Technology

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ControlRad Announces FDA Clearance and Launch of ControlRad Trace
Technology | Radiation Dose Management | May 23, 2019

ControlRad Inc. announced that the U.S. Food and Drug Administration (FDA) granted 510(k)...

Medtronic Launches Telescope Guide Extension Catheter
Technology | Guidewires | May 21, 2019

Medtronic plc announced its entrance into the guide extension catheter market with the global...

MaxQ AI Launches Accipio Ax Slice-Level Intracranial Hemorrhage Detection
Technology | Stroke | May 21, 2019

Medical diagnostic artificial intelligence (AI) company MaxQ AI announced that Accipio Ax will...

Philips Launches IntraSight Interventional Applications Platform
Technology | Intravascular Imaging | May 20, 2019

Philips announced the launch of the new IntraSight interventional applications platform. The...

Fragmin (dalteparin sodium) injection was cleared by the FDA for use in pediatric patients. It was initially approved by the FDA in 1994 for adults and is a type of heparin.

Fragmin (dalteparin sodium) injection is now cleared by the FDA for use in pediatric patients. It was initially approved by the FDA in 1994 for adults and is a type of heparin.

Technology | Antiplatelet and Anticoagulation Therapies | May 17, 2019

May 17, 2019 — The U.S.

Murj Launches Murj Analytics Device Management Platform
Technology | Analytics Software | May 17, 2019

Digital healthcare company Murj announced the availability of the Murj Analytics software-as-a-...

Biosense Webster Launches Cartonet Analytics Software for Electrophysiology
Technology | Analytics Software | May 16, 2019

Johnson & Johnson Medical Devices Companies announced the launch of Biosense Webster Inc.’s...

Biocardia Receives FDA Clearance for Avance Steerable Introducer Family
Technology | Catheters | May 16, 2019

BioCardia Inc. announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Avance...

Gore Receives FDA Approval for Gore Tag Conformable Thoracic Stent Graft
Technology | Stent Grafts | May 15, 2019

W. L. Gore & Associates Inc. (Gore) announced the U.S. Food and Drug Administration (FDA)...

Cordis Announces U.S. Launch of Radial 360 Portfolio
Technology | Radial Access | May 15, 2019

Cordis, a Cardinal Health company, recently announced the full U.S. launch of its Radial 360...

FDA Clears Aidoc's AI Solution for Flagging Pulmonary Embolism
Technology | Artificial Intelligence | May 15, 2019

Artificial intelligence (AI) solutions provider Aidoc has been granted U.S. Food and Drug...

FDA Approves Impella 5.0 and Impella LD Extended Duration of Use
Technology | Ventricular Assist Devices (VAD) | May 14, 2019

The U.S. Food and Drug Administration (FDA) has approved the expansion of Abiomed’s Impella 5.0...

FDA Clears AliveCor's KardiaMobile 6L as First Six-Lead Personal ECG Device
Technology | ECG | May 13, 2019

AliveCor announced its third U.S. Food and Drug Administration (FDA) clearance in three months,...

Spacelabs Debuts Sentinel 11 Cardiology Information Management System
Technology | Cardiac PACS | May 10, 2019

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

FDA Approves Attain Stability Quad MRI SureScan Lead from Medtronic
Technology | Leads Implantable Devices | May 06, 2019

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

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

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

Technology | Venous Therapies | May 06, 2019

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

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.

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. 

Technology | Heart Failure | May 06, 2019

May 6, 2019 — The U.S.

Medtronic Receives FDA Approval for CareLink SmartSync Device Manager
Technology | EP Device Monitoring Systems | May 02, 2019

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

Murj Launches Murj 2.0 Implantable Cardiac Device Management Software
Technology | EP Device Monitoring Systems | May 01, 2019

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

PhaseBio Receives FDA Breakthrough Therapy Designation for Ticagrelor Reversal Agent
Technology | Antiplatelet and Anticoagulation Therapies | April 30, 2019

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

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