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Noninvasive Brain Biopsy Device Nears Market Approval

Device for noninvasive brain biopsies via blood draw moves closer to market approval - The Source

A device aimed at enabling physicians to perform noninvasive blood-based biopsies in adults with brain tumors has received Food and Drug Administration “Breakthrough Device” designation. The device includes Washington University in St. Louis technology.

Ultrasound-based brain biopsy is feasible, noninvasive and safe in people

Noninvasive, ultrasound-based brain biopsy is feasible, safe in people: Study

Ultrasound-Based Brain Biopsy Proves Safe, Feasible for Humans

Noninvasive, ultrasound-based brain biopsy is feasible, safe in people - The Source - Washington University in St. Louis

Researchers at Washington University in St. Louis have developed a noninvasive technique called sonobiopsy that uses ultrasound and microbubbles to release biomolecules from brain tumors. A blood draw can collect the biomolecules to help inform treatment decisions.

Genin, Guilak named to National Academy of Inventors - The Source - Washington University in St. Louis

The National Academy of Inventors has elected two Washington University in St. Louis faculty members to its 2022 cohort of fellows: Guy Genin, at the McKelvey School of Engineering, and Farshid Guilak, at the School of Medicine.

Podcast: Giving stroke patients a hand – Washington University School of Medicine in St. Louis

Stroke-recovery device using brain-computer interface receives FDA market authorization | The Source

Innovative multidisciplinary research at Washington University led to development of 'breakthrough' device Eric Leuthardt, MD, professor of neurosurgery at Washington University School of Medicine, models a device that helps people disabled by stroke regain significant control over their arm and hand function by using their minds. Called the IpsiHand Upper Extremity Rehabilitation System, the first-of-its-kind device has received market authorization from the Food and Drug Administration. It was developed by Neurolutions Inc., a Washington University startup company that leverages brain-computer interface technology licensed from the university. (Photo: Elizabethe Holland Durando/School of Medicine) April 27, 2021 SHARE A first-of-its kind device that helps people disabled by stroke regain significant control over their arm and hand function by using their minds has received market authorization from the Food and Drug Administration (FDA). The IpsiHand Upper Extremity Rehabilitation System, developed by Neurolutions Inc. — a Washington University in St. Louis startup company — leverages brain-computer interface (BCI) technology licensed from the university.

Neurolutions Receives U.S. Food and Drug Administration De Novo Market Authorization for IpsiHand™ Upper Extremity Rehabilitation System

Neurolutions Receives U.S. Food and Drug Administration De Novo Market Authorization for IpsiHand™ Upper Extremity Rehabilitation System April 26, 2021 07:00 ET | Source: Neurolutions Neurolutions IpsiHand also has been granted U.S. FDA Breakthrough Device Designation SANTA CRUZ, Calif. and ST. LOUIS, Mo., April 26, 2021 (GLOBE NEWSWIRE) -- Neurolutions, Inc., a medical device company developing and commercializing a first-of-its-kind device leveraging brain-computer interface (BCI) technology for upper extremity chronic stroke rehabilitation, announced today that the U.S. Food and Drug Administration (FDA) granted De Novo market authorization for its groundbreaking IpsiHand Upper Extremity Rehabilitation System. The IpsiHand System has been cleared for use in chronic stroke patients to facilitate muscle re-education through its novel BCI platform. In addition to the De Novo Authorization, the IpsiHand device notably received Breakthrough Device designation from the FDA as well. The Breakthrough designation is a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The Breakthrough designation may also streamline the process required for Medicare reimbursement.