FDA Clears Stryker’s Incompass Total Ankle System; Glaukos Receives EU MDR Approval for iStent infinite and Key MIGS Devices; STENTiT Announces First Patient Enrollment in Trial of Regenerative Stent for Limb Preservation; Autonomix Medical Treats First Patient in Next Phase (“PoC 2”) of Proof-of-Concept Clinical Trial; Getinge Expands Servo-C Ventilator Capabilities for Neonatal Care; Medtronic Partners With Philips to Advance Patient Monitoring Solutions

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FDA Clears Stryker’s Incompass Total Ankle System; Glaukos Receives EU MDR Approval for iStent infinite and Key MIGS Devices; STENTiT Announces First Patient Enrollment in Trial of Regenerative Stent for Limb Preservation; Autonomix Medical Treats First Patient in Next Phase (“PoC 2”) of Proof-of-Concept Clinical Trial; Getinge Expands Servo-C Ventilator Capabilities for Neonatal Care; Medtronic Partners With Philips to Advance Patient Monitoring Solutions

Jul 03, 2025

Stryker Received FDA Clearance for Incompass Total Ankle System 

On June 25, 2025, Stryker, a global leader in medical technologies, announced that the U.S. Food and Drug Administration (FDA) received 510(k) approval for its Incompass™ Total Ankle System. The implant is designed for patients suffering from severe ankle joint damage due to rheumatoid, post-traumatic, or degenerative arthritis. This next-generation platform unifies key features of Stryker’s Inbone® and Infinity® systems into a single, all-inclusive solution for total ankle replacement.

The Incompass system features Adaptis® Boney Ingrowth Technology and newly designed instrumentation to promote long-term fixation, surgical adaptability, and an efficient workflow. Engineered to overcome persistent challenges in total ankle arthroplasty, such as intraoperative flexibility and procedural efficiency, the design draws on insights from over 85,000 CT scans and 100,000 clinical cases. It also provides an extensive selection of implant and instrument options to enable personalized, patient-specific treatment.

Developed using Stryker’s Orthopaedic Modeling & Analytics (SOMA) platform and anatomical data from its Prophecy Surgical Planning System, the Incompass system offers a seamless continuum of implants and tools tailored to both surgeon preferences and individual patient anatomy. Key system improvements include a new alignment system for enhanced control across multiple planes, upgraded implant holders and trial instruments for better handling, and refined instrumentation designed to reduce surgical steps and minimize setup time.

“Incompass reflects our commitment to redefining what’s possible in total ankle replacement,” said Adam Jacobs, vice president and general manager of Stryker’s Foot & Ankle business. “By building on decades of clinical experience and leveraging extensive data insights, we’re setting a new standard—one that empowers surgeons to deliver more personalized care with greater efficiency and confidence.”

As per DelveInsight’s “Total Ankle Replacement Market Report,” The global total ankle replacement market is estimated to grow at a CAGR of 6.1% during the forecast period from 2024 to 2030. The demand for total ankle replacement is primarily being boosted by the growing prevalence of osteoarthritis, rheumatoid arthritis, and other orthopedic diseases. The increasing geriatric population base, increasing preference for total ankle replacement (TAR) over ankle fusion, development of efficient and advanced technology, rise in awareness among people, and rising new product launches and approvals, among others, are some of the key factors thereby contributing to the overall growth of the total ankle replacement market during the forecast period from 2024 to 2030.

Glaukos Announced EU MDR Certification for iStent infinite® and Other Leading MIGS Therapies 

On June 25, 2025, Glaukos Corporation, a leading ophthalmic pharmaceutical and medical technology company specializing in innovative treatments for glaucoma, corneal disorders, and retinal diseases, announced that it received European Union (EU) Medical Device Regulation (MDR) certification for the iStent infinite®, along with several other key micro-invasive glaucoma surgery (MIGS) technologies, including the iStent inject® W. The company’s iStent® trabecular micro-bypass stent platform features micro-scale surgical implants designed to lower intraocular pressure by restoring natural aqueous humor outflow pathways in glaucoma patients.

This certification confirms that iStent infinite and iStent inject W comply with the rigorous standards set by the EU MDR a robust regulatory framework aimed at ensuring the safety, effectiveness, and high quality of medical devices sold in the European market.

