Spineart and eCential Robotics Gain FDA Clearance for PERLA® TL Robotic Surgery Application; ZEISS CLINIC 360 Earns FDA 510(k) Clearance, Strengthening Data-Driven Patient Care; Bittium Introduces Faros Pro™ and EasyFlex™ for Extended Ambulatory ECG Monitoring; Cytrellis Expands ellacor® Micro-Coring® Technology to Australia for Full-Body Skin Resurfacing; Galmed Announces Successful First-in-Human Study of Colospan’s Novel Tissue Assessment Technology; FastWave Medical Secures FDA IDE Approval for Pivotal Artero™ Peripheral IVL Trial

Spineart and eCential Robotics Received FDA 510(k) Clearance for the PERLA® TL Application for Use with eCential® Op.n® Navigation System for Robotic Procedures 

On 26 August 2026, Spineart and eCential Robotics received FDA 510(k) clearance for the PERLA TL application for use with eCential Robotics’ Op.n Navigation and Robotic-Assisted Platform. The clearance extended the previously established compatibility between the PERLA platform and the Op.n navigation system to robotic-assisted workflows.

The clearance enabled surgeons to integrate Spineart’s PERLA TL Open and MIS pedicle screw systems with real-time navigation and robotic assistance for both open and minimally invasive spine procedures. The integrated solution was designed to support implant placement accuracy, procedural workflow efficiency, and consistent execution during spinal surgery.

The PERLA application operated on the Op.n platform and combined Spineart’s implant and instrument technologies with eCential Robotics’ navigation and robotic capabilities. The regulatory clearance strengthened the companies’ collaboration and expanded the availability of integrated robotic and navigation solutions for spine surgery in the U.S. market.

“This is an exciting milestone for our PERLA® range and for our commitment to innovation in spine surgery. Together with eCential Robotics, we are introducing a truly collaborative robotic platform that brings simplicity, precision, and active robotics capabilities together to help redefine the surgical experience for spine surgeons and their patients”, said Laurent Nodé-Langlois, Chief Technology Officer at Spineart.

As per DelveInsight’s “Next Generation Surgical Robotics Market Report,” the next generation surgical robotics market is estimated at USD 11.20 billion in 2025 and is projected to reach USD 38.50 billion by 2034. Growth is anchored in the rising demand for minimally invasive surgery, a wave of new competitive platforms challenging long-standing market dominance, and the integration of AI, force feedback, and digital surgery ecosystems. The global Next Generation Surgical Robotics market is growing at a CAGR of 14.7% during the forecast period from 2026 to 2034.

ZEISS CLINIC 360 Received FDA 510k Clearance, Amplifying Patient Care Through Simplified Clinical Insights 

On 19 August 2026, ZEISS Medical Technology announced that ZEISS CLINIC 360 had received 510(k) clearance from the U.S. Food and Drug Administration. The cloud-based, browser-accessible platform was designed to consolidate diagnostic information, electronic medical records, and practice-system data into a unified patient view. The solution enabled ophthalmologists to review information from multiple diagnostic modalities, monitor disease progression, support treatment decisions, and improve clinical workflow efficiency. 

It also incorporated analytical tools for conditions such as glaucoma by enabling clinicians to assess trends across OCT, intraocular pressure, and visual field data. The platform was built on the ZEISS Health Data Platform and provided practices with a scalable alternative to on-premise data management, with subscription-based access designed to reduce upfront infrastructure requirements. The FDA clearance strengthened ZEISS’s digital ophthalmology portfolio and supported the company’s expansion of connected and cloud-based eye-care workflows in the U.S.

“Our strategic focus on digitally connected workflows, combined with the increasing adoption of digital ophthalmic tools in the U.S., has firmly positioned ZEISS at the forefront of empowering ophthalmologists. As ophthalmology continues to adopt connected technologies, clinicians need solutions that fit seamlessly into how their practice operates,” says Federico Villegas, Head of ZEISS Medical Technology U.S. and President of Carl Zeiss Meditec USA, Inc. “ZEISS CLINIC 360 reflects our commitment to reducing complexity across the care journey and helping practitioners work more efficiently while maintaining focus on their patients, marking a significant advancement toward the delivery of more personalized patient care.”

As per DelveInsight’s “Ophthalmological Devices Market Report,” the ophthalmology devices market was valued at USD 60.22 billion in 2024, growing at a CAGR of 4.83% during the forecast period from 2025 to 2032 to reach USD 87.62 billion by 2032. The demand for Ophthalmology Devices is primarily being boosted by the increasing prevalence of eye disorders such as cataracts, glaucoma, and refractive disorders, among others. Additionally, growing technological advancement in the domain of ophthalmology, increasing ocular injuries due to trauma, and a growing geriatric population are some of the contributing factors to the growth of the Ophthalmology Devices market during the forecast period from 2025-2032.

