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Third FDA Clearance Announced for Zebra-Med's AI Solution for Brain Bleed Alerts
Technology | Artificial Intelligence | June 19, 2019

Zebra Medical Vision announced it has received its third U.S. Food and Drug Administration (FDA...

Philips Receives FDA PMA for HeartStart OnSite and HeartStart Home Defibrillators

The Philips HeartStart OnSite automated external defibrillator. Image courtesy of Philips Healthcare.

Technology | Defibrillator Monitors | June 19, 2019

Philips announced the U.S. Food and Drug Administration (FDA) has approved the company’s...

Canon Medical Receives FDA Clearance for AiCE Reconstruction Technology for CT
Technology | Computed Tomography (CT) | June 18, 2019

Canon Medical Systems USA Inc. has received 510(k) clearance on its new deep convolutional...

Materialise Receives FDA Clearance for Cardiovascular Planning Software Suite
Technology | Advanced Visualization | June 13, 2019

Three-dimensional (3-D) printing software and solutions company Materialise has received U.S....

Gore Cardioform ASD Occluder Receives FDA Approval
Technology | Structural Heart Occluders | June 10, 2019

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

Medivis SurgicalAR Gets FDA Clearance
Technology | Virtual and Augmented Reality | June 10, 2019

Medivis announced that its augmented reality (AR) technology platform for surgical applications...

Medis QAngio XA 3D Receives FDA 510k Clearance
Technology | Angiography | June 04, 2019

Medis Medical Imaging Systems B.V. has received clearance from the U.S. Food and Drug...

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,...

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