Medtronic plc's (NYSE: MDT) Deep Brain Stimulation (DBS) Clinician Programmer and Activa Programming Application have been approved by the US Food and Drug Administration (FDA), the medical technology company announced on Wednesday.
It follows European approval in March.
The European launch is currently underway, with the US launch expected to take place before the end of July 2018.
DBS therapy uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver electrical stimulation to precisely targeted areas of the brain as adjunctive treatment for movement and neuropsychiatric disorders.
The Activa Programming Application was designed with the input of over 100 clinicians and is managed on the Samsung Galaxy Tab S2 tablet interface.
According to Medtronic, the new tool will enhance the clinical programming experience, streamline workflows and provide actionable information to support neurologists and neurosurgeons in their treatment of patients that use the Medtronic Activa DBS system as therapy for neurological disorders such as dystonia and Parkinson's disease.
Additionally, it will enable the service life of Activa rechargeable implantable neurostimulators to be extended to 15 years, giving patients an additional six years until their next device replacement.
The Medtronic DBS Clinician Programmer is also approved for use with Medtronic Activa DBS systems that treat medically refractory epilepsy, a therapy that will be launched in the United States later this year.
OSR Holdings to acquire Korean non-invasive glucose monitor developer Woori IO
Autonomix Medical secures new US patent to expand precision nerve-targeted therapies
MedHub-AI's AutocathFFR receives national reimbursement approval in Japan
Microbot Medical secures first Japanese patent for Liberty robotic system following FDA clearance
Polarean Imaging signs new supply agreementwith UVA Health for clinical Xenon MRI
Femasys partners with Kebomed to expand FemBloc permanent birth control in France and Benelux
Implantica receives positive FDA feedback on final RefluxStop PMA submission
Tempus secures FDA clearance for RNA-based xR IVD diagnostic device
Shoulder Innovations expands I-Series portfolio with launch of InSet 70 Humeral Stem
GSK commits USD30bn to US R&D and manufacturing expansion
ArtPlayer Promotes Elderly Wellbeing with Digital Signage and Streaming Art in Finnish Care Homes
Implantica produces 10,000 RefluxStop units ahead of planned US launch
Elute partners Spartan Medical
Saol Therapeutics receives US FDA Complete Response Letter for SL1009 (DCA) in PDCD