Could Ultrasound-Beating Diagnostic Specificity in Breast Cancer Screening Remove Need for Biopsy?

The use of the Seno Imagio breast imaging system and its associated predictive model appear to have the potential to significantly improve the physicians’ ability to accurately rule out breast cancer compared to traditional ultrasound alone.

Prep-Less Colon Imaging Capsule Aims to Improve Screening Compliance

A new “swallowable” GI imaging device device has the potential to safely produce high-resolution images of the colon without requiring patients to go through the bowel cleansing process beforehand, says data presented at a research forum during DDW2014.

CE Mark for Acutus Medical’s New 3D Diagnostic Imaging and Mapping Catheter

Acutus Medical has pioneered an innovative approach in the minimally invasive imaging and mapping of cardiac arrhythmias. Now the company has announced the gaining of CE Mark approval for its proprietary real-time 3D diagnostic imaging and dipole density mapping catheter.

First U.S. Implant of Full-Body MRI-Compatible ICD in IDE Study

Medtronic recently gained the FDA’s nod to commence its IDE study into Evera, and the device has now seen its first implant performed, as part of the Medtronic randomized, global pivotal clinical trial that will enroll up to 275 patients at approximately 45 centers.

FDA Clears Disposable Feeding Tube Placement Under Direct Vision

Covidien plc has gained U.S. FDA 510(k) Clearance for its Kangaroo™ feeding tube with IRIS Technology. This first-of-its-kind camera-equipped disposable feeding tube is designed to enhance patient safety by providing visualization for a procedure that is currently blinded.

FDA and CE Nods for Boston’s Expect™ Slimline (SL) Needle for Fine Needle Aspiration During Endoscopic Ultrasound

Boston Scientific Corporation has received U.S. FDA clearance and CE Mark approval in Europe for the Expect™ Slimline (SL) Needle, which means it is now globally available for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA) procedures.

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