Notizia - Recent Pharma, Healthcare and Biotech Happenings
May 01, 2025
Table of Contents
On April 25, 2025, Medtronic plc., a global leader in healthcare technology, received U.S. Food and Drug Administration (FDA) approval for its OmniaSecure™ defibrillation lead. This next-generation lead is designed for precise, catheter-based placement in the right ventricle and builds on the proven performance of the SelectSecure™ Model 3830 pacing lead platform.
At just 4.7 French (1.6mm), OmniaSecure is the smallest defibrillation lead available globally, representing a significant advancement in cardiac rhythm management. It is designed to connect with an implantable cardioverter-defibrillator (ICD) to deliver life-saving therapy for ventricular tachyarrhythmias, ventricular fibrillation (VT/VF), and bradyarrhythmias. The lead is approved for use in adult and adolescent patients aged 12 and older, including individuals with smaller anatomical structures, expanding treatment access and positioning Medtronic at the forefront of electrophysiological innovation.
Article in PDF
In parallel with its FDA-approved application for right ventricular use, Medtronic plc. is actively investigating the novel use of its OmniaSecure™ defibrillation lead in the left bundle branch (LBB) area—an approach with the potential to deliver physiologic pacing that more closely replicates the heart’s natural conduction pathways.
“FDA approval for the OmniaSecure defibrillation lead furthers our ability to offer physicians and patients a transvenous solution designed to be smaller to help minimize complications−including vascular complications and valve interaction−with strong, reliable lead durability. We engineered the OmniaSecure lead based on the trusted SelectSecure Model 3830 pacing lead, which has been the lead of choice for many physicians for more than 20 years,” said Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. “This milestone underscores our commitment to driving clinical innovations that help patients today while paving the way for future innovations that will usher in the next era of electrophysiology.”
“The left bundle branch area is emerging as an option for more physiologic pacing for patients who receive an ICD or CRT-D to treat dangerous heart rhythms,” said Pugazhendhi Vijayaraman, M.D., cardiac electrophysiologist at Geisinger Wyoming Valley Medical Center in Wilkes-Barre, Pa., who presented the data at the meeting. “The option to place a lead in the left bundle branch area may provide for physiologic pacing by engaging the heart’s natural conduction system. These positive preliminary results for the LEADR LBBAP study are encouraging and highlight the potential versatility of the OmniaSecure defibrillation lead.”
Early data from this investigational approach, presented at Heart Rhythm 2025 in San Diego, demonstrated a 100% defibrillation success rate at implant when OmniaSecure was placed in the LBB region. These promising results highlight the potential for OmniaSecure to redefine standards in cardiac pacing and defibrillation, particularly for patients requiring more physiologically accurate therapy.
The investigational use of OmniaSecure in the LBB area is currently under evaluation in the LEADR LBBAP Trial, a global, prospective, non-randomized, multi-center study. The trial enrolled approximately 300 patients across 24 clinical sites in 11 countries, including locations in North America, Europe, Asia, and Australia. Patients indicated for implantable cardioverter-defibrillator (ICD) therapy are being followed for up to 3 months, while those indicated for cardiac resynchronization therapy with defibrillation (CRT-D) are followed for up to 6 months post-implant.
This milestone further strengthens Medtronic’s differentiated cardiac lead portfolio and reinforces its commitment to advancing minimally invasive solutions that address unmet clinical needs and improve patient outcomes.
As per DelveInsight’s “Defibrillators Market Report”, the global defibrillators market was valued at USD 10.19 billion in 2023, growing at a CAGR of 3.11% during the forecast period from 2024 to 2030, to reach USD 12.24 billion by 2030. 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 developmental activities by leading companies, and the rising geriatric population are expected to escalate the overall growth of the defibrillators market during the forecast period from 2024 to 2030.
On April 29, 2025, Roche announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation (BDD) for the VENTANA® TROP2 (EPR20043) RxDx Device, marking the first time this designation awarded to a computational pathology-based companion diagnostic (CDx) device. The VENTANA TROP2 RxDx Device is a next-generation immunohistochemistry (IHC) assay integrated with an artificial intelligence-driven digital pathology algorithm designed to support more accurate and reproducible treatment decisions in oncology. By leveraging AI-powered image analysis, the platform delivers a level of diagnostic precision beyond the capabilities of traditional manual scoring.
