Masimo Archives - Medical Design Sourcing

Masimo stock dips despite Street-beating Q4

Masimo (Nasdaq: MASI) + shares fell slightly despite fourth-quarter results that came in ahead of the consensus forecast.

Shares of MASI dipped 2.6% at $126.76 apiece in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.3%.

The Irvine, California-based patient monitoring technology developer posted profits of $34 million. That equals 63¢ per share on sales of $548.9 million for the three months ended Dec. 30, 2023. Healthcare revenue totaled $339.9 million for the quarter.

Masimo recorded a 17.3% bottom-line slide on a sales decline of 11%.

Adjusted to exclude one-time items, earnings per share came in at $1.25. That landed 38¢ ahead of the forecasts on Wall Street. Sales also topped expectations as analysts expected $545.7 million in revenue.

“We exited 2023 with growing momentum driven by record contra…

FDA clears first over-the-counter fingertip pulse oximeter from Masimo

The MightSat Medical fingertip pulse oximeter. [Image courtesy of Masimo]Masimo (Nasdaq: MASI) + announced today that it received FDA clearance for its MightySat Medical over-the-counter fingertip pulse oximeter.

The company says that the regulatory nod makes MightySat Medical the first and only FDA-cleared medical fingertip pulse oximeter available over the counter (OTC), direct to consumers without a prescription.

Irvine, California-based Masimo powers its OTC pulse oximeter with its SET technology. Hospitals and clinics around the world utilize the SET technology. Just last week, the company announced that SET pulse oximetry technology performs consistently across a variety of skin pigmentations as well.

Masimo said in a news release that MightySat Medical offers accurate and reliable oxygen saturation (SpO2) and pulse rate (PR) measurements on patients of all skin colors and patients with low perfusion.

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Study says Masimo pulse oximetry is accurate for different skin colors

[Image from Masimo]Masimo today announced findings from a study evaluating its pulse oximetry technology across a variety of skin pigmentations.

Dr. Vikrant Sharma, Dr. Steven Barker, Dr. William C. Wilson and colleagues at Masimo performed a focused analysis of previously published data evaluating the impact of low perfusion on the performance of Masimo SET pulse oximetry across multiple skin pigmentations. They published their retrospective, peer-reviewed study in the Journal of Clinical Monitoring and Computing.

The analysis demonstrated accurate oxygen saturation (SpO2) measurements with Masimo RD SET sensors for both Black and White subjects with a normal perfusion index (Pi) and a low Pi. Masimo said it adds to the body of evidence supporting its pulse oximetry’s accuracy across the skin tone range. It saw no clinically significant difference in accuracy or bias, even in challenging conditions.

This data adds to a growing body of clinical eviden…

Court denies Apple’s watch ban appeal in Masimo patent spat

The Apple Watch Series 9 [Image courtesy of Apple]Bloomberg reports that the U.S. Court of Appeals declined to grant a longer pause on the Apple Watch import ban as a result of patent litigation with Masimo (Nasdaq: MASI) + .

Shares of MASI grew 2.1% to $122.57 apiece just before the market closed today on the back of the news.

The patent battle goes back as far as January 2020, centering around light-based pulse oximetry technology used by the watches. Masimo develops a number of technologies that use pulse oximetry, including its recently FDA-cleared W1 smartwatch.

A turning point in the long-running dispute came in October when the U.S. International Trade Commission (ITC) ruled in Masimo’s favor. The ITC recommended a limited exclusion order for infringing Apple Watches with light-based pulse oximetry functionality. It found that Apple violated U.S. laws by incorporating this patented technology in its products.…

Apple reportedly pulling pulse oximetry from watches if Masimo appeal fails

The Apple Watch Series 9 [Image courtesy of Apple]Federal customs officials have reportedly approved Apple’s workaround to continue importing Series 9 and Ultra 2 watches if it fails in its appeal of an import ban in its patent dispute with Masimo.

The consumer tech giant has told U.S. Customs and Border Protection that redesigned watches “definitively do not contain pulse oximetry functionality,” according to a Masimo filing with the Federal Circuit that was recounted in media outlets. Masimo said the agency has signed off on Apple’s plan to get around the International Trade Commission import ban, though the decision has not yet been published in the Federal Register.

In a statement shared with MassDevice, Masimo said: “Apple’s claim that its redesigned watch does not contain pulse oximetry is a positive step toward accountability. It is especially important that one of the world’s largest and most powerful companies res…

PTAB to review Apple’s ECG patents amid legal battle with AliveCor

A figure from AliveCor’s patent, included in the PTAB ruling

The U.S. Patent Trial and Appeal Board (PTAB) will review two Apple-owned electrocardiogram technology patents in an infringement suit as AliveCor looks to reverse the board’s opinion from December 2023.

A panel of administrative patent judges granted AliveCor’s bid for a review, citing a “reasonable likelihood” that AliveCor would successfully show the unpatentability of Apple’s technology. The PTAB will formally review the validity of certain patent claims, considering AliveCor’s arguments. However, it’s important to note that this is just the beginning of the process, and no final decisions on the patentability of the claims have been made yet.

