FDA Grants Tem Systems 510(K) Clearance for Blood Analysis Medical Device

Medical device firm Tem Systems aims to speed up blood analysis during surgeries and trauma situations. Tem Systems has received U.S. Food and Drug Administration 510(k) clearance on new tests for its hemostasis analyzer and now the company aims to offer the technology to a wider group of users in the United States. Tem Systems, based in Durham, North Carolina, has developed an analyzer called ROTEM that can test for what is causing bleeding in a patient. That analysis comes in five to 10 minutes — much faster than traditional laboratory coagulation tests that can take 30 minutes.

MORE ON THIS TOPIC