New Pentax ENT Videoscope Delivers a “Different World” of Image and Illumination
Imaging
FDA 510(k) Clearance for Philips IQon Spectral CT
Royal Philips’ IQon Spectral CT presents an entirely new approach to spectral imaging, enhanced image quality helping to improve confidence in diagnoses and deliver operational efficiency.
HipGrid™ Rolled Out for Non-invasive Fluoroscopic Guidance in Total Hip Replacement
OrthoGrid® Systems, Inc. has announced the release of HipGrid™ for anterior and posterior approach THR.
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.
First Arteriovenous Malformation Radiosurgery with New Brainlab Software
Brainlab’s new Elements SmartBrush® Angio system uses sophisticated imaging software to facilitate AVM surgery and has been used clinically for the first time in an Irish Hospital.
Medtronic Boosts Neuro Portfolio with MIS Imaging Acquisition
Medtronic, Inc. has completed the acquisition of Visualase, Inc., and its FDA-approved MRI-guided laser and image guided system for minimally invasive neurosurgery.
Terason Launches uSmart® 3300 Ultrasound System
The new Terason uSmart 3300 Ultrasound System is a portable ultrasound system that fuses Smart Technology and Smart Resolution Imaging for shared service, hospital and outpatient sectors of point-of-care ultrasound.
FDA 510(k) Clearance for Fujifilm’s Aspire Cristalle Breast Imaging Solution
Fujifilm Medical Systems has gained U.S. FDA 510(k) clearance for its Aspire Cristalle which it says “resets the bar in digital mammography.”
Toshiba’s Patient-Friendly Claims for New PET/CT System
Toshiba says its new imaging system offers a package of features that make it the most patient friendly PET/CT system on the market.
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.
OR Lighting in NHS Spotlight
A new initiative, funded by the European Commission, is targeting a radical improvement in the performance of surgical lighting and medical video systems.
Regulatory Nods for Combined SonoHysterography and Endometrial Sampling Device
CrossBay Medical, Inc., has announced a bevvy of regulatory clearances. The company’s SonoSure™ Sonohysterography and Endometrial Sampling Device now has U.S.FDA and Health Canada clearance as well as CE mark approval.
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.