Galderma Secures Triple Approval for Its New Cutting-Edge Restylane® Syringe Across the European Union, United States, and Canada; 4WEB Medical Secures FDA 510(k) Clearance for New SI Joint Truss System; Medtronic Debuts MiniMed Go Smart Insulin-Delivery System Featuring Simplera Sensor in the EMEA Region; Olympus Expands Labeling to Include Pediatric Use for Two Single-Use Bronchoscopes; Neurent Medical Reports Positive Randomized Controlled Trial Outcomes for the NEUROMARK® System; Envoy Medical Approaches Final Enrollment Phase for Its Fully Implanted Acclaim Cochlear Implant Trial

Galderma Announced Triple Approval of new state-of-the-art Restylane® Syringe in the EU, the U.S., and Canada, Reaffirming the Company’s Position at the Forefront of Injectable Aesthetics 

On February 25, 2026, Galderma announced that regulatory authorities in the EU, the U.S., and Canada had approved a new state-of-the-art syringe for use with its NASHA® lidocaine range of Restylane products. The syringe was approved for multiple facial indications, including the cheeks, nose, chin, jawline, tear troughs, nasolabial folds, marionette lines, and for use in the hands.

The syringe featured a next-generation ergonomic design that enhanced precision and control. It included an optimized syringe-needle connection integrated with the new Terumo K-Pack Enhance needle and offered premium color-coded packaging and syringe design to support easier range navigation for practitioners. It set a new benchmark in injectable aesthetic devices and reflected Galderma’s commitment to innovation to address the evolving needs of practitioners and patients.

Designed in collaboration with more than 70 aesthetic practitioners, the next-generation Restylane syringe was optimized for ergonomic functionality, ease of aspiration, smooth operation, and an enhanced look and feel. This resulted in an advanced delivery system that supported practitioners in achieving premium treatment outcomes. The syringe was also developed with sustainability in mind. It featured compact, paper-only carton packaging that was 100% recyclable and reduced in-clinic waste by up to 30% through volume reduction.

Galderma’s versatile Restylane portfolio remained the only hyaluronic acid (HA) range offering four distinct technologies: NASHA®, NASHA HD™, OBT™, and SB-NASHA™. These technologies ranged from firmer gels designed for contouring and structural support to softer, flexible formulations intended to smooth facial lines and wrinkles for a more youthful appearance. With HA closely resembling the skin’s natural composition, the portfolio was designed to deliver personalized, natural-looking outcomes that provided contour, definition, and hydration across key treatment areas of the face, décolletage, and hands.

The new state-of-the-art syringe represented the next step in Restylane’s evolution, introducing a novel delivery approach for its established premium aesthetic results.

“Developing this new syringe in close collaboration with practitioners to address their specific needs has really set it apart. Repetitive hand movements like performing numerous injections every day can lead to strain and reduced mobility, but the syringe’s ergonomic design, with a cushioned finger grip and thumb rest ensure maximum comfort when injecting, supporting consistent, high‑quality results for patients.” Dr. Luddi Luiz Oliveira, Plastic Surgeon, Brazil.

As per DelveInsight’s “Dermal Fillers Market Report,” the dermal fillers market was valued at USD 6,238.22 million in 2024, growing at a CAGR of 8.25% during the forecast period from 2025 to 2032 to reach USD 11,695.43 million by 2032. The demand for dermal fillers is driven by several key factors. Firstly, the rising number of cosmetic procedures performed globally is primarily attributed to the aging population and a growing desire to maintain a youthful appearance, alongside increasing aesthetic consciousness. Secondly, there is a strong shift towards minimally invasive cosmetic procedures due to their convenience, shorter recovery times, and lower costs compared to traditional surgeries. Lastly, increasing investments and continuous innovations in the research and development of dermal fillers are further propelling market growth. These factors collectively are expected to drive significant expansion in the dermal fillers market during the forecast period from 2025 to 2032.

4WEB Medical Received 510(k) Clearance to Market its New SI Joint Truss System

On February 25, 2026, 4WEB Medical, an orthopedic implant company specializing in proprietary Truss Implant Technology™, announced that it had received 510(k) clearance from the U.S. FDA to market its SI Joint Truss System™.

The SI Joint Truss System™ was indicated for sacroiliac joint fusion in patients suffering from sacroiliac joint dysfunction, including joint disruption and degenerative sacroiliitis. The newly introduced system expanded 4WEB’s product portfolio and initially included two implant designs: a fully threaded SI fusion device and a second version incorporating a lag feature. Each design was offered in three diameters and multiple lengths to better accommodate varying patient anatomies.

