LiviWell Receives FDA Clearance for Livi, Pioneering Post-Intercourse Vaginal Care; Medtronic Advances Spine and Cardiac Care with ViaVerte Partnership and FDA Approval of OmniaSecure Lead; ZEISS Broadens Its Ophthalmic Workflow Portfolio in Canada; Starlight Cardiovascular Reports First-Ever Infant Treated with Lifeline Stent System at Cincinnati Children’s Hospital; Belay Diagnostics Highlights 82% Clinical Impact Rate for Summit™ and Vantage™ in CNS Lymphoma

LiviWell Secured FDA Clearance for Livi, Introducing a New Category in Post-Intercourse Vaginal Care 

On 24 March 2026, LiviWell announced that the U.S. Food and Drug Administration had granted clearance for Livi, a novel device developed to support vaginal health by absorbing semen and other post-intercourse fluids.

This regulatory approval represented a key milestone for the company, positioning Livi as a first-of-its-kind solution in the intimate health space. The device was designed for vaginal insertion after intercourse, where it functioned to quickly absorb fluids, typically within about 60 seconds. It was constructed from soft polyurethane foam and came with an applicator similar to a tampon for ease of use. The single-use device could be worn for up to 15 minutes post-intercourse before removal.

“Receiving FDA clearance for Livi marks a defining milestone for LiviWell and signals the introduction of a new category in women’s intimate health,” said Dawn Halkuff, Chief Executive Officer of LiviWell. “For too long, the realities women experience after sex have gone largely unaddressed by innovation. This clearance allows us to bring a simple, easy-to-use solution to market – one that fits seamlessly into a woman’s routine and helps her feel more comfortable and confident.”

“From a clinical perspective, many patients have questions about post-sex complaints such as discharge and odor,” said Dr. Michael Ingber, MD, board-certified urogynecologist, Co-Founder and Chief Medical Officer of LiviWell. “Our research has shown that semen disrupts vaginal pH and can contribute to those common post-intercourse complaints. Conversations around post-sex vaginal health have historically been limited. Achieving FDA clearance for Livi represents an important step toward bringing greater medical recognition and innovative solutions to women experiencing these everyday concerns.”

As per DelveInsight’s “FemTech Market Report,” the global femtech market is estimated to grow at a CAGR of 13.52% during the forecast period from 2025 to 2032. The demand for femtech is being boosted by a rise in the adoption of digital health solutions, advancement in artificial intelligence and virtual assistance, growth in investments and funding, growing female awareness of personal health and hygiene, rising infectious diseases among women, large investments made by the government and other organizations, among others are thereby contributing to the overall growth of the femtech market during the forecast period from 2025 to 2032.

Medtronic OmniaSecure Defibrillation Lead, the First Lead of its Kind, Received FDA Approval for Conduction System Pacing

On 24 March 2026, Medtronic plc announced that it had received approval from the U.S. Food and Drug Administration for an expanded indication of its OmniaSecure™ defibrillation lead. The approval allowed the device to be used in the left bundle branch (LBB) area, enabling conduction system pacing (CSP), a method that more closely replicates the heart’s natural electrical activity.

This milestone made OmniaSecure the first defibrillation lead approved for placement in the LBB region. Designed to connect with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), the lead was developed to manage life-threatening arrhythmias such as ventricular tachycardia, ventricular fibrillation, and bradyarrhythmias. Its compact design (4.7 French) made it the smallest defibrillation lead available, and it was approved for both adults and pediatric patients aged 12 years and older.

Built on the foundation of the SelectSecure Model 3830 pacing lead, the OmniaSecure lead featured a lumenless structure that enhanced durability and enabled catheter-based delivery for precise placement. By leveraging CSP, the device could activate the heart’s intrinsic conduction pathways, potentially reducing complications associated with conventional pacing approaches.

The approval was supported by findings from the LEADR LBBAP trial, which demonstrated strong safety and efficacy outcomes, including a 100% defibrillation success rate at implantation and a low complication rate at three months. The therapy could also be combined with left ventricular pacing in advanced approaches such as LOT-CRT to further improve synchronization and patient outcomes.

“Conduction system pacing is a rapidly growing therapy for patients who need a pacemaker. Now, patients who require a defibrillator and pacing have an option that can safely deliver life-saving defibrillation therapy and activate the heart’s natural electrical system to enable a more synchronous, physiologic pattern,” said Trevor Cook, vice president and general manager of the Defibrillation Solutions business, which is part of the Cardiac Rhythm Management operating unit at Medtronic. “This approval underscores the versatility of the OmniaSecure defibrillation lead and supports its use across a variety of implant approaches to best serve a broad range of patients.” 

