Neurolutions Inc., the leader in the use of non-invasive brain computer interface (BCI) technology for post-stroke therapy, received dual certifications under the Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO 13485). These certifications confirm that Neurolutions meets regulatory audit, compliance, and global medical device manufacturer quality standards for market entry of the IpsiHand® Upper Extremity Rehabilitation System.
The IpsiHand Upper Extremity Rehabilitation System is a breakthrough therapeutic device and the only FDA-cleared commercially available solution that provides non-invasive at-home rehabilitation for stroke survivors affected by chronic motor deficits. Utilizing BCI technology, the IpsiHand enables stroke survivors to engage in thought-actuated therapy that connects movement to the intent to move via signals in the brain, helping rebuild neuronal pathways.
The MDSAP certification allows Neurolutions to undergo an audit of their Quality Management System (QMS) for medical devices that meets the regulatory requirements of multiple jurisdictions simultaneously.
The MDSAP certification allows Neurolutions to undergo an audit of their Quality Management System (QMS) for medical devices that meets the regulatory requirements of multiple jurisdictions simultaneously. This includes the United States, Canada, Brazil, Australia, and Japan, thereby facilitating a seamless pathway for introducing Neurolutions’ IpsiHand System to a broader global patient base.
Achieving ISO 13485 certification highlights Neurolutions’ adherence to the highest standards in developing, manufacturing, and delivering medical devices, denoting their quality management system ensures safety and compliance from design to delivery to the patient. Javad Seyedzadeh, Neurolutions’ COO, described how this achievement speaks to the maturity of the company’s quality system, expressing:
“Achieving these certifications for Neurolutions’ quality system signifies our unwavering commitment to excellence, ensuring that our innovative neurotechnology meets the highest standards of safety and efficacy for our customers.”
Neurolutions is a medical technology company dedicated to transforming the lives of patients with neurological conditions. Our mission is to develop innovative solutions that address the unmet needs of patients while advancing the field of neurorehabilitation through cutting-edge research and development.
The IpsiHand System is a breakthrough therapeutic device that uses brain-computer interface technology to help chronic stroke patients with an impaired upper extremity regain movement. The IpsiHand device has been clinically validated and has received FDA clearance for use in the United States.
To learn more about IpsiHand, visit our Clinicians page.
About Kandu, Inc.
Kandu, Inc. is pioneering an integrated approach to stroke recovery, combining FDA-cleared brain-computer interface technology with personalized care delivery models. The company’s IpsiHand® device enables stroke survivors with upper-extremity paralysis to regain functional movement by leveraging neural intent and neuroplasticity. Kandu’s solutions are designed to extend recovery beyond the hospital, supporting improved mobility, independence, and quality of life while creating durable value for patients, providers, and investors.
For more information, visit kandu.com.
IpsiHand® is manufactured by Neurolutions, a Kandu, Inc company.