hematoma

Johnson & Johnson MedTech introduces Dualto Energy System for use across surgical treatment approaches

Ruchika Sharma28 March 2025 10:30 AM IST
New Brunswick: Johnson & Johnson MedTech has announced the launch of the DUALTO Energy System, a surgical solution that combines multiple...
WHO partners with regulators, experts to strengthen safety and access to medical devices

WHO collaborates with regulators, experts to strengthen safety, access to medical devices

Ruchika Sharma26 March 2025 1:15 PM IST
The five-day workshop, held from 17-21 February in Colombo, focused on advancing the safety, quality, and accessibility of medical devices.
CDSCO Panel Directs Abbott to Incorporate New Safety, Follow-up Measures in Clarithromycin Study

Abbott begins new Intravascular Lithotripsy trial to improve outcomes in Coronary Artery Disease patients

Ruchika Sharma25 March 2025 2:30 PM IST
Abbott Park: Abbott has announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for its...
Sun Pharma unit Taro recalls over 17k units of antifungal medication in US

Recall of Medtronic embolization devices classified as most serious by USFDA

Ruchika Sharma20 March 2025 4:45 PM IST
Medtronic's recall of embolization device has been classified most serious by the U.S. Food and Drug Administration (USFDA), citing potential risks of...
JnJ Medtech bags USFDA nod for TRUFILL n-BCA Liquid Embolic System for Symptomatic Chronic Subdural Hematoma

JnJ MedTech gets clearance for MONARCH QUEST for enhanced Robotic-Assisted Bronchoscopy

Ruchika Sharma14 March 2025 10:00 AM IST
Santa Clara: Johnson & Johnson MedTech has announced U.S. 510(k) regulatory clearance for MONARCH QUEST, the latest advancement in MONARCH...
Parliamentary Panel Slams CDSCO for Slow Drug Approvals, Calls for Conditional Licensing in 45 Days

Parliamentary Panel Slams CDSCO for Slow Drug Approvals, Calls for Conditional Licensing in 45 Days

Farhat Nasim13 March 2025 7:17 PM IST
The delays and frequent queries raised by CDSCO have become a major obstacle for applicants, particularly startups and entrepreneurs.
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Efficacy and Safety of Dapagliflozin-Vildagliptin in Indian T2DM Patients with CV Risk Factors

Efficacy and Safety of Dapagliflozin-Vildagliptin in Indian T2DM Patients with CV Risk Factors

SURPASS-2: Superior HbA1c and Weight Reduction With Tirzepatide vs. Semaglutide

SURPASS-2: Superior HbA1c and Weight Reduction With Tirzepatide vs. Semaglutide

Regulatory Approval Granted for Reformulated Ranitidine

Regulatory Approval Granted for Reformulated Ranitidine

Robust Glycemic Control & Cardio-Renal Protection: Meeting the Advanced Needs of Indian Uncontrolled T2D with Empagliflozin, Sitagliptin, Metformin

Robust Glycemic Control & Cardio-Renal Protection: Meeting the Advanced Needs of Indian Uncontrolled...

Evaluation of Biologic Efficacy and Cost per NNT in Moderate-to-Severe Psoriasis: Indian Analysis

Evaluation of Biologic Efficacy and Cost per NNT in Moderate-to-Severe Psoriasis: Indian Analysis

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Dermatologists Warn Collagen Supplements May Not Deliver Expected Skin Benefits

Dermatologists Warn Collagen Supplements May Not Deliver Expected Skin Benefits

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Health Bulletin 31/January/2026

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