Bay Area Medical Device Companies Doing Well
December 20, 2014
By Andrew Hoglund

There were several medical device companies from the Bay Area that made the news this week.

A small company in South San Francisco, diaDexus, received FDA 510(k) clearance for its PLAC Activity test to assess coronary heart disease risk. The new test checks the activity of Lp-PLA₂ (Lipoprotein-Associated Phospholipase A2) in human plasma and serum. The enzyme assay is based on a National Institutes of Health-funded study of 4,500 people with no prior history of heart problems which found that elevated Lp-PLA₂ activity levels are associated with a much greater risk of coronary heart disease. According to the 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk, more than 16 million Americans are at moderate risk of having their first cardiovascular disease event over the next ten years. This test will help to predict that risk.

Cerus, a small company headquartered in Concord, was approved by the FDA for its Intercept Blood System for plasma and a similar version was approved for blood platelets as well. It is the first pathogen-reduction system to be approved by the FDA. This device allows blood that is collected to be treated for any potential pathogens like HIV, Hepatitis B/C and West Nile virus. Normally blood donation agencies rely entirely on screening processes; this device would help minimize any potential risks that could be involved in the process. Cerus’s stock has jumped nearly 50% in the last week over news of the FDA approvals.

An ECG monitoring company is hoping to become more widespread by dropping prices and improving its technology. AliveCor, a small company located in San Francisco, produces an ECG monitor that attaches to the back of your smartphone. AliveCor has reduced the price from $199 to $74.99 and just released the third generation of the device, which is 40% lighter and 50% thinner. The FDA cleared the device earlier this year to detect atrial fibrillation.

These three small companies are just a few of the many new medical device startups popping up in the Bay Area. This area has always been a hotbed for new startups and these companies are proof that development in the Bay Area is still going strong.