FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections

USA – FDA permits marketing of first diagnostic test to aid in detecting prosthetic...

Today, the U.S. Food and Drug Administration permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic...
FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies

USA – FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies

Today, the U.S. Food and Drug Administration authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect...
FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea

USA – FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea

Today, the U.S. Food and Drug Administration cleared for marketing two tests that can detect the presence of the bacteria Chlamydia trachomatis and Neisseria...
Developing a Wearable Display for Surgeons

USA – Developing a Wearable Display for Surgeons

Cameras and screens have been used to augment surgeons’ vision for years, enabling them to see magnified surgical sites for greater precision. But as...
Spring Regulatory Agenda for FDA: What New Rulemakings are Coming

USA – Spring Regulatory Agenda for FDA: What New Rulemakings are Coming

The US Food and Drug Administration (FDA) on Wednesday published its plans for the latest proposed and final rulemakings for drug and medical device...
Spring Regulatory Agenda for FDA: What New Rulemakings are Coming

USA – FDA provides updates on postmarket safety review of Bayer’s Essure

Months after Bayer ended US sales and distribution of its permanent birth control device Essure, the US Food and Drug Administration (FDA) on Wednesday...
Performance Standards for the Fees in Respect of Drugs and Medical Devices Order

Canada – Performance Standards for the Fees in Respect of Drugs and Medical Devices...

The purpose of this document is to provide the performance standards to be used to determine whether a remission should be granted, under the Fees...
Connected medical device design for the Internet of Things

International – Connected medical device design for the Internet of Things

Connected medical device design and development paradigm shifting due to impact of Internet of Things (IoT); Closer aligment of human factors research with...
Final FDA Q-Submission guidance includes medical device cybersecurity coverage

USA – Final FDA Q-Submission guidance includes medical device cybersecurity coverage

US FDA publishes final guidance on Q-Submission Program for medical device and IVD manufacturers; Sample Q-Sub questions provided by FDA now include those...
FDA Finalizes Two Guidances to Align X-Ray Imaging Devices With International Standards

USA – FDA Finalizes Two Guidances to Align X-Ray Imaging Devices With International Standards

The US Food and Drug Administration (FDA) on Tuesday finalized two guidance documents related to harmonizing X-ray device performance standards with international standards, and...

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