Leica Biosystems Expands Digital Pathology Portfolio with Multiple FDA Clearances; Bracco’s VueJect Ultrasound Contrast Delivery System Gains FDA and Health Canada Authorizations; Oticon Introduces Next-Generation Reveal Hearing Aid With AI; Zepto Life Technology Secures Up to $8.9 Million NIAID Award for Infectious Disease Liquid Biopsy Platform; Nitinotes Broadens EASE IDE Trial Network for EndoZip; FastWave Medical Secures FDA IDE Approval for Pivotal Artero Peripheral IVL Trial

Leica Biosystems Expanded Digital Pathology Portfolio with Multiple FDA Clearances 

On 11 August 2026, Leica Biosystems announced that it had received multiple U.S. FDA 510(k) clearances for its connected clinical digital pathology portfolio. The regulatory clearances strengthened the company’s digital pathology offerings and supported faster, more consistent cancer diagnosis by improving laboratory workflow efficiency. 

The expanded portfolio included the FDA-cleared Aperio iQC DX software, the new Aperio GT 180 DX digital pathology scanner, and enhanced clinical capabilities for the Aperio GT 450 DX scanner. These additions provided pathology laboratories with greater flexibility to scale digital pathology while maintaining image quality and operational efficiency. 

Aperio iQC DX became the first standalone FDA-cleared AI-assisted quality control software for clinical digital pathology. The software automatically identified common image artifacts during the scanning process, allowing laboratories to detect quality issues earlier, reduce rescanning and rework, and improve the consistency of whole-slide image review. The newly introduced Aperio GT 180 DX scanner expanded Leica Biosystems’ clinical scanning portfolio for mid-volume laboratories, while updates to the Aperio GT 450 DX scanner added manual scanning capabilities, advanced DICOM functionality, and clinical z-stacking support. These enhancements enabled laboratories to build more connected and standardized digital pathology workflows across different case volumes. Through these FDA clearances, Leica Biosystems advanced the adoption of AI-assisted digital pathology and reinforced the transition from conventional slide-based pathology toward scalable, integrated, and technology-driven cancer diagnostic workflows.

“This approval closes the last gap between a strong technical repair offer and a genuinely frictionless international repair service,” said Frank Zhu, General Manager of Rongtao Medical. “For years, the hardest part of cross-border ultrasound repair for our customers has been logistics and customs, not electronics. A defined bonded channel replaces case-by-case workarounds with a clearly sanctioned path: no duties on their equipment, no temporary-import deposits, and end-to-end customs traceability.”

As per DelveInsight’s “Digital Pathology Market Report,” the global digital pathology market size was valued at USD 1.25 billion in 2025 and is projected to reach USD 3.90 billion by 2034. The market is expected to expand at a CAGR of 13.5% during the forecast period 2026-2034, supported by regulatory clearance of whole slide imaging for primary diagnosis, the global pathologist shortage, and the integration of artificial intelligence into the pathology workflow.

Bracco Received FDA and Health Canada Authorizations for VueJect Ultrasound Contrast Delivery System 

On 11 August 2026, Bracco Imaging announced that its VueJect ultrasound contrast delivery system had received 510(k) clearance from the U.S. Food and Drug Administration and authorization from Health Canada. The regulatory milestones represented an important step in the company’s plans to commercialize the system globally and expand its contrast-enhanced ultrasound portfolio.

VueJect had been developed as a dedicated contrast delivery system for cardiology imaging. The system was designed to streamline the administration of ultrasound contrast agents, improve workflow efficiency, and reduce variations in contrast administration between operators. It also enabled continuous delivery of ultrasound contrast agents to support more consistent enhancement during cardiac imaging procedures.

Following the regulatory clearances, Bracco planned to make VueJect available initially in the United States and Canada while preparing additional regulatory submissions for other international markets. The launch expanded the company’s integrated contrast-enhanced ultrasound ecosystem and complemented its existing portfolio of ultrasound-enhancing agents.

The system was intended to support echocardiography procedures involving ultrasound contrast agents, providing cardiac sonographers and physicians with a more standardized approach to contrast administration. This was expected to improve consistency across contrast-enhanced ultrasound examinations and support more efficient clinical workflows.

