MiniMed Secures FDA Clearance for MiniMed Flex; Spinal Elements Expands Portfolio with FDA-Cleared Ventana® Platform and Initial ALIF Launch; Mindray North America Strengthens Respiratory Care Offering Through Ventilator Market Entry; Micro-Tech Endoscopy Enters Definitive Deal to Acquire Key GI Product Lines from CONMED; Composite Manufacturing Inc. Unveils Study Showing NekSpine® Exoskeleton Eases Neck and Back Load During Simulated Surgeries; SkinVision Partners on Landmark Trial to Expand Dermatology Care Access in the U.S.

MiniMed Announced the FDA Clearance of MiniMed Flex™, the Company’s Smallest Insulin Pump Featuring its First Smartphone-Controlled Design 

On 18 March 2026, MiniMed announced that it had received clearance from the U.S. Food and Drug Administration (FDA) for its MiniMed Flex™, a next-generation, discreet insulin pump designed for seamless integration into daily life. The device was introduced as the company’s first screenless, smartphone-controlled insulin pump, developed in collaboration with people living with diabetes to enhance usability and convenience. Approximately half the size of the MiniMed™ 780G system and comparable to two stacked insulin vials, the MiniMed Flex™ featured a compact design with a 300-unit insulin reservoir, allowing flexibility in wear and supporting diverse insulin needs.

The system was powered by MiniMed’s advanced SmartGuard™ algorithm with Meal Detection™ technology, which had demonstrated strong clinical performance in maintaining glucose levels within the recommended Time in Range. It was also designed to be compatible with the company’s latest sensor portfolio, including the Simplera Sync™ sensor and sensors developed by Abbott Laboratories. Additionally, the pump supported extended infusion set options, including the Extended™ infusion set, enabling up to seven days of wear and significantly reducing the frequency of injections compared to traditional insulin therapy.

The company also introduced the MiniMed™ Forward Program, allowing users of the MiniMed™ 780G system to upgrade to the MiniMed Flex™ system at no additional cost once commercially available. The launch strategy included an initial customer experience phase with select users, followed by a broader commercial rollout in the United States. The device was cleared for individuals aged 7 years and older with type 1 diabetes and for adults with insulin-requiring type 2 diabetes, marking a significant advancement in automated insulin delivery and patient-centric diabetes management.

“At MiniMed, our Mission is to make every day a better day for people with diabetes,” said Que Dallara, chief executive officer of MiniMed. “MiniMed Flex™ embodies that promise. It’s designed to work quietly and reliably in the background advanced automation wrapped in a compact, smartphone‑controlled pump. The result is technology that lets people spend less time managing diabetes and more time living their lives. Securing FDA clearance for our first product as a standalone, public company just one week after our IPO marks a major milestone and underscores our commitment to delivering the breakthrough innovation our customers deserve.”

As per DelveInsight’s “Insulin Infusion Pumps Market Report,” the global insulin infusion pumps market was valued at USD 6.48 billion in 2023, growing at a CAGR of 8.69% during the forecast period from 2024 to 2030 to reach USD 10.68 billion by 2030. The insulin infusion pumps market is slated to witness prosperity owing to factors such as growing prevalence of diabetes, increasing sedentary lifestyle, growing aging population base which is susceptible to the development of diabetes, and the growing focus on improving the safety and usability of insulin infusion pumps are further expected to result in the appreciable revenue growth in the insulin infusion pumps market during the forecast period from 2024 to 2030.

Spinal Elements Expanded Ventana® Platform with FDA 510(k) Clearance and First Cases of Ventana® A ALIF System

On 18 March 2026, Spinal Elements®, a spine technology company focused on innovative surgical solutions, announced that it had received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and had successfully performed the first clinical cases using its Ventana A Anterior Lumbar Interbody Fusion (ALIF) System. The launch strengthened the company’s portfolio of 3D-printed titanium interbody implants for both lumbar and cervical fusion procedures and was introduced through a limited market rollout.

The Ventana A system was designed to enhance fusion outcomes by supporting improved surgical performance and efficiency. It featured a unique hinged implant architecture intended to maximize bone graft volume and maintain graft containment during implantation. Manufactured using a specialized 3D printing process, the system enabled better restoration of segmental alignment and spinal stability. Additionally, it incorporated reduced titanium density to optimize load sharing, thereby helping to mitigate the risk of subsidence while also improving intraoperative visualization for surgeons. 

“ALIF is a powerful procedure and a workhorse for many spine surgeons, which is why we set out to develop a best-in-class system that maximizes its clinical benefits,” said Ron Lloyd, Chief Executive Officer. “Building on the proven Ventana platform, this contemporary system increases Spinal Elements’ portfolio offering and procedural reach to a greater number of surgeon and distribution partners. Combined with intuitive instrumentation and efficient packaging, Ventana A is designed to enhance clinical performance and operating room efficiency, demonstrating our commitment to continued innovation – working with surgeon partners to develop systems that are meaningfully differentiated and deliver improved outcomes”.

