Esaote’s MyLab™ A50 and A70 Ultrasound Systems Achieve FDA 510(k) Clearance; Health Canada Approves MedMira’s Reveal® TP Rapid Test for Syphilis; MolecuLight’s Transformative Effect on Wound Care Confirmed by Large Randomized Trial; Arctx Medical’s ACC Kit Receives FDA IDE Approval and Dr. Robert Kieval Appointed CEO; Quest’s Haystack MRD Test Awarded FDA Breakthrough Device Designation for Post-Surgical Colorectal Cancer Monitoring; Sonic Healthcare USA Strengthens Oncology Diagnostics with Acquisition of Cairo Diagnostics

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Esaote’s MyLab™ A50 and A70 Ultrasound Systems Achieve FDA 510(k) Clearance; Health Canada Approves MedMira’s Reveal® TP Rapid Test for Syphilis; MolecuLight’s Transformative Effect on Wound Care Confirmed by Large Randomized Trial; Arctx Medical’s ACC Kit Receives FDA IDE Approval and Dr. Robert Kieval Appointed CEO; Quest’s Haystack MRD Test Awarded FDA Breakthrough Device Designation for Post-Surgical Colorectal Cancer Monitoring; Sonic Healthcare USA Strengthens Oncology Diagnostics with Acquisition of Cairo Diagnostics

Aug 28, 2025

FDA Granted Approval to Esaote’s MyLab™ A50 and MyLab™ A70 Ultrasound Systems

On August 25, 2025, Esaote announced that its MyLab™ A50 and MyLab™ A70 ultrasound systems had received FDA approval, marking a significant milestone that confirmed the systems’ compliance with the highest standards of safety and clinical performance.

Previously introduced to the international medical community, these advanced platforms were now cleared for distribution in the United States, highlighting Esaote’s ongoing commitment to innovation in diagnostic imaging. The MyLab™ A50 and MyLab™ A70 were engineered to deliver exceptional flexibility and performance across a wide range of clinical settings. The systems were designed to be highly portable, featuring compact sizes and battery operation to meet the mobility needs of healthcare practitioners.

Both models were equipped to handle a broad array of clinical applications, from routine diagnostics to advanced imaging techniques. They supported the latest ultrasound functionalities, including liver elastography and attenuation imaging, as well as comprehensive cardiology tools such as strain analysis, enabling detailed, multiparametric assessments.

By harnessing artificial intelligence in medical imaging advancements, these systems empowered healthcare providers to make precise and informed diagnoses with greater confidence. The launch of the MyLab™ A50 and MyLab™ A70 represented a key milestone in Esaote’s renewed brand mission, demonstrating the company’s dedication to enhancing patient outcomes through innovative technology and compassionate care.

According to Thomas Will, Director of Ultrasound Sales at Esaote North America, “the new A-series emphasizes user experience with a diverse range of interface options, including both a conventional and touch control panel. The devices boast an intuitive, easy-to-clean design that allows clinicians to operate efficiently and confidently.”

As per DelveInsight’s “Ultrasound Devices Market Report”, the global ultrasound devices market was valued at USD 6.76 billion in 2023, growing at a CAGR of 6.82% during the forecast period from 2024 to 2030 to reach USD 10.05 billion by 2030. The ultrasound devices market is witnessing positive growth owing to the rising incidence of severe chronic diseases such as cardiovascular, urology, and others, further rapid technological developmental activities, growing awareness for early disease detection, and increasing geriatric population across the globe who are more susceptible to developing chronic disorders, and rising adoption owing to no radiation exposure, thereby contributing to the growth of the ultrasound devices market during the forecast period.

Health Canada Approved MedMira’s Reveal® Rapid TP Test – Urgent New Tool in the Battle Against Syphilis

On August 26, 2025, MedMira Inc. announced that it had received approval from Health Canada for its Reveal® TP (Syphilis) Antibody Test (Reveal® TP), the fastest standalone screening device for syphilis in Canada.

