Samsung Electronics Co., Ltd.

A little more than a year after its high-profile proxy battle , Masimo has agreed to be acquired by Danaher in a cash deal valued at $9.9 billion. Danaher has agreed to pay $180 per share in cash for the Irvine, CA-based company. The transaction has been unanimously approved by both Masimo’s board and Danaher’s board. Masimo will become a standalone business unit and brand within Danaher’s diagnostics segment and is expected to operate autonomously while strengthening Danaher’s offering in acute care settings. “We look forward to joining Danaher and continuing our growth and momentum as the global leader in patient monitoring,” Masimo CEO Katie Szyman said. “Danaher shares our commitment to investing in talent and innovation and will be an ideal fit to help power the next chapter of Masimo. Importantly, becoming part of Danaher’s Diagnostics segment will strengthen our ability to scale our monitoring technologies globally and accelerate our mission of delivering Masimo innovations that empower clinicians to transform patient care.” Michelle Brennan, chairman of Masimo’s board of directors, said the board evaluated a broad range of opportunities over the past several months and engaged with multiple other potential partners. “Ultimately, it became evident that this transaction with Danaher was the most value-enhancing path for Masimo and all its stakeholders.” The acquisition is subject to the satisfaction or waiver of certain closing conditions, including the receipt of required regulatory approvals. It is expected to close in the second half of 2026. “We’ve followed this innovative company for many years and see it as an exceptional strategic fit for Danaher,” said Danaher CEO Rainer M. Blair. “Masimo is a leader in pulse oximetry and other patient monitoring solutions, which, combined with its trusted brand and differentiated technology, will greatly strengthen our diagnostics franchise. With the Danaher Business System and our global scale, we see opportunities to expand Masimo's reach and continue improving outcomes for patients, particularly those in acute care settings." Masimo’s advanced sensor technology and AI-enabled monitoring bring powerful new capabilities to Danaher’s diagnostics portfolio, said Julie Sawyer Montgomery, EVP for diagnostics at Danaher. “Integrating these strengths into Danaher will create meaningful opportunities to innovate for clinicians and improve decision-making in critical settings,” she said. Citing Masimo’s position in a duopoly serving the hospital market (competing against Medtronic’s patient monitoring business), Marie Thibault, a medtech analyst at BTIG, wrote in a report that there could be potential for other interested players to assess an acquisition of Masimo. She noted that in 2023, there were media reports of a couple of medical device players working with private equity firms to submit bids for Medtronic’s patient monitoring business, so it could make sense for similar players to be interested in Masimo. Masimo is expected to be accretive to adjusted diluted net earnings per common share by $0.15 to $0.20 in the first full year and roughly $0.70 in the fifth full year following completion of the acquisition. Masimo is expected to deliver high single-digit core revenue growth over the long term, accelerating Danaher's diagnostics segment's core revenue growth profile. Under Danaher's ownership, Masimo is expected to generate EBITDA of more than $530 million in 2027. Additionally, Danaher expects to realize more than $125 million of annual cost synergies and more than $50 million of annual revenue synergies by the fifth full year following completion of the acquisition. Danaher expects to fund the acquisition using cash on hand and proceeds from debt financing. Revisiting Masimo’s proxy war It wasn’t that long ago that Masimo was locked in a high-profile proxy war that resulted in the ousting of founder and former CEO Joe Kiani from the board. Kiani founded Masimo in 1989, growing the company from a garage startup into a $2B public patient monitoring company. But when Kiani tried to push Masimo into consumer electronics, everything changed. Investors found the company’s $1.02 billion acquisition of Sound United confusing , to say the least. Politan Capital Management, an activist shareholder, came for Kiani in two consecutive proxy battles. After Kiani was ousted, Masimo finally sold Sound United for $350 million to Harman International, a subsidiary of Samsung Electronics.