The first case was performed by Dr. A.J. Rush III at Texas Spine Consultants in Addison, TX. Dr. Rush shared: “The Ventana A system delivers a clinical advantage to everyday challenges for spine surgeons. The large graft window allows for maximal graft delivery as well as improved visualization for fusion assessment and distributes load across the entire surface to reduce subsidence risk. Having used the instrumentation in both lab and clinical settings, I can attest to Ventana A’s ability to offer a best in class ALIF solution.”

As per DelveInsight’s “Spinal Fusion Devices Market Report,” the global spinal fusion devices market size is expected to increase from USD 7,139.71 million in 2024 to USD 10,762.88 million by 2032, growing at a CAGR of 5.31% during the forecast period from 2025 to 2032. The spinal fusion devices market is witnessing steady growth, driven by several key factors. Increasing instances of spinal disorders, such as degenerative disc disease, spinal stenosis, and vertebral fractures, have significantly raised the demand for surgical interventions that provide spinal stability and pain relief. The rising adoption of biologics in spinal fusion procedures is further enhancing bone healing and fusion success rates, making these devices more effective and attractive to surgeons. Lifestyle-related factors, including growing sedentary habits and obesity, are contributing to higher risks of disc degeneration and spinal instability, which in turn fuels the need for spinal fusion solutions. Additionally, intensified product development activities by leading market players are introducing advanced implants with improved design, materials, and minimally invasive options, supporting broader adoption. These drivers, combined with technological innovations and increasing clinical awareness, continue to propel the expansion of the spinal fusion devices market globally.

Mindray North America Revolutionized Respiratory Care with Landmark Entry into the Ventilator Market 

On 18 March 2026, Mindray, a global leader in healthcare innovation across perioperative care, medical imaging, and critical care, announced its entry into the ventilator market with the launch of the SV900 and SV700 ventilators. As one of the world’s largest providers of acute care hospital ventilators, the company leveraged its global expertise to establish a strong presence in the North American market. This strategic expansion broadened its critical care portfolio by offering clinicians adaptable, flexible, and efficient respiratory support technologies designed for high-pressure clinical environments.

The SV900 and SV700 ventilators were developed to support patients of all ages and varying respiratory needs across different care settings. They integrated invasive, non-invasive, and high-flow oxygen therapies into a single platform, thereby streamlining clinical workflows and ensuring appropriate respiratory support throughout the patient recovery process. Additionally, the systems incorporated advanced tools for weaning and lung-protective ventilation strategies, which enhanced clinical decision-making and contributed to improved patient outcomes.

Both ventilators were supported by a three-year warranty, reflecting the company’s commitment to long-term value and reliability. This warranty was part of a broader total cost of ownership approach, ensuring that healthcare providers received consistent service, support, and operational efficiency beyond initial installation. Overall, Mindray’s entry into the ventilator segment represented a significant step in expanding access to advanced respiratory care solutions and reinforced its focus on driving innovation in critical care.

“Entering the U.S. ventilator market with the SV900 and SV700 represents a pivotal moment in our company’s growth and commitment to healthcare providers,” said Wayne Quinn, President of Mindray North America. “We are enabling our partners to achieve significant economies of scale, streamline procurement processes, and enhance patient care by integrating our new respiratory solutions into our critical care portfolio and equipping their teams with a full suite of cutting-edge tools from a single, trusted provider.”

As per DelveInsight’s “Ventilators Market Report,” the global ventilators market is expected to grow at a CAGR of 11.65% during the forecast period from 2024 to 2032. The Ventilators market is expected to witness substantial growth, fueled by several important factors. Primarily, the increasing prevalence of respiratory and cardiovascular diseases serves as a major growth driver. Conditions such as chronic obstructive pulmonary disease (COPD), asthma, acute myocardial infarction, congestive heart failure exacerbations, severe arrhythmias, and cardiogenic shock create a rising demand for advanced ventilator support. Additionally, the expansion of critical care units significantly contributes to the market’s growth.

Micro-Tech Endoscopy Signed Definitive Agreement to Acquire Duraclip™, Precisor®, and Optibite® Product Lines from CONMED 

On 18 March 2026, Micro-Tech Endoscopy announced that it had entered into a definitive agreement to acquire the global distribution rights for the Duraclip™, Precisor®, and Optibite® product lines from CONMED Corporation. These products had previously been distributed by CONMED on behalf of Micro-Tech for more than a decade. The agreement followed CONMED’s strategic decision to exit the gastroenterology segment as part of a broader portfolio realignment.

Through this transaction, Micro-Tech integrated these product lines into its gastrointestinal (GI) endoscopy portfolio, ensuring continued availability for clinicians. The addition of Duraclip™ strengthened its hemostasis product portfolio, while Precisor® and Optibite® expanded its biopsy device offerings. Combined with its existing range of diagnostic and therapeutic solutions, including the Dual Action Tissue (DAT) Closure device and the eyeMAX cholangioscopy system, the company further enhanced its ability to address clinical needs across both ambulatory surgical centers and hospital settings. 

“This agreement reflects our continued commitment to expanding access to a broad range of GI endoscopy tools,” said Scott VanderMeer, President of Micro-Tech Endoscopy Americas. “By adding Duraclip, Precisor, and Optibite to our portfolio, we are strengthening our position in the GI market and reinforcing our role as a trusted partner to clinicians.”

