Legacy Expands Diagnostic Portfolio with New York CLEP Approval for Two LDTs; Quest Diagnostics Expands Patient Access to ctDNA MRD Testing with New York Approval of Haystack MRD; MVZ MedDiagnost and Sectra Ink 10-Year Deal to Unify Radiology Network Across 10 Sites; ALZpath and Abbott Enter Global Licensing Deal to Expand Blood-Based Alzheimer’s Diagnostics; Corvention Reaches Key Commercial Milestone with First U.S. Procedure and Balloon Catheter Launch; ZETA SURGICAL® Achieves First Clinical Milestone with Initial Patient Treatment at HOPE Therapeutics

Legacy Received New York State CLEP Approval for Two Laboratory-Developed Tests: Semen Analysis and DNA Fragmentation

On 24 June 2026, Legacy announced that the New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP), administered by the Wadsworth Center, had validated and approved its laboratory-developed semen analysis and sperm DNA fragmentation analysis tests. The approvals marked a significant milestone as New York’s rigorous pre-market review process evaluates the validity of individual laboratory-developed tests beyond standard federal laboratory certification requirements. Both tests, which utilize computer-assisted sperm analysis (CASA) technology, successfully met the state’s stringent standards.

The approved tests were validated for use with at-home sample collection and laboratory processing. Legacy’s semen analysis assessed key sperm parameters, while its DNA fragmentation analysis evaluated the integrity of sperm genetic material, an important indicator in fertility assessment. The approvals enabled New York patients and healthcare providers to access comprehensive male fertility evaluations through convenient at-home testing services.

“New York is arguably the most rigorous state-based evaluation of laboratory testing methodology in the country,” said Dr. Scott Lundy, Chief Medical Officer of Legacy. “Obtaining certification for both semen analysis and DNA fragmentation reaffirms our commitment to clinical excellence and provides strong evidence of the clinical validity of our at-home test relative to the gold standard. For New York patients and the physicians who care for them, this is strong reassurance that the platform and its results can be trusted.”

“New York sets the highest bar in the country for laboratory testing, and clearing its review for an individual test is its own milestone,” agrees Khaled Kteily, founder and CEO of Legacy. “Having both our semen analysis and DNA fragmentation tests approved means a New Yorker can get a clinical-grade result without leaving home and trust that it has been validated against the most rigorous standard that exists. That’s the kind of access we’ve spent years building toward.”

As per DelveInsight’s “Fertility Monitoring Devices Market Report,” The Global Fertility Monitoring Devices Market is estimated to grow at a CAGR of 7.41% during the forecast period from 2024 to 2030. The demand for fertility monitoring devices is primarily being boosted due to rising delays in parenthood and the growing prevalence of infertility issues across the globe. Furthermore, lifestyle changes, alcohol consumption, smoking, and others can also increase infertility issues, thereby increasing the demand for fertility monitoring devices. Further, the rising cases of miscarriage, the rising adoption of advanced technologies, and the increasing product launches and approvals, among others, are also contributing to the overall growth of fertility monitoring devices during the forecast period from 2024 to 2030.

Quest Diagnostics Receives New York State Approval for Haystack MRD®, Broadening Patient Access to ctDNA Minimal Residual Disease Testing

On 24 June 2026, Quest Diagnostics announced that the New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP) had approved its Haystack MRD® circulating tumor DNA (ctDNA) liquid biopsy test for detecting minimal residual disease and cancer recurrence in patients with various solid tumors. The approval enabled the test to become available for patient use across all 50 U.S. states, following its availability in 49 states and the District of Columbia since late 2024.

The approval reflected New York’s stringent laboratory test review process, which requires detailed technical evaluation of laboratory-developed tests before they can be offered to patients. Developed under CLIA regulations, Haystack MRD has also demonstrated strong clinical utility in research settings. Notably, a study led by Dr. Andrea Cercek and colleagues at Memorial Sloan Kettering Cancer Center, published in The New England Journal of Medicine in May 2025, found that the test served as a reliable liquid biopsy surrogate for identifying clinical complete response in patients with locally advanced mismatch repair-deficient (dMMR) solid tumors. The study showed that ctDNA testing using Haystack MRD detected clinical complete response at a median of 1.4 months, significantly earlier than the more than six months typically required with imaging-based assessments.

“This approval represents the culmination of our many years of hard work and commitment to delivering a highly accurate test that can meaningfully improve patient care,” said Dan Edelstein, Vice President and General Manager for Haystack Oncology, a Quest Diagnostics company. “Haystack MRD was designed to give oncologists the confidence to detect residual disease earlier, catch recurrence before it becomes clinically apparent, and help identify response to treatment. New York’s approval is another proof point for Haystack MRD’s quality and technical sophistication, and we look forward to extending access to this important innovation for clinicians and patients in the state.”

