Empatica Secures FDA Clearance for Parkinson’s Monitoring; ZEISS CLINIC 360 Secures FDA 510(k) Clearance; BioLab Holdings Strengthens Tissue Restoration Portfolio With Addition of FastSkin® Technology; Surity™ Expands Urinary Incontinence Care Portfolio with New At-Home Urinary Management System; Galmed Announces Positive First-in-Human Proof-of-Concept Results for Colospan’s Intraoperative Tissue Assessment Platform; FastWave Medical Secures FDA IDE Approval for Pivotal Artero™ Peripheral IVL Trial

Empatica Received FDA Clearance for Parkinson’s Monitoring 

On 19 August 2026, Empatica announced that its Health Monitoring Platform for Parkinson’s disease had received 510(k) clearance from the U.S. Food and Drug Administration. The clearance expanded Empatica’s clinical-grade monitoring capabilities into Parkinson’s disease and followed the company’s acquisition of PKG Health in 2025. By integrating PKG’s validated Parkinson’s disease measures with Empatica’s wearable devices and connected technology, the platform enabled continuous monitoring of symptoms and generated objective data to support individualized treatment and disease management.

The platform combined clinical-grade wearables, a patient application, secure cloud infrastructure, and a clinician portal to track Parkinson’s-related measures over time. It provided assessments of bradykinesia, dyskinesia, tremor, sleep, medication adherence, and other disease-management parameters. The underlying algorithms had been evaluated through more than 70 peer-reviewed publications and had been deployed across more than 150 hospitals and clinical sites worldwide. The technology had also been used in Parkinson’s research involving disease progression, treatment response, and digital endpoints for clinical trials. The FDA clearance represented Empatica’s 12th FDA clearance and further strengthened its position in remote neurological monitoring, digital biomarkers, clinical research, and patient-care applications.

“This clearance marks an important step forward for Parkinson’s care,” said Matteo Lai, CEO and co-founder of Empatica. “We are bringing objective monitoring into a platform designed for great user experience and scale. This can help people better understand their symptoms, provide clinicians with data to support more personalized care, and give researchers deeper insight into disease progression and treatment response.”

As per DelveInsight’s “Neurological Diagnostic and Monitoring Equipment Market Report,” the neurological diagnostic and monitoring equipment market was valued at USD 11.81 billion in 2023, growing at a CAGR of 6.66% during the forecast period from 2024 to 2030, and will reach USD 17.33 billion by 2030. The market for neurological diagnostic and monitoring equipment is experiencing robust growth driven by several key factors. First, the increasing prevalence of neurological disorders, such as brain cancer, epilepsy, Alzheimer’s disease, and Parkinson’s disease, underscores a growing demand for advanced diagnostic tools that can accurately assess and monitor these conditions. Secondly, the rising incidence of traumatic brain injuries (TBIs) globally has further bolstered the demand for neurological diagnostic equipment. Prompt and accurate diagnosis of TBIs is crucial for initiating timely treatment and minimizing long-term complications, driving the adoption of sophisticated monitoring technologies in emergency and critical care settings. Additionally, the government initiatives not only contribute to increased patient awareness and engagement but also foster a proactive approach towards healthcare, thereby stimulating the uptake of diagnostic and monitoring equipment. Furthermore, the regulatory support not only ensures the safety and efficacy of these devices but also encourages healthcare providers to invest in state-of-the-art equipment that enhances diagnostic accuracy and patient care outcomes, thereby boosting the overall market during the forecast period from 2024 to 2030.

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.

BioLab Holdings Added FastSkin®Autologous Wound Care Technology to Tissue Restoration Portfolio 

On 19 August 2026, BioLab Holdings announced a strategic partnership with mimiX AWC to expand its tissue restoration portfolio through the addition of FastSkin® Patch, an autologous wound care technology. The partnership enabled BioLab to incorporate the whole-blood clot-based technology into its regenerative wound care portfolio and broaden its solutions for chronic and hard-to-heal wounds. 

