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The FDA has given 510(k) clearance to Biosite’s Triage TOX Drug Screen with Acetaminophen, the first drug screen to include a rapid, point-of-care test for the qualitative detection of acetaminophen in urine.
Cyberonics announced that the FDA deemed the Vagus Nerve Stimulation (VNS) Therapy System approvable as an adjunctive treatment for chronic treatment-resistant depression for adults over the age of 18.
Diagnostic medical device maker Novadaq Technologies has received FDA clearance for the use of its SPY Intra-operative Imaging System during coronary artery bypass surgery and will begin marketing the system in the U.S. immediately, the company announced.
Clinical diagnostic company Dade Behring received FDA clearance for use of its Advanced D-Dimer assay as an aid in the diagnosis of venous thromboembolism (VTE).
The FDA’s approval of a new DNA microarray test will allow doctors to screen a patient’s genetic information to select medications and doses for a variety of common illnesses.
Confluent Surgical's DuraSeal Dural Sealant System moved a step closer to gaining U.S. approval last week when an FDA advisory committee returned a favorable review of the device.
A new FDA-cleared device based on radio-frequency identification (RFID) technology could help safeguard patients against physician and clerical mistakes.
Medtronic’s Endeavor drug-eluting coronary stent is moving closer to approval in Europe, as the firm announced last week that it completed all of the required submissions for CE Mark approval.
The Center for Devices and Radiological Health (CDRH) is on track to meet review targets for expedited premarket approval applications (PMAs) submitted in fiscal 2004, but it remains to be seen whether the agency can maintain its pace in the face of a growing number of submissions.