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The rapid test does not differentiate between the SARS-CoV-2 virus, which causes COVID-19, and SARS-CoV, which caused an outbreak of respiratory illness in 2003. Read More
Sensory Cloud of Boston, Mass., has received a warning letter from the FDA for promoting an unapproved saline spray device as a COVID-19 treatment. Read More
The FDA has released two final guidances outlining a new product review pathway for developers of orthopedic fracture fixation plates and surgical suture devices. Read More
A recent independent clinical test of the assay in Europe with 1,928 participants found that 16.5 percent (318 people) tested positive for respiratory viruses, excluding COVID-19. Read More
NICE is recommending further UK-based research to confirm the positive results compiled so far for people with long-term catheters and to determine whether people with short-term catheters would benefit from using UroShield. Read More
Paige Breast Lymph Node has not yet been approved or cleared by the FDA for use in diagnostic procedures, although it is available for research purposes. Read More
Natera’s Prospera lung donor-derived DNA test has shown positive results in a study assessing rejection and lung-function injury in transplant patients. Read More
When examining submissions for approval or clearance of device software, the FDA will carefully assess whether it has adequate cybersecurity, the agency said in a draft guidance released yesterday. Read More
The clearance covers the device’s use in an anterior approach that will be particularly useful for deformity correction, said Stéphane Bette, SpineGuard’s co-founder and deputy CEO. Read More