The FDA clearance and Health Canada authorization therefore marked a significant commercial and regulatory milestone for Bracco Imaging. The development strengthened the company’s position in the contrast-enhanced ultrasound market and supported the broader adoption of dedicated technologies for standardized ultrasound contrast administration.

“VueJect represents a significant strategic milestone for Bracco as we continue investing in innovations that advance contrast-enhanced ultrasound worldwide,” said Fulvio Renoldi Bracco, Vice Chairman and CEO, Bracco Imaging. “Beginning with regulatory approvals in the United States and Canada, VueJect further advances our integrated ultrasound portfolio and reflects our commitment to expanding access to innovative diagnostic solutions around the world.”

As per DelveInsight’s “Ultrasound Devices Market Market Report,” the global ultrasound devices market size is expected to increase from USD 9,315.06 million in 2024 to USD 13,054.68 million by 2032, reflecting strong and sustained growth. The global ultrasound devices market is growing at a CAGR of 4.38% during the forecast period from 2025 to 2032. The global ultrasound device market is growing due to rising demand for early and accurate diagnosis, increasing use in minimally invasive procedures, and advancements like 3D/4D imaging, AI, and portable systems. Its cost-effectiveness, safety, and wide applications in obstetrics, cardiology, and chronic disease management further boost adoption. Expanding healthcare access in emerging markets also supports growth.

Oticon Introduced AI-Powered Reveal Hearing Aid 

On 11 August 2026, Oticon introduced Oticon Reveal, an advanced hearing aid featuring a Dual AI system designed to provide a more natural hearing experience. The technology combined dedicated Speech AI and Context AI systems that operated continuously in real time to enhance speech while maintaining awareness of surrounding sounds.

The new hearing aid was powered by the Reveal AI platform, which provided faster and more precise sound processing across different listening environments. Its feedback prevention technology was designed to improve fitting stability and enable greater amplification. Oticon also incorporated a new connectivity platform that supported improved streaming stability and range, along with compatibility with iPhone and Android devices, Bluetooth LE Audio, and Auracast technology.

Oticon Reveal additionally featured adaptive personalization capabilities that responded to changes in listening situations and user preferences. The device incorporated enhanced wind and handling-noise reduction and rechargeable power intended to support all-day use. Through these technologies, Oticon expanded its portfolio of AI-enabled hearing solutions and strengthened the integration of artificial intelligence, connectivity, and personalized sound processing within the hearing aid market.

“We’ve been leading the development of AI and innovation in hearing care for years. With our new Dual AI system, we’re again setting a benchmark in the industry by taking a decisive step forward in how technology supports the brain in making sense of sound,” says Anja Nagel L’harraki, Senior Vice President, Global Marketing at Oticon.

As per DelveInsight’s “Hearing Aids Market Report,” the hearing aids market size is estimated at USD 10.90 billion in 2025 and is projected to reach USD 22.80 billion by 2034. Growth is anchored in the rising global prevalence of disabling hearing loss, rapid adoption of AI-enabled and Bluetooth-connected devices, and expanding direct-to-consumer and over-the-counter (OTC) accessibility. The global hearing aids market is growing at a CAGR of 8.2% during the forecast period from 2026 to 2034.

NIAID Awarded Zepto Life Technology Up to $8.9 Million to Advance Infectious Disease Liquid Biopsy Platform  

On 11 August 2026, Zepto Life Technology announced that it had received a contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, valued at up to $8.9 million. The funding was intended to advance the company’s plasma cell-free DNA liquid biopsy technology for detecting invasive fungal infections.

The contract included an initial award of $1.9 million, while additional funding could increase the total value to $8.9 million if specified development milestones and contract options were achieved. The funding was expected to support engineering and manufacturing activities, followed by planned clinical validation and preparation for a potential FDA submission.

Zepto Life Technology had previously received FDA Breakthrough Device Designation for its FungiFlex Mold Panel, which was available through the company’s CLIA-certified reference laboratory. The company was also developing the Zepto MDx platform to enable liquid biopsy testing within hospital and clinical microbiology laboratories.

The platform was designed to identify pathogen-derived cell-free DNA directly from plasma obtained through a standard blood draw. This approach was intended to reduce reliance on invasive specimen collection and potentially shorten the time required to identify infectious pathogens. The initial development program focused on invasive fungal infections, which can be particularly difficult to diagnose in vulnerable patient populations.

