Medtronic Wins FDA Green Light for Stealth AXiS; Retia Medical Secures FDA 510(k) Clearance for Argos Infinity; Danaher Announces Plan to Acquire Masimo Corporation; Dynarex Introduces New Advanced Negative Pressure Therapy Device; Valcare Medical Reports First U.S. Transseptal AMEND™ Implant in Early Feasibility Study; Envoy Medical Reports Enrollment Nearly Complete for Acclaim Cochlear Implant Pivotal Trial

Medtronic Received FDA Clearance for Stealth AXiS™ Surgical System, First Integrated Planning, Navigation and Robotics Platform for Spine Surgery

On February 13, 2026, Medtronic, a global leader in healthcare technology, announced U.S. Food and Drug Administration (FDA) clearance of the Stealth AXiS™ surgical system, a next-generation platform that brought planning, surgical navigation system, and robotics together into a single, intelligent system for spine surgery.

The Stealth AXiS™ system was cleared for spine procedures in the United States, with an underlying architecture designed to support future cranial and ENT applications, pending 510(k) clearance. It was built to support a wide range of surgeon preferences, clinical complexity, and care settings, and was designed for use across hospitals and ambulatory surgery centers without relying on multiple standalone technologies.

Grounded in more than 50 years of Medtronic leadership in surgical navigation and robotics, the Stealth AXiS™ system created a clear pathway for adoption by combining familiar navigation workflows with a modular robotic design, allowing institutions to deploy what they needed at the time and expand over time as clinical needs evolved.

“The Stealth AXiS™ system represents a meaningful step forward in how we think about navigation and robotics working together,” said Ronald A. Lehman, Jr., M.D., Tenured Professor of Orthopaedic Surgery (Neurological Surgery) at Columbia University, Division Chief of Spine Surgery, and Spine Medical Director at The Spine Hospital at NewYork-Presbyterian/The Allen Hospital, and a paid consultant to Medtronic. “One of the biggest challenges in spine surgery has been understanding and responding to how the spine moves during a procedure. The Stealth AXiS™ system gives surgeons real-time visibility into that motion, helping us more consistently achieve our surgical plan without interrupting workflow. To me, this is truly game changing technology.”

A key innovation of the Stealth AXiS™ system was LiveAlign™ segmental tracking, an industry-first capability that allowed surgeons to visualize anatomic motion, surgical adjustments, and patient alignment in real time during spine surgery, without the need for repeated imaging. This capability helped reduce reliance on manual steps and workflow disruption, supporting more consistent execution of patient-specific surgical plans.

As a cornerstone of Medtronic’s AiBLE™ smart ecosystem, the Stealth AXiS™ system enabled a more intuitive and seamless flow of information across the surgical continuum. By natively integrating planning, navigation, and execution within a single platform, the Stealth AXiS™ system helped streamline workflows and supported the exchange of insights before, during, and after spine surgery, allowing the broader AiBLE™ ecosystem to connect devices, software, and data in a more meaningful way.

“Spine surgery is complex, and variability remains a real challenge,” said Michael Carter, Senior Vice President and President of Medtronic Cranial & Spinal Technologies. “The Stealth AXiS™ system is designed to make advanced technology more usable and clinically meaningful, helping surgeons deliver more predictable, personalized care while laying the foundation for continued innovation.”

The Stealth AXiS™ surgical system reflected Medtronic’s focus on building durable platforms that simplified surgical workflows at the time while enabling future expansion across procedures, specialties, and care settings.

As per DelveInsight’s “Spinal Surgery Devices Market Report,” the global spinal surgery devices market size is expected to increase from USD 13,716.76 million in 2024 to USD 20,967.57 million by 2032, growing at a CAGR of 5.50% during the forecast period from 2025 to 2032. The market of spinal surgery devices is being primarily driven by the increasing cases of spinal disorders such as degenerative disc disease, herniated discs, spinal stenosis, and scoliosis, increasing cases of spinal cord injuries, growing preference for minimally invasive spinal procedures, an increase in technological advancement, and an increase in product development activities among the key market players.

Retia Medical Received FDA 510(k) Clearance for Argos Infinity™, Expanding Cardiovascular Intelligence Across High-Risk Surgical and Critical Care Environments

On February 17, 2026, Retia Medical announced that the U.S. Food and Drug Administration (FDA) had granted 510(k) clearance for Argos Infinity™, the company’s cardiovascular intelligence software platform designed for high-risk surgical and critical care environments across health systems.

