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Class 1 Recall: Cybersecurity Vulnerabilities Identified in St. Jude Medical's Implantable Cardiac Devices and Merlin@home Transmitter: FDA Safety Communication

Many medical devices—including St. Jude Medical's implantable cardiac devices—contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits....


Class 1 Recall: Boston Scientific Corporation Recalls Fetch 2 Aspiration Catheter Due to Shaft Breakage

Boston Scientific Corporation is recalling the Fetch 2 Aspiration Catheter because the catheter shaft may break at various points along the device, before or during procedures....


FDA Issues Draft Guidance On Electromagnetic Compatibility Of Medical Devices

FDA Issues Draft Guidance On Electromagnetic Compatibility Of Medical Devices...


Sorin Group Announces First World Implant of Crown PRT Heart Valve

New stented aortic bioprosthesis with outstanding ease of use and performance successfully implanted in Austria...


Sorin Group Launches Intensia Family of ICD and CRT-D Devices Featuring DF-4 High Voltage Connector

Sorin Group announced today that the INTENSIA family of implantable cardioverter defibrillators and cardiac resynchronization therapy devices received CE mark approval....


Sorin Group Announces First European Implant of Mitroflow Valsalva Conduit

Sorin Group’s innovative approach to aortic root surgery now available to European cardiac surgeons and their patients....


Do You Know Your State’s Defibrillator Legislation?

Like many aspects of American life, AEDs and manual defibrillators are regulated on both the federal and state levels. This can make keeping track of each state’s particular legislation pertaining to AEDs in schools, training, and Good Samaritan Laws...


Philips HeartStart FR3 earns U.S. Army Airworthiness Certification

Philips received an Airworthiness Release (AWR) Certification for its HeartStart FR3 automated external defibrillator (AED) from the U.S. Army....


Direct Flow Transcatheter Aortic Heart Valve Gets FDA Feasibility Trial OK (VIDEO)

Direct Flow Medical out of Santa Rosa, California received an FDA green light to begin a feasibility trial of the company’s second-generation Transcatheter Aortic Heart Valve System in patients with aortic stenosis....


CARMAT Hydraulic Artificial Heart Set to Begin Human Trials (w/video)

CARMAT (Velizy Villacoublay, France) today announced that its bioprosthetic total artificial heart is now scheduled to be trialed for the first time in human patients at four medical centers in Europe and Middle East. The CARMAT...

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