Hologic Gains FDA Clearance for Aptima® HPV Assay as Primary Screening Tool; ZOLL Zenix Monitor/Defibrillator Achieves MDR Approval; Labcorp Unveils FDA-Cleared Blood Test for Alzheimer’s Screening; P&F SecureD EU MDR CE Mark Approval for the TricValve® System; Valcare Medical Performs First U.S. Transseptal AMEND™ Implant as Part of Early Feasibility Study; Hyperfine Unveils New Clinical Results Showing Improved Stroke Detection with the Swoop® System

Hologic Received FDA Approval for Aptima® HPV Assay Primary Screening Option, Expanding Cervical Health Portfolio 

On February 04, 2026, Hologic, Inc. announced that its Aptima® HPV Assay had received FDA approval for clinician-collected HPV primary screening. The test, which was the only FDA-approved mRNA-based assay at the time, had been specifically designed to detect infections most likely to lead to cervical cancer.

Screening for cervical cancer has been critically important for women’s health. In the United States, it was estimated that in 2026, around 13,490 new cases of invasive cervical cancer would be diagnosed, and approximately 4,200 women would die from the disease. Many of these deaths, however, could have been prevented with regular screening and appropriate follow-up on abnormal results. Timely follow-up had been essential for early detection and treatment, helping to reduce both cervical cancer cases and mortality.

The additional indication for the Aptima HPV Assay expanded Hologic’s portfolio to include Pap + HPV co-testing, Pap testing, and HPV primary testing, three major FDA-approved and guideline-recommended methods for cervical cancer screening. This approval followed clearance of the Genius® Digital Diagnostics System and the Genius® Cervical AI Algorithm, which use advanced digital imaging and artificial intelligence to aid in the detection of cytologic abnormalities and precancerous lesions.

The approval came after the completion of one of the largest real-world evidence HPV screening studies, which involved over 650,000 women across multiple U.S. health systems and reflected diverse patient populations and clinical settings. This study compared the Aptima HPV Assay with an FDA-approved DNA-based HPV test for primary screening and found that the Aptima HPV Assay’s sensitivity was clinically comparable to that of the comparator test. It was shown to be effective for primary screening to detect CIN2+ and CIN3+.

Although co-testing had remained the most comprehensive screening method with over 90% of providers reporting high confidence for women aged 30 to 65, and data showing that Pap + HPV co-testing detected up to 95% of cervical cancers Hologic’s expanded range of testing options had provided providers with greater flexibility to choose an approach based on a patient’s age, access, and risk factors.

“Hologic has been at the forefront of cervical cancer screening for decades, and the additional indication of the Aptima HPV Assay reflects our ongoing commitment to advancing women’s health through innovative, evidence-based solutions,” said Jennifer Schneiders, Ph.D., President of Diagnostic Solutions at Hologic. “Our commitment to providing comprehensive cervical health solutions that meet provider and patient needs is unwavering, and by offering providers more choice and flexibility, we can help them deliver the most personalized care for each patient.”

According to DelveInsight’s “Molecular Diagnostics Market Report,” the molecular diagnostics market was valued at USD 9.56 billion in 2024 and is projected to grow at a CAGR of 9.21% from 2025 to 2032, reaching USD 16.12 billion by 2032. The molecular diagnostics market is experiencing significant growth due to the increasing cases of infectious diseases, including HIV, Hepatitis B, Hepatitis C, Influenza, and human papillomavirus (HPV). The introduction of new and innovative products by key Molecular Diagnostics Companies, among others, is expected to drive the Molecular Diagnostics Market from 2025 to 2032.

New ZOLL Zenix Monitor/Defibrillator Received the MDR Approval

On February 10, 2026, ZOLL®, an Asahi Kasei company specializing in medical devices and related software solutions, announced that its Zenix® professional monitor/defibrillator had received approval under the European Union (EU) Medical Device Regulation 2017/745 (EU MDR).

The Zenix monitor/defibrillator has been recognized as a clinically advanced, user-friendly device that redefined efficiency, clarity, and intelligence in both EMS and hospital environments. Developed from years of customer feedback, Zenix combines intuitive design with powerful functionality to enhance patient care and streamline workflows, improving ease of use. Its large, durable touchscreen provided critical information when needed, and its on-the-fly customization enabled healthcare professionals to make real-time adjustments, helping them maintain control in high-pressure situations.

Incorporating ZOLL’s innovative Real BVM Help® and exclusive Real CPR Help® technologies, Zenix has delivered real-time clinical feedback to improve ventilation quality and support high-quality CPR. The device’s advanced capabilities have enabled EMS teams and hospital clinicians to make informed decisions confidently, ensuring consistent delivery of exceptional patient care. 

