The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.

Consensus report CR511 from the Association for the Advancement of Medical Instrumentation highlights common system elements for engineers, and outlines safety and risk-control measures that manufacturers and caregivers should consider.

Already cleared to monitor the viral load in HIV-positive individuals, the test has now been approved for initial diagnosis as well.

Attorneys tell Medtech Insight a recent proposal to review regulations every 10 years could lift some burdens from the medical device industry, but warned that the full effects may not be seen for some time.

No device-related warning letters were released by the US FDA the week of 24 November.

The Stark Law ban on self-referrals wouldn’t apply to some physician owners of advanced imaging facilities under a CMS final rule.

The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.

Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?

Medical device manufacturers initiated fewer recalls in the third quarter of 2020. Check out our Q3 recalls infographic.

The company will use the proceeds to fund clinical trials, expand commercialization of its targeted radiation therapy, and file for CE marking in Europe.

COVID-19 put a dampener on Conmed’s 50^th anniversary of operations, but CFO Todd Garner says the company is poised to resume its growth strategy, post-pandemic.

J&J said its Ottava robotic platform has six robotic arms, “zero footprint,” and can be used for various procedures.

In this week’s podcast, Marion Webb reviews her interview with Glooko CEO Russ Johannesson and Reed Miller explains how Boston Scientific is restructuring its transcatheter aortic valve business.

The pandemic has led to a rise in sleep problems. Somryst seeks to address chronic insomnia by training the body and brain to fall asleep faster and stay asleep longer.

Abbott will commit $5m to support the ADA’s efforts to bring diabetes technologies and education to underserved diabetes populations.

UK start up Iceni Diagnostics has secured funding to develop its test for the live, intact SARS-CoV-2 virus and the UK government is evaluating a lateral flow device based on the technology for testing saliva samples as part of efforts to step up rapid testing in the country.

The company will use the proceeds to fund clinical trials, expand commercialization of its targeted radiation therapy, and file for CE marking in Europe.

J&J said its Ottava robotic platform has six robotic arms, “zero footprint,” and can be used for various procedures.

The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.

Data from the EARLY AF First, Cryo-FIRST and STOP AF trials show cryoablation is a better option than drugs for patients with symptomatic atrial fibrillation.

Nano-X Imaging is on a mission to disrupt the market for X-ray imaging equipment by offering a low-cost medical imaging service to untapped markets through a network of equipment dotted around the world. However, some shareholders are claiming the company mislead investors.