NEW

GE Healthcare Invests $50M in Wisconsin Facility

GE Healthcare has announced a $50 million investment in its existing West Milwaukee facility as part of its intention (proposal only; final decision to be made after required bargaining with relevant unions) to concentrate teams and resources in key facilities across...

New Version of c.cam Cardiac SPECT System Debuts in U.S.

Siemens Healthineers has introduced a new version of its c.cam dedicated cardiac nuclear medicine system to the U.S. market. This single-photon emission computed tomography (SPECT) scanner with a reclining patient chair offers nuclear cardiology providers a low total...

Physicians Highlight Potential of Radiopharmaceuticals in Oncology

The Medical Imaging & Technology Alliance (MITA), along with the Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR) and the Society of Nuclear Medicine & Molecular Imaging (SNMMI), hosted a virtual briefing for Capitol Hill staff this month with...

Nanox Signs Agreement to Deploy 630 Units in Mexico

NANO-X IMAGING LTD, an innovative medical imaging technology company, announced that it has entered into an exclusive distribution agreement with SPI Medical (SPI) for the deployment and introduction of Nanox’s medical imaging services in Mexico. SPI Medical, S. A. P....

FDA Reclassifies Medical Image Analyzers, Including Computer-Assisted Detection (CADe) Devices

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, postamendments class III devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. These devices are intended to direct the clinician’s attention to portions of an image that may reveal abnormalities during interpretation of patient radiology images by the clinician. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device type.

This order is effective February 21, 2020.

For more information, click here.

Previous

Next

Submit a Comment

Your email address will not be published. Required fields are marked *