Sibel Health Secures EU MDR CE Mark, Subtle Medical Wins FDA Clearance, Roche Acquires PathAI, Carestream Launches Lux HD Detectors, and New Clinical Milestones in Atopic Dermatitis & Carpal Tunnel Care

Sibel Health Received EU MDR Class IIb CE Mark for ANNE® One: The First Wireless Wearable Patient Monitoring Platform Certified to Key Interoperability Standards (Regulatory Update)

On 10 June 2026, Sibel Health Inc., an award-winning medical technology company, announced that its ANNE® One system had received CE Mark certification under the European Union Medical Device Regulation (EU MDR 2017/745) as a Class IIb medical device. The certification came at a critical time for the European healthcare sector, where an aging population and a growing shortage of healthcare professionals were placing significant pressure on care delivery systems. Continuous wireless monitoring with intelligent alert capabilities enabled healthcare providers to monitor more patients efficiently, identify signs of deterioration earlier, and reduce the burden of routine manual assessments.

As a Class IIb medical device, ANNE® One provided continuous monitoring of multiple physiological parameters, including ECG, heart rate, respiratory rate, oxygen saturation (SpO₂), pulse rate, skin temperature, body position, activity levels, and fall detection. The system was integrated with the ANNE® View bedside application and a centralized dashboard that allowed healthcare professionals to oversee multiple patients simultaneously and receive alerts when patient data exceeded predefined clinical thresholds. The technology offered a wireless, skin-mounted monitoring solution that combined patient comfort with the advanced clinical capabilities and safety features required across hospital wards, step-down units, and home healthcare settings.

“From day one, our mission has been to bring high-quality continuous monitoring to every patient, everywhere, whether that’s a maternal patient in the Global South, a postoperative patient in Chicago, or a hospital ward in Copenhagen,” said Steve Xu, MD, CEO and Co-Founder of Sibel Health. EU MDR is widely regarded as one of the most rigorous medical device regulatory frameworks in the world. “A Class IIb device requires deep scrutiny across design, clinical performance, post-market surveillance, and quality management systems from our notifying body. I am proud of our entire organization for reaching this bar,” said Kevin Dwyer, Director of Quality Assurance and Regulatory Affairs at Sibel Health.

As per DelveInsight’s“Wearable Medical Devices – Market Insights, Competitive Landscape, and Market Forecast – 2032,” 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.

Subtle Medical Received FDA Clearance for SubtleHD™(CT), Expanding AI-Powered Image Enhancement into CT Imaging (Regulatory Update)

On 10 June 2026, Subtle Medical, a leader in AI-powered medical imaging software, announced that it had received FDA clearance for SubtleHD™ (CT), an artificial intelligence-driven image enhancement solution designed to reduce image noise and improve low-contrast detectability in computed tomography (CT) scans.

The clearance represented the company’s first CT-focused product and expanded its AI imaging portfolio beyond MRI and PET applications into the CT imaging segment. It also marked the company’s 11th FDA-cleared product, building upon technology that had already been deployed on more than 1,300 imaging scanners globally.

The launch came as healthcare providers faced increasing demand for diagnostic imaging services and growing pressure to maintain consistent image quality across a wide range of imaging systems, including aging CT scanners that continued to play a vital role in clinical practice. To address these challenges, SubtleHD™ (CT) was developed to enhance image quality through AI-based image processing, reducing noise and improving image clarity while integrating smoothly into existing clinical workflows.

The newly cleared solution joined the company’s broader portfolio of AI-powered imaging technologies, including SubtleHD™ (MR), SubtleHD™ (PET), SubtleSYNTH™, and SubtleALIGN™. Collectively, these solutions advanced Subtle Medical’s vision of a vendor-neutral AI imaging platform that enabled healthcare providers to improve diagnostic image quality, streamline radiology operations, and maximize the performance and lifespan of their existing imaging infrastructure across multiple imaging modalities.

“Healthcare organizations are looking for ways to improve imaging performance while maximizing the value of the infrastructure they already have,” said Ohad Arazi, Chief Executive Officer of Subtle Medical. “With SubtleHD(CT), we’re extending our expertise in AI-powered image enhancement to CT and taking another step toward our vision of helping providers enhance image quality across the imaging enterprise.”

As per DelveInsight’s “Artificial Intelligence in Medical Imaging – Market Insights, Competitive Landscape, and Market Forecast – 2032,” the global artificial intelligence in medical imaging market is expected to increase from USD 1,673.03 million in 2024 to USD 13,181.93 million by 2032, growing at a CAGR of 29.48% during the forecast period from 2025 to 2032. The global artificial intelligence in medical imaging market is being driven by the rising prevalence of chronic diseases such as cancer, cardiovascular disorders, and neurological conditions, which increase demand for accurate and efficient diagnostics. Government initiatives and funding are promoting healthcare digitization and AI adoption, while key players are investing in product development and strategic collaborations to enhance imaging solutions. Rapid advancements in deep learning, machine learning, and computer vision are further improving diagnostic accuracy, workflow efficiency, and predictive capabilities, collectively accelerating market growth across regions.

