FDA Issues Clearance for ReWalk 7 Exoskeleton
Lifeward (Nasdaq: LFWD) has received FDA 510(k) clearance for its ReWalk 7, the newest generation of its personal exoskeleton device designed for individuals with spinal cord injury (SCI). This seventh-generation wearable exoskeleton enables SCI patients to stand and walk again, featuring new enhancements and upgrades.
This milestone follows significant developments including the 2023 FDA clearance of ReWalk 6.0 for stairs and curbs usage, and the 2024 Centers for Medicare & Medicaid Services (CMS) national reimbursement policy approval for qualified beneficiaries. The company, which made history in 2014 with the first FDA-cleared exoskeleton medical device for SCI patients, will commence ReWalk 7 sales in the United States once the product becomes available.
Lifeward (Nasdaq: LFWD) ha ricevuto l'approvazione 510(k) della FDA per il suo ReWalk 7, la nuova generazione del suo dispositivo esoscheletrico personale progettato per persone con lesioni del midollo spinale (SCI). Questo esoscheletro indossabile di settima generazione consente ai pazienti con SCI di stare in piedi e camminare di nuovo, con nuove migliorie e aggiornamenti.
Questo traguardo segue importanti sviluppi, tra cui l'approvazione della FDA nel 2023 del ReWalk 6.0 per l'uso su scale e marciapiedi, e l'approvazione della politica di rimborso nazionale dei Centers for Medicare & Medicaid Services (CMS) nel 2024 per i beneficiari qualificati. L'azienda, che ha fatto la storia nel 2014 con il primo dispositivo medico esoscheletrico approvato dalla FDA per i pazienti con SCI, inizierà le vendite del ReWalk 7 negli Stati Uniti non appena il prodotto sarà disponibile.
Lifeward (Nasdaq: LFWD) ha recibido la aprobación 510(k) de la FDA para su ReWalk 7, la última generación de su dispositivo de exoesqueleto personal diseñado para personas con lesiones de médula espinal (SCI). Este exoesqueleto portátil de séptima generación permite a los pacientes con SCI volver a estar de pie y caminar, con nuevas mejoras y actualizaciones.
Este hito sigue a desarrollos significativos, incluida la aprobación de la FDA en 2023 del ReWalk 6.0 para su uso en escaleras y bordillos, y la aprobación de la política de reembolso nacional de los Centros de Servicios de Medicare y Medicaid (CMS) en 2024 para beneficiarios calificados. La empresa, que hizo historia en 2014 con el primer dispositivo médico de exoesqueleto aprobado por la FDA para pacientes con SCI, comenzará las ventas del ReWalk 7 en los Estados Unidos una vez que el producto esté disponible.
라이프워드 (Nasdaq: LFWD)는 척수 손상(SCI) 환자를 위해 설계된 개인용 외골격 장치인 ReWalk 7에 대해 FDA 510(k) 승인을 받았습니다. 이 7세대 착용형 외골격은 SCI 환자가 다시 서고 걸을 수 있게 해주며, 새로운 개선 사항과 업그레이드를 특징으로 합니다.
이번 이정표는 2023년 FDA가 계단 및 연석 사용을 위한 ReWalk 6.0을 승인하고, 2024년 메디케어 및 메디케이드 서비스 센터(CMS)의 자격이 있는 수혜자를 위한 국가 환급 정책 승인을 포함한 중요한 발전을 따릅니다. 2014년 SCI 환자를 위한 최초의 FDA 승인 외골격 의료 장치를 통해 역사를 만든 이 회사는 제품이 출시되는 즉시 미국에서 ReWalk 7의 판매를 시작할 예정입니다.
Lifeward (Nasdaq: LFWD) a reçu l'approbation 510(k) de la FDA pour son ReWalk 7, la dernière génération de son dispositif d'exosquelette personnel conçu pour les personnes ayant subi une lésion de la moelle épinière (SCI). Cet exosquelette portable de septième génération permet aux patients SCI de se lever et de marcher à nouveau, avec de nouvelles améliorations et mises à jour.
Ce jalon fait suite à des développements significatifs, y compris l'approbation en 2023 par la FDA du ReWalk 6.0 pour une utilisation sur les escaliers et les bordures, ainsi que l'approbation en 2024 de la politique de remboursement nationale des Centers for Medicare & Medicaid Services (CMS) pour les bénéficiaires qualifiés. L'entreprise, qui a marqué l'histoire en 2014 avec le premier dispositif médical d'exosquelette approuvé par la FDA pour les patients SCI, commencera à vendre le ReWalk 7 aux États-Unis dès que le produit sera disponible.
