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Medtronic's (MDT) INVOS System Gets FDA 510 (k) Clearance
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Medtronic plc (MDT - Free Report) recently announced the receipt of the FDA 510 (k) clearance for its INVOS 7100 cerebral/somatic oximetry system for children from birth to age 18. The INVOS 7100 system with pediatric indications will be available for commercial use in spring 2022 across the globe.
The receipt of the FDA 510(k) clearance for the INVOS 7100 cerebral/somatic oximetry system is likely to bolster Medtronic’s patient monitoring business, which is part of the company’s Medical Surgical Portfolio.
More on INVOS System
The INVOS system is designed to pick up crucial signals to inform time-sensitive decisions by pediatric clinicians. These signals are associated with hemodynamic management, ventilation and resuscitation for premature infants, neonates, children and other patients treated by pediatric clinicians.
The INVOS 7100 system delivers first-alert performance with unique algorithms for measuring acute alterations in hemodynamics, regional oxygen saturation and oxygen metabolism. The system offers continuous, non-invasive readings of organ-specific regional blood oxygen levels in up to four site-specific areas as selected by the care team as well as oxygen saturation from vascular beds to evaluate organs individually or in combination to track brain/body perfusion shifts.
Significance of the INVOS System
Per Medtronic’s management, the INVOS 7100 system can alert clinicians to changes in patient condition before traditional monitored parameters can even react. Moreover, the INVOS 7100 system allows clinicians to decide if intervention is necessary, which acts as a core element in successful outcomes.
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Further, the FDA clearance expands the use of the INVOS 7100 system, helping clinicians better monitor organ-specific oxygen levels and detect warnings signs for neonates and children in advance.
Industry Prospects
Per a report by Market Research Future, the global cerebral oximetry monitoring market was $130 million in 2018 and is projected to see a CAGR of 7.1% by 2024. Increasing demand for non-invasive procedures and rising penetration in surgical procedures are the factors driving the market.
Recent Developments
In December 2021, Medtronic’s subsidiary, Medtronic Canada ULC, received a Health Canada license for the Hugo robotic-assisted surgery (RAS) system for utilization in urologic and gynecologic laparoscopic surgical procedures. The Hugo RAS system is a modular, multi-quadrant platform that brings together wristed instruments, 3D visualization and a cloud-based surgical video capture option in Touch Surgery Enterprise.
In the same month, Medtronic Canada ULC received a Health Canada license for the GI Genius intelligent endoscopy module. The GI Genius is a computer-aided detection (CADe) system that employs artificial intelligence (AI) to highlight colon regions that may have visual characteristics associated with various forms of mucosal abnormalities.
Price Performance
Shares of the company have lost 12.1% in a year against the industry's decline of 6.2%.
Few better-ranked stocks from the broader medical space are Thermo Fisher Scientific Inc. (TMO - Free Report) , Laboratory Corporation of America Holdings (LH - Free Report) or LabCorp and Medpace Holdings, Inc. (MEDP - Free Report) .
Thermo Fisher, currently carrying a Zacks Rank #2 (Buy), reported third-quarter 2021 adjusted earnings per share (EPS) of $5.76, which surpassed the Zacks Consensus Estimate by 23.3%. Revenues of $9.33 billion outpaced the Zacks Consensus Estimate by 12%.
Thermo Fisher has an estimated long-term growth rate of 14%. TMO surpassed estimates in the trailing four quarters, the average surprise being 9.02%.
LabCorp, carrying a Zacks Rank #2, reported third-quarter 2021 adjusted EPS of $6.82, which surpassed the Zacks Consensus Estimate by 42.9%. Revenues of $4.06 billion outpaced the Zacks Consensus Estimate by 13.4%.
LabCorp has an estimated long-term growth rate of 10.6%. LH surpassed estimates in the trailing four quarters, the average surprise being 25.7%.
Medpace reported third-quarter 2021 adjusted EPS of $1.29, surpassing the Zacks Consensus Estimate by 20.6%. Revenues of $295.57 million beat the Zacks Consensus Estimate by 1.2%.
Medpace has an estimated long-term growth rate of 16.4%. MEDP surpassed estimates in the trailing four quarters, the average surprise being 11.9%. It currently sports a Zacks Rank #2.