In a statement to MassDevice, AliveCor said: “AliveCor applauds the U.S. Patent Trial and Appeal Board (PTAB) decisions to institute Inter Partes Review (IPR) of two patents Apple meritlessly asserted aga…

Apple Watch ban goes into effect after Masimo patent battle, presidential review

Sales of the Apple Watch Series 9 have been halted as a result of an ongoing patent dispute with Masimo. [Image courtesy of Apple]President Joe Biden’s administration declined to veto an import ban on Apple Watches after the government ruled in favor of Masimo (NYSE: PHG) + in a patent spat.

The long-running battle between companies came to a head last week when Apple paused sales of two models of its smartwatch. This spat centers around light-based pulse oximetry technology used by the watches. Masimo develops a number of technologies that use pulse oximetry, including its recently FDA-cleared W1 smartwatch.

This followed an an October ruling in Masimo’s favor from the U.S. International Trade Commission (ITC). The ITC recommended a limited exclusion order for infringing Apple Watches with light-based pulse oximetry functionality. It found that Apple violated U.S. laws by incorporating this patented technolog…

Apple reportedly stops U.S. sales of certain smartwatches amid Masimo patent spat

Apple stopped sales of its Watch Series 9 due to a patent dispute with Masimo. [Image from Apple]Apple reportedly paused sales of two models of its smartwatches in the U.S. as it looks to resolve a patent dispute with Masimo (Nasdaq: MASI) + .

Apple confirmed the decision in a statement to 9to5Mac.

The patent spat goes back as far as January 2020, centering around light-based pulse oximetry technology used by the watches. Masimo develops a number of technologies that use pulse oximetry, including its recently FDA-cleared W1 smartwatch.

A turning point in the long-running dispute came in October when the U.S. International Trade Commission (ITC) ruled in Masimo’s favor. The ITC recommended a limited exclusion order for infringing Apple Watches with light-based pulse oximetry functionality. It found that Apple violated U.S. laws by incorporating this patented technology in its products.

When the ITC issue…

FDA clears Masimo Stork home baby monitoring system

The Stork boot on a baby next to an image of the components of Stork. [Image courtesy of Masimo]The FDA today published a 510(k) premarket notification granting clearance to the Stork baby monitoring system from Masimo (Nasdaq: MASI) + .

Stork offers a continuous and accurate view of a baby’s health data. It leverages Masimo’s noninvasive neonate monitoring technologies.

Masimo’s smart home baby monitoring system officially received its clearance on Dec. 15. The company already began its U.S. rollout to major retailers in August, having kicked off its initial launch in May. BTIG analysts Marie Thibault and Sam Eiber say the company plans to ramp up to around 250 outlets by year-end. They expect approximately 1,000 by 2024.

According to the analysts, prices range from $249 to $549 depending on the bundle for the Stork system. They say Masimo projects a market opportunity for Stork at around $500 million, making…

FDA clears Masimo W1 medical watch

The Masimo W1 medical watch [Image courtesy of Masimo]Masimo (NASDAQ: MASI) + has received FDA 510(k) clearance for its medical watch for both over-the-counter and prescription use.

The FDA clearance is the latest good news for Masimo, which has been making headway in its patent battle with tech giant Apple. MASI shares were up more than 1% to $94.75 apiece by midday trading today on the news, which came out on the evening of Friday, Nov. 17. MassDevice‘s MedTech 100 Index is up slightly.

According to the company, the Masimo W1 is the first FDA-cleared watch capable of continuously monitoring real-time oxygen saturation (SpO2) and pulse rate for both general and medical use. The FDA’s clearance enables people to use the watch in hospitals, clinics, long-term care facilities, at home, and more.

“Clinicians at numerous prestigious institutions in Europe and the Middle East are already using Masimo W1 in…

GE HealthCare, Masimo collaborate on patient monitoring tech

The Portrait Mobile system. [Image courtesy of GE HealthCare]GE HealthCare (Nasdaq: GEHC) + and Masimo (Nasdaq: MASI) + today announced a joint agreement to integrate patient monitoring technologies.

The agreement aims to integrate Masimo Signal Extraction Technology (SET) pulse oximetry into GE HealthCare’s Portrait Mobile wireless, wearable patient monitoring solution.

Portrait Mobile, built as an internet of medical things (IoMT) platform, uses cloud-native technology. It provides an end-to-end experience for wearable, continuous monitoring. The FDA cleared Portrait Mobile in August of this year.

Integrating Masimo SET enables clinicians to leverage Masimo’s measure-through motion and low-perfusion oxygen saturation (SpO2) measurement technology. It allows for noninvasive detection and continuous monitoring of changes in patient status.

Uses of SET te…

ITC rules in favor of Masimo in Apple Watch patent spat, stock rises

The W1 smartwatch [Image from Masimo]Masimo (Nasdaq: MASI) + announced that the U.S. International Trade Commission (ITC) ruled in its favor in an ongoing patent battle with tech giant Apple.

Shares of MASI ticked up more than 5% at $85.26 apiece by midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell slightly.

The ITC recommended a limited exclusion order for infringing Apple Watches with light-based pulse oximetry functionality. It found that Apple violated U.S. laws by incorporating this patented technology in its products, Masimo said. The exclusion goes into effect after a 60-day presidential review period, according to a news release.

“Today’s ruling by the USITC sends a powerful message that even the world’s largest company is not above the law,” said Joe Kiani, founder, chair, and CEO of Masimo. “This important determ…