Roche Entered into a Definitive Merger Agreement to Acquire PathAI to Transform AI-driven Diagnostics (Commercial Update)

On 07 June 2026, Roche announced that it had entered into a definitive merger agreement to acquire PathAI, a U.S.-based provider of digital pathology and AI-powered solutions for pathology laboratories and the biopharmaceutical industry. The acquisition built upon the companies’ strategic partnership, which had been established in 2021 and expanded in 2024 to include the development of artificial intelligence-enabled companion diagnostic algorithms. Upon completion of the transaction, which was anticipated during the second half of the year, PathAI was expected to become part of Roche’s Diagnostics division.

The acquisition further strengthened Roche’s position in the digital pathology sector, where conventional manual pathology workflows were increasingly being transformed into automated, AI-driven processes. Digital pathology enabled the conversion of tissue samples on glass slides into high-resolution digital images, allowing pathologists to leverage advanced AI tools to improve diagnostic efficiency and accelerate result delivery for patients.

In addition, the transaction enhanced Roche’s capabilities in precision medicine and biopharmaceutical services. PathAI’s expertise in AI-powered pathology solutions, including clinical trial support and translational research applications, complements Roche’s established leadership in companion diagnostics. By combining their technological strengths, the companies aimed to accelerate biomarker discovery, identify potential therapeutic targets, and develop innovative diagnostic solutions, ultimately expanding the value delivered to biopharmaceutical partners and healthcare providers.

Chris DeNicola, President and CEO of Precision Spine Inc., stated, “This addition to our Reform family of products broadens the breadth of indications that can be addressed by offering surgeons the ability to provide stabilization in compromised bone while still utilizing the advanced features of the Reform Ti System.”

As per DelveInsight’s“Digital Pathology – Market Insights, Competitive Landscape, and Market Forecast – 2032,” the digital pathology market is experiencing significant expansion. Valued at approximately USD 1.2 billion in 2024, it is projected to reach USD 2.6 billion by 2032, reflecting a robust CAGR of 10.51%. The digital pathology market is primarily driven by the rising prevalence of cancer and other chronic diseases that require accurate and timely pathological diagnosis, increasing adoption of artificial intelligence (AI) and machine learning in pathology workflows, and growing demand for remote diagnostics and telepathology services. The transition from traditional glass-slide microscopy to digital imaging solutions enables faster diagnosis, improved collaboration among pathologists, enhanced workflow efficiency, and better data management. In addition, increasing investments in healthcare digitalization, expanding applications of digital pathology in drug discovery and clinical research, and supportive regulatory approvals for digital pathology systems are further accelerating market growth worldwide.

Carestream Launched NEW Lux HD 35 and Lux HD 43 Detectors for Medical Imaging (Commercial Update)

On 10 June 2026, Carestream announced the global availability of its next-generation Cesium Iodide (CsI) glass-free X-ray detectors, the Lux HD 35 and Lux HD 43. The launch represented an advancement in digital radiography technology, offering improved image quality, enhanced workflow efficiency, and greater versatility across a wide range of clinical imaging environments.

The Lux HD 35 and Lux HD 43 detectors were developed with a 100-micron pixel pitch, enabling higher image resolution and improved visualization of fine anatomical structures, microstructures, and small objects. The enhanced resolution also supported image magnification, helping clinicians obtain greater diagnostic detail during examinations.

The detectors were engineered with lightweight and ergonomic designs to simplify handling and positioning for radiographers while improving patient comfort during imaging procedures. In addition, the new detector generation featured increased durability and improved ingress protection (IP) ratings, making the devices more suitable for demanding clinical settings.

The systems also incorporated advanced Dose Efficient Control (DEC) technology for wireless operation, allowing more effective dose management and extending Automatic Exposure Control (AEC) functionality beyond traditional bucky examinations to include mobile radiography applications. These enhancements helped optimize radiation dose efficiency while maintaining high-quality image acquisition.

The Lux HD 35 and Lux HD 43 detectors were made compatible with multiple Carestream digital radiography platforms, including DRX-Evolution Plus, DRX-Revolution Plus, DRX-Compass, DRX-RISE, DRX-1 System, and DRX-Transportable System/Lite. Through Carestream’s X-Factor technology, the detectors could also be shared across compatible DRX systems within a healthcare facility, improving equipment utilization and operational flexibility.

Furthermore, the detectors operated alongside Carestream’s advanced ImageView software platform, powered by Eclipse AI technology, supporting enhanced image processing and workflow optimization. The company also indicated that an additional Lux HD 2530 detector based on the same technological platform was planned for launch during the second half of 2026.

According to DelveInsight’s “Digital Radiography Systems – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global digital radiography or X-ray systems market is expected to grow at a CAGR of 5.53% during the forecast period from 2024 to 2030. The digital radiography systems market is witnessing positive growth owing to various factors such as rising cases of cancer, chronic disorders such as cardiovascular disorders, orthopedic disorders, & other disorders, and the escalating burden of the geriatric population. Additionally, technological advancements pertaining to the digital radiography systems, such as high-quality image acquisition in a short duration by digital detectors and reduced radiation exposure, among others, will also aid in the growth of the digital radiography systems market. Therefore, the market for digital radiography systems is estimated to grow at a significant CAGR during the forecast period from 2024 to 2030.

