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The 3D models can be used for medical diagnosis, anatomical measuring, treatment planning and generating output files for additive manufacturing. Read More
Roche has acquired Germany-based TIB Molbiol, a long-time partner on diagnostic products, and the company has just released three new tests that can differentiate mutations in the Omicron variant of the SARS-CoV-2 virus. Read More
The FDA is expanding the applications that can be made using its electronic Submission Template and Resource (eSTAR) filing system from 510(k) clearance requests to include de novo device applications. Read More
The assay will help meet the increasing demand for tuberculosis detection, particularly in larger reference laboratories and hospitals, the companies said. Read More
There are no one-size-fits-all methods for modeling cybersecurity threats facing medical devices, but developers and manufacturers of medical devices can help mitigate the threats by considering four simple questions suggests a new “playbook” endorsed by the FDA. Read More
Medical device recalls increased by more than 35 percent to 235 incidents in the third quarter of 2021, up from just 173 in the second quarter, reversing a year-long trend of declining numbers, a new analysis suggests. Read More