Johnson & Johnson Wins FDA 510(k) Clearance for MONARCH QUEST 3 Update

Johnson & Johnson JNJ recently received FDA 510(k) clearance for MONARCH QUEST 3, the latest software update for its MONARCH Platform for robotically assisted bronchoscopy. The update advances planning, navigation and targeting capabilities, with a focus on supporting clinicians during complex procedures and improving confidence in the early detection of lung cancer.

The MONARCH Platform is the first flexible, robotically assisted bronchoscopy platform and provides continuous visualization throughout procedures, including navigation to and biopsy of targets under direct vision. MONARCH QUEST 3 builds on this foundation by enhancing the platform’s ability to account for CT-to-body divergence and anatomical changes that may occur during bronchoscopy.

The latest release incorporates Polyphonic for MONARCH, Johnson & Johnson’s open digital ecosystem. The technology enables clinicians to review procedural volume data and collaborate through a centralized video library. By organizing each MONARCH case into a consistent format, the platform can support procedural review and learning.

Per management, being an early market entrant comes with the responsibility to continuously innovate. With MONARCH QUEST 3, Johnson & Johnson is advancing the MONARCH Platform through collaboration with clinicians, incorporating artificial intelligence, enhancing imaging integration and introducing software improvements to support procedural confidence and precision for patients.

Likely Trend of JNJ Stock Following the News

JNJ stock has gained 1.9% since the announcement on Monday. Year to date, shares of the company have climbed 29.2% compared with the industry’s 16.8% growth and the S&P 500’s 11.2% rise.

In the long run, MONARCH QUEST 3 could strengthen JNJ’s position in robotically assisted bronchoscopy and expand the clinical utility of the MONARCH Platform. Continued software innovation may support physician adoption, improve the platform’s competitive differentiation and create opportunities for recurring technology-driven revenue. Broader compatibility with existing imaging systems could also reduce infrastructure barriers for healthcare providers and support commercial expansion.

JNJ currently has a market capitalization of $658.89 billion.

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More on MONARCH QUEST 3

A key advancement in MONARCH QUEST 3 is AI-powered nodule segmentation, which is designed to automatically generate more accurate nodule boundaries with a single click during pre-procedural planning.

The software introduces enhancements to registration and navigation accuracy, helping clinicians maintain confidence as patient anatomy shifts during bronchoscopy. A new 3D Compass overlay improves visual orientation by connecting joystick controls with patient anatomy, simplifying scope-tip orientation during navigation.

Another important enhancement is broader compatibility with commonly used mobile and fixed cone-beam computed tomography (CBCT) imaging systems. This allows clinicians to leverage existing imaging infrastructure to manage CT-to-body divergence and improve lung nodule targeting.

Industry Prospects Favoring the Market

Per a report by Precedence Research, the global bronchoscopy market size is predicted to be valued at $3.77 billion in 2026 and is expected to witness a CAGR of 7.7% through 2035.

Growth is largely attributed to the increasing cases of respiratory diseases in the geriatric population, the use of disposable equipment and chronic obstructive pulmonary disease. The robotic-assisted bronchoscopy segment expects the fastest growth in the market, backed by the high precision, stability and advanced navigation capabilities offered by robotic systems, early and precise diagnosis of lung cancer and other pulmonary diseases, along with increasing adoption of robotic technology in minimally invasive procedures.

Other News

Johnson & Johnson recently announced that the FDA granted De Novo authorization for its OTTAVA Robotic Surgical System, the world’s first table-integrated soft tissue robotic system. The authorization covers multiple general surgery procedures, including gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, appendectomy and hernia repair. OTTAVA integrates robotic arms into the operating table, offering a compact footprint, automated positioning, advanced instruments and connectivity to the Polyphonic digital ecosystem to support more efficient, data-driven surgical workflows.

Johnson & Johnson also announced FDA approval for its Dual Energy THERMOCOOL SMARTTOUCH SF Platform, an integrated catheter ablation solution enabling electrophysiologists to deliver both radiofrequency (RF) and pulsed field (PF) energy through a single catheter. Integrated with the CARTO ecosystem, the platform combines advanced mapping, imaging and PF Index guidance to support precise, adaptable procedures.

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JNJ’s Zacks Rank & Key Picks

Currently, JNJ carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are Globus Medical GMED, West Pharmaceutical WST and The Cooper Companies COO.

Globus Medical, currently sporting a Zacks Rank #1 (Strong Buy), reported a second-quarter 2026 adjusted earnings per share (EPS) of $1.34, which surpassed the Zacks Consensus Estimate by 19.6%. Revenues of $789.6 million beat the Zacks Consensus Estimate by 0.4%. You can see the complete list of today’s Zacks #1 Rank stocks here.

GMED has an estimated long-term earnings growth rate of 12.4%. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 27.9%.

West Pharmaceutical, carrying a Zacks Rank #2 (Buy) at present, reported second-quarter 2026 adjusted EPS of $2.37, which beat the Zacks Consensus Estimate by 13.9%. Revenues of $872.3 million surpassed the Zacks Consensus Estimate by 4.2%.

WST has an estimated long-term earnings growth rate of 16%. WST’s earnings surpassed estimates in the trailing four quarters, the average surprise being 17.4%.

The Cooper Companies, carrying a Zacks Rank #2 at present, reported a second-quarter fiscal 2026 adjusted EPS of $1.21, which beat the Zacks Consensus Estimate by 10%. Revenues of $1.08 billion beat the Zacks Consensus Estimate by 2.6%.

COO has an estimated long-term earnings growth rate of 8.3%. COO’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 5.8%.

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