As per DelveInsight’s “Defibrillators Market Report,” the defibrillators market was valued at USD 10.19 billion in 2023, growing at a CAGR of 3.11% during the forecast period from 2025 to 2032, to reach 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.

ZEISS Expanded Ophthalmic Workflow Portfolio in Canada 

On 24 March 2026, ZEISS Medical Technology announced the expansion of its ophthalmology and optometry clinical workflows in Canada, introducing advanced diagnostic systems, next-generation laser treatment devices, and enhanced digital workflow solutions. These innovations were showcased at major industry events, including the Ontario Association of Optometrists conference and the Canadian Ophthalmological Society conference.

The company enhanced its imaging capabilities with the CLARUS® 700, adding features such as advanced angiography modes and ultra-widefield imaging for retina and glaucoma care. It also expanded its therapeutic portfolio with the VISULAS® green laser for glaucoma and retinal treatments, along with the VISULAS® yag laser for anterior segment procedures within cataract workflows.

Additionally, ZEISS introduced new diagnostic tools like the VISUREF® 600 and VISUCORE 500, designed to streamline refraction workflows and improve clinical efficiency. The rollout also included the FORUM® digital platform, enabling centralized data management and fully paperless clinical workflows. Overall, the expansion strengthened ZEISS’s presence in Canada by improving clinical efficiency, enhancing patient care, and advancing digital integration in eye care practices. 

“ZEISS is proud to expand access to advanced therapeutic lasers, diagnostic technologies, and digital workflow solutions in Canada. These innovations help enhance patient care across our clinical workflows and reflect our commitment to supporting eye care professionals with integrated solutions which offer tools that support them in making informed care decisions, improving practice efficiency, and delivering better outcomes for patients across the country,” says Bryan Rossi, President of ZEISS Canada.

As per DelveInsight’s “Ophthalmic Devices Market Report,” the global ophthalmic devices market is expected to increase from USD 31,902.50 million in 2024 to USD 44,247.53 million by 2032, growing at a CAGR of 7.13% during the forecast period from 2025 to 2032. The global ophthalmic device market is witnessing robust growth, primarily driven by the rising incidence of eye disorders such as cataracts, glaucoma, age-related macular degeneration, diabetic retinopathy, and refractive errors. Factors such as aging populations, increasing prevalence of diabetes and hypertension, and greater exposure to digital screens are significantly contributing to the growing patient pool. This surge in eye-related conditions is fueling demand for advanced diagnostic, surgical, and vision correction devices, prompting continuous innovation and adoption of technologies like minimally invasive surgeries, laser systems, and AI-enabled diagnostics. Consequently, the escalating burden of eye diseases is a key catalyst shaping the expansion of the ophthalmic device market worldwide.

Medtronic and Merit Medical Systems Entered into Agreement to Offer New, FDA-cleared ViaVerte System, a Basivertebral Nerve Ablation Treatment for Chronic Vertebrogenic Lower-back Pain 

On 24 March 2026, Medtronic plc announced that it had entered into a distribution agreement with Merit Medical Systems, Inc. to offer the FDA-cleared ViaVerte™ system, a minimally invasive and implant-free basivertebral nerve ablation (BVNA) technology.

This system was recognized as the first and only BVNA solution featuring a physician-controlled steerable mechanism, enabling precise targeting of the basivertebral nerve for the treatment of chronic vertebrogenic lower back pain. The agreement marked another strategic step for Medtronic in strengthening its core business areas and further expanding its collaboration with Merit Medical.

Merit had already been a supplier for Medtronic, providing products such as the Kyphon™ Xpander™ Inflation Syringes and Kyphon™ KyphoFlex™ steerable balloon catheter, which are used in procedures for vertebral compression fractures. The addition of ViaVerte™ complemented Medtronic’s existing pain management portfolio.

With chronic pain affecting a significant portion of the population, the ViaVerte™ system was positioned as a growing therapeutic option. It was designed to offer a minimally invasive, same-day outpatient procedure, aligning with Medtronic’s objective of expanding access to innovative and effective pain treatment solutions.

