Described by Artivion as the world’s first aortic arch remodeling device for treating acute DeBakey Type I aortic dissections, the AMDS Hybrid Prosthesis is designed to reduce the incidence of distal anastomotic new entry (DANE) tears while complementing hemiarch replacement without increasing procedural complexity. The device is deployed during a standard ascending aorta replacement, preserves the native aortic arch and supports minimally invasive reinterventions when required. FDA approval follows results from the PERSEVERE U.S. IDE trial, which reported a 72% reduction in all-cause mortality and a 54% reduction in primary major adverse events at 30 days.

Pat Mackin, chair, president and CEO of Artivion, said: “We are thrilled to receive AMDS PMA approval, as it not only validates the enduring benefits shown in the PERSEVERE clinical data but also removes a barrier to broader adoption by eliminating the IRB requirement that came with the HDE. Having already built commercial and clinical infrastructure during our HDE launch, and with strong reordering momentum among accounts already using AMDS, we expect this PMA to help accelerate adoption of this life saving technology.

“This approval, following our recent acquisition of the PMA-approved NEXUS system and continued clinical trial enrollment progress for ARCEVO LSA, marks another step forward in our vision of Artivion as the only company globally with a complete portfolio of market leading aortic arch solutions. We are deeply grateful to every PERSEVERE investigator and patient who helped make this possible.”

The company said hospitals are handling a growing number of procedures that demand greater collaboration across surgical teams, making conventional software approaches less effective in meeting evolving clinical requirements. To address these challenges, the Hamburg-based center has been developed around real surgical workflows rather than standardized software models. By aligning digital capabilities with day-to-day clinical practice, Getinge aims to provide flexible and scalable solutions that better support operating room teams while strengthening connectivity throughout the perioperative process.

Charlotte Enlund, VP, Digital Health Solutions, Getinge, said: “Technology alone is not the goal. What clinical teams need are solutions that are flexible, scalable, and designed for real-life challenges. AI and connected workflows are reshaping how hospitals operate, and the bar for what good software must deliver is rising. For a digital MedTech company at the forefront of that shift, Hamburg is where we build what clinical teams need next.”

The company added that the Digital OR Hub is intended to strengthen the relationship between clinical requirements and software innovation while encouraging closer collaboration between development teams and healthcare professionals. Matthias Rath, director, Getinge product management & business development, Digital OR Solutions, said: “This investment is not only about where we work, but how we work. It creates the conditions for closer collaboration, accelerates development, and lays the foundation for a connected OR ecosystem. Delivered as a service designed to support healthcare providers.” Through this initiative, Getinge Opens Digital OR Hub as part of its broader effort to advance connected operating room technologies and support digital transformation across surgical care.

The company currently provides services to more than 1.1 million individuals and has demonstrated significant operating leverage by scaling its operations with limited headcount growth. This partnership is expected to yield mutual strategic advantages, as Prosus intends to support the scaling of the consumer ecosystem and facilitate expansion into large international territories where Prosus maintains a strong presence. Furthermore, the collaboration will accelerate AI-led product development, granting Alan access to the Prosus Large Commerce Model (LCM). This move aligns with the life assistant strategy of the investor, aiming to broaden its reach within the healthcare domain. The completion of the Prosus Alan investment remains contingent upon receiving necessary regulatory approvals, including those required by the relevant financial authorities in France.

Executive Perspectives on the Partnership

“Healthcare presents one of the most significant global opportunities for AI-led transformation,” stated Fahd Beg, Head of Investments at Prosus Group. “Alan has built something unique: an integrated platform where insurance, prevention and care delivery reinforce each other, creating an exceptional healthcare experience for consumers and outstanding platform engagement. We’re excited to partner with Alan to accelerate its international expansion and unlock value through our ecosystem.”

Jean-Charles Samuelian-Werve, Co-founder and CEO of Alan, emphasized the urgency of modernizing medical access: “Health can’t wait, not for symptoms to get worse, not for a six-month appointment, not for the system to catch up. Yet that is exactly how healthcare works today. We believe great health is a universal right, and that prevention should be too. For ten years we have shown that technology can turn healthcare from reactive to proactive, helping people act early instead of reacting late. That is what prevention insurance is, and it’s the category we are building. We selected Prosus for their very deep expertise in international expansion and consumer products and to benefit from the incredible ecosystem they are building. We are still at the very beginning of what Alan can become.” As the company moves forward, it will continue to manage its consumer ecosystem and life assistant strategy to maintain its market position while awaiting final clearance from financial authorities. The firm’s ability to maintain headcount growth at a controlled rate while utilizing primary and secondary equity for expansion remains a core component of its operational model.