Glaukos is widely recognized as a pioneer and global leader in the MIGS space. Its iStent product line is backed by over 400 peer-reviewed publications, more than two decades of clinical and commercial expertise, and the implantation of over one million iStent devices worldwide. The company offers one of the most comprehensive portfolios of minimally invasive, tissue-preserving glaucoma solutions designed to support a broad spectrum of surgeon preferences and treatment strategies. These solutions are intended to provide optimal benefit-to-risk profiles throughout the entire continuum of glaucoma care, from ocular hypertension to advanced, treatment-resistant cases and are suitable for both combination cataract and standalone procedures.

“We are pleased to receive these important regulatory clearances for our leading trabecular micro-bypass stenting devices, marking our company’s first approvals under the new EU regulatory framework,” said Thomas Burns, Glaukos chairman and chief executive officer. “These important milestones will not only help us maintain and grow our presence in Europe but also advance and accelerate our broader Interventional Glaucoma initiatives globally. We are eager to commence commercial launch activities for these novel MIGS therapies over the coming months.”

The iStent infinite Trabecular Micro-Bypass System Model iS3 is an implantable device designed to lower intraocular pressure (IOP) in the eye. It is intended for adult patients with primary open-angle glaucoma who have not responded to prior medical and surgical treatments.

As per DelveInsight’s “Micro Invasive Glaucoma Surgery (MIGS) Devices Market Report”, the global micro invasive glaucoma surgery (MIGS) device market was valued at USD 406.55 million in 2023, growing at a CAGR of 13.34% during the forecast period from 2024 to 2030 to reach USD 972.26 million by 2030. The demand for micro-invasive glaucoma surgery devices is primarily being boosted by the growing prevalence of glaucoma. Furthermore, the increasing lifestyle disorders such as diabetes and hypertension double the chances of causing glaucoma, leading to vision loss and blindness, thereby boosting the market of micro-invasive glaucoma surgery devices. Additionally, increasing technical innovation in product development, such as less invasiveness and more effectiveness, is one of the other key drivers that are responsible for contributing to the positive growth of the micro-invasive glaucoma surgery (MIGS) device market during the forecast period from 2024 to 2030.

STENTiT Enrolled First Patient in Clinical Trial Evaluating a Novel Stent with Regenerative Properties to Support Limb Preservation 

On June 26, 2025, STENTiT, a trailblazing medical device company developing a new generation of regenerative stents, announced the successful implantation of its resorbable fibrillated scaffold (RFS). This milestone was achieved as part of the VITAL-IT 1 clinical study, targeting patients with below-the-knee chronic limb-threatening ischemia (CLTI). The RFS device was implanted using a minimally invasive endovascular technique to restore blood flow to the foot through revascularization.

The RFS is a fully bioresorbable stent composed of microfibers that provide immediate structural support and promote arterial regeneration. Thanks to its porous architecture, the scaffold allows for the infiltration of the patient’s own cells, triggering the growth of new vascular tissue. As the artery is gradually rebuilt from the inside out, the synthetic scaffold is naturally resorbed by the body, leaving behind no permanent implant.

The VITAL-IT 1 study (ClinicalTrials.gov Identifier: NCT07006467) is a prospective, non-randomized feasibility trial designed to evaluate the safety and performance of STENTiT’s RFS in up to 10 patients with below-the-knee CLTI. The study is currently being conducted at the Medical University of Graz, Austria, with patients to be followed for 24 months.

“This first-in-human clinical study will provide an important indication on the translational potential of this new technology in CLTI patients,” said Prof. Marianne Brodmann, MD, Head of Division of Angiology at the Medical University of Graz. “This device combines key attributes of temporary structural support with regenerative properties, which could minimize the need for reinterventions.” 

“Our goal is to bring the next generation of stents with regenera2ve proper2es, to guide the body rebuilding functional arteries and improve long-term clinical outcomes,” said Bart Sanders, CEO of STENTiT. “We are extremely proud to reach this first clinical milestone to show the potential of our technology in providing a durable solution for advanced peripheral artery disease.”

STENTiT’s RFS is an innovative, microfiber-based, fully bioresorbable stent developed to restore blood flow in patients with below-the-knee chronic limb-threatening ischemia (CLTI). Its porous structure promotes patient-specific cellular infiltration, triggering the body’s natural healing response to regenerate vascular tissue. As this regeneration occurs, the scaffold gradually and safely degrades, removing the need for a permanent implant. The RFS is currently being evaluated in its first-in-human trial, the ongoing VITAL-IT 1 study.

