Lifeward Ltd. LFWD recently announced that it has received FDA 510(k) clearance for its latest innovation, the ReWalk 7 Exoskeleton. This next-generation wearable device is designed to help individuals with spinal cord injuries (SCI) stand and walk, featuring new and enhanced functionalities aimed at improving user experience and mobility outcomes.

The FDA clearance marks a significant milestone for Lifeward, reinforcing its leadership in the medical exoskeleton market. With prior regulatory and reimbursement wins, the launch of ReWalk 7 positions the company to expand its reach and continue delivering cutting-edge solutions to the SCI community.

Likely Trend of LFWD Stock Following the News

Following the announcement, shares of the company moved south 5.6% and closed at $1.51 on Friday. In the past six months, LFWD shares have lost 52.2% against the industry’s 8.4% growth. The S&P 500 improved 0.4% in the same time frame.

However, the FDA clearance of the ReWalk 7 Exoskeleton positions Lifeward for long-term stock growth by strengthening its leadership in the exoskeleton market and expanding its addressable customer base. With enhanced features and regulatory approval, the product is more attractive to healthcare providers and patients, potentially increasing adoption rates. As Lifeward continues to innovate and solidify market trust, investor confidence is likely to rise, driving sustained upward momentum in its stock price over time.

Meanwhile, LFWD currently has a market capitalization of $16.1 million. It expects 91.4% earnings growth in the current year compared with the industry’s 15% growth.

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Details on LFWD’s ReWalk 7

The ReWalk 7 is the seventh generation of Lifeward’s industry-leading exoskeleton technology, specifically designed for individuals with SCI. Building on two decades of development, this wearable robotic device enables users to stand upright and walk independently, addressing both mobility limitations and improving quality of life. Compared to previous versions, the ReWalk 7 includes new features and key enhancements, though specifics were not fully detailed in the announcement.

The FDA 510(k) clearance for the device signifies its safety and effectiveness for personal use. This clearance builds on Lifeward’s earlier achievements, such as the FDA’s approval of the ReWalk 6.0 for use on stairs and curbs in 2023 and the establishment of a national reimbursement policy by the Centers for Medicare & Medicaid Services in 2024.

In addition to regulatory and functional advancements, the ReWalk 7 is strategically positioned to drive Lifeward’s long-term growth. The device aligns with the company's broader mission to offer life-changing rehabilitation solutions, complementing Lifeward’s portfolio of innovative products such as the AlterG Anti-Gravity System and the ReStore Exo-Suit. The anticipated commercial rollout of the ReWalk 7 in the U.S. market is expected to strengthen Lifeward’s competitive edge and revenue streams.

LFWD’s Recent Developments

Recently, LFWD and MYOLYN, Inc. expanded their partnership to enhance patient access to the MyoCycle Functional Electrical Stimulation (FES) Cycling Therapy System for home use. This collaboration broadens Lifeward's distribution rights, enabling them to include referral sales of the MyoCycle FES system for home-based therapy. The MyoCycle FES Cycling Therapy System is designed to assist individuals with neurological disorders in maintaining muscle health and improving mobility through electrical stimulation during cycling exercises.

LFWD’s Zacks Rank & Stocks to Consider

LFWD carries a Zacks Rank #3 (Hold) at present.

Some better-ranked stocks in the broader medical space are Masimo MASI, Boston Scientific BSX and Cardinal Health CAH. At present, Masimo sports a Zacks Rank #1 (Strong Buy), whereas Boston Scientific and Cardinal Health carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Masimo’s shares have rallied 30.1% in the past year. Estimates for MASI’s 2024 earnings per share (EPS) have increased 1.2% to $4.10 in the past 30 days. MASI’s earnings beat estimates in each of the trailing four quarters, the average surprise being 17.1%. In the last reported quarter, it posted an earnings surprise of 16.6%.

Estimates for Boston Scientific’s 2025 EPS have jumped 2.9% to $2.85 in the past 30 days. Shares of the company have surged 56.7% in the past year compared with the industry’s growth of 12.5%. BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 8.25%. In the last reported quarter, it delivered an earnings surprise of 7.69%.

Estimates for Cardinal Health’s fiscal 2025 EPS have increased 1.5% to $7.94 in the past 30 days. Shares of the company have gained 15.2% in the past year against the industry’s 4.1% decline. CAH’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 9.6%. In the last reported quarter, it delivered an earnings surprise of 10.3%.

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This article originally published on Zacks Investment Research (zacks.com).

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