Medtech titan Medtronic says that it's not involved with research on an orgasm-inducing neurostimulation system, despite reports to the contrary.
Medical device industry giant Medtronic (NYSE:MDT) told MassDevice.com today that despite reports of the company's participation in upcoming studies, Medtronic is not involved with research on an implantable neurostimulator designed for treatment of sexual dysfunction.
Valor Medical and 4 of its top brass admit to concealing required data from FDA regulators while undergoing review for an aneurysm treatment implant.
California biotech company Valor Medical, 4 executives and a consultant admitted to the Dept. of Justice that they concealed information about their Neucrylate diagnostic assay, hiding toxicity reports that were required as the product was undergoing FDA premarket review.
Menssana Research's experimental 6-minute breath-test identifies women with early stage breast cancer or an abnormal mammogram, researchers report.
MASSDEVICE ON CALL — Diagnostics maker Menssana Research is making promising progress with a breath-test that the company says can identify at-risk breast cancer cases in just 6 minutes.
In a study of nearly 250 women at 3 centers in New Jersey, Washington and the Netherlands the test was able to accurately identify women with early stage breast cancer or with abnormal mammogram, Menssana said.
FDA inspectors rebuke Advanced Medical Research Institute for human clinical trials conducted without approval from an Institutional Review Board, as well as illegal marketing and missing adverse event reports.
Updated February 28, 2014, at 10 a.m. with comments from AMRI.
FDA regulators had strong words for Advanced Magnetic Research Institute International following an inspection of the electromagnetic therapy center's practices.
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