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Masimo's (MASI) W1 Watch Gains FDA Nod for SafetyNet Connectivity
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Masimo Corporation (MASI - Free Report) recently announced the receipt of the FDA’s 510(k) clearance for its W1 medical watch. The approval allows the watch to be integrated with the Masimo SafetyNet comprehensive telemonitoring solution.
The Masimo W1 medical watch and the integrated Masimo MW-1 module are indicated for adults in hospitals, clinics, long-term care facilities and homes.
It is worthwhile to note that the Masimo W1 medical watch received the FDA’s clearance last year as the first medical watch to provide continuous oxygen saturation and pulse rate for over-the-counter and prescription use at home and in hospitals.
The latest regulatory clearance of Masimo’s medical watch is expected to significantly strengthen its remote patient monitoring (RPM) business across the nation.
Significance of FDA Approval
Per Masimo, the combination of the W1 Medical and SafetyNet will likely enable accurate and reliable patient data, that has been collected conveniently and comfortably via the wrist, to be made available on the Masimo SafetyNet smartphone app and reviewed by remote caregivers. The remote caregivers, including hospital clinicians, will be able to review the collected patient data on the web-based Masimo SafetyNet clinician portal, irrespective of time and location.
Per management, the caregivers are expected to get customized notifications, based on data from an unobtrusive pulse oximeter worn on the patient’s wrist, especially in situations where there are logistical difficulties to provide care in person. Management believes that Masimo W1 Medical watch with Masimo SafetyNet will likely provide an opportunity for caregivers to improve the quality of care and outcomes for patients.
Currently, institutions in Europe and the Middle East are already integrating Masimo W1 with Masimo SafetyNet into their practices in various ways, such as programs that support more confident patient discharge and help anesthesiologists better understand each patient’s unique physiology prior to surgery. With the latest FDA clearance, management expects to bring these capabilities to the United States and allow regular people to take better care of each other.
Industry Prospects
Per a report by MarketsandMarkets, the global patient monitoring devices market is anticipated to reach from $48.5 billion in 2024 to $71.1 billion by 2029 at a CAGR of 8%. Factors like the rising burden of chronic diseases due to lifestyle changes, growth in the elderly population, increasing preference for home and remote monitoring and the ease of use of portable devices are expected to drive the market.
Given the market potential, the latest FDA clearance is likely to provide a significant boost to Masimo’s business.
Recent Developments
This month, Masimo reported its second-quarter 2024 results, wherein it registered an uptick in consolidated revenues and Healthcare revenues. On the earnings call, Masimo’s management confirmed that it saw strong demand for Masimo sensors due to the combination of strong hospital conversions over the past few years, normalization of installations, and rising hospital admissions after a tumultuous post-COVID environment.
In July, Masimo announced the findings of a prospective study in which researchers evaluated the impact of RPM using Masimo SafetyNet and a hospital’s virtual response center on 30-day readmission rates for patients undergoing acute postoperative recovery after total joint arthroplasty. The results were published in the Journal of Orthopaedics.
The same month, Masimo announced that the Masimo W1 Sport advanced health tracking wearable had been equipped with a new feature — scientifically-based sleep analysis with Sleep Halo.
Comparison With Peers
A notable player in the patient monitoring space and Masimo’s peer is Medtronic plc (MDT - Free Report) . This month, MDT announced the receipt of the FDA’s approval for its Simplera continuous glucose monitor (CGM). In the same press release, Medtronic announced a global partnership with Abbott to expand CGM options for diabetics. Under the agreement, Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and Smart MDI systems.
In June, Medtronic presented a comprehensive body of favorable new data at the American Diabetes Association's (ADA) Scientific Sessions that showcased the benefits of the MiniMed 780G system.
Another notable peer of Masimo is DexCom, Inc. (DXCM - Free Report) . Last month, DXCM reported its second-quarter 2024 results, wherein it registered a solid uptick in its revenues both on a reported and organic basis. Its U.S. and international revenues were also robust, both on a reported and organic basis.
During the quarter, DexCom launched Direct-to-Watch in the United States and several international markets, providing G7 customers the option to use an Apple Watch as their primary display for glucose readings.
Teladoc Health, Inc. (TDOC - Free Report) is another notable peer of Masimo in the patient monitoring space. Last month, TDOC announced the availability of comprehensive mental healthcare for children, adolescents and their families. The innovative offering, in partnership with Brightline, is offered through Teladoc’s virtual front door.
In June, Teladoc released positive new data from two studies that illustrate that its predictive modeling capabilities aid members with type 2 diabetes in controlling their blood sugar through participation in TDOC’s diabetes management program. The data was presented at the ADA’s Scientific Session.