The VENTANA® TROP2 (EPR20043) RxDx Device is indicated as an aid in identifying patients with previously treated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have actionable genomic alterations. After initial evaluation by the pathologist, the device’s integrated navify® Digital Pathology (nDP) TROP2 algorithm independently detects tumor cells within the digitized tissue slide and quantifies TROP2 immunohistochemistry (IHC) staining intensity in both the membrane and cytoplasm. Using this data, the algorithm calculates a Normalized Membrane Ratio (NMR) score, which reflects the extent and pattern of TROP2 expression. Based on a pre-defined NMR cutoff, the algorithm then classifies the TROP2 expression status as either positive or negative, supporting clinicians in determining patient eligibility for targeted therapies.
“This FDA Breakthrough Device Designation is another example of our commitment to deliver innovation that enables more precise diagnosis in oncology,” said Matt Sause, CEO of Roche Diagnostics. “This solution, which leverages our industry-leading expertise in companion diagnostics development, uses artificial intelligence for a greater depth of sample analysis, helping to deliver truly personalised treatment.”
“This FDA Breakthrough Device Designation underscores the potential of our computational pathology platform to enable more personalised treatment decisions for people with cancer,” said Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca.
The VENTANA® TROP2 (EPR20043) RxDx Device is an advanced computational pathology solution developed by Roche to support precision diagnostics in non-small cell lung cancer (NSCLC). This integrated device combines several key components, including the AI-powered TROP2 algorithm, the navify® Digital Pathology Image Management System, Roche Digital Pathology scanners (DP 200 and DP 600), and the VENTANA TROP2 (EPR20043) RxDx Assay, which is used with the OptiView DAB Detection Kit on the BenchMark ULTRA IHC/ISH staining instrument. Together, these technologies enable the analysis of whole-slide images of TROP2-stained NSCLC tissue to generate a quantitative TROP2 score. This automated, AI-based approach enhances diagnostic accuracy and consistency beyond what is possible with traditional manual scoring, enabling more precise and personalized treatment decisions in oncology.
This milestone reinforces Roche’s leadership in both companion diagnostics and digital pathology, underscoring the company’s commitment to advancing personalized cancer care through cutting-edge innovation. The BDD designation also provides a pathway for accelerated development and review, aiming to bring this transformative diagnostic technology to patients more quickly.
As per DelveInsight’s “Companion Diagnostics Market Report, the global companion diagnostics market was valued at USD 5.91 billion in 2023, growing at a CAGR of 12.32% during the forecast period from 2024 to 2030, to reach USD 11.89 billion by 2030. The increase in the market for companion diagnostics is predominantly owing to an exponential rise in cancer cases across the globe. Additionally, the rise in awareness regarding precision medicine among the patient population, as well as the growing focus of the manufacturers concerning the development of precision medicine, has bolstered the demand for companion diagnostics. Furthermore, an increase in research and developmental activities for developing companion diagnostics for non-cancer disorders and growing approvals and launches of various companion diagnostic products in the market, among others, are some of the key factors anticipated to augment the global market for companion diagnostics during the forecast period from 2024 to 2030.
On April 26, 2025, Medtronic plc, a global leader in healthcare technology, announced that its Expand URO Investigational Device Exemption (IDE) clinical study, the largest clinical study ever conducted for robotic-assisted urologic surgery, successfully met both its primary safety and effectiveness endpoints. This prospective, multi-center, single-arm trial evaluated 137 patients who underwent urologic procedures using Medtronic’s Hugo™ robotic-assisted surgery (RAS) system. The groundbreaking results were presented at the American Urological Association (AUA) annual meeting in Las Vegas by Dr. Michael R. Abern, national principal investigator and urologic surgeon at Duke University Hospital. The AUA recognized the study as a “practice-changing, paradigm-shifting (P2) clinical trial in urology,” underscoring the potential of Hugo RAS to transform urologic surgical care through advanced, minimally invasive technology.
“The study demonstrated that the Hugo RAS system met the safety and effectiveness endpoints, and the outcomes are consistent with published literature for robotic-assisted urologic surgery,” said Dr. Abern. “Having performed the first case in the Expand URO clinical study, it’s incredibly rewarding to see the results of this rigorous and important study in the field of robotic surgery.”