As per DelveInsight’s “Minimal Residual Disease Testing 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, and the increasing product development and launch activities by key market players continue 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.

MVZ MedDiagnost GmbH signed a 10-year agreement with Sectra to unify radiology across 10 sites and standardize patient care 

On 25 June 2026, International medical imaging IT and cybersecurity company Sectra signed a 10-year agreement with MVZ MedDiagnost GmbH, part of the LifeLink Group, to deploy its Sectra One enterprise imaging platform across ten practice locations in Germany’s Aachen region. The project consolidated three separate imaging systems into a centralized platform, enabling improved collaboration among radiologists and streamlined image management across all sites. The expansion extended a long-standing 20-year partnership and allowed the healthcare provider to manage approximately 300,000 annual imaging examinations through a scalable infrastructure while establishing a secure pathway for future cloud-based imaging operations.

“With a centralized solution, we can collaborate seamlessly across locations, and our teams can rely on a fast, stable system that provides the necessary information regardless of where patients are located. The ability to switch to the cloud if needed helps ensure that this is a sound long-term investment,” says Dr. Alexander Klemm, Director of IT at LifeLink Medical GmbH.

“This agreement reflects what we are seeing across the entire region: healthcare providers want unified systems, as the seamless sharing of imaging resources across locations is becoming a genuine operational necessity. For the locations of MVZ MedDiagnost GmbH, Sectra One already offers this capability today, with a platform designed to grow with the company over the next ten years,” says Fabian Henke, Account Manager at Sectra DACH.

As per DelveInsight’s “Interventional Radiology Devices Market Report,” the global interventional radiology devices market is expected to grow at a CAGR of 5.23% during the forecast period of 2024 to 2030. The increase in demand for interventional radiology devices is primarily attributed to the increasing patient pool due to an increasing prevalence of chronic disorders & cancer, and due to the increasing number of geriatric patients globally. The interventional radiology devices work on minimally invasive techniques, so it involves less severe surgical procedures, thereby leading to less hospitalization period. Thus, the rising demand for reducing healthcare expenditure across the world is anticipated to bolster the market for these devices. Furthermore, the rising awareness and demand for minimally invasive techniques and the technological advancements in devices such as illumination rendering technology, real-time images, and others across the world are anticipated to bolster the market, thereby contributing to the growth of the interventional radiology devices market during the forecast period from 2024 to 2030.

ALZpath Signed Global Licensing Agreement with Abbott to Advance Blood-Based Alzheimer’s Disease Testing 

On 24 June 2026, ALZpath Inc. announced that it had entered into a licensing agreement with Abbott to integrate ALZpath’s proprietary phosphorylated Tau 217 (pTau217) antibody into the development of an in vitro diagnostic (IVD) blood test for Alzheimer’s disease. The test was intended for use on Abbott’s Alinity ci-series systems, one of the most widely installed immunoassay platforms globally, expanding access to Alzheimer’s disease diagnostics in clinical laboratories.

ALZpath’s pTau217 antibody had been extensively validated for the detection of Alzheimer’s disease pathology and was supported by more than 200 peer-reviewed studies conducted across 18 countries. The agreement aimed to support the development of scalable and accessible blood-based diagnostic solutions as the availability of disease-modifying therapies increased. Compared with PET imaging and cerebrospinal fluid (CSF) testing, the pTau217-based assay offered a less invasive and more cost-effective approach for identifying patients with Alzheimer’s disease. The biomarker also showed potential for monitoring disease progression and evaluating treatment response in routine clinical practice.

“This agreement further strengthens ALZpath’s leadership in blood-based Alzheimer’s testing and reinforces our position as the foundational component supporting the overwhelming majority of the pTau217 IVD market,” said Mike Banville, CEO of ALZpath. “As blood-based biomarkers become central to how Alzheimer’s disease is detected and managed, partnering with a global healthcare leader like Abbott can enable high-performance testing to reach clinicians and patients around the world at scale. Together with our diagnostic partners, we remain focused on bringing our highly accurate and sensitive antibody into routine care, including primary care, to reach patients in need.”

According to DelveInsight’s “Alzheimers Disease Diagnostic Market Report”, the global Alzheimer’s disease (AD) diagnostic market will grow at a CAGR of 10.97% during the forecast period from 2024 to 2030. The Alzheimer’s disease (AD) diagnostic market is observing an optimistic market growth due to factors such as a rise in the regulatory approvals for Alzheimer’s disease (AD) diagnostics across the globe. Further, the rising prevalence of head injuries owing to accidents, workplace injuries, and others, and the rise in the geriatric population will increase the prevalence of Alzheimer’s disease, thereby increasing the demand for Alzheimer’s disease diagnostic devices across the globe. Additionally, the increasing research and development of novel biomarkers, the presence of key players in the market, increasing product launches and approvals, and other factors will create a need for Alzheimer’s disease diagnostics in the upcoming years. Therefore, the market for Alzheimer’s disease (AD) diagnostics is estimated to grow at a substantial CAGR during the forecast period from 2024 to 2030.