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Masimo's (MASI) W1 Watch Gains FDA Nod for SafetyNet Connectivity
Masimo Corporation (MASI - Free Report) recently announced the receipt of the FDA’s 510(k) clearance for its W1 medical watch. The approval allows the watch to be integrated with the Masimo SafetyNet comprehensive telemonitoring solution.
The Masimo W1 medical watch and the integrated Masimo MW-1 module are indicated for adults in hospitals, clinics, long-term care facilities and homes.
It is worthwhile to note that the Masimo W1 medical watch received the FDA’s clearance last year as the first medical watch to provide continuous oxygen saturation and pulse rate for over-the-counter and prescription use at home and in hospitals.
The latest regulatory clearance of Masimo’s medical watch is expected to significantly strengthen its remote patient monitoring (RPM) business across the nation.
Significance of FDA Approval
Per Masimo, the combination of the W1 Medical and SafetyNet will likely enable accurate and reliable patient data, that has been collected conveniently and comfortably via the wrist, to be made available on the Masimo SafetyNet smartphone app and reviewed by remote caregivers. The remote caregivers, including hospital clinicians, will be able to review the collected patient data on the web-based Masimo SafetyNet clinician portal, irrespective of time and location.
Per management, the caregivers are expected to get customized notifications, based on data from an unobtrusive pulse oximeter worn on the patient’s wrist, especially in situations where there are logistical difficulties to provide care in person. Management believes that Masimo W1 Medical watch with Masimo SafetyNet will likely provide an opportunity for caregivers to improve the quality of care and outcomes for patients.
Currently, institutions in Europe and the Middle East are already integrating Masimo W1 with Masimo SafetyNet into their practices in various ways, such as programs that support more confident patient discharge and help anesthesiologists better understand each patient’s unique physiology prior to surgery. With the latest FDA clearance, management expects to bring these capabilities to the United States and allow regular people to take better care of each other.
Industry Prospects
Per a report by MarketsandMarkets, the global patient monitoring devices market is anticipated to reach from $48.5 billion in 2024 to $71.1 billion by 2029 at a CAGR of 8%. Factors like the rising burden of chronic diseases due to lifestyle changes, growth in the elderly population, increasing preference for home and remote monitoring and the ease of use of portable devices are expected to drive the market.
Given the market potential, the latest FDA clearance is likely to provide a significant boost to Masimo’s business.
Recent Developments
This month, Masimo reported its second-quarter 2024 results, wherein it registered an uptick in consolidated revenues and Healthcare revenues. On the earnings call, Masimo’s management confirmed that it saw strong demand for Masimo sensors due to the combination of strong hospital conversions over the past few years, normalization of installations, and rising hospital admissions after a tumultuous post-COVID environment.
In July, Masimo announced the findings of a prospective study in which researchers evaluated the impact of RPM using Masimo SafetyNet and a hospital’s virtual response center on 30-day readmission rates for patients undergoing acute postoperative recovery after total joint arthroplasty. The results were published in the Journal of Orthopaedics.
The same month, Masimo announced that the Masimo W1 Sport advanced health tracking wearable had been equipped with a new feature — scientifically-based sleep analysis with Sleep Halo.
Comparison With Peers
A notable player in the patient monitoring space and Masimo’s peer is Medtronic plc (MDT - Free Report) . This month, MDT announced the receipt of the FDA’s approval for its Simplera continuous glucose monitor (CGM). In the same press release, Medtronic announced a global partnership with Abbott to expand CGM options for diabetics. Under the agreement, Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and Smart MDI systems.
In June, Medtronic presented a comprehensive body of favorable new data at the American Diabetes Association's (ADA) Scientific Sessions that showcased the benefits of the MiniMed 780G system.
Another notable peer of Masimo is DexCom, Inc. (DXCM - Free Report) . Last month, DXCM reported its second-quarter 2024 results, wherein it registered a solid uptick in its revenues both on a reported and organic basis. Its U.S. and international revenues were also robust, both on a reported and organic basis.
During the quarter, DexCom launched Direct-to-Watch in the United States and several international markets, providing G7 customers the option to use an Apple Watch as their primary display for glucose readings.
Teladoc Health, Inc. (TDOC - Free Report) is another notable peer of Masimo in the patient monitoring space. Last month, TDOC announced the availability of comprehensive mental healthcare for children, adolescents and their families. The innovative offering, in partnership with Brightline, is offered through Teladoc’s virtual front door.
In June, Teladoc released positive new data from two studies that illustrate that its predictive modeling capabilities aid members with type 2 diabetes in controlling their blood sugar through participation in TDOC’s diabetes management program. The data was presented at the ADA’s Scientific Session.