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Australian diagnostic device developer ResApp Health has entered into a $74 million purchase deal with Pfizer, which will help the drugmaker expand into digital health products. Read More
In the latest in a seemingly endless series of FDA warning letters directed at unapproved COVID-19 products, the agency cited a Michigan-based company about claims it has been making online for its nasal spray. Read More
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