Reveal® TP was recognized as a vital point-of-care diagnostic tool for healthcare professionals and represented an important advancement in expanding access to syphilis testing across Canada, particularly in the Prairie provinces, where rates of infectious and congenital syphilis had been surging.

The test detected syphilis antibodies from a single finger-prick blood sample and delivered immediate results that did not fade. It was the fastest syphilis test licensed in Canada using MedMira’s proprietary Rapid Vertical Flow (RVF) Technology. Designed to be precise and easy to use, the test could be deployed across a wide range of healthcare settings, including hospitals, doctors’ offices, community health clinics, and non-profit agencies. It provided a valuable new option in Canada for identifying syphilis cases and ensuring that individuals were connected to timely treatment and care.

In recent years, Canada has experienced a dramatic rise in syphilis cases. Syphilis, a sexually transmitted infection caused by the bacterium Treponema pallidum, could present with painless sores or, in more advanced stages, cause severe organ damage. Congenital syphilis, when an untreated or inadequately treated pregnant person transmits the infection to their baby, could lead to stillbirth or other serious health outcomes.

“We are proud to expand Canada’s diagnostic toolbox with a solution that aligns with the need for speed, reliability, and scalability,” said Hermes Chan, CEO of MedMira. “This approval reflects our commitment to developing technologies that address urgent public health challenges while improving access to care.”

As per DelveInsight’s “Infectious Disease Diagnostics Market Report,” the infectious disease diagnostics market was valued at USD 38.52 billion in 2023 and is estimated to grow at a CAGR of 3.80% during the forecast period from 2024 to 2030 to reach USD 48.10 billion by 2030. The infectious disease diagnostics market is experiencing significant growth due to the increasing cases of communicable diseases including HIV, hepatitis B & C, and influenza, the introduction of new and innovative products by key players, and others that are acting as significant factors contributing to the overall growth of the infectious disease diagnostics market during the forecast period from 2024 to 2030.

Large Independent Randomized Controlled Trial Validated MolecuLight’s Transformative Impact on Wound Debridement, Showing Improved Outcomes and Lower Costs

On August 27, 2025, MolecuLight Inc., a global pioneer in point-of-care fluorescence imaging for wound care, together with its Taiwanese distributor Healtdeva Company Ltd., announced the results of the largest-ever randomized controlled trial (RCT) on its technology. The independent study, conducted by clinicians at Shuang-Ho Hospital in Taipei, was published in the Advances in Wound Care Journal. The findings demonstrated that the use of MolecuLight® devices to guide high-quality surgical wound debridement had significantly improved clinical outcomes while also reducing healthcare costs.

The 200-patient clinical trial, titled “Application of Perioperative Real-Time Fluorescence Imaging to Achieve High-Quality Debridement: A Randomized Control Trial,” showed that adding MolecuLight’s real-time fluorescence imaging to standard surgical protocols resulted in higher-quality debridement with a marked reduction in residual bacterial load.

Clinical outcomes were notably better in the MolecuLight group. Wounds healed in an average of 49 days, compared to 63 days in the standard surgical debridement group. The postoperative infection rate was also significantly reduced, with only 4% of patients experiencing infections compared to 22% in the control group.

Additionally, the trial highlighted benefits in terms of hospital resource utilization and costs. Patients in the MolecuLight-guided group had an average hospital stay of 18 days, compared to 22 days in the control group. The duration of antibiotic use was also shorter, which contributed to nearly a 40% reduction in overall antibiotic costs.

“This randomized trial demonstrates that MolecuLight delivers measurable, clinically significant benefits in wound management,” said Dr. Shun-Cheng Chang, senior author and Associate Professor, Department of Surgery, Integrated Burn & Wound Care Center, Shuang-Ho Hospital. “The ability to visualize bacterial burden in real time allows surgeons to achieve higher-quality debridement and faster healing, while also serving as an invaluable teaching tool for training younger physicians in infection control and intraoperative wound assessment.”

