Equipment & Devices
Equipment & Devices
Edwards Gets FDA Nod for Sapien M3 Mitral Valve Replacement System
In recent news, Edwards Lifesciences has gone on to win the FDA approval for its Sapien M3 mitral valve replacement system so as to treat mitral...
Equipment & Devices
Abbott to Enter U.S. PFA Market with Volt PFA System
Abbott is soon going to enter the competitive U.S. pulsed field ablation - PFA market, having just attained an FDA approval for its Volt PFA...
Equipment & Devices
Amplatzer Piccolo Occluders from Abbott Get FDA, CE Mark Nod
Abbott has gone on to secure the US Food and Drug Administration - FDA and CE Mark approvals for its Amplatzer Piccolo delivery system, which...
Equipment & Devices
Zoll Launches Next-Gen LifeVest Wearable in the U.S.
ZOLL, a medical device and related software solutions maker, has gone ahead and introduced its next-gen LifeVest wearable cardioverter defibrillator - WCD in the US.
The...
Equipment & Devices
EU Commission Proposes Reforms in Medical Device Regulation
The European Commission has proposed targeted reforms that are aimed at simplifying the rules for medical devices. The proposed reforms are part of the package...
Equipment & Devices
RECTIFIER from AIwithCare of Mass General Brigham Launched
Mass General Brigham has revealed the development of an AI company and also a screening tool, which has sped up the process to determine eligibility...
Equipment & Devices
FDA Cuts RWE Limitation in Drug, Device Application Reviews
The FDA has confirmed through an announcement that it has removed a limitation on the use of real-world evidence -RWE when it comes to reviews...
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