Argos Infinitywas  built on Retia’s clinically validated Multi-Beat Analysis® (MBA®) algorithm and analyzed real-time physiologic data streams from existing monitoring and tele-ICU systems. By transforming routine signals into actionable cardiovascular insight, Argos Infinity supported earlier recognition of hemodynamic instability in operating rooms and intensive care units.

High-risk patients often began to deteriorate before changes appeared in standard vital signs. In cardiac surgery patients, nearly 70% of low cardiac index time occurred while blood pressure remained normal. Delayed recognition could drive ICU escalation and organ injury, including acute kidney injury (AKI).

Beginning with the 2026 reporting period, AKI was included as a hospital harm measure tied to reimbursement under CMS quality programs and would affect reimbursement in 2027. As hospitals faced increasing accountability for preventable harm, earlier insight into cardiovascular instability became even more essential.

“In high-risk patients, deterioration can begin before traditional vital signs clearly reflect it,” said Chiedozie Udeh, MD, MHEcon, MBA, FCCM, FASA, Professor of Anesthesiology and Medical Director, Cleveland Clinic eHospital. “By analyzing the monitoring data we already collect, Argos Infinity expands visibility into patients’ cardiovascular status across surgical settings and critical care units without requiring additional bedside hardware.”

“FDA clearance of Argos Infinity marks an important step in extending reliable cardiovascular insight beyond individual devices and into the broader digital care environment,” said Marc Zemel, Chief Executive Officer of Retia Medical. “Hospitals already collect vast amounts of physiologic data. Infinity analyzes those existing data streams to deliver consistent hemodynamic intelligence across operating rooms and intensive care units, without requiring replacement of current monitoring infrastructure.”

Argos Infinity had been deployed under IRB approval across more than 400 beds in multi-hospital tele-ICU environments, where it operated on top of existing digital monitoring platforms. With FDA clearance, Retia could now expand that deployment. The software applied Retia’s Multi-Beat Analysis algorithm, which had been validated in 14 peer-reviewed clinical publications and shown to perform reliably in complex conditions, including arrhythmia, low cardiac output states, and unstable blood pressure.

Argos Infinity complemented Retia’s Argos® Cardiac Output Monitor, extending the same patented algorithmic foundation from the bedside to high-risk surgical and critical care environments across health systems. In the United States, the Argos monitor was distributed by Medtronic plc.

As per DelveInsight’s “Cardiac Monitoring Devices Market Report,” the global cardiac monitoring devices market is expected to increase from ~USD 21,360.61 million in 2024 to ~USD 31,602.55 million by 2032, growing at a CAGR of 5.11% during the forecast period from 2025 to 2032. The Cardiac Monitoring Devices Market is being primarily driven by the growing instances of cardiovascular diseases and their associated risk factors, increasing demand for remote patient monitoring, technological advancements in the product designs, and an increase in product development activities among the key market players.

Danaher To Acquire Masimo Corporation

On February 17, 2026, Danaher Corporation, a global science and technology innovator, announced that it had entered into a definitive agreement to acquire Masimo Corporation, a leading specialty diagnostics provider of pulse oximetry and other patient monitoring solutions, primarily in acute care settings. Under the terms of the agreement, Danaher agreed to acquire all of the outstanding shares of Masimo common stock for $180 per share in cash, representing a total enterprise value of approximately $9.9 billion, including assumed indebtedness and net of acquired cash. This represented a transaction multiple of approximately 18x estimated 2027 EBITDA, or 15x 2027 estimated EBITDA, including the full benefit of expected annual synergies.

Rainer M. Blair, President and Chief Executive Officer, Danaher, said: “We are excited to welcome the Masimo team to Danaher. We’ve followed this innovative company for many years and see it as an exceptional strategic fit for Danaher. 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.”

Julie Sawyer Montgomery, Executive Vice President for Diagnostics, Danaher, said: “Masimo’s advanced sensor technology and AI-enabled monitoring bring powerful new capabilities to our diagnostics portfolio. Integrating these strengths into Danaher will create meaningful opportunities to innovate for clinicians and improve decision making in critical settings.”

