Technology

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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...

Acutus Medical Receives FDA Clearance for Second-generation AcQMap Platform
Technology | EP Mapping and Imaging Systems | April 26, 2019

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

Orchestra BioMed Receives FDA Breakthrough Device Designation for Virtue Sirolimus-eluting Balloon
Technology | Drug-Eluting Balloons | April 24, 2019

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

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) | April 15, 2019

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

BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019

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

DiA Imaging Analysis Introduces LVivo SAX Ultrasound Analysis Tool
Technology | Cardiovascular Ultrasound | April 09, 2019

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

TherOx Receives FDA Approval for SuperSaturated Oxygen Therapy
Technology | Cath Lab | April 08, 2019

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

Healthereum Launches Beta Version of HELIO Blockchain Patient Engagement App
Technology | Mobile Devices | April 05, 2019

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

 Omega Medical Imaging Launches AI-enabled FluoroShield for Radiation Reduction
Technology | Radiation Dose Management | April 04, 2019

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

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 | April 03, 2019

April 3, 2019 — The U.S.

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