NEW

Canon Medical’s AI-Powered, Premium Large Bore CT Receives FDA Clearance

Canon Medical Systems USA, Inc. has received FDA clearance for the Aquilion Exceed LB CT system, giving clinicians the opportunity to see more during radiation therapy planning for accuracy, precision and speed.

FDA Clears MULTIX Impact C Ceiling-Mounted DR System

Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the MULTIX Impact C ceiling-mounted digital radiography (DR) system as well as the MULTIX Impact VA20, a new version of the established floor-mounted parent DR system.

FDA Approves Seno Medical’s Breast Cancer Diagnostic Technology

The Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) has granted Texas-based Seno Medical Instruments Inc.

Philips to Acquire Capsule Technologies Inc.

Royal Philips has signed an agreement to acquire Capsule Technologies Inc., a provider of medical device integration and data technologies for hospitals and healthcare organizations.

Detection Technology Awarded ISO 13485:2016 Certification for Medical Flat Panel Detectors

Detection Technology, a leader in X-ray detector solutions, has been awarded the ISO 13485:2016 certificate from the TÜV SÜD Product Service GmbH certification body. The certification covers the development, production and distribution of X-ray flat panel detectors.

“We are proud to have a certified Medical Device Quality Management System (MDQMS) that will support us to ensure the quality of our newly launched X-Panel product family. The implementation of ISO 13485:2016 is internationally one of the most valued models for demonstrating compliance with the customer and the applicable regulatory requirements of the medical industry,” says Kai Utela, vice president operations at Detection Technology.

“The certification represents an important milestone for our company and our commitment to deliver solutions for stringent applications with a quality-first attitude. With the certified MDQMS, our customers can be confident that our CMOS X-ray flat panel detector solutions will enhance safety and the patient experience, and that we are meeting their efficiency and responsiveness expectations. Furthermore, we can easily widen the scope of the certification to also cover our other existing and future medical product portfolios, if it is seen to benefit both our customers and our business,” he adds.

The company’s MDQMS was audited in September, and the ISO 13485:2016 certification was granted to its Beijing manufacturing site in October. The new certification complements the company’s existing ISO 9001:2015 and ISO 14001:2015 certifications.

Previous

Next

Submit a Comment

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