FastSkin® Patch was designed to use a patient’s own blood to generate a personalized bioactive tissue at the point of care in approximately 10 minutes. The technology was intended to support the management of exuding cutaneous wounds, including diabetic ulcers, pressure ulcers, venous leg ulcers, and surgically debrided wounds. Its preparation required a simple blood draw and did not require capital equipment, supporting its use across different wound care settings. Through the collaboration, BioLab expanded its regenerative medicine and tissue restoration offerings and supported wider adoption of the technology across wound care settings.

“At BioLab, we believe the best clinicians don’t want one answer but the best answer,” said BioLab President & CEO Jaime Leija. ” FastSkin® Patch offers a personalized, autologous approach that complements our existing portfolio and gives clinicians another valuable tool to support healing and improve patient outcomes.”

“Our mission is to advance wound care through science-driven innovation that works in harmony with the body’s own healing processes,” said Marc Thurner, CEO of mimiX AWC. “Partnering with BioLab allows us to expand access to FastSkin® Patch through an organization that shares our commitment to improving patient care and providing clinicians with practical, effective regenerative solutions.”

As per DelveInsight’s “Advanced Wound Care Market Report,” the advanced wound care market was valued at USD 9.45 billion in 2023, growing at a CAGR of 10.51% during the forecast period from 2025 to 2032, to reach USD 16.97 billion by 2032. The advanced wound care market is expanding rapidly due to the collective impact of rising chronic and acute wound prevalence, such as diabetic ulcers and pressure sores, increasing surgical procedures, and the growing product launches and approvals by key market players is expected to significantly drive the demand for advanced wound care from 2025 to 2032.

New At-Home Surity™ Urinary Management System Designed to Provide Comfort and Reliable Care for People Living with Urinary Incontinence  

On 19 August 2026, Wellspect HealthCare announced the U.S. launch of the Surity™ Urinary Management System, an at-home urine collection solution developed for people living with urinary incontinence and their caregivers. The launch completed the company’s Surity™ portfolio in the U.S., following the earlier introduction of its female and male external catheters. The system was designed to provide a discreet and convenient approach to urine management by working with the existing external catheter products. It used gentle suction to collect urine away from the body and included an additional suction function for situations requiring increased collection support. The system also incorporated quiet operation and odor-reducing carbon filters, making it suitable for nighttime use and helping minimize interruptions during sleep. The product was initially made available for home purchase in the U.S. and was expected to subsequently become accessible through healthcare institutions. The launch strengthened Wellspect HealthCare’s presence in the urinary incontinence management market and expanded the availability of non-invasive, home-based continence care solutions.

“The evolution of the Surity™ portfolio is focused on addressing many of the practical challenges of urinary incontinence that more than 13 million Americans and their caregivers face in the U.S.9 The introduction of the Urinary Management System builds on our commitment to develop innovative solutions for incontinence care, providing a discreet, at-home option to help manage incontinence,” said Chris Schlenk, Group Vice President at Wellspect HealthCare. “This comprehensive system is designed to integrate into daily and nighttime routines and support individuals and their caregivers in restoring confidence, comfort, and rest.”

According to DelveInsight’s “Stress Urinary Incontinence Devices Market Report”, the global stress urinary incontinence devices market size is expected to increase from USD 2,232.79 million in 2025 to USD 3,929.46 million by 2034, reflecting strong and sustained growth. The global stress urinary incontinence devices market is growing at a CAGR of 6.53% during the forecast period from 2026 to 2034. The market for stress urinary incontinence devices is being primarily driven by the rising prevalence of stress urinary incontinence, an increasing elderly population driving higher rates of stress urinary incontinence due to pelvic floor weakness, and increasing technological advancements in SUI devices among the key market players.

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, which is expected to escalate the demand for lithotripsy devices during the forecast period from 2024 to 2030.