“We are honored to bring MolecuLight’s advanced imaging technology to clinicians in Taiwan,” remarked Wei-Pin Hsieh, CEO of Healtdeva Company Ltd. “This RCT confirms what many clinicians are already seeing in practice that real-time fluorescence imaging empowers them to make more precise decisions, reduce complications, and improve patient outcomes, all while lowering the overall burden on healthcare systems.” 

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 2024 to 2030, to reach USD 16.97 billion by 2030. 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 2024 to 2030.

Arctx Medical Receives IDE approval from the FDA for a Pivotal Clinical Trial of its ACC Kit for the Treatment of Acute Pancreatitis, Announced New Leadership 

On August 26, 2025, Arctx Medical, Inc., a clinical-stage medical device company, announced that it had achieved three significant milestones. The Company had completed a First-in-Human clinical trial evaluating its flagship product, the Arctx Cool Catheter™ Kit, as a treatment for patients suffering from Acute Pancreatitis (AP). The study included 21 AP patients who were treated with pancreatic cooling therapy provided by the Arctx device. Results of the study were being prepared for peer-review publication.

Arctx had also been granted approval from the US Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) application to conduct a pivotal clinical trial of its novel therapy in approximately 200 patients with AP at up to 25 US hospitals. The clinical trial was being conducted to support marketing authorization for the Arctx Cool Catheter Kit in the US as a first-of-its-kind treatment of AP.

In July 2025, the company hired Dr. Robert Kieval, a successful veteran of the medical device industry, as its new Chief Executive Officer. Dr. Kieval succeeded Co-founder Don Gurskis, who continued with Arctx as the company’s chief technology officer. Dr. Kieval brings more than 20 years of CEO and C-level leadership experience at the intersection of healthcare, technology, and business, with a proven track record of innovating, financing, and commercializing sophisticated medical technologies. He stated, “I was honored and excited to join the Arctx team. We were poised to be able to offer a desperately needed therapy to patients with a devastating condition that had no established treatments available for it. We believed that the Arctx Cool Catheter provided an elegant solution that could establish a new standard of care for treating patients with Acute Pancreatitis.”

Arctx Co-founder and Executive Chairman Steve Bacich had added, “The Arctx team was delighted to have Rob on board. He joined an experienced group of medical device professionals, and his leadership further strengthened the company.”

According to DelveInsight’s “Minimally Invasive Surgical (MIS) Devices Market Report”, the MIS devices market was valued at USD 30,798.01 million in 2024, growing at a CAGR of 7.13% during the forecast period from 2024 to 2030, to reach USD 53,259.85 million by 2032. The MIS devices market is witnessing a positive market growth owing to factors such as the rising prevalence of various cancers, such as lung cancer, which accounted for the highest number of cancer-related deaths and highest cancer incidence in 2023, and other indications such as cardiovascular diseases and neurodegenerative diseases, among others. Furthermore, the presence of factors such as the aging population’s growth, wherein age plays a key role in the development of various indications, is another factor driving the growth of the MIS devices market. Moreover, the technological advancements in product development, such as the development of surgical robots, are further driving the MIS devices market as new products are gaining regulatory approvals and are entering the market.

FDA Approved Breakthrough Device Status for Haystack MRD Test by Quest Diagnostics 

On August 25, 2025, Quest Diagnostics, a leading provider of diagnostic information services, announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Device Designation for the company’s Haystack MRD® test. The test was designed to identify MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment, who could potentially benefit from adjuvant therapy in accordance with therapeutic product labeling.

This designation added to the growing evidence of the Haystack MRD test’s value for both clinical and pharmaceutical applications. It is also aligned with a robust body of research supporting the potential of ctDNA-based MRD tests to detect residual or recurrent cancer from solid tumors. Quest had introduced a clinical laboratory-developed version of the Haystack MRD test in late 2024 and had been expanding access to oncologists and pharmaceutical partners.