Gregg Albano, Senior Vice President of Sales for 4WEB’s Spine Division, stated that obtaining regulatory clearance allowed the company to enter and compete in a rapidly expanding market. The company aimed to enhance SI joint procedural outcomes by leveraging its proprietary Truss Implant Technology and anticipated that the SI Joint Truss System would become its fastest-growing product line.

Across the industry, companies had invested considerable time and resources in educating surgeons about SI joint pain and available treatment options, which had contributed to steady market growth. Because many surgeons were already trained in performing SI joint fusion procedures, 4WEB faced relatively low barriers to entry. The company believed that by introducing an advanced structural implant design, it could capture meaningful market share, as surgeons familiar with the procedure might transition to next-generation fusion technologies offering improved structural performance.

“Receiving regulatory clearance of the SI Joint Truss System provides 4WEB the opportunity to expand our portfolio into a high-growth market. Our goal will be to improve SI joint procedural outcomes by utilizing 4WEB’s proprietary Truss Implant Technology. We expect this to be our fastest-growing product line to date,” said Gregg Albano, Senior Vice President of Sales, 4WEB’s Spine Division.

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 global spinal fusion devices market is driven by the increasing instances of spinal disorders, rising adoption of biologics in fusion procedures, growing sedentary lifestyles and obesity leading to higher risks of disc degeneration and spinal instability, and intensified product development activities by key market players.

Medtronic Launched MiniMed Go Smart MDI system with Simplera sensor in EMEA

On February 25, 2026, Medtronic announced the commercial launch in Europe of its MiniMed Go™ Smart MDI system integrated with the Simplera™ sensor. The rollout began gradually across European markets. The system became the first and only solution to combine data from the InPen™ smart insulin pen and the Simplera™ continuous glucose sensor into a single mobile application, specifically designed to support individuals managing diabetes through multiple daily injections (MDI).

The MiniMed Go™ Smart MDI system represented a shift from traditional connected insulin pens by offering real-time, personalized insights, dose reminders, actionable missed-dose alerts, a built-in advanced bolus calculator, and continuous guidance — all accessible via a smartphone app. The platform functioned as an intelligent decision-support tool aimed at helping people overcome daily challenges associated with MDI therapy.

Clinical evidence highlighted the importance of dose adherence. Research has shown that skipping just two insulin doses per week could increase HbA1c levels by up to 0.4%, thereby raising the risk of short- and long-term diabetes-related complications. Additional studies indicated that missing two basal doses or four bolus doses within 14 days was associated with more than a 5% reduction in Time in Range (TIR). Furthermore, real-world data from the previous generation of Medtronic’s Smart MDI system demonstrated that users who responded to more than 75% of missed-dose alerts within one hour achieved a TIR of 67.2%, compared to the cohort average of 55.7%, and up to 71.5% TIR when high blood sugar alerts were addressed promptly.

“Real-time actionable alerts are becoming the key to better clinical outcomes for people with diabetes using multiple daily injections,” said Que Dallara, EVP and president of Medtronic Diabetes and CEO-designate of MiniMed. “The MiniMed Go™ system remembers, reminds, and recommends the right dose at the right time so you don´t have to.”

As per DelveInsight’s “Insulin Pens Market Report,” the global insulin pens market will grow at a CAGR of 3.45% during the forecast period from 2024 to 2030. The increase in demand for insulin pens is primarily attributed to the increase prevalence of diabetes mellitus due to genetic factor, age, obesity, and unhealthy lifestyles, increasing number of geriatric patients, enhanced awareness of self-management through insulin pens and advancements in telemedicine across the world are anticipated to bolster the market, thereby contributing to the growth of the insulin pens market during the forecast period from 2024 to 2030.

Olympus Announced the Pediatric Use Indication for Two Single-Use Bronchoscopes 

On February 24, 2026, Olympus Corporation of the Americas announced that the U.S. FDA had granted clearance for pediatric use indications for two single-use bronchoscopes within its respiratory portfolio.

The H-SteriScope™ single-use video flexible bronchoscopes were manufactured by Hunan Vathin Medical Instrument Co., Ltd. and distributed exclusively in the United States by Olympus America Inc. The FDA granted Vathin Medical 510(k) clearance, expanding the use of specific models to pediatric patients.