“The Expand URO clinical study provides important clinical evidence about the Hugo RAS system and is an exciting milestone that brings us closer to our goal of offering surgeons in the U.S. long-awaited choice in robotic technology,” said James Porter, M.D., chief medical officer, Robotic Surgical Technologies and Digital Technologies within the Surgical business, part of the Medical Surgical portfolio at Medtronic, and a urologic surgeon at Swedish Medical Center in Seattle, WA. “Surgeons want to deliver the best care to our patients and robotic technology is key to making that possible today by enabling minimally invasive surgery and leveraging technology that is shaping the future of surgery.“
The clinical results from the Expand URO IDE study demonstrated robust performance of the Hugo™ robotic-assisted surgery (RAS) system across a diverse patient population. On average, patients were approximately 63 years old and classified as American Society of Anesthesiologists (ASA) category ≥3, indicating the presence of severe systemic disease affecting overall health. The study involved 11 surgeons across six U.S. hospitals and included three common urologic procedures: prostatectomies (n=55), nephrectomies (n=53), and cystectomies (n=29), with primary patient cohorts consisting of prostate cancer, renal tumors, and bladder tumors, respectively. Conducted under stringent standards aligned with FDA premarket requirements, the study featured prospective patient enrollment and data collection, independent event adjudication by a Clinical Events Committee, comprehensive data monitoring, and strong follow-up compliance approximately 98% of patients completed the 30-day follow-up. In addition, all cancer patients enrolled in the study will be followed for five years, ensuring long-term data to support the safety and effectiveness of the Hugo RAS system in urologic oncology procedures.
According to DelveInsight’s “Surgical Robotic System Market Report”, the global surgical robotic systems market was valued at USD 5.02 billion in 2023, growing at a CAGR of 11.50% during the forecast period from 2024 to 2030 to reach USD 9.64 billion by 2030. The demand for Surgical Robotic Systems is witnessing a surge due to increasing surgical procedures which can be attributed to various factors such as increasing geriatric population who form a big part of at-risk population for prostate cancer, valvular diseases, endometriosis among other diseases, growing need for robot-assisted surgery systems due to the growing inclination towards minimally invasive surgical approaches, and the innovation in product development which is paving the way for miniaturized surgical robots ultimately contributing in the overall growth of the Surgical Robotic Systems market during the forecast period from 2024 to 2030.
On April 24, 2025, Boston Scientific Corporation announced the successful 12-month primary endpoint results from the second phase of its ADVANTAGE AF clinical trial, which evaluated the FARAPULSE™ Pulsed Field Ablation (PFA) System and the adjunctive use of the FARAPOINT™ PFA Catheter in patients with persistent atrial fibrillation (AF). These positive findings demonstrate the potential of the FARAPULSE system as an effective treatment option for AF patients. The results were presented at the second annual PFA Live Case Summit in San Diego, highlighting the system’s promising impact on patient outcomes in the management of atrial fibrillation.
“Continuous rhythm monitoring in phase two of the ADVANTAGE AF study allowed for a detailed picture of patients’ cardiac rhythm after ablation, including asymptomatic AF recurrence, which is not often captured in U.S. Food and Drug Administration clinical trial monitoring but is important for the ability to provide more individualized care to patients,” said Vivek Reddy, M.D., director, Cardiac Arrhythmia Services, Mount Sinai Health System and Leona M. and Harry B. Helmsley Charitable Trust professor of medicine, Cardiac Electrophysiology, Icahn School of Medicine and study principal investigator. “The data collected in this trial continues to support the FARAPULSE PFA System as a safe and effective therapy, now with evidence highlighting positive results for its use in treating patients who suffer from persistent AF.”
“These positive study results are an important step forward in the continued innovation of the proven FARAPULSE PFA System and our broader portfolio of products that treat AF,” said Brad Sutton, M.D., chief medical officer, AF Solutions, Boston Scientific. “The performance of the devices in this trial – the FARAPOINT and FARAWAVE PFA Catheters as well as the LUX-Dx ICM System – is an encouraging sign as we work towards expanding our portfolio to provide physicians with an even more robust toolset to treat the growing number of patients with AF.”
Boston Scientific Corporation announced the successful results from the second phase of the ADVANTAGE AF clinical trial, which evaluated the FARAWAVE™ PFA Catheter for pulmonary vein isolation (PVI) and posterior wall ablation (PWA), along with the FARAPOINT™ PFA Catheter for cavotricuspid isthmus (CTI) ablation to treat typical atrial flutter (AFL) in patients with persistent atrial fibrillation (AF). Persistent AF, which represents approximately 25% of all AF cases, is an abnormal rapid heartbeat that can lead to serious complications like stroke and heart failure.
