Neuromod Devices announced it received significant regulatory nods to bring its Lenire device to Europe and other geographies.
Dublin, Ireland-based Neuromod won approval to the Medical Device Single Audit Program (MDSAP) and EU Medical Device Regulation (MDR) certification.
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MDSAP approval verifies compliance with specific requirements in multiple jurisdictions, including Canada and Australia. Following the certification, Neuromod secured both Health Canada and TGA approval to bring Lenire to those territories. Meanwhile, MDR certification, the current regulatory framework in Europe, positions the company to expand the availability of Lenire in markets using Europe’s CE mark as a basis for regulatory approvals.
“The transition from MDD to MDR in Europe introduced more rigorous standards for medical device approval. Globally, many non-European markets recognise these standards which paves the way for us to make Lenire available to more people living with tinnitus worldwide,” Diarmuid Flavin, Neuromod COO, said in a news release.
Lenire, a neuromodulation device for treating tinnitus, received FDA de novo approval in March 2023 and has availability throughout Europe. It delivers mild electrical pulses to the tongue, combined with sound played through headphones. It drives long-term changes or neuroplasticity in the brain to treat tinnitus. An audiologist or ENT surgeon prescribes and fits the device for a tailored treatment plan.
Neurmod labeled Lenire the first non-invasive, bimodal neuromodulation tinnitus treatment shown to soothe and relieve the condition. The company raised $10.9 million to support the device earlier this year.
“Neuromod’s commitment to delivering the highest quality of patient care begins with ensuring our quality management systems are best-in-class,” said Dr. Ross O’Neill, Neuromod founder & CEO. “MDSAP and MDR certification allows Neuromod to continue expanding Lenire’s availability in Europe while positioning the company to commercialize Lenire in new geographies such as Australia, Canada and beyond.”