Bittium Launched new Faros Pro™ ECG device and EasyFlex™ single-use Electrode Patch for long-term Ambulatory ECG Monitoring 

On 27 August 2026, Bittium launched the Faros Pro ambulatory ECG device and EasyFlex single-use one-lead electrode patch for long-term ECG monitoring. The Faros Pro was designed to provide high-quality ECG recording during patients’ daily activities and supported continuous monitoring for periods ranging from 24 hours to 30 days, with up to 21 days of recording on a single charge depending on device settings. 

The longer monitoring capability was intended to improve the detection of intermittent arrhythmias that could be missed during shorter ECG examinations. The Faros Pro received CE marking under the EU Medical Device Regulation, while the EasyFlex patch was introduced to support long-term ambulatory ECG monitoring. The launch strengthened Bittium’s international ECG product portfolio and expanded its presence in the long-term ambulatory ECG monitoring market.

“This is an important launch for Bittium Medical. We combine decades of experience in biosignal measurement with patient-friendly devices. Clinically validated ECG devices provide reliable data that help healthcare professionals make more confident care decisions for patients with heart rhythm disorders. Longer recordings provide more opportunities to detect arrhythmias that may otherwise be missed in shorter examinations. This can help patients get answers about their health sooner,” says Niina Huikuri, Senior Vice President, Medical Business Segment. “Faros Pro demonstrates our ability to develop trusted medical technology and strengthens our offering in international long-term ECG recording markets. In line with our strategy, we will continue to advance ECG technology, with the aim of bringing increasingly cutting edge ECG technology to market in the future.”

As per DelveInsight’s “Holter Monitor Market Report,” the global Holter monitor market will grow at a CAGR of 6.13% during the forecast period from 2024 to 2030. The stellar growth observed in the market is primarily due to the growing burden of various cardiovascular disorders, which lead to abnormal heart rhythms such as atrial fibrillation and heart palpitations, among others, that may require monitoring through Holter monitors. Additionally, a rise in sedentary lifestyles and lifestyle-associated disorders that increase the risk of developing CVDs manyfold is also expected to increase the demand for Holter monitors in the upcoming years. Also, an increased burden of the geriatric population and growing technological advancement in the product portfolio are some of the other factors propelling the market for Holter monitors currently and will also drive the market during the forecast period from 2024 to 2030.

Cytrellis Launched ellacor® Micro-Coring® Technology for Full-Body Skin Resurfacing in Australia 

On 26 August 2026, Cytrellis Biosystems launched its ellacor Micro-Coring technology for full-body skin resurfacing in Australia following regulatory approval from the Therapeutic Goods Administration. The technology became available to Australian physicians through exclusive distributor Device Consulting Pty. Ltd. and provided a non-surgical approach for treating skin laxity and improving skin quality.

The ellacor system had initially been developed for treating moderate to severe facial wrinkles and excess skin and was subsequently expanded for use across multiple body areas. Following the Australian approval, physicians were able to perform skin resurfacing procedures on areas including the neck, abdomen, arms, thighs, and knees. The technology precisely removed microscopic cores of skin while preserving surrounding tissue, supporting the natural healing process and collagen remodeling without the use of heat or surgery.

The Australian launch represented an important step in Cytrellis Biosystems’ international expansion and strengthened the company’s presence in the medical aesthetics market. The expansion also supported growing demand for minimally invasive and non-surgical solutions for skin laxity associated with aging, weight loss, pregnancy, and other factors.

“This approval represents another major milestone in our mission to redefine what’s possible in skin health and restoration,” said Denise Dajles, CEO of Cytrellis. “As demand for nonsurgical solutions continues to grow around the world, we’re proud to bring ellacor’s unique Micro-Coring Technology to physicians and patients throughout Australia. This expansion reflects our commitment to delivering meaningful innovation that addresses skin laxity without the downtime, scarring, or thermal injury associated with many traditional procedures.”

According to DelveInsight’s “Medical Aesthetic Devices Market Report”, the global medical aesthetic devices market was valued at USD 13,533.26 million in 2023, growing at a CAGR of 11.46% during the forecast period from 2024 to 2030, to reach USD 25,808.43 million by 2030. The increase in the market for medical aesthetic devices is predominantly owing to an exponential rise in the aging population and an increase in the adoption of various aesthetic procedures. Additionally, the growing awareness among the population to look aesthetically presentable and also regarding the various cosmetic procedures performed across the globe is likely to boost the market. Also, shifting preferences towards less complex minimally invasive or non-invasive aesthetic procedures, a rise in obesity among the population, and growing technological advancement in the product arena, among others, are some of the key factors expected to raise the market for these devices during the forecast period from 2024 to 2030.