According to DelveInsight’s “Resorbable Vascular Scaffolds Market Report”, the global resorbable vascular scaffolds market is estimated to grow at a CAGR of 5.43% during the forecast period from 2025 to 2032. The rising prevalence of cardiovascular diseases globally has significantly increased the demand for advanced treatment options like resorbable vascular scaffolds. Technological advancements in scaffold design, including the development of bioresorbable materials, enhance the efficacy and safety of these devices, making them a preferred choice among healthcare professionals. Additionally, growing awareness among physicians and patients about the benefits of resorbable vascular scaffolds, such as reduced long-term complications and natural vessel restoration, is driving adoption. Coupled with an increase in product development activities and regulatory approvals, these factors are expected to collectively propel the growth of the resorbable vascular scaffolds market worldwide during the forecast period from 2025 to 2032.

Autonomix Medical, Inc. Treated First Patient in Follow-On Market Expansion Phase (“PoC 2”) of Proof-of-Concept Human Clinical Study 

On June 30, 2025, Autonomix Medical, Inc., a medical device company developing cutting-edge technologies for diagnosing and treating nervous system-related diseases, announced the enrollment and treatment of the first patient in the follow-on phase of its proof-of-concept human clinical trial (“PoC 2”). This trial is designed to evaluate the safety and efficacy of using transvascular energy to ablate targeted nerves and alleviate cancer-related pain.

Following the encouraging outcomes from the initial phase (“PoC 1”) of its first-in-human trial in patients suffering from severe pancreatic cancer pain, Autonomix has launched PoC 2 to explore a broader market opportunity. This expanded phase aims to assess the technology’s effectiveness in addressing pain associated with additional visceral cancers that transmit pain through the Celiac Plexus, as well as earlier-stage pancreatic cancers with moderate to severe pain, potentially doubling the addressable market beyond pancreatic cancer.

“We’re executing on a bold vision to expand the reach of our technology beyond pancreatic cancer pain and into a broader range of high-need visceral cancer indications,” said Brad Hauser, CEO of Autonomix. “The start of patient treatment in our PoC 2 study represents a major milestone that reinforces our momentum and marks a critical step toward unlocking substantial clinical and commercial potential. We believe this expansion strengthens our value proposition and positions us to deliver meaningful impact for patients while creating long-term value for shareholders. We look forward to sharing further updates as clinical data become available.”

Autonomix’s platform technology is designed to target a wide range of conditions, including those in cardiology, hypertension, and chronic pain management. The PoC 2 phase will specifically focus on interventional pain management for cancers such as pancreatic, gall bladder, liver, and bile duct. The Company also sees future potential for expansion into oncology, gastroenterology, and other fields, supported by growing preclinical data and collaborations with key opinion leaders.

According to DelveInsight’s “Pain Management Devices Market Report”, the pain management devices market was valued at USD 4.86 billion in 2023, growing at a CAGR of 7.90% during the forecast period from 2024 to 2030, to reach USD 7.67 billion by 2030. The rising prevalence of chronic pain conditions, coupled with an increase in product launches and growing awareness about pain management, is set to significantly boost the market for pain management devices. As more people suffer from chronic pain, the demand for effective and innovative solutions grows, prompting major companies to introduce advanced and minimally invasive devices. This influx of new products not only provides patients with more treatment options but also drives competition and innovation within the market. Additionally, heightened awareness of pain management techniques and devices among the global population, spurred by educational campaigns and patient advocacy, leads to greater acceptance and adoption of these devices. Together, these factors create a favorable environment for the expansion and growth of the pain management devices market, ensuring better patient outcomes and improved quality of life for those suffering from chronic pain during the forecast period from 2024 to 2030.

Getinge Extends the Servo-C Ventilator With a Neonatal Option

On June 30, 2025, Getinge expanded its Servo-c ventilator with a new neonatal option, making it a comprehensive solution for respiratory care across all patient groups from extremely premature infants to fully grown adults. Since its debut, the Servo-c ventilator has been recognized for its sleek design, user-friendly interface, and adaptability. With this latest enhancement, Getinge elevates its offering even further.

The neonatal feature is specifically engineered to support newborns as small as 500 grams, without the need for additional hardware. It also includes invasive leakage compensation and meets the latest global standards for safety, biocompatibility, and cybersecurity.

“Hospitals are under increasing pressure to deliver high-quality care for diverse patient needs while managing costs. Servo-c now supports this by enabling personalized respiratory treatment across all patient categories – from premature newborns to full-grown adults – with full flexibility in targeted markets. This is part of our commitment to make life-saving technology accessible for more people,” says Cecilia Sjöstedt, Vice President Critical Care at Getinge.