“Whether you are a hospital clinician or an EMS professional, the ZOLL Zenix monitor/defibrillator is designed to work the way you work,” said Elijah White, President of ZOLL Acute Care Technology. “Zenix is our most advanced monitor/defibrillator, and yet it’s incredibly easy to use virtually all functions of the device are accessible with three screen-touches or less. Along with the X Series®, R Series® and ZOLL M2®, Zenix extends ZOLL’s leadership in professional monitors/defibrillators with unique features and intuitive design.”

According to DelveInsight’s “Defibrillator Market Report,” the defibrillator market was valued at USD 10.19 billion in 2023 and is projected to grow at a CAGR of 3.11% from 2025 to 2032, reaching USD 12.24 billion by 2032. The defibrillator market is observing substantial market growth, primarily owing to the increasing cases of chronic disorders such as cardiovascular diseases, including atrial fibrillation and coronary artery disease (CAD), innovative product development activities by leading companies, and the rising geriatric population, which are expected to escalate the overall growth of the defibrillators market during the forecast period from 2025 to 2032.

Labcorp Launched First FDA-Cleared Blood Test for Alzheimer’s Disease Assessment in Primary Care 

On February 11, 2026, Labcorp, a global leader in innovative and comprehensive laboratory services, announced that the Elecsys® pTau-181 test had become available nationwide. It was the first and only blood test cleared by the U.S. Food and Drug Administration (FDA) to assist in the initial assessment of Alzheimer’s disease in the primary care setting. This launch further expanded Labcorp’s comprehensive portfolio of Alzheimer’s disease blood tests, providing clinicians with solutions across both primary and specialty care.

The Elecsys® pTau-181 test helped clinicians rule out Alzheimer’s disease by identifying symptomatic patients aged 55 and older who were unlikely to have amyloid pathology, abnormal protein buildup in the brain associated with Alzheimer’s disease, within the context of all clinical findings. Patients with negative results could be evaluated for alternative causes of cognitive decline, while those with positive results could be referred for additional testing. The test had been developed by Roche Diagnostics and received FDA clearance in 2025.

“Primary care clinicians are often the first point of contact for patients with concerns related to cognitive symptoms, yet Alzheimer’s testing has historically required a visit to a specialist,” said Dr. Brian Caveney, chief medical and scientific officer at Labcorp. “By making this first-of-its-kind blood test available nationwide, Labcorp is giving primary care clinicians a powerful tool to help patients get answers sooner and guide next steps with confidence.”

As per DelveInsight’s “Alzheimer’s 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 growing research and development of novel biomarkers, the presence of key players in the market, rising product launches and approvals, and other factors will drive demand for Alzheimer’s disease diagnostics in the coming 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.

On February 05, 2026, P&F Products and Features GmbH, a global medtech company specializing in heart valve solutions for structural heart disease, announced that it had secured CE certification under the European Union Medical Device Regulation (MDR) 2017/745 for its TricValve® Transcatheter Bicaval Valve System. This certification confirmed that the device met the EU’s most stringent regulatory standards for medical devices.

The updated CE marking was granted for the TricValve system as a Class III active implantable device intended to treat patients with symptomatic severe tricuspid regurgitation and caval reflux who faced a high risk of open-heart surgery. The approval allowed use of the system regardless of tricuspid annulus size or right heart anatomy, and the presence of pacemaker leads did not preclude treatment.

This MDR certification replaced the earlier CE mark obtained under the Medical Device Directive (MDD) and reinforced TricValve’s regulatory foundation in Europe. It ensured that the device could continue to be marketed in EU countries beyond the 2027 compliance deadline.

The TricValve system was designed as a minimally invasive, catheter-based therapy to reduce caval reflux and improve cardiac output by implanting self-expanding valves within the venae cavae. Clinical experience has shown that it alleviates symptoms of right heart failure and improves patient condition.

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, 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.

Valcare Medical Announced the First U.S. Transseptal AMEND™ Implant in Early Feasibility Study 

On February 11, 2026, Valcare Medical, Inc., a pioneering developer of transcatheter mitral valve repair solutions, announced the successful first U.S. transseptal implantation of its AMEND™ Transcatheter Mitral Valve Repair (TMVr) Annuloplasty System as part of the ongoing AMEND TS Early Feasibility Study (EFS).