The Zero BCV1-02 model, featuring a 2.2 mm distal end, was approved for use in children aged six months to six years. The Slim BCV1-C2 model, equipped with a 3.2 mm distal end and a 1.2 mm working channel, was cleared for pediatric patients aged six years and older.

The H-SteriScopes™ offered several features beneficial for respiratory care, including 90-degree left and right rotation, 210-degree up and down angulation, and passive bending technology to enhance maneuverability during procedures.

The bronchoscopes were compatible with the DVM-B2 Digital Video Monitor, also manufactured by Vathin Medical and exclusively distributed by Olympus America Inc. The portable 12.1-inch monitor allowed clinicians to deliver care efficiently in critical or emergency settings, as it could be mounted on an IV pole or placed on a nearby cart for bedside use.

“Patient safety and proper diagnoses are paramount, so physicians must have access to medical devices that meet the specific needs of pediatric patients,” said Dr. Erik Hysinger, pediatric pulmonologist, Cincinnati Children’s Hospital. “This is particularly important in infants, where airway size is dramatically smaller than in adult patients. These bronchoscopes provide the optics and maneuverability critical for making the best diagnosis, while simultaneously being small enough to support the unique physiology of pediatric patients.”

According to DelveInsight’s “Bronchoscopes Market Report”, the global bronchoscopes market was valued at USD 17.89 billion in 2023, growing at a CAGR of 7.43% during the forecast period from 2024 to 2030 to reach USD 27.48 billion by 2030. The overall market for bronchoscopes is significantly boosted by several interrelated factors. The rising burden of chronic respiratory diseases creates a growing demand for advanced diagnostic and therapeutic tools, including bronchoscopes, to manage and treat these conditions effectively. Further, the surge in cigarette smoking further exacerbates respiratory issues, increasing the need for bronchoscope evaluations and interventions. Additionally, heightened awareness and the implementation of screening programs for early detection of respiratory diseases drive more individuals to seek bronchoscope procedures, contributing to market growth. Furthermore, the continuous increase in product launches and approvals by key market players across the globe introduces innovative bronchoscope technologies, enhancing their capabilities and broadening their applications, thereby escalating the overall market during the forecast period from 2024 to 2030.

Neurent Medical Announced the Publication of Positive Randomized Controlled Trial Results for the NEUROMARK® System 

On February 24, 2026, Neurent Medical reported that positive findings from its randomized controlled trial evaluating the NEUROMARK® System had been published in the International Forum of Allergy & Rhinology. The impedance-controlled radiofrequency ablation device, designed for the treatment of chronic rhinitis, demonstrated superiority over a sham procedure in improving nasal symptoms and patient quality of life. The prospective, multicenter, single-blind superiority trial enrolled 132 participants who were randomized to receive either active treatment with the NEUROMARK System or a sham control. The primary endpoint assessed the reflective Total Nasal Symptom Score (rTNSS) responder rate at 90 days. Results showed that 73.3% of patients in the active treatment group achieved responder status compared to 35.0% in the sham group (p < 0.001), successfully meeting the primary endpoint. Additionally, patients treated with NEUROMARK experienced significantly greater improvements in rTNSS, postnasal drip, chronic cough, Nasal Obstruction Symptom Evaluation (NOSE) scores, mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) scores, and Patient Health Questionnaire-9 (PHQ-9) scores compared to the control group. Responder rates for both NOSE and mini-RQLQ were also significantly higher in the active treatment arm, further supporting the device’s clinical benefit.

“These results provide high-level clinical evidence supporting posterior nasal nerve ablation with impedance-controlled radiofrequency energy as an effective treatment option for patients suffering from chronic rhinitis,” said Mas Takashima, MD, Principal Investigator of the trial and lead author of the publication. “The significant improvements observed across both symptom-based and quality-of-life measures highlight the meaningful impact this therapy can have for patients whose symptoms persist despite medical management.”

According to DelveInsight’s ”ENT Devices Market Report,” the global ENT devices market is expected to increase from USD 23,750.10 million in 2024 to USD 38,588.11 million by 2032, growing at a CAGR of 6.30% during the forecast period from 2025 to 2032. The ENT devices market’s growth is fueled by the rising prevalence of chronic disorders and an aging population, which is driving a strong demand for minimally invasive procedures and innovative technologies like advanced surgical systems and smart hearing aids.

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.