Corvention Announces First Case in the U.S. and Initiates Limited Commercial Launch of Innovative Balloon Catheter

On 24 June 2026, Corvention announced the successful completion of the first U.S. procedure using its proprietary KardiaPSI™ balloon catheter. The milestone case was performed by interventional cardiologist Dr. Alan Zajarias in St. Louis, Missouri, marking an important advancement for the company’s structural heart technology platform.

The procedure officially initiated the limited commercial launch of the KardiaPSI balloon catheter in the United States following its recent FDA 510(k) clearance for balloon valvuloplasty. Designed to provide enhanced procedural control and consistent performance during valvuloplasty interventions, the catheter demonstrated its clinical utility in the inaugural case. Through the limited launch program, Corvention planned to work closely with selected healthcare institutions to support clinical adoption, optimize procedural outcomes, and gather real-world experience with the technology.

“We are thrilled to achieve this pivotal milestone alongside Dr. Zajarias and his exceptional team in St. Louis,” said Michael Franklin, CEO of Corvention. “The successful clinical debut of the KardiaPSI balloon catheter underscores our commitment to providing interventionalists with advanced, high-performance tools designed to optimize outcomes in structural heart procedures. This first case lays the foundation for our controlled rollout across elite cardiovascular centers nationwide.”

According to DelveInsight’s ”Transcatheter Heart Valve Replacement Devices Market Report,” the Transcatheter Heart Valve Replacement Devices Market is estimated to grow at a CAGR of 13.75% during the forecast period from 2024 to 2030. The Transcatheter Heart Valve Replacement Devices Market is expanding rapidly due to the growing prevalence of cardiovascular disorders, including circulatory diseases, various heart valve diseases, increasing product developmental activities such as regulatory clearances, rising sedentary lifestyle & lifestyle-associated disorders, and increasing preference for minimally invasive surgeries that are expected to escalate the overall growth of the transcatheter heart valve replacement market during the forecast period from 2024 to 2030.

ZETA SURGICAL® Announced Successful Treatment of First Patient with Zeta TMS Navigation System at HOPE Therapeutics 

On 23 June 2026, ZETA SURGICAL and HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, announced that the first patient had been treated using the FDA-cleared Zeta TMS Navigation System at a HOPE Therapeutics clinic in Sarasota, Florida. The companies also deployed the navigation system at a clinic in West Palm Beach, with patient treatments commencing at both locations during the same week.

The Zeta TMS Navigation System was integrated into HOPE Therapeutics’ outpatient transcranial magnetic stimulation (TMS) programs for eligible patients, including those undergoing treatment for major depressive disorder. Utilizing proprietary RealTrack™ technology, the system provided real-time, markerless image guidance during TMS procedures. By combining artificial intelligence and computer vision, the platform aligned patient MRI or CT images with facial anatomy in less than two minutes and continuously tracked TMS coil positioning relative to the targeted brain region with sub-millimetric precision. The implementation was intended to enhance treatment accuracy and consistency for patients receiving TMS therapy for depression and other neuropsychiatric disorders.

“Beginning patient treatments with the Zeta TMS Navigation System marks a major milestone in bringing surgical-grade accuracy to the TMS clinic,” said Raahil Sha, Co-Founder and Chief Technology Officer of ZETA. “We are excited to see our technology now supporting real patients in the treatment of depression, and to support clinicians in expanding access to more personalized, precision-guided TMS across the country.”

According to DelveInsight’s “Transcranial Magnetic Stimulators Market Report,” the global transcranial magnetic stimulation (TMS) market was valued at USD 1,134.61 million in 2023, growing at a CAGR of 9.19% during the forecast period from 2024 to 2030 to reach USD 1,917.05 million by 2030. The demand for transcranial magnetic stimulation (TMS) is primarily being boosted by the increasing patient population suffering from various neurological diseases such as Alzheimer’s Disease and Parkinson’s disease among others, as the surge in cases of psychiatric comorbidities such as bipolar disorder, obsessive-compulsive disorder, and others, rising awareness regarding mental health, rise in many smokers, growing preference for non-invasive treatment methods, and innovation in product development among others, thereby contributing to the overall growth of the transcranial magnetic stimulation (TMS) market during the forecast period from 2024 to 2030.