The ablation catheter integrates a precision sensor near its tip that measures the force applied to cardiac tissue during the procedure. This contact force data is displayed in real time, enabling physicians to assess catheter-to-tissue interaction more effectively. According to Johnson & Johnson, this capability is intended to help electrophysiologists optimize lesion formation while performing ablation for atrial fibrillation and other arrhythmias. The THERMOCOOL SMARTTOUCH catheter is compatible with the company’s CARTO 3 System, which is widely used in electrophysiology labs for three-dimensional cardiac mapping.

Biosense Webster developed the force-sensing technology to address variability in catheter contact during ablation procedures. Inconsistent contact force has been identified in clinical literature as a factor that may affect procedural outcomes. By equipping physicians with direct feedback on the force being applied, the device aims to improve consistency across procedures. The THERMOCOOL SMARTTOUCH catheter builds upon the established THERMOCOOL platform, which has been used extensively in ablation catheter procedures worldwide.

The European launch positions Johnson & Johnson to compete in the growing market for advanced electrophysiology devices. Atrial fibrillation remains one of the most common cardiac arrhythmias globally, and demand for catheter-based treatments continues to rise. With the THERMOCOOL SMARTTOUCH catheter now available in Europe, Biosense Webster expands its portfolio of ablation catheter technologies equipped with real-time sensing capabilities. The company has stated that clinical data supporting the device’s performance will continue to be gathered as adoption increases across European electrophysiology centers.

“Our goal with SureTome SW was not only to provide a sphincterotome that worked well for endoscopic retrograde cholangiopancreatography (ERCP) procedures, but also to show physicians that their feedback matters and helps fuel Cook’s innovation,” Cook Medical MedSurg Senior Vice President DJ Sirota said in a news release. “SureTome delivers on that promise and also integrates seamlessly into existing workflows, helping physicians as well as hospital systems achieve their goals,” he continued. SureTome SW incorporates Cook’s DomeTip technology to support smooth cannulation, Protector insulated coating intended to assist with targeting desired tissues during sphincterotomy, a proprietary pre-slit catheter that facilitates short-wire transitions, and a rotatable handle designed for controlled positioning and torque response. The company stated that these capabilities help physicians cannulate the desired duct, perform precise and controlled cuts, and maintain procedural efficiency throughout ERCP procedures.

Cook Medical also noted that the device is compatible with a range of guide wires and comes preloaded with the company’s Acrobat 2 Calibrated Tip Wire Guide, allowing physicians to integrate it into existing clinical settings with minimal training. “With little training required, SureTome SW is a quick ‘plug-and-play’ addition to any endoscopy suite,” the company said. The company added that SureTome SW was designed in response to customer recommendations drawn from real-world clinical experiences. “By combining physician feedback with new techniques, Cook created SureTome SW, which is used for cannulation of the ductal system and for sphincterotomy,” the company said. “If SureTome SW is preloaded with a wire guide, it can also aid in bridging difficult strictures.”

“With the launch of SureTome SW, we are reinforcing our dedication to innovation in endoscopy,” Cook Medical MedSurg Director of Global Marketing John Devlin said. “This device allows physicians to perform more ERCP procedures with confidence and control, ultimately enhancing patient care.” The launch further expands Cook Medical’s offerings in Endoscopy while reflecting the company’s emphasis on incorporating physician input into product development.

The Thunderbolt platform broadens Penumbra’s existing CAVT portfolio and is engineered to detect, fatigue and completely ingest clot during procedures. According to the company, the technology represents an advancement in acute ischemic stroke care and is powered by its Engine platform. With the European authorization, Penumbra said the device becomes the first and only CAVT technology available for stroke treatment in both the U.S. and Europe. The Thunderbolt Thrombectomy system will be supplied pre-packaged with one of the company’s catheter options, including Red 62, Red 68, Red 72, Silver Label or Red 72 Silver Label with SENDit technology.

The Alameda, California-based company described the approval as a significant milestone for its neurovascular business. Penumbra noted that the technology builds on two decades of research and development focused on clot-treatment solutions. The company also stated that it remains the only provider offering CAVT technology across both vascular and neurovascular care applications.

Commenting on the approval, Shruthi Narayan, president of Penumbra, said: “Thunderbolt is a culmination of two decades of research and innovation at Penumbra. By introducing CAVT to the neurovascular field in Europe, we are ushering in a new era of stroke management that will have a significant impact on patient care. We are the only company to offer CAVT technology across both vascular and neurovascular care as we are committed to transforming how life-threatening clots are treated from head-to-toe worldwide.”

Joan Kristensen, head of EMEA for Penumbra, added: “Thunderbolt has the potential to shorten procedure times improving patient safety, delivering better outcomes and streamlining care for the physicians who treat them. Bringing this technology to Europe is a significant milestone and a reflection of Penumbra’s ongoing commitment to putting the most advanced stroke care tools in the hands of physicians across the region.”

