Technology

Merit Medical Systems, SwiftNINJA Steerable Microcatheter, FDA 510(k) clearance

Technology | Catheters |

Merit Medical Receives 510(k) Clearance for SwiftNINJA Steerable Microcatheter

November 9, 2016 — Merit Medical Systems Inc.

November 09, 2016

St. Jude Medical, Amplatzer PFO Occluder, FDA approval, U.S. launch

Technology | Structural Heart Occluders |

St. Jude Medical Announces FDA Approval and U.S. Launch of Amplatzer PFO Occluder

St. Jude Medical Inc. announced this week the U.S. Food and Drug Administration (FDA) approval…

November 02, 2016

Aggrastat Bolus Vial, IV antiplatelet agent

Technology | Antiplatelet and Anticoagulation Therapies |

FDA Approves Aggrastat Bolus Vial to Improve Delivery in the Cath Lab

October 28, 2016 — Medicure Inc. recently received U.S.

October 28, 2016

Corindus, Corpath, robotic navigation, Robotic PCI, CorPath GRX

Technology |

FDA Clears Next Generation Interventional Cardiology Robotic System

October 27, 2016 — Corindus Vascular Robotics Inc.

October 27, 2016

BioTrace Medical Tempo temporary pacing lead, TAVR

Technology | Heart Valve Technology |

FDA Clears Temporary Pacing Technology for Transcatheter Aortic Valve and EP Procedures

October 27, 2016 — BioTrace Medical Inc. said it received U.S.

October 27, 2016

Medtronic, CoreValve Evolut R, TAVR system, 34 mm valve, FDA approval, largest in the U.S.

Technology | Heart Valve Technology |

FDA Approves 34 mm CoreValve Evolut R TAVR System

Medtronic announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the…

October 26, 2016

Technology | Atherectomy Devices |

Medtronic Receives FDA Clearance of New Lower Profile HawkOne 6F Directional Atherectomy System

October 24, 2016

Siemens Healthineers, Symbia Intevo SPECT/CT system, xSPECT Quant, RSNA 2016

Technology | SPECT-CT |

Siemens Debuts Expanded xSPECT Quant Technology at RSNA 2016

At the 2016 annual meeting of the Radiological Society of North America (RSNA 2016), Siemens…

October 18, 2016

Philips, Lumify smart-device ultrasound, S4-1 cardiac transducer, RSNA 2016

Technology | Cardiovascular Ultrasound |

Philips Receives FDA 510(k) Clearance for Lumify S4-1 Ultrasound Transducer

Philips announced at The American College of Emergency Physicians' (ACEP) annual meeting that it…

October 14, 2016

Medtronic, FDA approval, MRI, MR-conditional scanning, cardiac devices

Technology | EP Lab |

Medtronic Cardiac Devices Gain FDA Approval for Full 3T MRI Scanning

Medtronic plc is the first company to receive U.S. Food and Drug Administration (FDA) approval…

October 13, 2016

Medtronic, FDA clearance, TrailBlazer peripheral angled support catheter, PAD, peripheral artery disease

Technology | Peripheral Artery Disease (PAD) |

Medtronic Receives FDA Clearance of TrailBlazer Angled Peripheral Support Catheter

Medtronic plc announced recently that the U.S. Food and Drug Administration (FDA) has cleared…

October 12, 2016

AirStrip One, ECG management, web client, U.S. clearance

Technology | ECG |

AirStrip One Web Client Receives U.S. Regulatory Clearance

The U.S. Food and Drug Administration (FDA) has issued 510(K) Class II clearance to a web client…

October 11, 2016

St. Jude Medical, PressureWire X Guidewire, FDA, launch, FFR catheter

Technology | FFR Technologies |

St. Jude Medical Announces FDA Clearance and Launch of PressureWire X Guidewire

St. Jude Medical Inc. announced the U.S. clearance and launch of the company’s new PressureWire…

October 10, 2016

Toshiba America Medical Systems, Infinix-i Sky + double sliding C-arm, RSNA 2016

Technology | Angiography |

Toshiba Introduces Infinix-i Sky + Double Sliding C-arm

Interventional labs now have an imaging system that provides clinicians flexibility to perform a…

October 05, 2016

GE Healthcare, Discovery MI PET/CT system, FDA clearance, RSNA 2016

Technology | PET-CT |

GE Healthcare Announces FDA Clearance of Discovery MI PET/CT System

GE Healthcare recently announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its…

October 05, 2016

GE Healthcare, Optison ultrasound contrast agent, FDA labeling change, cardiac shunts, intra-arterial injection

Technology | Contrast Media |

GE Healthcare Announces FDA Labeling Change for Optison Ultrasound Contrast Agent

GE Healthcare announced that the U.S. Food and Drug Administration (FDA) has approved a label…

October 04, 2016

Bard, Lutonix 014 DCB, drug-coated balloon, six-month endpoint, FDA IDE trial

Technology | Drug-Eluting Balloons |

FDA Approves Six-Month Primary End Point for Lutonix Below-the-Knee Drug Coated Balloon

C. R. Bard Inc. announced the U.S. Food and Drug Administration (FDA) approved an…

September 26, 2016

GE Healthcare, Vivid iq portable cardiovascular ultrasound, RSNA 2016, launch

Technology | Cardiovascular Ultrasound |

GE Healthcare Launches Vivid iq Portable Compact Cardiovascular Ultrasound System

September 22, 2016 — GE Healthcare announced the global commercial launch of its new generation…

September 22, 2016

Medtronic, IN.PACT Admiral drug-coated balloon, DCB, FDA approval, in-stent restenosis, ISR

Technology | Drug-Eluting Balloons |

Medtronic IN.PACT Admiral Drug-Coated Balloon Approved for Treatment of In-stent Restenosis

Medtronic plc announced that the U.S. Food and Drug Administration (FDA) approved the IN.PACT…

September 19, 2016

Technology | Peripheral Artery Disease (PAD) |

FDA Clears Lithoplasty Balloon That Shatters Calcified Lesions With Ultrasound

September 16, 2016 — The U.S.

September 16, 2016