The trial, conducted across 29 U.S. sites with 255 patients, achieved all pre-specified safety and effectiveness endpoints. Key findings included 73.4% freedom from AF, AFL, and atrial tachycardia (AT), exceeding the performance goal of 40%, and a low safety event rate of 2.4%, with no reports of pulmonary vein stenosis, atrio-esophageal fistula, or phrenic nerve palsy, meeting the goal of 12% or lower. Additionally, 81% of patients experienced freedom from symptomatic AF recurrence, and 71.6% had virtually no atrial arrhythmia burden, which is associated with fewer clinical interventions and improved quality of life. Moreover, 96.4% of patients treated with the FARAPOINT PFA Catheter had no recurrence of AFL. All patients were continuously monitored with the LUX-Dx™ Insertable Cardiac Monitor (ICM) System, which tracks arrhythmia recurrence and AF burden. These results underscore the potential of the FARAPULSE™ system to improve outcomes for patients with persistent AF and related arrhythmias.
As per DelveInsight’s “Cardiac Ablation Devices Market Report”, the global cardiac ablation devices market was valued at USD 2.25 billion in 2023, growing at a CAGR of 12.77% during the forecast period from 2024 to 2030, to reach USD 4.63 billion by 2030. The demand for cardiac ablation devices is motivated by a rise in the prevalence of cardiovascular diseases like cardiac arrhythmia, atrial fibrillation, and stroke. Additionally, minimally invasive procedures like cardiac ablation are gaining traction due to their advantages over traditional open-heart surgeries. Patients prefer these procedures because they offer shorter recovery times, reduced hospital stays, and lower risks of complications such as infection and bleeding. Furthermore, the growing awareness about cardiac arrhythmias and advancements in diagnostic technologies have led to earlier detection through screening programs. As awareness increases among patients and healthcare providers alike, there is a corresponding rise in the number of cases diagnosed and treated. This trend not only expands the market for cardiac ablation devices but also supports timely intervention and better management of cardiac conditions, improving overall patient outcomes during the forecast period from 2024 to 2030.
On April 25, 2025, Bausch Health Companies Inc., a global diversified pharmaceutical leader, and its aesthetics business, Solta Medical, announced the launch of Fraxel FTX™ at the American Society for Laser Medicine & Surgery, Inc. (ASLMS) 2025 Annual Conference, taking place on April 25 in Orlando, FL. This event marks the beginning of Fraxel FTX™’s rollout to dermatologists, plastic surgeons, and licensed aesthetic professionals across the United States, with plans for global expansion in the coming months.
Fraxel® is a leading treatment for skin rejuvenation, effectively addressing common skin concerns such as sun damage, wrinkles, acne scars, and pigmentation irregularities. With the introduction of Fraxel FTX™, Bausch Health is raising the bar for laser skin resurfacing. The next-generation technology is designed to provide even more precise, efficient, and comfortable treatments, offering dermatologists and aesthetic professionals advanced tools for achieving noticeable results after just one session, across all skin types.
“We are pleased to unveil Fraxel FTX™ at the ASLMS 2025 Conference,” said Thomas J. Appio, CEO of Bausch Health. “This improved technology marks a significant milestone in our commitment to advancing aesthetic medicine and enhancing the patient experience. Fraxel FTX™ embodies our dedication to providing healthcare professionals with the cutting-edge tools they need to help deliver exceptional care.”
“Fraxel FTX™ retains its trusted, proven laser technology offering customized treatments to deliver noticeable results, while combining a modern design, ergonomic enhancements, and efficiency to support today’s aesthetic practices.” said Jiny Kim, Senior Vice President, Solta Medical, Bausch Health.
Fraxel FTX™ introduces several key features and benefits designed to enhance skin rejuvenation treatments. The system utilizes a dual-wavelength fractional laser, combining a 1550 nm erbium-glass laser and a 1927 nm thulium laser to effectively treat both superficial and deeper skin layers, addressing aging and sun-damaged skin while preserving healthy tissue for rapid healing. The redesigned ergonomic handpiece is 20% lighter and smaller, incorporating integrated cooling technology to enhance patient comfort during treatment. Patients can expect visible results with minimal downtime, as the treatment improves skin texture, tone, and clarity with minimal disruption to daily routines.
