Technology

Technology | Cardiovascular Information Systems (CVIS) |

Spacelabs Debuts Sentinel 11 Cardiology Information Management System

Spacelabs Healthcare debuted Sentinel 11 at the 40th Annual Heart Rhythm Society (HRS)…

May 10, 2019

Technology | Leads Implantable Devices |

FDA Approves Attain Stability Quad MRI SureScan Lead from Medtronic

Medtronic has received U.S. Food and Drug Administration (FDA) approval for the Attain Stability…

May 06, 2019

Illustration showing the self-expanding deployment of the Boston Scientific Vici venous stent in the iliofemoral vein.

Technology | Venous Therapies |

FDA Clears Boston Scientific Vici Venous Stent to Treat Deep Venous Blockages

May 6, 2019 — The U.S Food and Drug Administration (FDA) has cleared the Boston Scientific Vici…

May 06, 2019

Tafamidis meglumine (Vyndaqel) is one of two new drugs cleared by the FDA for the treatment of the cardiomyopathy caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. U.S. Food and Drug Administration (FDA) approved tafamidis meglumine (Vyndaqel) and tafamidis (Vyndamax) capsules for the treatment of the cardiomyopathy.

Technology | Heart Failure |

FDA Clears New Treatments for Cardiomyopathy Caused by Transthyretin Mediated Amyloidosis

May 6, 2019 — The U.S.

May 06, 2019

Technology | EP Device Monitoring Systems |

Medtronic Receives FDA Approval for CareLink SmartSync Device Manager

Medtronic announced the company has received U.S. Food and Drug Administration (FDA) approval…

May 02, 2019

Technology | EP Device Monitoring Systems |

Murj Launches Murj 2.0 Implantable Cardiac Device Management Software

Digital healthcare company Murj announced the immediate availability of the Murj 2.0 implantable…

May 01, 2019

PhaseBio Receives FDA Breakthrough Therapy Designation for Ticagrelor Reversal Agent

Technology | Antiplatelet and Anticoagulation Therapies |

Ticagrelor Reversal Agent Gains FDA Breakthrough Therapy Designation

PhaseBio Pharmaceuticals Inc. announced the U.S. Food and Drug Administration (FDA) has granted…

April 30, 2019

Technology | EP Mapping and Imaging Systems |

Acutus Medical Receives FDA Clearance for Second-generation AcQMap Platform

Acutus Medical announced U.S. Food and Drug Administration (FDA) clearance of its second-…

April 26, 2019

Technology | Drug-Eluting Balloons |

Orchestra BioMed Receives FDA Breakthrough Device Designation for Virtue Sirolimus-eluting Balloon

Orchestra BioMed Inc. has secured Breakthrough Device designation by the U.S. Food and Drug…

April 24, 2019

Intact Vascular Inc. received U.S. Food and Drug Administration (FDA) market clearance for the Tack Endovascular System. This is a purpose-built dissection repair device implanted post-angioplasty in patients with peripheral arterial disease (PAD).

Technology | Peripheral Artery Disease (PAD) |

FDA Clears Intact Vascular’s Tack Endovascular System

April 15, 2019 – Intact Vascular Inc. received U.S.

April 15, 2019

BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.

Technology | Cath Lab |

Biotronik Begins U.S. Launch of PK Papyrus Covered Coronary Stent

April 15, 2019 — Biotronik began its U.S.

April 15, 2019

Technology | Cardiovascular Ultrasound |

DiA Imaging Analysis Introduces LVivo SAX Ultrasound Analysis Tool

DiA Imaging Analysis announced the launch of LVivo SAX, a cardiac analysis tool that helps…

April 09, 2019

Technology | Cath Lab |

TherOx Receives FDA Approval for SuperSaturated Oxygen Therapy

TherOx Inc. announced that the U.S. Food and Drug Administration (FDA) granted premarket…

April 08, 2019

Technology | Mobile Devices |

Healthereum Launches Beta Version of HELIO Blockchain Patient Engagement App

Healthereum LLC released the beta version of the Healthereum Life Portfolio, or HELIO, a mobile…

April 05, 2019

Technology | Radiation Dose Management |

Omega Medical Imaging Launches AI-enabled FluoroShield for Radiation Reduction

The U.S. Food and Drug Administration (FDA) granted Omega Medical Imaging 510(k) clearance to…

April 04, 2019

The U.S. Food and Drug Administration (FDA) recently granted an additional indication to Bard Peripheral Vascular's Covera Vascular Covered Stent for the treatment of a stenosis or blockage which has developed anywhere in the access circuit of patients on hemodialysis using an arteriovenous (AV) fistula.

Technology | Stents |

New Indication Added for Covered Stent to Treat Hemodialysis AV Fistula

April 3, 2019 — The U.S.

April 03, 2019

The U.S. Food and Drug Administration (FDA) recently cleared Bard Peripheral Vascular's Venovo Venous Stent System intended to treat narrowed iliofemoral veins.

Technology | Venous Therapies |

FDA Clears Venous Stent for the Iliofemoral Veins

April 3, 2019 — The U.S.

April 03, 2019

Essential Medical Inc. received U.S. Food and Drug Administration (FDA) clearance for its large bore Manta Vascular Closure Device. It is designed to close large puncture sites in the femoral artery from larger sized transcatheter devices, including the Impella heart pump, endovascular stent grafts and transcatheter valves.

Technology | Vascular Closure Devices |

Large-Bore Vascular Closure Device Cleared by the FDA

April 3, 2019 — Essential Medical Inc. received U.S.

April 03, 2019

Medtronic's Resolute Integrity Zotarolimus-eluting Coronary Stent System received an additional U.S. Food and Drug Administration (FDA) indication for treatment of de novo chronic total occlusion (CTO) lesions.

Technology |

Resolute Integrity Now Indicated for CTOs

April 3, 2019 — Medtronic's Resolute Integrity Zotarolimus-eluting Coronary Stent System…

April 03, 2019

Technology | Virtual and Augmented Reality |

Medivis Unveils AnatomyX Augmented Reality Education Platform

Medical imaging and visualization company Medivis announced the launch of AnatomyX, its…

April 02, 2019