Upon completion of the transaction, Masimo would operate as a standalone operating company within Danaher’s Diagnostics segment alongside Radiometer, Leica Biosystems, Cepheid, and Beckman Coulter Diagnostics. Masimo was expected to be accretive to adjusted diluted net earnings per common share by $0.15 to $0.20 in the first full year and approximately $0.70 in the fifth full year following completion of the acquisition. It was also expected to deliver high-single-digit core revenue growth over the long term, accelerating Danaher’s Diagnostics segment core revenue growth profile.

Under Danaher’s ownership, Masimo was projected to generate EBITDA of more than $530 million in 2027. Additionally, Danaher anticipated realizing 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.

The transaction was anticipated to close in the second half of 2026, subject to customary conditions, including receipt of applicable regulatory clearances and Masimo shareholder approval. Danaher expected to fund the acquisition using cash on hand and proceeds from debt financing.

As per DelveInsight’s “Pulse Oximeters Market Report,” the pulse oximeters market was valued at USD 2.16 billion in 2023 and expected to reach USD 3.98 billion by 2030, growing at a CAGR of 10.73% during the forecast period from 2024 to 2030. The pulse oximeters market is expanding rapidly due to the rising prevalence of respiratory conditions such as asthma & chronic obstructive pulmonary disease (COPD), coupled with advancements in technology, and rising government initiatives concerning the usage of pulse oximeters are expected to escalate the overall growth of the pulse oximeters market during the forecast period from 2024 to 2030.

Dynarex Launched New Negative Pressure Therapy System

On February 17, 2026, Dynarex Corporation, a leading manufacturer of medical supplies and durable medical equipment, announced the launch of its new Negative Pressure Wound Therapy (NPWT) Pump along with an expanded portfolio of compatible wound care products designed to support complex wound management across acute, post-acute, and homecare environments including chronic, surgical, and traumatic wounds.

The portable system weighed just 11.3 ounces and offered up to 72 hours of battery operation a combination rarely seen in non-disposable NPWT platforms. The new NPWT system served as the anchor of Dynarex’s broader wound care offering, combining a portable therapy platform with a comprehensive range of consumables, dressings, and accessories. It was developed to address the growing prevalence of chronic and complex wounds and was designed to support continuity of care while simplifying product selection and therapy management across different care settings.

“This is the next generation of negative pressure therapy,” said Dynarex Category Manager Shauna Winston (RRT, RCP). “As wound care continues to shift beyond the hospital setting, providers need solutions that balance clinical performance with mobility and ease of use, and this platform was built to deliver exactly that.”

At the core of the launch was the Dürma+ Negative Pressure Wound Therapy Pump, which was engineered to deliver controlled negative pressure therapy in a lightweight and portable format. The system was supported by a full range of dedicated accessories and consumables, including disposable canisters, foam dressing kits, suction tubing, wound drapes, and a carrying case designed to enhance patient mobility during therapy.

With multiple dressing sizes and accessory configurations, the NPWT system was designed to integrate into various wound care protocols and settings, supporting consistent therapy delivery from inpatient treatment through post-acute and home care use.

In addition to NPWT, Dynarex’s expanded wound care portfolio included a wide range of advanced dressings and topical products intended to support different stages of wound management. These included collagen-based wound care products, calcium alginate dressings, silicone bordered foam dressings, petrolatum and impregnated gauze dressings, transparent film and island dressings, wound gels, and measurement tools.

Collectively, the portfolio provided healthcare providers and distribution partners with a streamlined wound care solution designed to support clinical flexibility, simplified sourcing, and continuity of care.

According to DelveInsight’s “Negative Pressure Wound Therapy Systems Market Report”, the negative pressure wound therapy systems market was valued at USD 3.35 billion in 2023, growing at a CAGR of 5.09% during the forecast period from 2024 to 2030, to reach USD 4.50 billion by 2030. The negative pressure wound therapy systems market is expanding rapidly due to the collective impact of rising chronic and acute wound prevalence, such as diabetic ulcers and pressure sores, increasing surgical procedures, and the growing product launches and approvals by key negative pressure wound therapy systems companies, which are expected to significantly drive the demand for negative pressure wound therapy systems from 2024 to 2030.