The milestone procedure had been performed by Dr. Paul Sorajja, a nationally recognized expert in interventional cardiology and structural heart disease, at Banner – University Medical Center in Phoenix. The AMEND™ System delivered a closed, D-shaped, semi-rigid annuloplasty ring via a transseptal catheter-based approach. It had been specifically designed to replicate the anatomical remodeling and clinical outcomes achieved with traditional surgical annuloplasty, the standard technique in most open-heart mitral valve repairs. Unlike other transcatheter mitral repair technologies, the AMEND System was engineered to preserve future treatment options for patients if additional interventions were necessary.

“For many patients with mitral regurgitation, open-heart surgery is either too risky or simply not an option due to age or other health conditions,” said Dr. Sorajja. “The AMEND transseptal approach offers physicians a percutaneous alternative designed to deliver a surgical-style repair option for their patients with less pain, faster recovery, and the potential for excellent long-term outcomes.”

According to DelveInsight’s ”Transcatheter Mitral Valve Repair Devices Market Report,” the transcatheter mitral valve repair devices market was valued at USD 1,197.06 million in 2023, growing at a CAGR of 14.95% during the forecast period from 2024 to 2030 to reach USD 2,756.71 million by 2030. The transcatheter mitral valve repair 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, increasing preference for minimally invasive surgeries that are expected to escalate the overall growth of the transcatheter mitral valve repair devices market during the forecast period from 2024 to 2030.

Hyperfine Announced the Publication of Breakthrough Clinical Data Demonstrating the Swoop® System’s Enhanced Stroke Detection Capabilities 

On January 27, 2026, Hyperfine, Inc., a health technology company recognized for introducing the first FDA-cleared, AI-powered portable MRI system for brain imaging, reported results from the largest dataset to date assessing the use of the Swoop® system for stroke detection. The findings provided strong clinical evidence supporting the application of AI-enabled portable MRI for stroke identification across multiple care settings, including hospital emergency departments.

The prospective, multicenter observational study, published in the November issue of Stroke: Vascular and Interventional Neurology (SVIN), analyzed data from 95 patients. The dataset combined results from the ACTION PMR study conducted at Massachusetts General Hospital and Buffalo General Medical Center, along with additional patient data from Yale New Haven Hospital. The study assessed the sensitivity and specificity of ischemic lesion detection, compared performance between the original and next-generation Swoop® MRI systems, and evaluated two diffusion-weighted imaging (DWI) sequences, which are critical for accurate stroke diagnosis.

Results demonstrated that the advanced multidirectional DWI sequence available on the next-generation Swoop® system delivered substantial improvements in diagnostic performance compared with the original scanner. The updated system successfully detected ischemic lesions as small as 2.8 mm (0.15 mL), enabling identification of very small strokes that might otherwise go undetected. For clinically significant lesions larger than 1.0 mL, the system achieved 100% sensitivity and 100% specificity, indicating perfect diagnostic accuracy within this range.

In addition, the next-generation Swoop® system reduced scan times by approximately 30%, making rapid stroke imaging more feasible in time-sensitive emergency care environments. The system also demonstrated improved image uniformity across the brain, enhancing image quality and increasing diagnostic confidence among clinicians.

“Stroke detection represents a critical driver of the Swoop® system’s expansion into emergency departments,” commented Maria Sainz, President and CEO of Hyperfine. “The results from our next-generation Swoop® system, combined with our new, advanced multi-direction DWI sequence that was recently cleared by the FDA, are truly remarkable. This data gives us even greater confidence that the Swoop® system can reliably detect clinically relevant strokes, streamline workflows, and further strengthen the value of integrating portable MRI into stroke diagnosis and care.”

According to DelveInsight’s “Magnetic Resonance Imaging (MRI) Devices Market Report”, the magnetic resonance imaging devices market was valued at USD 8,207.06 million in 2024, growing at a CAGR of 6.54% during the forecast period from 2025 to 2032 to reach USD 13,553.33 million by 2032. The rising prevalence of various chronic disorders, such as cardiovascular diseases, cancer, and neurological conditions, is fueling the demand for precise diagnostic tools like MRI, which offers superior imaging capabilities for soft tissues and organs. Additionally, the increasing awareness and the emphasis on early diagnosis of chronic disease are encouraging patients and healthcare providers to adopt MRI for timely intervention. Furthermore, technological advancements are driving growth in the MRI market, with innovations such as high-field and open MRI systems, functional MRI (fMRI), and shorter scan times improving imaging accuracy, comfort, and efficiency. Collectively, these factors are expected to increase global demand for magnetic resonance imaging devices over the forecast period from 2025 to 2032.