Health insurer Cigna has issued a positive coverage decision on Uroplasty’s (NSDQ:UPI) overactive bladder (OAB) treatment, Percutaneous Tibial Nerve Stimulation (PTNS).
TEI, Novation sign contract for biologic mesh products
Regenerative medicine company TEI Biosciences said that it has been awarded a supply contract by group purchasing organization Novation for its biologic mesh products.
FDA clears Bioness’ StimRouter device for chronic pain
The FDA has granted market clearance for Bioness' Stimrouter for the treatment of chronic peripheral pain.
The company describes StimRouter as a minimally invasive, implanted neuromodulation device that sends electrical signals to the pain's point of origin. The device is controlled by a wireless, hand-held unit.
Uroplasty, Vision-Sciences set date for merger vote
Uroplasty and Vision-Sciences shareholders will vote on the proposed all-stock merger deal between the two companies on March 30, according to a regulatory filing.
Report: C.R. Bard to settle W. Va. pelvic-mesh case
FDA clears Neuronetrix portable EEG device
The FDA has cleared Neuronetrix’s portable device for the recording of electrical brainwaves in patients with neurological conditions such as Alzheimer’s disease, concussion, schizophrenia and ADHD.
The device, called the Cognision System, is designed to run brainwave tests such as EEGs and auditory event-related potentials (ERPs). Neuronetrix said the device allows doctors to run tests in their offices that used to be only available in a hospital setting.
FDA panel green lights VertiFlex spinal stenosis device
A FDA advisory panel has recommended the agency approve VertiFlex Inc.’s Superion interspinous spacer system for the treatment of spinal stenosis.
According to VertiFlex, the panel based their vote largely on results from the company's 470-patient clinical trial.
HeartWare issues urgent recall for heart-pump controllers
HeartWare International (NSDQ:HTWR) has issued an urgent recall for certain computerized controllers for its ventricular assist devices over concerns that they may malfunction and cause the heart pump to stop.
Medicare ups reimbursement for Medtronic PAD device
FDA warns on ERCP endoscope, CRE “superbug” link
The FDA is warning that ERCP endoscopes may allow for the transmission of certain drug-resistant “superbugs,” even if the devices are properly cleaned.
The advisory was issued in the wake of news that contaminated endoscopes are suspected of causing a deadly outbreak of the superbug CRE, or carbapenem-resistant enterobacteriaceae (CRE), among patients at the UCLA Ronald Reagan Medical Center in Los Angeles.
UK appoints top med device regulator
The UK’s equivalent of the FDA has named a prominent British anesthesiologist as its top medical devices regulator.