FDA OKs new use for BladderChek test:
This article was originally published in Clinica
Matritech has gained US approval to expand the use of its rapid, doctor's office bladder cancer test to help in the diagnosis of the disease. The NMP22 BladderChek test, previously cleared for monitoring patients already diagnosed with the disease, detects a bladder cancer nuclear matrix protein in urine. Matritech, of Newton, Massachusetts, notes that according to the American Cancer Society, 41,500 new cases of bladder cancer are diagnosed in men each year. The BladderChek test will be distributed in the US by Princeton, New Jersey-based, Cytogen.
You may also be interested in...
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.
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.
A nasal spray formulated using compounds already approved by regulatory bodies in Europe and the US can “prevent and slow” transmission of COVID-19, according to UK researchers who are now seeking a partner to commercialize the product.