“Since our first Servo ventilator was introduced over 50 years ago, our focus has been on continuous innovation, better outcomes, increased patient safety, and outstanding user experience. We are proud of our legacy and remain committed to leading the way in developing ventilators for the future,” Sjöstedt says.

This extension of the Servo-c ventilator adds a neonatal option, transforming it into a comprehensive solution that supports respiratory care across all patient groups—from vulnerable premature newborns to fully grown adults.

According to DelveInsight’s “Fetal & Neonatal Care Equipment Market Report”, the fetal & neonatal care equipment market was valued at USD 8,276.38 million in 2024, growing at a CAGR of 8.33% during the forecast period from 2025 to 2032 to reach USD 15,616.87 million by 2032. The demand for fetal and neonatal care equipment is being significantly driven by the rising number of preterm births globally. In addition to this, the increasing prevalence of congenital anomalies and birth defects, along with continuous advancements in technology, are fueling the growth of the market. Moreover, the ongoing product developments and frequent launches by leading market players are further contributing to the expansion of the fetal and neonatal care equipment market. These factors are expected to play a pivotal role in shaping the market’s positive growth trajectory during the forecast period from 2025 to 2032.

Medtronic Announced Strategic Partnership With Philips to Expand Access to Patient Monitoring Technology 

On July 1, 2025, Medtronic and Philips, two global healthcare technology leaders, took a major step forward in their long-standing collaboration by signing a multi-year partnership agreement aimed at advancing patient care and broadening access to cutting-edge monitoring technologies.

Both companies have collaborated in the field of patient monitoring since 1992, consistently integrating their best-in-class technologies to enhance individual monitoring capabilities. This new agreement builds on that foundation, introducing next-generation Medtronic technologies into Philips’ monitoring solutions to deliver a more integrated and efficient offering for healthcare providers.

Philips’ current patient monitoring systems already feature advanced Medtronic technologies such as Nellcor™ pulse oximetry, Microstream™ capnography, and BIS™ brain monitoring. Under the new agreement, Philips will further integrate essential supplies including ECG, NIBP, and batteries into its Medtronic-enabled monitors. This comprehensive solution is designed to meet the evolving needs of clinicians worldwide, improving access to advanced monitoring equipment and offering joint training and education programs to elevate the standard of care.

“We’re proud to strengthen our collaboration with Medtronic, a partner that shares our commitment to expanding access to safe, reliable patient care,” said Sachin Chaudhari, vice president and general manager, Clinical Applications and Devices, Philips Hospital Patient Monitoring. “By providing a comprehensive monitoring solution that is validated throughout all stages, we’re supporting clinicians’ heavy workloads and complex patient cases by providing tools that can help address the daily challenges care teams face.

“Together with Philips, we are eager to continue to integrate next-generation technologies and leverage our combined global presence to empower healthcare professionals with world-class technology to personalize patient care, anytime, anywhere,” said Brian Blomerth, vice president of strategy operations and chief financial officer for the Acute Care & Monitoring business, which is part of the Medical Surgical Portfolio at Medtronic. “The patient monitoring technology from Philips already incorporates the market-leading Medtronic brands of Nellcor™ pulse oximetry, Microstream™ capnography, and BIS™ brain monitoring, and building on this foundation exemplifies our dedication to advancing innovation and enhancing patient care.”

To further emphasize their commitment to quality and safety, Medtronic and Philips are launching a pledge program that ensures all monitoring products used are rigorously tested and validated across both platforms, reinforcing patient safety as a top priority. With this enhanced collaboration, the combination of Medtronic’s innovative technologies and Philips’ industry-leading monitoring systems is set to deliver deeper clinical insights and more dependable monitoring, benefiting clinicians, patients, and caregivers alike.

According to DelveInsight’s “Patient Monitoring Devices Market Report,” the global patient monitoring devices market was valued at USD 35.21 billion in 2023, growing at a CAGR of 8.20% during the forecast period from 2024 to 2030, to reach USD 56.46 billion by 2030. The escalating demand for patient monitoring devices is primarily attributed to the increase in the prevalence of various chronic and lifestyle-associated disorders. Additionally, the growing preferences for remote patient monitoring systems among the patient and healthcare providers, increase in technological advancement in the product arena, and rise in the approval of various patient monitoring devices in the current year, among others are also some of the factors responsible for potentially increasing the global patient monitoring devices market during the forecast period from 2024 to 2030.

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