The U.S. Office of Inspector General (OIG) said a review of claims for implant of neurostimulation devices indicates that many of these claims lack the data to ensure that the devices were appropriately implanted.
Zoll Medical Corp. has released its Remedē EL-X system for the treatment of central sleep apnea in adults, following the receipt of FDA approval. The next-generation implantable neurostimulation device will be rolled out in a phased launch in implanting centers in the U.S.
Merck KGaA is partnering with Neuroloop GmbH, a subsidiary of B. Braun SE, to develop a neurostimulator device that can complement existing drug therapies for people with chronic inflammatory diseases. The collaboration aims to adapt Neuroloop’s neurostimulation platform to enable targeted treatment of chronic inflammatory ailments. The new bioelectronics program intends to open up new technologies and markets that are close to Merck’s electronics and health care business sectors.
Livanova plc has launched an IDE trial of its Aura6000 sleep apnea device, following approval by the FDA to proceed with the study. The implantable pulse generator (IPG) is designed to treat patients with moderate to severe obstructive sleep apnea (OSA) who do not get relief from a traditional continuous positive airway pressure (CPAP) machine or refuse to use one.
LONDON – Wise Srl has received CE marking for its cortical strip electrode, validating the underlying flexible electronics technology and opening the door to the development of implantable devices for long-term neurostimulation.
New investors think Brainsgate Ltd. has some valuable new ideas, including its novel treatment for ischemic stroke, so they headed up the latest investment round. BNP Joint Capital led the $14 million round as a first-time investor along with Spero and previous investors Elron, Medtronic, Agate, Pitango, and Cipio.
The U.S. FDA has granted breakthrough device designation to Salvia Bioelectronics BV for its implantable neurostimulation system to treat chronic migraine. The designation, which provides for priority review and consultation with the agency on product development, underscores the need for effective treatments for the costly and debilitating condition. According to a summary in a patent filing, the wireless system comprises a treatment pulse generator unit and an implantable electrode unit to provide neurostimulation therapy for headaches.
SAN FRANCISCO – This was the final presentation for Omar Ishrak at the J.P. Morgan (JPM) Healthcare Conference. He has held the CEO position at Medtronic plc since June 2011. During that period, the Dublin-based company managed to roughly quadruple its valuation to $160 billion from $40 billion – making Ishrak’s tenure clearly a successful one.
LONDON – Nyxoah SA reported positive clinical results for Genio, its lead-free, battery-less implantable neurostimulation device, showing it resulted in a significant reduction of the severity of obstructive sleep apnea (OSA), the world's most common sleeping disorder.