Boston Scientific Corp. received CE mark certification under the Medical Device Regulation for its Intracept intraosseous nerve ablation system, bringing another treatment option to patients with chronic pain.
An advisory committee for the U.S. Centers for Medicare & Medicaid Services endorsed a series of patient- and clinician-reported outcomes that might not be reflected in the evidentiary bases for currently available technologies. This development suggests some manufacturers will have to conduct new studies of their devices in order to sustain Medicare coverage.
Rebrain SAS's Optimmri platform received European Medical Device Regulation CE mark certification to enable surgeons to identify areas of interest in the brain during deep brain stimulation procedures for Parkinson's disease and essential tremor.
The U.S. Centers for Medicare & Medicaid Services will hold an advisory meeting regarding devices for treatment of symptoms for Parkinson’s disease, but the agency indicated that it expects to see longer-term data for these treatments if manufacturers want Medicare coverage.
A recent patent application from Laleh Rad, associate professor of Biomedical Engineering and Radiology at Northwestern University, describes the use of machine learning for real-time risk assessment of magnetic resonance imaging in patients with conductive implants for whom tissue heating from radiofrequency excitation fields remains a major concern.
Newronika SpA's AlphaDBS recently secured an investigational device exemption from the U.S. FDA allowing it to begin a pivotal trial to evaluate the safety and efficacy of its adaptive deep brain stimulation system in patients with movement disorders, including Parkinson's disease.
Medtronic plc secured CE mark approval under the EU Medical Device Regulation for its Brainsense adaptive deep brain stimulation system. The technology represents a major advancement in the treatment of Parkinson’s disease as it provides real-time, self-adjusting brain stimulation based on the patient’s brain activity, offering a more personalized therapy.
The U.S. FDA recently granted Medtronic plc approval for its deep brain stimulation (DBS) system to be used to treat Parkinson’s disease or essential tremor while a patient is asleep, under general anesthesia. The approval gives patients another option for DBS therapy which can transform their quality of life, Amaza Reitmeier, vice president and general manager for Medtronic brain modulation, told BioWorld in an interview.
An implanted deep brain stimulator that calibrates its electrical pulses based on changes in brain activity reduced patients’ most bothersome symptoms of Parkinson’s disease 50%, a small feasibility study published in Nature Medicine found.
As new treatment options are being continually investigated and trialed against Parkinson’s disease, the possibilities offered by deep brain stimulation (DBS) risk being overlooked. Though not a cure, the therapy could vastly improve the quality of life for patients with the disease.