Medtronic is touting its new CPT codes for the VenaSeal varicose vein closure device -- codes that company officials think bring the device closer to positive coverage from public and private insurers in the US. The CMS announced the new codes on Nov. 1 as part of final rules for the 2018 Medicare Physician Fee Schedule (CMS-1676-F) and Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (CMS-1678-FC), according to Medtronic officials. The VenaSeal system uses a proprietary adhesive to close superficial veins in lower extremities in people suffering from symptomatic venous reflux, or varicose veins. The procedure, however, remains under a self-pay model since its FDA clearance and US launch in 2015. Read the story.
Intra-Cellular Therapies' schizophrenia drug candidate lumateperone was granted fast-track designation by the FDA.
The FDA gave orphan drug status to Revance Therapeutics' daxibotulinumtoxina injection, or RT002, which is being developed as a treatment for patients with cervical dystonia.
Late-stage studies of the Parkinson's disease candidate tozadenant were suspended by Acorda Therapeutics and development of the drug was halted after the deaths of five patients who developed agranulocytosis-associated sepsis during the trials. The company, which will immediately stop the dosing of the remaining patients enrolled in its studies, said the decision came after it received new information from the trials "related to previously disclosed agranulocytosis and associated serious adverse events."
Tasigna, or nilotinib, a drug developed by Novartis as a treatment for pediatric patients diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase, gained approval from the European Commission and is indicated for use in the frontline setting or for those who experienced resistance or were intolerant to other treatment regimens.
The Nov. 15 recall of Casa Sanchez Foods' Real Guacamole has expanded to include Spicy Guacamole because of possible Listeria monocytogenes contamination. The expansion includes five lots with the UPC 0 78732 00431 3, 11 lots with the UPC 0 78732 00426 9 and 21 lots with the UPC code 0 78732 00412 2, which were shipped to California, Hawaii and Nevada.
Medtronic obtained approval from the FDA for its Azure XT MRI and Azure S MRI pacemakers, which are designed for bradycardia treatment, and announced the US launch of the devices. The pacemakers, which feature the company's Reactive ATP pacing algorithm and BlueSync secure wireless remote monitoring capability to prevent against device hacking, come in single- and dual-chamber models and have 27% greater longevity than their predecessor.
The first human trial of the FDA-approved DiLumen Endolumenal Interventional Platform, a single-use sleeve intended for stabilizing colonoscopes, was completed by Lumendi, showing the device was safe to use during routine colonoscopy without any serious adverse events. The observational registry study met its primary safety endpoint, which was the absence of significant mucosal injuries, and its primary study endpoint, which was the ability of scope navigation with the device to the cecum.
Researchers from France and China have developed biotech tomatoes with greater levels of nutrients tied to anti-aging. The biotech tomatoes contain 494% more vitamin E, 94% more phytosterol, 169% more provitamin A, 210% more squalene and 111% more lycopene, all which are thought to have anti-aging properties.
Canada-based Agrisoma Biosciences and Qantas Airlines signed a deal that will allow farmers in Australia to grow Canadian carinata oilseed for use in making jet biofuel. The collaboration aims to grow nearly 1 million acres of the oilseed, which is expected to produce close to 53 million gallons of biofuel for Qantas.
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