“For 50 years, we have advanced how chronic pain is treated,” said Paolo Di Vincenzo, president, Medtronic Neuromodulation, which is part of the Medtronic Neuroscience Portfolio. “Adding ViaVerte™ Basivertebral Nerve Ablation expands our world-leading pain interventions portfolio and gives patients and their physicians another meaningful option for lasting relief. 2,3”

“We are thrilled to expand our ongoing business relationship with Medtronic by providing Merit’s proprietary articulating technology,” said Michael Blackham, executive vice president, Global OEM, Merit Medical Systems, Inc. “We believe ViaVerte™ represents a significant advancement in the BVNA market.”

According to DelveInsight’s “Pain Management Devices Market Report”, the global pain management devices market is expected to increase from USD 5,277.30 million in 2024 to USD 9,350.72 million by 2032, growing at a CAGR of 7.53% during the forecast period from 2025 to 2032. The global pain management devices market is set to grow rapidly from 2025 to 2032, driven by the rising prevalence of chronic pain, frequent product launches, and increasing awareness of pain management solutions. Growing demand for minimally invasive devices and supportive awareness campaigns are boosting adoption, creating strong opportunities for innovation and improved patient outcomes.

Starlight Cardiovascular Announced the First Baby in the World Treated with Lifeline Stent System at Cincinnati Children’s Hospital 

On 24 March 2026, Starlight Cardiovascular announced that the first infant in the world had been treated using its Lifeline™ Ductus Arteriosus Stent System at Cincinnati Children’s Hospital in January. The procedure was conducted as part of a clinical study under the U.S. Food and Drug Administration Investigational Device Exemption (IDE) program.

The intervention was performed by Dr. Shabana Shahanavaz on an 8-day-old infant diagnosed with complex congenital heart defects, including Double Inlet Left Ventricle and Pulmonary Atresia, conditions that severely restrict blood flow to the lungs. The Lifeline™ stent was specifically designed to keep the ductus arteriosus open—a temporary fetal blood vessel that typically closes after birth, thereby ensuring adequate pulmonary blood circulation in critical cases.

Unlike conventional approaches that often require high-risk open-heart surgery or the use of adult-designed stents, the Lifeline™ system offered a minimally invasive alternative tailored for neonatal anatomy. Its flexible design enabled it to adapt to the highly curved structure of the ductus arteriosus, improving safety and ease of use. The clinical trial was led by Dr. Aimee Armstrong from Nationwide Children’s Hospital, who highlighted its potential advantages over existing treatment options. 

According to DelveInsight’s ”Interventional Cardiology Devices Market Report,” The global interventional cardiology devices market is expected to increase from USD 20,192.60 million in 2024 to USD 34,866.30 million by 2032, growing at a CAGR of 7.09% during the forecast period from 2025 to 2032. The global interventional cardiology devices market is driven by the growing prevalence of cardiovascular diseases (CVDs) and their associated risk factors, increasing preference for minimally invasive procedures, increasing technological advancement in product design, and an increase in strategic activities among the key market players.

Belay Diagnostics Reported 82% Clinical Impact Rate for Summit™ and Vantage™ in CNS Lymphoma Study 

On 24 March 2026, Belay Diagnostics announced that a retrospective study had been published demonstrating the clinical value of its Summit and Vantage tests in patients with central nervous system (CNS) lymphoma. The study evaluated 50 specimens from 48 patients during the first year of the tests’ commercial availability and found that the assays delivered meaningful clinical impact in 82% of cases.

The findings showed that the tests had helped clinicians address key diagnostic challenges, including resolving uncertain differential diagnoses, confirming disease recurrence or progression, supporting disease stratification, and assisting in clinical trial decision-making where traditional diagnostic tools had limited sensitivity. In 64% of the samples, Summit successfully identified clinically relevant genetic variants, while negative results also proved useful in ruling out CNS lymphoma or confirming treatment response.

Notably, in one highlighted case, Summit was the only test that provided actionable insights after other diagnostic methods, such as MRI, biopsy, and blood-based testing, had yielded inconclusive results. The study also identified key genetic alterations, including MYD88, TP53, and CD79B, which are strongly associated with CNS lymphoma. Additionally, findings related to aneuploidy helped indicate potential metastatic disease in certain cases, while longitudinal monitoring demonstrated treatment effectiveness through the absence of previously detected variants.

According to DelveInsight’s “Molecular Diagnostics Market Report,”  the molecular diagnostics market was valued at USD 9.56 billion in 2024, growing at a CAGR of 9.21% during the forecast period from 2025 to 2032, to reach 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.