“We are pleased to transition these product lines from CONMED to Micro-Tech and believe they are well positioned to continue the strong legacy these products have established in the GI market,” said Pete Shagory, Vice President & General Manager, Advanced Endoscopic Technologies at CONMED. “Micro-Tech has long served as the original manufacturer behind the Duraclip, Precisor, and Optibite devices and brings extensive experience in its design and production. We are committed to supporting a smooth transition for customers.”

According to DelveInsight’s “Endoscopes Market Report,” the global endoscopes market was valued at USD 12.95 billion in 2023, growing at a CAGR of 6.05% during the forecast period from 2024 to 2030 to reach USD 18.32 billion by 2030. The increase in demand for endoscopes is primarily attributed to the increasing prevalence of chronic disease which require the use of endoscopes for diagnosis, such as some gastrointestinal diseases like irritable bowel syndrome (IBD), gastroesophageal reflux disease (GERD), peptic ulcer disease, and crohn’s disease, increase in number of geriatric population who are more prone to chronic ailments, increasing awareness and demand of minimally invasive surgeries and no blood loss surgery, and rise in technological advancements in endoscopes like image magnification, high-definition optical systems and digital imaging are anticipated to bolster the market, thereby contributing to the growth of the endoscopes market during the forecast period from 2024 to 2030.

Composite Manufacturing Inc. Announced that the new Study Showed NekSpine® Exoskeleton Significantly Reduces Neck and Back Strain in Simulated Surgical Tasks 

On 16 March 2026, A peer-reviewed study published in Sensors reported that the NekSpine passive exoskeleton developed to support both the neck and lower back—significantly reduced muscle strain and discomfort during tasks simulating the physical demands of surgery. The findings positioned NekSpine as a promising ergonomic solution for professionals such as surgeons, dentists, and industrial workers who frequently maintain forward-flexed postures for extended periods.

The study was conducted by researchers from the University of Alberta in collaboration with EWI Works International Inc. The researchers assessed the device’s performance across various neck-flexion angles using electromyography (EMG) sensors alongside user-reported exertion scores.

The results demonstrated up to a 31% reduction in neck muscle activity at moderate flexion angles and up to a 19% reduction in lower-back muscle activity. Participants also reported a 50% decrease in neck discomfort and a 41% reduction in lower-back discomfort. Additionally, the use of the exoskeleton led to a 55% increase in endurance time, highlighting its effectiveness in improving comfort and sustaining performance during prolonged tasks.

According to DelveInsight’s ”Wearable Medical Devices Market Report,” the global wearable medical devices market is expected to increase from USD 42,981.29 million in 2024 to USD 185,415.73 million by 2032, growing at a CAGR of 20.07% during the forecast period from 2025 to 2032. The global wearable medical devices market is surging, fueled by rising chronic disease prevalence, the shift toward remote patient monitoring, and rapid tech advances. With miniaturized sensors, AI-driven insights, and 5G connectivity, wearables are evolving from fitness gadgets into essential medical tools for proactive and connected healthcare.

SkinVision Collaborated on Pivotal Trial to Improve Access to Dermatology Care in the United States 

On 16 March 2026, SkinVision, a global provider of AI-powered skin health solutions, announced that it had entered into a research collaboration with Mayo Clinic to conduct a pivotal clinical study required by the U.S. Food and Drug Administration (FDA) to support its regulatory pathway in the United States. The collaboration was established under a formal research agreement aimed at facilitating scientific exchange and enabling the execution of an advanced clinical study.

The initiative was launched in response to the rising incidence of melanoma and non-melanoma skin cancers, along with limited access to timely dermatology care in the U.S. Factors such as workforce shortages, insurance constraints, geographic disparities in dermatologist availability, and socioeconomic barriers had contributed to delayed diagnosis and poorer patient outcomes.

The pivotal study was designed to evaluate the performance and intended use of the SkinVision app’s AI-based assessment for skin lesions, while also assessing the role of digital tools in improving access to dermatological guidance. This collaboration marked a significant step in strengthening the company’s clinical evidence base and advancing toward FDA clearance, to validate the application for use within the U.S. population.

Additionally, the SkinVision app was developed to assist users in documenting and monitoring suspicious skin spots by guiding them to capture high-quality images and relevant information during self-examinations. The app provided indications when further evaluation by a healthcare professional was recommended, reinforcing the company’s focus on delivering accessible, affordable, and research-driven digital skin health solutions.

According to DelveInsight’s “Dermatology Devices Market Report, the global dermatology devices market was valued at USD 6.27 billion in 2023, growing at a CAGR of 12.47% during the forecast period from 2024 to 2030 to reach USD 12.69 billion by 2030. The Dermatology Devices market is slated to witness prosperity owing to factors such as the growing prevalence of chronic skin problems such as acne, atopic dermatitis, and psoriasis among others, further increasing awareness of skin care and the growing focus on improving the safety and usability of dermatology devices for end-users are further expected to result in the appreciable revenue growth in the dermatology devices market during the forecast period from 2024 to 2030.