The NIAID contract therefore represented an important development milestone for Zepto Life Technology and supported the advancement of liquid biopsy technology beyond oncology into infectious disease diagnostics. The program also had the potential to expand the use of molecular diagnostics for faster and minimally invasive identification of fungal infections in hospital settings.

“Today, FungiFlex® is available through our CLIA reference laboratory, but we’ve always been building toward something bigger,” said Hannah Zhang, Chief Executive Officer of Zepto Life Technology. “This award helps us advance Zepto’s technology as a deployable liquid biopsy platform for infectious disease and bring that capability directly into hospital microbiology laboratories. That means getting clinicians actionable answers closer to the moment they first suspect an infection.”

According to DelveInsight’s “Liquid Biopsy in Cancer Diagnostics Market Report”, the global liquid biopsy in cancer diagnostics market was valued at USD 7.64 billion in 2025 and is expected to reach USD 19.24 billion by 2034. The global liquid biopsy in cancer diagnostics market is expected to grow at a CAGR of 16.64% during the forecast period from 2026 to 2034. Factors such as the rising incidence of various cancers, growing demand for minimally invasive procedures, increasing demand for precision medicine, and technical innovation in product development, among other factors, are expected to drive the liquid biopsy in cancer diagnostics market.

Nitinotes Expanded EASE IDE Trial with New Clinical Sites for EndoZip 

On 11 August 2026, Nitinotes announced that Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center had been activated as clinical sites for its pivotal U.S. EASE Investigational Device Exemption trial. The milestone was marked by completion of the first study procedure at the institutions under the direction of Reem Z. Sharaiha, MD, Professor of Medicine at Weill Cornell Medicine and Director of Endoscopy at the affiliated medical centers. The EASE IDE trial evaluated the safety and effectiveness of Nitinotes’ EndoZip Automated Suturing System for performing Endoscopic Sleeve Gastroplasty in patients with obesity. The multicenter randomized study was designed to generate clinical evidence supporting a potential future FDA marketing submission for the device. The addition of the two New York institutions expanded the clinical network participating in the EASE trial. The study involved leading medical centers with expertise in advanced endoscopy and obesity care, supporting broader evaluation of the EndoZip system across clinical settings.

EndoZip had been developed as an automated minimally invasive suturing system intended to facilitate the delivery of restrictive sutures to the stomach wall during ESG. Nitinotes had previously conducted clinical studies evaluating the system’s safety, usability, and weight-loss outcomes, while the U.S. IDE study represented a further step toward regulatory evaluation in the United States. The company had also received CE Mark approval for EndoZip, allowing commercial launch in the European Union and other markets accepting the CE Mark. In the United States, the system remained limited to investigational use as the EASE IDE trial progressed. The activation of additional clinical sites therefore represented an important development for Nitinotes’ U.S. regulatory program and strengthened the clinical evidence base for automated endoscopic suturing and minimally invasive obesity treatment.

According to DelveInsight’s ”Bariatric Surgery Devices Market Report,” the global bariatric surgery devices market was valued at USD 2.082 million in 2023, growing at a CAGR of 5.22% during the forecast period from 2024 to 2030 to reach USD 2,823 million by 2030. The increase in demand for bariatric surgery devices is primarily attributed to the increasing prevalence of obesity due to sedentary and unhealthy lifestyles. Furthermore, childhood obesity is rising at an alarming rate. Moreover, due to severe and untreated obesity, chronic diseases like high cholesterol, hypertension, and diabetes are rising steeply, thereby propelling the market growth of the product. Furthermore, rising demand for minimally invasive surgeries and pain-free surgeries is increasing the demand for the device. Additionally, the demand for bariatric surgery is increasing, so the availability of surgeons specialized for bariatric surgeries is increasing, ultimately increasing the number of surgical procedures and the product demand. Moreover, the government is increasing support and awareness about unhealthy foods and drinks and is increasing funding for bariatric surgery in developed countries across the world are anticipated to bolster the market, thereby contributing to the growth of the bariatric surgery devices market during the forecast period from 2024-2030.

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.