Masimo's smartSET™ FDA Clearance Offers Breakthrough Innovation in Pulse Oximetry to Help Improve Critical Patient Outcomes
Masimo received FDA 510(k) clearance for an AFib detection capability on its Radius VSM monitor, completing the smartSET pulse oximetry platform alongside previously cleared AI-enabled opioid-induced respiratory depression (OIRD) detection. Clinical validation of the PPG AFib feature showed 97% sensitivity and 100% specificity versus ECG-based ground truth, positioning smartSET to move pulse oximetry from spot-check measurement toward AI-driven clinical insight. Masimo, now a Danaher company, said it intends to keep expanding the smartSET platform to address additional clinical needs, extending its core monitoring franchise into earlier detection of arrhythmias and respiratory compromise.
Masimo Wins Two OCTANE High Tech Awards - Company Recognized for 'Deal of the Year' and 'Best Technology Leadership Team'
Masimo won two 2026 Octane High Tech Awards: 'Deal of the Year' for Danaher's $9.9 billion acquisition completed in June 2026, and 'Best Technology Company Leadership Team.' President Tim Benner highlighted the leadership team's focus on patient-centricity and innovation during the transition into Danaher's Diagnostics platform. The release is promotional recognition with no new financial or operational disclosures; it confirms Masimo now operates as a Danaher company.
Masimo Receives FDA 510(k) Clearance for Root® with LiDCO® and the Masimo LiDCO Sensor to Provide Continuous Oxygen Delivery (DO₂)
Masimo received FDA 510(k) clearance for its Root patient monitor integrated with LiDCO hemodynamic monitoring and the Masimo LiDCO sensor to provide continuous oxygen delivery (DO₂) assessment. The new capability combines noninvasive hemoglobin, pulse oximetry, and cardiac output to offer a real-time view of oxygen transport to tissues, addressing a limitation of prior intermittent lab measurements. Clinical data cited in the release indicates that DO₂-guided care can significantly reduce mortality in high-risk surgical patients.
Masimo Receives CE Mark for AI-Powered smartSedLine™ Brain Function Monitor to Advance Anesthetic Management
Masimo announced it has received CE Mark for smartSedLine, a next-generation brain function monitor featuring an AI-powered algorithm designed to improve responsiveness during anesthesia induction. The device monitors the brain's electrical activity to provide a Patient State Index, with enhancements specifically targeting stability for geriatric and critically ill patients. smartSedLine PSi is now available in applicable markets, though 510(k) clearance is still pending in the United States.
Masimo Appoints Tim Benner as President
Masimo appointed Tim Benner as President effective August 3, 2026, elevating him from Chief Commercial Officer where he led global commercial strategy. Benner joined Masimo in June 2025 and played a key role in the company's integration and transition following its acquisition by Danaher. He brings over 30 years of med-tech experience from senior roles at Edwards Lifesciences, Abbott, and Terumo.
Masimo Receives FDA 510(k) Clearance for the Pediatric Patient State Index, the First-and-Only Sedation Score Specifically Designed for the Unique Physiology of the Pediatric Brain
Masimo received FDA 510(k) clearance for the Pediatric Patient State Index (PSi), the first sedation score specifically designed for the unique physiology of the pediatric brain. The feature, part of the Masimo SedLine brain function monitoring platform, enables clinicians to monitor depth of sedation in children aged four and older using bilateral brain data. Clinical data from 169 pediatric patients supported the clearance, showing the score's responsiveness and correlation with manually scored anesthesia stages.
Masimo Receives FDA 510(k) Clearance for AI-Enabled Opioid-Induced Respiratory Depression (OIRD) Detection on Radius VSM® to Help Identify Respiratory Risk Sooner
MASI: 8-K · acquisition merger
Danaher Corporation completed its acquisition of Masimo Corporation on June 10, 2026, for $180.00 per share in cash. Masimo shareholders received this fixed cash consideration, and Masimo’s common stock ceased trading on Nasdaq and was delisted. Masimo became a wholly owned subsidiary of Danaher, triggering a change in control. The company terminated its existing credit agreement with Bank of America and paid off all outstanding obligations in full. Several Masimo directors resigned, and key executives including Catherine Szyman, Gregory Meehan, and Charles Dadswell entered into separation agreements. These executives will provide consulting services for three months post-closing in exchange for severance benefits and consulting fees.
Sirius XM Holdings Set to Join S&P MidCap 400
Sirius XM Holdings (SIRI) will replace Masimo Corp. (MASI) in the S&P MidCap 400 effective June 11, 2026. The release notes that Danaher Corp. (DHR) is acquiring Masimo in a deal expected to complete soon pending final conditions. This is an index maintenance announcement issued by S&P Dow Jones Indices; it has no direct material impact on Danaher's operations or financials.
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Masimo Shareholders Approve Acquisition by Danaher
Masimo shareholders voted to approve the proposed merger with Danaher, which values each share of Masimo common stock at $180.00 in cash. The transaction is expected to close in 2026, subject to the satisfaction of customary closing conditions including receipt of required regulatory approvals. Following the merger, Masimo is slated to operate as an independent company within Danaher’s Diagnostics segment.
Masimo SET Shows Accurate Pulse Oximetry in Newborns of All Skin Tones
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Masimo SET® Pulse Oximetry Performed Accurately on Hospitalized Newborns of All Skin Tones in Largest-Ever Prospective Real-World Study
Masimo announced results from the NIH-funded NeoPODS study demonstrating that its SET pulse oximetry technology had less than 1% overall statistical bias in critically ill newborns. The analysis of 136 paired readings from 70 patients revealed zero occult hypoxemia events in Black or Hispanic infants and no clinically meaningful discrepancies in performance across different skin pigmentation categories. Masimo CMO Dr. Daniel Cantillon noted the findings align with prior adult studies and emphasize the importance of device-specific evaluation under real-world conditions.
Apple Scores Key Win As Trade Commission Rejects Masimo's Bid To Reinstate Apple Watch Import Ban
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This Fund Built a $26 Million Stake in a Medical Tech Stock That's Soaring After a $9.9 Billion Deal Announcement
