NEW

Carestream Exhibits Innovative Digital Radiography Solutions at ECR 2020

Carestream Health will showcase advances in medical imaging at the largest radiology meeting in Europe—the upcoming European Congress of Radiology (ECR) in Vienna, Austria. This year, Carestream’s booth (#407, Expo X4) will feature a range of products that underscore...

Northwell to Open 4 Cardiac Catheterization Labs

Three Northwell Health facilities – Lenox Health Greenwich Village, Mather Hospital in Port Jefferson and Plainview Hospital – have received approval this month from the New York State Health and Health Planning Council to establish cardiac catheterization labs,...

Kubtec Granted 2 Breast Cancer Imaging Technology Patents

KUB Technologies, a U.S. medical device company that develops digital technologies used in the treatment of breast cancer, has been granted two new patents by the United States Patent and Trademark Office (USPTO). Patent US 15/892,482 describes both the system and the...

The InterMed Group Acquires Sigma Imaging Technologies

The InterMed Group, a Granite Bridge Partners company, has announced the acquisition of Sigma Imaging Technologies, a New Jersey-based provider of imaging system services. “Established as an expert in MRI/CT/PET imaging technology, Sigma’s core services include...

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Your email address will not be published.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 *