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HHS is excluding device and drugmakers from a new protection from the anti-kickback statute designed to promote adoption of electronic health records, arguing that these sectors cannot be trusted to abide by the law.
American Bio Medica Corporation announced that the US Food and Drug Administration (FDA) has granted the Company 510(k) clearance on its Rapid One lateral flow immunoassay test for the detection of Buprenorphine. Buprenorphine is semi-synthetic narcotic used in the treatment of narcotics addiction.
Using a form of genomic profiling for early non-small-cell lung cancer (NSCLC), researchers here believe they can cherry pick those patients who will benefit most from adjuvant chemotherapy.
Britain's decision to allow couples to screen embryos for possible cancer genes has highlighted the vastly different practice in the US and revived calls for global agreement on the issue.
Facing a growing wave of lawsuits from patients and insurers, Boston Scientific Corp. has set aside $381 million to pay for legal costs connected to faulty heart devices made by Guidant Corp. , according to a document filed with federal regulators yesterday.
Senate Finance Committee Chairman Charles Grassley (R-Iowa), and ranking Democrat Max Baucus (D-Mont.), want CMS to collect more information about how specialty hospitals affect local community health care delivery before completing a mandated study for Congress.
The briefs and evidence kept secret in a case involving heart devicemaker Guidant must be unsealed, Public Citizen said in a motion filed Aug. 8 in the U.S. District Court for the District of Minnesota.
The Union of Concerned Scientists (UCS) Aug. 8 briefed acting FDA Commissioner Andrew von Eschenbach about a recent survey on political interference with agency scientits' work.
The FDA has posted an updated guidance answering common questions about humanitarian use devices (HUDs) and applications for humanitarian device exemptions (HDEs).