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Medtronic's (MDT) INVOS System Gets FDA 510 (k) Clearance
Medtronic plc (MDT - Free Report) recently announced the receipt of the FDA 510 (k) clearance for its INVOS 7100 cerebral/somatic oximetry system for children from birth to age 18. The INVOS 7100 system with pediatric indications will be available for commercial use in spring 2022 across the globe.
The receipt of the FDA 510(k) clearance for the INVOS 7100 cerebral/somatic oximetry system is likely to bolster Medtronic’s patient monitoring business, which is part of the company’s Medical Surgical Portfolio.
More on INVOS System
The INVOS system is designed to pick up crucial signals to inform time-sensitive decisions by pediatric clinicians. These signals are associated with hemodynamic management, ventilation and resuscitation for premature infants, neonates, children and other patients treated by pediatric clinicians.
The INVOS 7100 system delivers first-alert performance with unique algorithms for measuring acute alterations in hemodynamics, regional oxygen saturation and oxygen metabolism. The system offers continuous, non-invasive readings of organ-specific regional blood oxygen levels in up to four site-specific areas as selected by the care team as well as oxygen saturation from vascular beds to evaluate organs individually or in combination to track brain/body perfusion shifts.
Significance of the INVOS System
Per Medtronic’s management, the INVOS 7100 system can alert clinicians to changes in patient condition before traditional monitored parameters can even react. Moreover, the INVOS 7100 system allows clinicians to decide if intervention is necessary, which acts as a core element in successful outcomes.
Further, the FDA clearance expands the use of the INVOS 7100 system, helping clinicians better monitor organ-specific oxygen levels and detect warnings signs for neonates and children in advance.
Industry Prospects
Per a report by Market Research Future, the global cerebral oximetry monitoring market was $130 million in 2018 and is projected to see a CAGR of 7.1% by 2024. Increasing demand for non-invasive procedures and rising penetration in surgical procedures are the factors driving the market.
Recent Developments
In December 2021, Medtronic’s subsidiary, Medtronic Canada ULC, received a Health Canada license for the Hugo robotic-assisted surgery (RAS) system for utilization in urologic and gynecologic laparoscopic surgical procedures. The Hugo RAS system is a modular, multi-quadrant platform that brings together wristed instruments, 3D visualization and a cloud-based surgical video capture option in Touch Surgery Enterprise.
In the same month, Medtronic Canada ULC received a Health Canada license for the GI Genius intelligent endoscopy module. The GI Genius is a computer-aided detection (CADe) system that employs artificial intelligence (AI) to highlight colon regions that may have visual characteristics associated with various forms of mucosal abnormalities.
Price Performance
Shares of the company have lost 12.1% in a year against the industry's decline of 6.2%.
Zacks Rank and Key Picks
Medtronic currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Few better-ranked stocks from the broader medical space are Thermo Fisher Scientific Inc. (TMO - Free Report) , Laboratory Corporation of America Holdings (LH - Free Report) or LabCorp and Medpace Holdings, Inc. (MEDP - Free Report) .
Thermo Fisher, currently carrying a Zacks Rank #2 (Buy), reported third-quarter 2021 adjusted earnings per share (EPS) of $5.76, which surpassed the Zacks Consensus Estimate by 23.3%. Revenues of $9.33 billion outpaced the Zacks Consensus Estimate by 12%.
Thermo Fisher has an estimated long-term growth rate of 14%. TMO surpassed estimates in the trailing four quarters, the average surprise being 9.02%.
LabCorp, carrying a Zacks Rank #2, reported third-quarter 2021 adjusted EPS of $6.82, which surpassed the Zacks Consensus Estimate by 42.9%. Revenues of $4.06 billion outpaced the Zacks Consensus Estimate by 13.4%.
LabCorp has an estimated long-term growth rate of 10.6%. LH surpassed estimates in the trailing four quarters, the average surprise being 25.7%.
Medpace reported third-quarter 2021 adjusted EPS of $1.29, surpassing the Zacks Consensus Estimate by 20.6%. Revenues of $295.57 million beat the Zacks Consensus Estimate by 1.2%.
Medpace has an estimated long-term growth rate of 16.4%. MEDP surpassed estimates in the trailing four quarters, the average surprise being 11.9%. It currently sports a Zacks Rank #2.