Lifeward (Nasdaq: LFWD) hat die FDA 510(k)-Zulassung für sein ReWalk 7 erhalten, die neueste Generation seines persönlichen Exoskelettgeräts, das für Personen mit Rückenmarksverletzungen (SCI) entwickelt wurde. Dieses tragbare Exoskelett der siebten Generation ermöglicht es SCI-Patienten, wieder zu stehen und zu gehen, und bietet neue Verbesserungen und Upgrades.
Dieser Meilenstein folgt auf bedeutende Entwicklungen, darunter die FDA-Zulassung von ReWalk 6.0 im Jahr 2023 für die Nutzung von Treppen und Bordsteinen sowie die Genehmigung der nationalen Erstattungspolitik der Centers for Medicare & Medicaid Services (CMS) im Jahr 2024 für berechtigte Begünstigte. Das Unternehmen, das 2014 mit dem ersten von der FDA zugelassenen Exoskelett-Medizinprodukt für SCI-Patienten Geschichte schrieb, wird den Verkauf von ReWalk 7 in den Vereinigten Staaten aufnehmen, sobald das Produkt verfügbar ist.
- FDA 510(k) clearance received for new ReWalk 7 exoskeleton
- Medicare/Medicaid national reimbursement policy secured in 2024
- Product portfolio expansion with enhanced features
- Sales timeline uncertain, pending product availability
Seventh Generation of Industry-Leading Exoskeleton Includes New and Enhanced Features for Individuals with Spinal Cord Injury
MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, March 13, 2025 (GLOBE NEWSWIRE) -- Lifeward Ltd., (Nasdaq: LFWD) (“Lifeward” or the “Company”), a global leader in innovative medical technology to transform the lives of people with physical limitations or disabilities, announced today that the Company has received 510(k) FDA clearance for the newest generation of its personal exoskeleton device, the ReWalk 7. The seventh generation of the ReWalk, a wearable exoskeleton that allows individuals with spinal cord injury (SCI) to stand and walk again, includes a number of new features, as well as enhancements and upgrades.
“FDA clearance is a major milestone for our Company and for the industry,” said Larry Jasinski, CEO of Lifeward. “For two decades, Lifeward has been committed to providing our users with the most advanced exoskeleton technology and expanding access to all those who can benefit from use of the device. With the ReWalk 7, we are able to deliver on that commitment, and will continue to look for opportunities to innovate and improve upon medical devices for the SCI community.”
Clearance for the ReWalk 7 follows other major developments. In 2023, the FDA cleared the ReWalk 6.0 for use on stairs and curbs. In 2024, the Centers for Medicare & Medicaid Services (CMS) issued a national reimbursement policy for all beneficiaries that qualify for use of the device. The Company made history in 2014 when it received the nation’s first FDA clearance for an exoskeleton medical device for individuals with SCI.
Lifeward will begin sales of the ReWalk 7 in the United States as soon as the product is available. For more information, please visit, GoLifeward.com
About Lifeward
Lifeward designs, develops, and commercializes life-changing solutions that span the continuum of care in physical rehabilitation and recovery, delivering proven functional and health benefits in clinical settings as well as in the home and community. Our mission at Lifeward is to relentlessly drive innovation to change the lives of individuals with physical limitations or disabilities. We are committed to delivering groundbreaking solutions that empower individuals to do what they love. The Lifeward portfolio features innovative products including the ReWalk Exoskeleton, the AlterG Anti-Gravity System, the ReStore Exo-Suit, and the MyoCycle FES System. Founded in 2001, Lifeward has operations in the United States, Israel, and Germany.
Lifeward®, ReWalk®, ReStore®, and Alter G® are registered trademarks of Lifeward Ltd. and/or its affiliates.
Forward-Looking Statements
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Lifeward Media Relations:
Kathleen O’Donnell
Vice President, Marketing & New Business Development
Lifeward Ltd.
E: media@golifeward.com
Lifeward Investor Contact:
Mike Lawless
Chief Financial Officer
Lifeward Ltd.
E: ir@golifeward.com
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