Historically, a prostate cancer exam like the prostate cancer antigen (PSA) test or the digital rectal exam (DRE) has helped doctors identify whether patients have prostate cancer.
But these screening tests are not always 100 percent accurate and may result in false positives, or need additional information for proper diagnosis and ongoing monitoring.
ProUroCare Medical, a Minnesota startup, is one company trying to develop a prostate imaging device to be used in conjunction with a DRE to help physicians confirm and visually record abnormalities identified in that DRE examination. The company is seeking to raise $1.2 million in convertible debt, according to a recent regulatory filing. Excluding this current round, the company has raised $13.9 million since 2007.
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The penny stock company has no revenue and as of Dec. 31, had a net loss of $6 million.
It appears that the company has run into some regulatory headwind.
According to the company’s website, an application for a 510(k) clearance was filed back in November 2009. In March 2010, ProUrocare said that a letter from the U.S. Food and Drug Administration said that the agency had not finished reviewing the application because a predicate device could not be identified. A 510(k) application for a new product has to demonstrate substantial equivalence to another product already on the market, known as a predicate device.
In May 2010, a de novo application was filed with the FDA. A de novo application asks for market clearance for low-risk devices that have no predicate device in the market. It appears that the FDA has not made a final determination on the fate of the ProUroScan imaging system.
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More than a year after the de novo application was filed, there are no updates on ProUroCare’s website to show that clearance was received. A call and email to Richard Carlson, ProUroCare’s CEO, was not immediately returned.
The FDA considers applications confidential and a spokeswoman declined to comment on the status of ProUroCare’s application.
However, it’s not clear whether it will win adoption in the marketplace even if the device is approved.
Updated Aug.9