First Patient Enrolled in New Study Assessing early prediction of flares in Atopic Dermatitis by Castle Biosciences in Collaboration with SciBase (Clinical Update)

On 10 June 2026, SciBase Holding AB, a developer of AI-powered skin health solutions, announced that the first patient had been enrolled in a new clinical study designed to evaluate the prediction of flare-ups in patients with atopic dermatitis (AD). The milestone represented an important advancement in research focused on improving the management of this chronic inflammatory skin disorder, which affects millions of individuals globally.

The multicenter prospective study, known as DETECT-AD, was initiated as the first project under SciBase’s collaboration with Castle Biosciences. The study was designed to evaluate the capability of SciBase’s Electrical Impedance Spectroscopy (EIS) technology to identify early physiological changes associated with the onset of atopic dermatitis flare-ups. By detecting these changes before symptoms became clinically apparent, the research aimed to support earlier intervention and improve long-term disease management.

Atopic dermatitis is characterized by alternating periods of remission and flare-ups that can significantly affect patients’ quality of life. Existing treatment approaches have traditionally focused on managing symptoms after flare-ups occur. Through the DETECT-AD study, researchers sought to explore a more proactive and personalized approach to patient care by leveraging predictive diagnostic insights. The findings were expected to help healthcare providers anticipate disease activity, optimize treatment decisions, reduce the frequency and severity of flare-ups, and enhance overall patient outcomes.

“The enrollment of the first patient is an exciting milestone in our mission to transform the management of atopic dermatitis. By predicting flares before they occur, we hope to offer patients greater control over their condition and improve their overall well-being,” said Pia Renaudin, CEO of SciBase.

According to DelveInsight’s ”Dermatology Devices – Market Insights, Competitive Landscape, and Market Forecast-2030,” 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.

Sonex Health Announced Data From Largest-Ever U.S. Study Proving Ultraguidectr™ Delivers Compelling Results for Carpal Tunnel Patients (Clinical Update)

On 10 June 2026, Sonex Health, Inc. and The Institute of Advanced Ultrasound Guided Procedures announced the publication of six-month clinical data demonstrating the safety and effectiveness of ultrasound-guided carpal tunnel release (UGCTR) performed using the UltraGuideCTR™ system. The results, published in the Journal of Hand Surgery Global Online, represented the largest prospective evaluation of the procedure conducted to date.

The findings were generated from the MISSION registry (Post-Market Registry of the Patient Experience when using UltraGuideCTR for Carpal Tunnel Release), a prospective, multicenter study designed to collect real-world clinical outcomes from patients undergoing treatment for carpal tunnel syndrome (CTS) in routine U.S. clinical practice. The registry evaluated outcomes among patients treated with UltraGuideCTR™, endoscopic carpal tunnel release (ECTR), and open carpal tunnel release (OCTR), to compare symptom improvement, functional recovery, pain reduction, quality of life, and patient satisfaction across the different treatment approaches.

The six-month analysis included data from 887 patients and 1,082 treated hands across 22 clinical sites in the United States. The study found that patients who underwent ultrasound-guided carpal tunnel release experienced rapid and sustained improvements in symptoms, hand function, and pain levels compared with baseline measurements. Most patients resumed normal daily activities within a median of three days and returned to work within four days following the procedure.

Patient satisfaction remained high throughout the six-month follow-up period, with nearly 90% of treated hands reporting positive outcomes. The majority of procedures were performed using wide-awake local anesthesia without a tourniquet (WALANT), eliminating the need for general anesthesia in many cases. The procedures were completed through a small wrist incision averaging approximately 5 mm, and most cases did not require sutures for wound closure.

The study also demonstrated the feasibility of treating both hands during a single procedure for patients with bilateral carpal tunnel syndrome, with clinical outcomes comparable to those observed in patients treated on only one hand. Importantly, investigators reported no intraoperative complications or serious adverse events, further supporting the safety and effectiveness of the ultrasound-guided minimally invasive approach for carpal tunnel syndrome treatment.

“This paper is significant because the results demonstrate real-world, patient-reported experiences across the largest set of CTS patients in a single study, establishing a new benchmark for safety, efficacy, and patient outcomes in carpal tunnel release procedures,” said Dr. Victor Marwin, an orthopedic hand surgeon with Bluegrass Orthopaedics in Lexington, Ky., and principal investigator for MISSION.

According to DelveInsight’s “Minimally Invasive Surgical Devices – Market Insights, Competitive Landscape, and Market Forecast – 2034,” the global minimally invasive surgical devices market is expected to increase from USD 30,798.01 million in 2025 to USD 53,259.85 million by 2034, growing at a CAGR of 7.13% during the forecast period from 2026 to 2034. The market of minimally invasive surgical devices is being primarily driven by the rising prevalence of chronic diseases such as cancer, cardiovascular disorders, increasing technological advancement in surgical devices, and an increase in product development activities among the key market players globally.