Galmed Announced Successful First-in-Human Proof-of-Concept Clinical Study Results for Colospan’s Novel Intraoperative Tissue Assessment Technology 

On 19 August 2026, Colospan Ltd., a subsidiary of Galmed Pharmaceuticals, announced the successful completion of a first-in-human feasibility study evaluating its novel intraoperative colon tissue quality assessment technology. The prospective study enrolled 32 colorectal cancer patients undergoing elective colorectal surgery at three clinical centers in Israel. The study demonstrated the technical feasibility of quantitatively measuring colon tissue compliance using an ex-vivo assessment method, with successful measurements obtained from all enrolled patients and no measurement failures or procedure-related technical problems.

The results established an initial clinical basis for the continued development of an intraoperative device designed to objectively evaluate colon tissue quality during colorectal procedures. The technology was being developed to provide surgeons with real-time quantitative information about the mechanical properties of colon tissue, which could support surgical decision-making and planning before colorectal anastomosis. The platform could also potentially assist in identifying patients who had a higher risk of developing low anterior resection syndrome. The successful feasibility study expanded Colospan’s development pipeline beyond its CG-100 intraluminal bypass device and strengthened its focus on developing technologies addressing unmet needs across colorectal cancer surgery.

“The acquisition of Colospan was driven by our conviction that the company represents far more than a single-product opportunity. We recognized an innovation platform with deep scientific expertise, a differentiated technology portfolio and the ability to develop multiple solutions addressing significant unmet needs in colorectal surgery. The data we are publishing today support our belief that Colospan’s engineering concepts have the potential to transition effectively into real-world clinical use. We believe that the data give Colospan a strong foundation for the continued development of the platform and support our plans to advance toward future clinical trials and regulatory submissions.”

According to DelveInsight’s ”Colorectal Surgical Devices Market Report,” the global colorectal surgical devices market is expected to increase from USD 20,139.74 million in 2024 to USD 36,776.06 million by 2032, reflecting strong and sustained growth. The global colorectal surgical devices market is growing at a CAGR of 7.87% during the forecast period from 2025 to 2032. The Colorectal Surgical Devices market growth is primarily driven by the increasing cases of colorectal cancer and other related disorders, such as inflammatory bowel disease (IBD), diverticulitis, and Crohn’s disease, coupled with growing awareness and widespread screening programs. This rising demand is further supported by ongoing product development activities among key market players, leading to the introduction of advanced and minimally invasive surgical devices.

FastWave Medical Received FDA IDE Approval for Pivotal Artero Peripheral IVL Trial

On 11 August 2026, FastWave Medical announced that it had received U.S. Food and Drug Administration approval for its Investigational Device Exemption application for the Artero electric intravascular lithotripsy system. The approval allowed the company to initiate a pivotal U.S. clinical trial evaluating the technology in patients with peripheral artery disease. The pivotal study was designed to evaluate the safety and effectiveness of the Artero system in treating peripheral arterial disease, with a particular focus on patients with calcified arterial lesions. The trial represented an important regulatory milestone for FastWave as it progressed toward potential FDA clearance of its peripheral IVL technology.

Artero had been developed as an electric IVL platform for modifying calcium within peripheral arteries. The system delivered circumferential sonic pressure waves through a balloon catheter, with the objective of disrupting vascular calcium while facilitating endovascular treatment. FastWave had previously reported progress in the clinical development of the technology, including preparations for the U.S. pivotal study. The FDA IDE approval followed FastWave’s continued development of its broader IVL technology portfolio. The company had also been advancing Sola, its laser-based IVL platform intended for coronary artery disease, while expanding intellectual-property protection for both platforms internationally.

The initiation of the pivotal Artero trial marked a significant step in the development of next-generation peripheral IVL technology. Successful clinical evaluation could support a future regulatory submission and potentially broaden the range of calcium-modification technologies available for patients undergoing peripheral vascular interventions.

“Reaching IDE approval takes a lot of people believing in this work, and I’m grateful to every employee, physician, and partner who helped us get here,” said Tristan Tieso, COO of FastWave Medical. “We’re looking forward to demonstrating the capabilities of ArteroTM in a rigorous IDE trial, and ultimately bringing an advanced IVL platform to the patients who need it most.”

According to DelveInsight’s “Lithotripsy Devices Market Report,” the lithotripsy devices market was valued at USD 1.39 billion in 2023, growing at a CAGR of 4.32% during the forecast period from 2024 to 2030 to reach USD 1.78 billion by 2030. The lithotripsy devices market is growing significantly due to the rising prevalence of urolithiasis, technological advancements in product development, increased risk of end-stage renal failure, and rising awareness of the procedure is expected to escalate the demand for lithotripsy devices during the forecast period from 2024 to 2030.