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Home » Johnson & Johnson MedTech to submit Ottava for FDA clearance in FY26 as sales rise in Q2 beat

Johnson & Johnson MedTech to submit Ottava for FDA clearance in FY26 as sales rise in Q2 beat

July 16, 2025 By Sean Whooley

This is the logo of Johnson & Johnson.

Johnson & Johnson (NYSE: JNJ) shares are up today on second-quarter results that came in ahead of the consensus forecast.

On the back of the results, J&J increased its 2025 guidance, projecting adjusted EPS to range between $10.80 and $10.90 for the full year. The company previously expected between $10.50 and $10.70. It projects between $93.2 billion and $93.6 billion in sales, rising from the previous range of $91 billion to $91.8 billion.

The company also shared its intent to submit its major entry into the soft tissue surgical robotics space for regulatory clearance.

Tim Schmid, EVP and Worldwide Chair of Johnson & Johnson MedTech, will open DeviceTalks West, Oct. 15–16, 2025 in Santa Clara, California. Register now at West.DeviceTalks.com.

Shares of JNJ rose more than 6% to $164.54 apiece in morning trading.

The New Brunswick, New Jersey–based medtech giant reported profits of $5.5 billion in the quarter. That equals $2.29 per share on sales of $23.7 billion for the three months ended June 29, 2025.

Johnson & Johnson recorded an 18.2% bottom-line gain on a sales increase of 5.8%.

Adjusted to exclude one-time items, earnings per share came in at $2.77. That landed 9¢ ahead of expectations on Wall Street. Sales also topped the forecast as experts projected $22.9 billion in revenue.

The company’s MedTech unit reported $8.5 billion in revenue for the quarter. That marked 7.3% reported growth and 6.1% operational growth. Net acquisitions and divestitures positively impacted growth by 2%, the company said. It pointed to electrophysiology products and Abiomed products in Cardiovascular as growth drivers. General Surgery’s wound closure products also drove growth.

Cardiovascular delivered 23.5% year-over-year reported sales growth in the quarter. Electrophysiology sales increased 11% as part of that, while Abiomed contributed 18.2% growth.

“Today’s strong results reflect the depth and strength of Johnson & Johnson’s uniquely diversified business operating across both MedTech and Innovative Medicine,” said Joaquin Duato, chair and CEO, Johnson & Johnson. “Our portfolio and pipeline position us for elevated growth in the second half of the year, with game-changing approvals and submissions anticipated in areas like lung and bladder cancer, major depressive disorder, psoriasis, surgery and cardiovascular, which will extend and improve lives in transformative ways.”

Company to submit Ottava for FDA clearance in fiscal 2026

BTIG analysts Ryan Zimmerman and Iseult McMahon say Johnson & Johnson MedTech plans to submit its Ottava surgical robot for FDA de novo 510(k) clearance in fiscal 2026.

Johnson & Johnson first shared details on the Ottava surgical robotic platform in November 2020. The company hoped to penetrate the soft tissue robotics space dominated for decades by Intuitive Surgical.

However, after that initial unveiling, the company remained quiet on the topic for the most part. In October 2021, it pushed back the platform’s development timeline by about two years due to multiple factors.

In October 2024, the company announced that it submitted Ottava for IDE. Less than a month later, the FDA approved that IDE, enabling J&J to initiate this study of the surgical robot. The company reported the first completed cases with Ottava in April of this year.

Ottava incorporates four robotic arms into a standard-size surgical table. Its unified architecture allows for an invisible design, J&J says. The robotic arms are available when needed and stowed beneath the surgical table when not.

The analysts’ view on the J&J results

BTIG analysts Ryan Zimmerman and Iseult McMahon say the MedTech unit’s results topped their projections for $8.248 billion in sales.

The analysts note that management expects growth from new products, plus the benefits of last year’s acquisition of Shockwave Medical.

With the Orthopedics business, the analysts note that $2.3 billion in revenue marked a 0.3% year-over-year decline. New products and procedure growth, plus commercial execution, drove growth in some areas, but the analysts highlighted a tough year-over-year comparison. They say the Trauma portfolio remains steady but headwinds on Knees may weigh on competitors Stryker and Zimmer Biomet even while they might take share from J&J as well.

The analysts also pointed to 6.5% growth in Vision Care and 2.7% growth in Surgery, alongside a 2.1% decline in Spine. They said the company continues to put pressure on Alcon with its intraocular lenses in Vision. In Surgery, technology penetration and Wound Closure upgrades drove growth, but competitive pressure hit the company in its Energy portfolio.

For Spine, the analysts say J&J cited competitive pressures, price pressures and organizational realignments. They said the company “continues to cede share in Spine,” with losses benefiting Medtronic, Globus Medical and Alphatec, primarily.

Tim Schmid, EVP and Worldwide Chair of Johnson & Johnson MedTech, will open DeviceTalks West, Oct. 15–16, 2025 in Santa Clara, California. Register now at West.DeviceTalks.com.

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, Robotic-Assisted, Surgical Robotics, Wall Street Beat Tagged With: Johnson & Johnson, Johnson & Johnson MedTech

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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