“We are committed to working with the FDA and our research partners to validate the use of Haystack MRD in a variety of solid tumors, building on this first designation for an early-stage colorectal cancer,” said Dan Edelstein, Vice President and General Manager, Haystack Oncology. “Our goal is to deliver highly accurate, personalized monitoring of treatment response and recurrence to more patients, both in clinical care and in pharmaceutical trials, and this Breakthrough Designation brings us closer to our goal.”

The breakthrough devices program applies to certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is intended to provide patients and healthcare providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization, after undergoing the FDA’s rigorous standards for device safety and effectiveness.

As per DelveInsight’s “Minimal Residual Disease Market Report”, the minimal residual disease testing market was valued at USD 2,031.45 million in 2024, growing at a CAGR of 10.61% during the forecast period from 2025 to 2032 to reach USD 4,514.74 million by 2032. The growing demand for minimal residual disease (MRD) testing is primarily fueled by the rising incidence of solid tumors and hematologic malignancies such as leukemia, multiple myeloma, and lymphoma. Advancements in molecular diagnostic technologies have significantly enhanced the accuracy of MRD detection, with the increasing product development and launch activities by key market players continuing to strengthen market dynamics. Collectively, these factors are expected to drive robust and sustained growth in the MRD testing market throughout the forecast period from 2025 to 2032.

Sonic Healthcare USA, Inc. Announced the Acquisition of Cairo Diagnostics LLC to Expand Sonic’s National Hematology Oncology Testing Capabilities 

On August 21, 2025, Sonic Healthcare USA, Inc., announced that it had acquired substantially all of the assets of Cairo Diagnostics, LLC, Cairo Diagnostics NJ, LLC, and Rye Management and Logistics Corp. (collectively known as “Cairo”). Cairo was a well-regarded provider of comprehensive hematology oncology diagnostics headquartered in White Plains, New York, with a second laboratory in Woodcliff Lake, New Jersey. Following the closing, SHUSA integrated Cairo’s medically led test menu and infrastructure into its national network, leveraging SHUSA’s logistics, payer contracting, and commercial organization.

Cairo, founded in 2013 by hematopathologist Dr. Sherif Ibrahim, had built a reputation for its integrated approach to oncology testing. The company provided personalized, comprehensive diagnostic reports by combining histopathology, molecular diagnostics, cytogenetics, flow cytometry, and immunohistochemistry within a single facility. This model minimized delays commonly seen when testing was distributed across multiple laboratories, enabling oncologists to receive more complete information and support timely treatment decisions.

“This acquisition reflects Sonic’s commitment to medical leadership in practice, not just in words,” said Cory A. Roberts, MD, CEO of Sonic Healthcare USA, Inc. “By bringing Cairo’s integrated oncology platforms into Sonic’s network, we expect to access, service and support  oncologists nationwide – expanding the reach of Cairo’s expertise while strengthening SHUSA’s capabilities in high-complexity oncology diagnostics.”

“By combining Cairo’s comprehensive menu with SHUSA’s nationwide infrastructure, we can deliver faster, more complete answers to care teams,” added Mohammed Salama, MD, Chief Medical Officer, Sonic Healthcare USA, Inc. “This acquisition positions us to expand into areas of innovation – including liquid biopsy and other emerging technologies—that will help anticipate the evolving needs of oncology care.”

As per DelveInsight’s “Hematology Market Report,” the hematology market was valued at USD 10,538.29 million in 2024, growing at a CAGR of 6.66% during the forecast period from 2025 to 2032 to reach USD 17,588.30 million by 2032. Several key factors, including the growing prevalence of blood-related disorders such as anemia, blood cancers, hemorrhagic conditions, thalassemia, and various infections, are propelling the demand for hematology. Additionally, the increasing incidence of cancer and autoimmune diseases, coupled with ongoing advancements in product development and frequent launches by leading industry players, is further fueling market momentum. Together, these factors are creating a favorable environment for sustained growth in the hematology market throughout the forecast period from 2025 to 2032.

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