For all the promise that artificial intelligence holds for medtech, the technology has reportedly had horrific patient outcomes when used in the operating room. A special report from Reuters , published Monday, paints a rather grim picture in its headline: As AI enters the operating room, reports arise of botched surgeries and misidentified body parts . Among other medical devices highlighted in the article, the article places a heavy amount of scrutiny around the TruDi Navigation System, which uses a machine-learning algorithm to assist ear, nose, and throat specialists in surgery. Integra LifeSciences acquired the TruDi system in late 2023 when it bought Acclarent from Johnson & Johnson for $275 million . According to the report, the device had been on the market for about three years before artificial intelligence was added to it. In those three years, FDA received unconfirmed reports of seven instances in which the device malfunctioned and another report of a patient injury. However, since AI was added to the device, the agency has received unconfirmed reports of at least 100 malfunctions and adverse events, Reuters reported. Allegedly, cerebrospinal fluid leaked from one patient’s nose. Another two patients suffered strokes after a major artery was accidentally injured, according to the report. It is not clear what role AI may have played in these events, the report cautions, as FDA device reports may be incomplete and are not meant to determine causation. The two stroke victims each filed a lawsuit in Texas alleging that the TruDi system’s AI contributed to their injuries. Integra told Reuters the FDA device reports “do nothing more than indicate that a TruDi system was in use in a surgery where an adverse event took place.” The company added that “there is no credible evidence to show any causal connection between the TruDi Navigation System, AI technology, and any alleged injuries.” Missed heart arrythmias and mislabeled body parts Medical device makers have been racing to incorporate AI into products for several years now. At least 1,357 medical devices using artificial intelligence are now authorized by FDA. In addition to the TruDi system, Reuters found that the agency has received reports involving dozens of devices that have been enhanced by AI. The report also mentions Medtronic’s Linq family of implantable cardiac monitors. At least 16 reports claimed that the AI-assisted heart monitors failed to recognize abnormal rhythms or pauses. None of the reports mentioned injuries, and Medtronic told FDA that some of the incidents were caused by “user confusion.” The company told Reuters it reviewed all the reports and concluded its device only missed one abnormal heart-rhythm event. Some of the incidents were related to problems with data display, not the AI technology used in the device, Medtronic noted. Another medical device mentioned in the article, the Sonio Detect from Samsung Medison, a unit of Samsung Electronics, uses AI to assist with prenatal ultrasounds. Allegedly, the AI software mislabeled fetal structures and associated them with the wrong body parts, according to an FDA device report filed in June 2022. Samsung Medison told Reuters the FDA report “does not indicate any safety issue, nor has the FDA requested any action from Sonio.” AI in medtech: use responsibly Over the past three decades, FDA authorized at least 1,357 medical devices that use AI, Reuters reported. More than half were added in the last three years, showing the rapid acceleration of the technology’s use in medtech. Maria Palombini, healthcare and life sciences global practice lead at the IEEE Standards Organization, a nonprofit group that establishes global technology standards for the medtech industry, spoke with MD+DI about the role of responsible AI in medtech . She said it will take some time to assess performance before comprehensive strategies can be taken to move AI forward effectively and safely. “Integrating AI responsibly and being able to validate the results is going to be a challenge for everybody,” Palombini said. “But if all pieces fall into the right place with consistent progress in showing that AI can be ethically or responsibly deployed, and we're able to validate outcomes on a consistent and continuous basis, AI can significantly impact the healthcare industry. But it's too early to tell. AI offers a lot of promise, but we have to take it with an extremely large grain of salt before we get too overly excited about it.” Regulatory challenges with AI in medtech Image credit: Kevin Dietsch/Getty Images The report also highlights the fact that about four years ago, FDA expanded its roster of scientists who specialize in AI, particularly for reviewing medical imaging and radiology devices that use it. But early last year things at the agency changed drastically as the Trump administration began to dismantle the AI team as part of Elon Musk’s Department of Government Efficiency (DOGE). About 15 of the 40 scientists in the Division of Imaging, Diagnostics and Software Reliability were either laid off or quit, Reuters reported, citing unnamed FDA insiders (current and former employees of the agency). Around the same time, the Digital Health Center of Excellence lost about a third of its staff of around 30. In February 2025, AdvaMed President and CEO Scott Whitaker raised concerns about the widespread cuts to FDA’s workforce . He cited the industry's latest user-fee agreement with FDA that, for the first time ever, created private sector-like incentives for FDA to be more efficient, transparent, and predictable in its review process. The idea behind this was to make leading-edge medical technologies and treatments available to American patients sooner while still ensuring the safety of the products being approved. "Working together, we can achieve a more efficient and effective FDA. But, on behalf of our members, I am concerned that the cuts made over the weekend will not accomplish that. I am also concerned that it puts at risk our nation's status as the top medtech market in the world — as the global leader in medtech innovation, manufacturing, and jobs." Whitaker also pointed out that eliminating FDA's recent critical hires in the AI space would dramatically slow review times and require reassigning non-experts that remain on staff to review these technologies. These non-experts in AI will, Whitaker says, "inevitably make slower and potentially inappropriately conservative decisions." AI silver linings On the bright side, AI does have the potential to impact medtech and the broader healthcare industry in positive ways. We’re already seeing companies like Johnson & Johnson leverage artificial intelligence to boost manufacturing productivity . We’re also hearing design and engineering experts talk about ways AI can have an impact at the design and engineering level . In terms of devices in the pipeline that are AI-powered, we’re seeing AI being used to help with early detection of stroke ; enhance usability of wheelchairs ; analyze pre-operative imaging to generate patient phenotypes for surgeons ; and so much more. However, medtech companies must place patient safety at the forefront by conducting thorough testing, validating AI algorithms, and ensuring transparency in device functionality.