The agreement underscores a shared commitment between the two organizations to address evolving healthcare challenges through technology-driven innovation. By combining their respective expertise and resources, Kaopiz Holdings and QuantumTX aim to create AI healthcare solutions that enhance disease prevention and patient outcomes. The collaboration encompasses the integration of IoT engineering capabilities with advanced analytics to build comprehensive health data ecosystems capable of supporting preventive care initiatives.

The partnership’s scope includes the development of AI healthcare solutions designed to deliver actionable insights for preventive medical interventions. Through the deployment of IoT-enabled monitoring systems and intelligent data processing frameworks, the organizations seek to establish next-generation platforms that can identify health risks before they escalate into serious conditions. This approach represents a meaningful shift toward proactive rather than reactive healthcare delivery models.

The MOU establishes a foundation for collaborative research, product development, and market implementation of these technologies. Both entities recognize the growing demand for intelligent healthcare infrastructure capable of processing vast quantities of health information in real-time. By pooling technical expertise in artificial intelligence, IoT engineering, and health data analytics, the partnership positions itself to deliver solutions with practical applications across multiple healthcare settings and patient demographics.

The initiative reflects broader industry trends toward digitalization and intelligent health management systems. The integration of AI-powered healthcare solutions with IoT infrastructure creates opportunities for continuous patient monitoring, early warning systems, and personalized preventive care recommendations. Through this strategic collaboration, Kaopiz Holdings and QuantumTX aim to contribute meaningfully to the advancement of preventive healthcare technology and improved health outcomes globally.

Noctrix Health had developed a wearable neurostimulation device designed to treat moderate-to-severe restless legs syndrome through its proprietary TOMAC therapy, which works by delivering targeted electrical stimulation to the legs. The therapy represents a non-pharmacological treatment pathway for RLS, an area where treatment options have historically been limited and where patients often face challenges with long-term medication adherence or side effects. The acquisition of Noctrix Health is structured as an upfront payment combined with additional milestone-based consideration, with the total deal reaching up to $340 million depending on the achievement of certain commercial and regulatory milestones.

ResMed’s Chief Executive Officer Mick Farrell highlighted the strategic importance of the transaction, describing Noctrix Health’s TOMAC therapy as a meaningful addition to the company’s growing portfolio of sleep health solutions. ResMed, which is widely known for its continuous positive airway pressure (CPAP) devices and software solutions for sleep apnea management, has been actively broadening its reach across various sleep-related conditions. The inclusion of an RLS-focused therapy aligns directly with that broader strategic direction, allowing the company to address a wider spectrum of sleep disorders beyond its core sleep apnea business.

Restless legs syndrome affects a significant portion of the global population and is frequently underdiagnosed and undertreated. The condition causes uncomfortable sensations in the legs, typically worsening at night, and leads to severe disruptions in sleep. By integrating Noctrix Health’s technology and clinical expertise through the acquisition of Noctrix Health, ResMed positions itself to serve patients who have not yet found effective relief through existing treatment options. The combined organization is expected to continue development efforts and pursue broader commercialization of the TOMAC platform as part of ResMed’s long-term growth strategy in sleep health.

According to the organizations, the collaboration is designed to improve financial performance, streamline administrative activities and reinforce the connection between supply chain strategy and clinical priorities. TMH will retain decision-making authority and leadership oversight while benefiting from broader support in areas including strategic sourcing, purchased services optimization, analytics-driven decision making and clinical-supply alignment. The integrated approach is expected to enable multiple value-focused initiatives to move forward simultaneously, helping accelerate results while reducing pressure on internal teams. Speaking about the agreement, David Adkins, Executive Director of Supply Chain Management, Tallahassee Memorial HealthCare, said, “This partnership allows us to build on that momentum—adding scale, expertise and advanced analytics while preserving local ownership. It strengthens our ability to continuously improve and ensures we are well-positioned to serve our patients and community for the long term.”

A key aspect of the arrangement is TMH’s established culture of clinical collaboration, including physician champion support and experience with co-management models. These capabilities are expected to support closer integration between clinical stakeholders and supply chain planning. Bruce Mairose, Vice President of Inspirity Health Partners and Division Chair, Supply Chain Management at Mayo Clinic, stated, “TMH brings a disciplined approach and a clear commitment to continuous improvement. Together, we are building one fully integrated TMH–Inspirity supply chain team—seamlessly combining local expertise with national scale to deliver meaningful, sustainable value.” The organizations said the partnership reflects a broader movement among health systems seeking stronger operating performance while maintaining community-focused governance. Through advanced analytics, operational methodologies and national-scale resources, the collaboration is intended to create a resilient Healthcare Supply Chain platform that supports continued strategic growth.