Valcare Medical Announced the First U.S. Transseptal AMEND™ Implant in Early Feasibility Study 

On February 11, 2026, Valcare Medical, Inc., a pioneering developer of transcatheter mitral valve repair solutions, announced the successful first U.S. transseptal implantation of its AMEND™ Transcatheter Mitral Valve Repair (TMVr) Annuloplasty System as part of the ongoing AMEND TS Early Feasibility Study (EFS).

The milestone procedure had been performed by Dr. Paul Sorajja, a nationally recognized expert in interventional cardiology and structural heart disease, at Banner – University Medical Center in Phoenix. The AMEND™ System delivered a closed, D-shaped, semi-rigid annuloplasty ring via a transseptal catheter-based approach. It had been specifically designed to replicate the anatomical remodeling and clinical outcomes achieved with traditional surgical annuloplasty, the standard technique in most open-heart mitral valve repairs. Unlike other transcatheter mitral repair technologies, the AMEND System had been engineered to preserve future treatment options for patients if additional interventions became necessary.

“For many patients with mitral regurgitation, open-heart surgery is either too risky or simply not an option due to age or other health conditions,” said Dr. Sorajja. “The AMEND transseptal approach offers physicians a percutaneous alternative designed to deliver a surgical-style repair option for their patients with less pain, faster recovery, and the potential for excellent long-term outcomes.”

According to DelveInsight’s ”Transcatheter Mitral Valve Repair Devices Market Report,” the transcatheter mitral valve repair devices market was valued at USD 1,197.06 million in 2023, growing at a CAGR of 14.95% during the forecast period from 2024 to 2030 to reach USD 2,756.71 million by 2030. The transcatheter mitral valve repair devices market is expanding rapidly due to the growing prevalence of cardiovascular disorders including circulatory diseases, various heart valve diseases, increasing product developmental activities such as regulatory clearances, rising sedentary lifestyle & lifestyle-associated disorders, increasing preference for minimally invasive surgeries that are expected to escalate the overall growth of the transcatheter mitral valve repair devices market during the forecast period from 2024 to 2030.

Envoy Medical Nears Completion of Enrollment in Pivotal Clinical Trial of Fully Implanted Acclaim(R) Cochlear Implant 

On February 17, 2026, Envoy Medical® Inc., a hearing health company focused on pioneering fully implanted hearing solutions, announced continued progress in enrollment for its pivotal clinical trial of the investigational fully implanted Acclaim® cochlear implant.

At that time, 45 patients had been successfully implanted and were officially enrolled in the study. The trial called for a total of 56 implanted participants, meaning Envoy Medical had completed more than 80% of its targeted enrollment. The Company expected the pivotal clinical trial to reach full enrollment by the end of March 2026.

Based on enrollment trends and follow-up timelines, Envoy Medical believed the trial remained on schedule for completion and a potential Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA) in the second quarter of 2027.

“We are extremely encouraged by the steady progress we’ve seen since receiving FDA approval to expand our pivotal study,” said Brent Lucas, Chief Executive Officer of Envoy Medical. “Reaching 45 implanted patients and being approximately one month away from full enrollment is an exciting milestone for our entire organization. The journey to get to this point has been long, but we are now moving quickly and with great confidence.”

Lucas added, “We remain encouraged by what we are hearing from the trial and look forward to sharing more as results are formally analyzed and published. We expect to provide an update at an industry meeting in May as we continue advancing toward our goal of redefining the standard of care with a fully implanted cochlear implant.”

The investigational Acclaim® fully implanted cochlear implant was designed to leverage the natural ear, rather than an external microphone, to capture sound using Envoy Medical’s proprietary implanted piezoelectric sensor technology. Unlike traditional cochlear implants, the Acclaim® device was designed without required externally worn components on or in the ear, representing a differentiated approach in the cochlear implant market.

According to DelveInsight’s “Cochlear Implants Market Report”, the cochlear implants market was valued at USD 1.38 billion in 2023, growing at a CAGR of 9.92% during the forecast period from 2024 to 2030 to reach USD 2.43 billion by 2030. The cochlear implants market is observing substantial market growth primarily owing to the increasing prevalence of hearing loss & incurs substantial economic costs. Investing in cochlear implants & improving access to these devices and supportive reimbursement policies are anticipated to further accelerate the overall growth of the cochlear implants market during the forecast period from 2024 to 2030.