BELLEVUE, WA / ACCESS Newswire / January 27, 2026 / OSR Holdings, Inc. (NASDAQ:OSRH) today announced the official closing of its acquisition of Woori IO, the reaffirmation of long-term equity alignment by Woori IO's historical shareholders, and the initiation of a strategic review regarding a potential combination of its medical device subsidiaries. Woori IO Acquisition Closed OSRH confirmed that the previously announced acquisition of Woori IO and the related share exchange transaction have been formally completed in Korea, effective January 26, 2026. As a result, Woori IO is now a consolidated subsidiary of OSRH, further strengthening the Company's medical device and digital health platform, particularly in noninvasive glucose monitoring and wearable health technologies. Three-Year Equity Alignment Secured by Legacy Shareholder In connection with the closing, historical shareholders of Woori IO reaffirmed a three-year equity alignment framework, under which they have agreed to exchange their equity interests in OSR Holdings Co., Ltd. (OSRK) into NASDAQ-listed OSRH common stock only at a reference price of USD $10.00 per share. This voluntary structure is designed to prevent near-term dilution and align legacy shareholders with the long-term performance of OSRH's public equity, reflecting confidence in the Company's strategic direction and capital markets positioning. Strategic Review of Medical Device Subsidiaries Separately, Peter Hwang, CEO of OSRH, indicated that the Company is conducting a strategic review of a potential combination of its two medical device subsidiaries, Woori IO and RMC, with the goal of forming a new, integrated medical technology and distribution company. The review reflects the complementary strengths of the two businesses, including Woori IO's digital health and wearable-device capabilities, supported by collaboration initiatives with Samsung Electronics, along with RMC's established hospital network in Korea and commercial revenue history. OSRH is evaluating whether a combined platform could support a standalone IPO in Korea, subject to market conditions, regulatory considerations, and board approvals. Positioned for Continued Value Creation "With the Woori IO acquisition now closed, long-term alignment secured from legacy shareholders, and a strategic review underway to unlock synergies across our medical device businesses, we believe OSR Holdings is well positioned to pursue multiple, disciplined pathways to value creation," said Mr. Hwang. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding expected benefits of the Woori IO acquisition, shareholder alignment, potential strategic transactions, and future business plans. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially, including regulatory, integration, market, execution, and capital markets risks, as well as other risks described in the Company's filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to update any forward-looking statements, except as required by law. About OSR Holdings, Inc. OSR Holdings, Inc. (NASDAQ:OSRH) is a global healthcare holding company dedicated to advancing biomedical innovation approaches to health and wellness. Through its subsidiaries, OSRH is engaged in immuno-oncology, regenerative biologics, and medical device technologies. Its vision is to build a portfolio of breakthrough healthcare solutions to improve global health outcomes. Learn more at . About Woori IO Co., Ltd. Woori IO is a South Korea-based medical device company developing noninvasive biosensing technologies for glucose monitoring and beyond. Its proprietary NIRS-based system enables accurate, pain-free glucose tracking and is designed for integration into wearables. The company has been recognized by a leading global consumer electronics company's startup program for its innovation in NIGM technology. CONTACT: Media & Investor Contacts OSR Holdings, Inc. Investor Relations ir@osr-holdings.com SOURCE: OSR Holdings, Inc. View the original press release on ACCESS Newswire