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Fierce Biotech·Aug 18·1 min read
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J&J MedTech secures FDA 510(k) clearance for Monarch Quest 3 bronchoscopy software update

Aug 18, 2026·read at Fierce Biotech ↗RegulatoryPositive

Johnson & Johnson MedTech announced that its Monarch bronchoscopy robot has received FDA 510(k) clearance for the latest software version, Monarch Quest 3. This marks the fourth major software launch for the platform in the past 18 months.

The new update enhances planning, navigation, and targeting capabilities, helping physicians account for CT‑to‑body divergence and anatomical changes during bronchoscopy. An AI‑driven nodule‑segmentation tool can generate precise nodule boundaries with a single click during pre‑procedural planning.

Monarch Quest 3 also integrates J&J’s Polyphonic digital ecosystem, allowing clinicians to review procedural volume data and collaborate through a centralized video library, extending surgical intelligence beyond the procedure.

The clearance underscores J&J MedTech’s commitment to advancing robotically‑assisted bronchoscopy and could aid in earlier detection of lung cancers.

source

This writeup was produced by pharmadog from original reporting by Fierce Biotech.

Original headline: “Johnson & Johnson MedTech nabs Monarch Quest 3 update for lung cancer detection”

read at Fierce Biotech ↗
414 words · retrieved Aug 18
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companies & drugs in this story

companies
JOHNSON & JOHNSON8
topics
Medical Device Company11Pulmonology9510(k) Clearance3NSCLC3Oncology3Approval2

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