Spineart’s PERLA® TL Application Receives FDA 510(k) Clearance for eCential Robotics’ Op.n® Platform; Alcon’s Clareon Monofocal IOL Earns EU MDR Certification; BTL Expands Into Laser Technology With New Division and EXOLASE ONE; Stryker, IAGE Collaborate to Enhance Fluorescence-Guided Surgery Training in India; Galmed Announces Positive First-in-Human Results for Colospan’s Novel Tissue Assessment Platform; 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 the 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.

Alcon’s Clareon Monofocal IOL Received EUMDR Certification Through TÜV SÜD 

On 01 September 2026, Alcon announced that its Clareon Monofocal intraocular lens had received EU MDR certification through TÜV SÜD. The certification confirmed that the lens met the applicable requirements under the European Union Medical Device Regulation.

The certification supported the continued commercialization of the Clareon Monofocal IOL across European markets and strengthened Alcon’s position in the cataract surgery and intraocular lens segment. The lens had been designed to provide predictable refractive outcomes and clear distance vision, while its portfolio also included a toric version for patients with astigmatism.

The regulatory milestone contributed to the expansion of compliant and advanced intraocular lens options for cataract procedures in Europe and supported the broader growth of the global IOL market.

“For nearly 80 years, Alcon has advanced cataract surgery through continuous innovation,” said Amar Vyas, Country Head India at Alcon. “Choosing the right IOL is about more than vision correction; it’s about aligning with each patient’s lifestyle and surgical objectives. Clareon Monofocal IOLs deliver exceptional optical clarity and consistent performance, enabling surgeons to achieve reliable distance and enhanced intermediate visual outcomes for their monofocal patients.”

As per DelveInsight’s “Intraocular Lens Market Report,” The global intraocular lens market was valued at USD 4,648.96 million in 2024, growing at a CAGR of 6.12% during the forecast period from 2025 to 2032 to reach USD 7,414.66 million by 2032. The intraocular lens market is being significantly boosted by the growing cases of eye-related disorders such as cataracts, presbyopia, and astigmatism, which are increasing the demand for corrective surgical interventions. This rising disease burden is complemented by improved awareness and accessibility to eye care services, especially in developing regions, enabling more patients to seek treatment. Additionally, ongoing technological advancements in lens materials and designs such as the development of multifocal, toric, and extended depth-of-focus lenses are enhancing visual outcomes and patient satisfaction. Furthermore, increased product development activities by key market players are leading to the introduction of innovative and customized IOL solutions, collectively accelerating the growth of the global intraocular lens market during the forecast period from 2025 to 2032.

BTL Established New Laser Division and Introduces EXOLASE ONE® – The World’s First Fused Erbium Laser 

On 02 September 2026, BTL established a dedicated laser division and introduced its EXOLASE ONE laser system, expanding its presence in the aesthetic laser technology sector. The system incorporated multiple erbium laser wavelengths into a single beam, enabling simultaneous treatment of the same area.

The technology was developed to address limitations associated with conventional facial rejuvenation lasers by combining treatment capabilities into a single platform. It was designed to improve treatment efficiency, clinical performance, and patient comfort while supporting facial rejuvenation procedures.

Following an early-access program involving selected clinical experts, BTL planned to expand the system through a broader global launch in 2027, initially targeting aesthetic medicine and dermatology. The development strengthened competition and technological innovation within the aesthetic laser devices market.

“The technology covers what normally requires multiple ablative and non-ablative systems, transforming it into a remarkably simple procedure that treats the entire face in under 10 minutes while delivering superior results for our patients,” said Dr. Reha Yavuzer, one of the first clinical investigators for the platform.

EXOLASE ONE® is the latest high-tech breakthrough originating from BTL’s extensive R&D infrastructure, which has powered many of the company’s industry-defining innovations.

“This is a historic moment for BTL. From the beginning, we knew that only a genuinely disruptive technology would allow us to build a true laser powerhouse,” said Tomas Schwarz, CEO of BTL Group of Companies. “Based on feedback from pioneering clinical centers worldwide, EXOLASE ONE® represents exactly this kind of breakthrough.”

As per DelveInsight’s “Energy-based Aesthetic Devices (EAD) Market Report,” the global energy-based aesthetic devices market is expected to increase from USD 5,961.09 million in 2024 to USD 12,001.69 million by 2032, reflecting strong and sustained growth. The global energy-based aesthetic devices market is growing at a CAGR of 9.18% during the forecast period from 2025 to 2032. The global energy-based aesthetic devices market is driven by the increasing instances of surgical and non-surgical aesthetic procedures, rising efforts by key players to develop and launch new and innovative products, coupled with the preference for minimally invasive procedures.

Stryker and IAGE Partnered to Advance Clinical Excellence in Fluorescence-guided Surgery in Gynaecology in India  

On 31 August 2026, Stryker entered into a strategic partnership with the Indian Association of Gynaecological Endoscopists (IAGE) to strengthen the clinical adoption and capabilities of fluorescence-guided surgery in gynecology in India.

The collaboration was aimed at expanding access to structured clinical education and training for gynecological surgeons. Over two years, the initiative was expected to provide pan-India educational programs and opportunities for surgeons to interact with Indian and international specialists and gain exposure to established surgical practices.

The partnership came amid increasing adoption of minimally invasive gynecological procedures and a growing need for standardized surgeon training. Fluorescence-guided surgery offered enhanced visualization during procedures, supporting surgical precision and intraoperative decision-making.

The initiative strengthened the development of fluorescence-guided surgical capabilities in India and supported the broader adoption of advanced visualization technologies in minimally invasive gynecological surgery.

According to DelveInsight’s “Image Guided Surgery Devices Market Report”, the global image-guided surgery devices market was valued at USD 5,540.87 million in 2021, growing at a CAGR of 5.81% during the forecast period from 2024 to 2030 to reach USD 7,765.22 million by 2030. The image-guided surgery devices market is observing remarkable market growth due to factors such as the escalating burden of the geriatric population prone to chronic diseases and the rising prevalence of chronic diseases such as cardiovascular, cancer, neurological, and others across the globe. Further, a gradual increase in approval of image-guided surgery devices, rapid technological advancement in the products, increasing demand for minimally invasive surgeries, and others will create a necessity for image-guided surgery devices in the market. Therefore, the market for image-guided surgery devices is estimated to grow at a substantial CAGR 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.