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The FDA unveiled its long-awaited Critical Path Opportunities List March 16, focusing on projects that will advance the use of biomarkers and streamline clinical trials.
Swedish-based Neoventa Medical received FDA approval to market its fetal monitor that uses an electrocardiogram (ECG) via a fetal scalp electrode to help healthcare providers determine when to deliver a baby.
Despite unanimous opposition from his staff and public criticism from Capitol Hill, a senior FDA official told D&DL he stands by his decision to approve an implanted pulse generator system to treat severe depression.
Canadian device manufacturer Nucryst announced Feb. 6 that its foam dressing with antimicrobial activity was approved for use in the European Union (EU).
Biotech firm Genzyme has launched a diagnostic test to monitor drug resistance in chronic myeloid leukemia (CML) patients who are treated with Novartis’ cancer drug Gleevec.
Cedars-Sinai Medical Center is among the first centers in southern California to begin offering vagus nerve stimulator (VNS) implantation for treatment-resistant depression. The device has been used to treat epilepsy for nine years and was approved by the FDA last year to treat depression.