The Fast Tracking Experience leverages Intelligent Optical Tracking® with AccuTRAC™ technology, ensuring efficient and consistent treatment delivery. Additionally, the redesigned console features a modern design with an integrated arm and cable assembly, while the refreshed user interface with a color touch screen offers flexible, personalized settings to cater to aesthetic goals and common skin concerns caused by sun damage and aging. With the launch of Fraxel FTX™, Solta Medical reinforces its position as an industry leader in innovation, offering practitioners advanced tools that help deliver best-in-class results and improve patient satisfaction.
According to DelveInsight’s “Laser Resurfacing Devices Market Report”, the global laser resurfacing devices market growing at a CAGR of 8.15% during the forecast period from 2025 to 2032. The increasing focus on personal appearance and self-care, particularly among aging populations, is fueling the demand for non-invasive skin rejuvenation treatments, including laser resurfacing. Continuous innovation in laser technology, such as the development of more precise, effective, and comfortable systems, along with a shift toward minimally invasive treatments, is driving the growth of the laser resurfacing devices market. Additionally, ongoing advancements in product development and the launch of new, cutting-edge devices are key factors contributing to the market’s expansion during the forecast period from 2025 to 2032.
On April 28, 2025, Gestalt, a leading innovator in AI-powered digital pathology solutions, announced the successful completion of a $7.5 million Series A financing round. The round was led by Cowles Ventures, TVF Funds, Inland Imaging Investments, KickStart Funds, and prominent angel investors from the Pacific Northwest. Gestalt’s PathFlow® platform is already in use by top healthcare providers, academic medical centers, and research organizations. Customers choose PathFlow for its seamless integration into existing laboratory information systems, which enhances diagnostic speed and accuracy while improving access to expert consultations, education, and research, irrespective of geographic location.
“PathFlow is transforming pathology by leveraging robust digital workflows and AI algorithms to support scoring of key biomarkers. This enables organizations to accurately match patients to known therapies and generate rich datasets for research and new drug development,” said Dan Roark, CEO, Gestalt. “Our technology is designed to improve patient outcomes by enabling faster, more accurate diagnoses and broadening access to clinical expertise.”
“We are incredibly grateful for the continued support from our investors,” Roark added. “This funding allows us to expand on the solid foundation we’ve built. We’ve already streamlined how pathologists navigate fragmented systems by creating PathFlow, a unified platform for viewing pathology cases digitally and collaborating with leading experts in real-time without the need to ship specimens. Now, we’ll accelerate innovation and scale our reach to meet the growing demands of modern pathology.”
The new $7.5 million Series A funding will enable Gestalt to accelerate market adoption and increase profitability. The capital will be allocated towards expanding the company’s customer base, enhancing its AI capabilities, and pursuing FDA clearance. This investment comes at a critical time, as rising cancer rates and a decreasing number of practicing pathologists underscore the need for scalable, digital-first diagnostic solutions. Gestalt’s PathFlow® platform not only improves diagnostic speed and precision, which is crucial for cancer patients who often face delays of days or weeks for a diagnosis, but also unlocks AI-powered insights.
These insights include biomarker scoring to optimize patient-therapy matching, image and data analysis for disease progression studies, and interoperability that provides pathologists with valuable aids and insights to streamline workflows, highlight areas of positivity, and reduce missed diagnoses. With this funding, Gestalt remains committed to expanding its impact by deploying PathFlow in healthcare, making high-quality, scalable pathology solutions more accessible to clinicians and researchers worldwide.
As per DelveInsight’s “AI in Diagnostics Market Report”, the global AI in diagnostics market is estimated to grow at a CAGR of 7.82% during the forecast period from 2025 to 2032. The increase in the market for AI in diagnostics is predominantly owing to an exponential rise in cancer cases across the globe. Additionally, the rise in awareness regarding precision medicine among the patient population as well as the growing focus of the manufacturers concerning the development of precision diagnostics, bolstered the demand for AI-driven diagnostics. Furthermore, an increase in research and developmental activities for developing AI-driven diagnostics for non-cancer disorders and growing approvals and launches of various advanced diagnostic products in the market, among others, are some of the key factors anticipated to augment the global market for AI in diagnostics during the forecast period from 2025 to 2032.
Article in PDF
