Ferronova Announces Preliminary MAGMAP Results in 62-Patient Gastric and Oesophageal Cancer Trial; Powerful Medical Secures FDA De Novo Authorization for AI ECG Model; ZEISS Advances Cataract Surgery with Introduction of AT LUCIA toric 721P; Waters Launches BD FACSDiscover A7 Cell Analyzer for Standardized Spectral Flow Cytometry; Nicklaus Children’s Hospital Completes One of the Country’s First Transcatheter Fontan Procedures in a Two-Year-Old

Ferronova Announced Preliminary Results of MAGMAP, a 62-Patient Gastric and Oesophageal Cancer Trial Investigating Lymph Node Mapping

On 09 September 2026, Emboline announced that it had received U.S. FDA 510(k) clearance for its Emboliner Embolic Protection System, supporting the company’s advancement in the embolic protection device market. The system was developed to capture and remove embolic debris generated during transcatheter heart procedures, particularly transcatheter aortic valve replacement procedures.

The Emboliner incorporated a dual-layer Nitinol mesh filter and an integrated access port that allowed procedural devices to pass through the filter while maintaining embolic protection. Its design provided coverage of all three cerebral vessels and was intended to capture debris that could potentially travel to the brain, kidneys, and other organs.

The regulatory clearance followed positive clinical development of the technology. Emboline had previously completed enrollment in its 500-patient PROTECT Head-to-Head IDE trial, which compared Emboliner with Boston Scientific’s Sentinel Cerebral Protection System during TAVR. Results presented in 2026 showed that Emboliner was non-inferior to Sentinel for the evaluated safety and efficacy endpoints and demonstrated superior debris capture.

The FDA clearance strengthened Emboline’s position in the embolic protection segment and supported the broader adoption of embolic protection technologies in structural heart procedures. The development also highlighted increasing efforts to reduce stroke and other ischemic complications associated with embolic debris released during TAVR and other transcatheter cardiac interventions.

“The liberation of embolic debris is a universal concern during TAVR, but until now our ability to provide comprehensive protection of both the cerebral and systemic circulation has been limited,” said Tamim Nazif, MD, Co-Director of the Structural Heart and Valve Center at Columbia University Irving Medical Center and Co-Principal Investigator of the PROTECT H2H study. “The Emboliner represents an important step forward, providing full brain and body protection, while integrating seamlessly into the TAVR procedure. Having this new capability may give physicians greater confidence when treating patients in whom embolic risk is an important consideration, and I look forward to incorporating this technology into our clinical practice.”

As per DelveInsight’s “Embolic Protection Devices Market Report,” the global embolic protection devices market size is expected to increase from USD 648.51 million in 2024 to USD 1,161.31 million by 2032, reflecting strong and sustained growth. The global embolic protection devices market is growing at a CAGR of 7.58% during the forecast period from 2025 to 2032. The market for embolic protection devices is being primarily driven by the rising cases of cardiovascular disorders and neurovascular disorders, growing awareness of the cardiovascular and stroke risks associated with medical procedures, and an increase in technological advancements.

Powerful Medical Received FDA De Novo Authorization for AI-Based ECG Model for Acute Heart Attack Detection

On 15 September 2026, Powerful Medical announced that the U.S. Food and Drug Administration had granted De Novo authorization for its Queen of Hearts ACS AI ECG Model. The AI-powered technology was developed to analyze ECGs for findings associated with urgent acute coronary syndrome (ACS), including ST-segment elevation myocardial infarction (STEMI) and STEMI-equivalent conditions, and to alert clinicians when urgent evaluation was required.

The FDA authorization established a new device classification for AI-based ECG models intended to support the identification of acute and potentially life-threatening cardiovascular conditions. The authorization followed the product’s earlier Breakthrough Device Designation in March 2025 and participation in the FDA’s Total Product Life Cycle Advisory Program. Queen of Hearts was developed as part of Powerful Medical’s PMcardio cardiovascular care platform, which used artificial intelligence to analyze ECG data and support clinical decision-making. The platform was designed to integrate ECG interpretation into healthcare workflows spanning pre-hospital care, emergency departments, and cardiology services.

The technology was intended to facilitate earlier identification of patients with suspected acute coronary syndrome and support rapid escalation to cardiology teams. This approach was designed to assist healthcare providers in prioritizing patients who could require urgent cardiology assessment and cardiac catheterization.

The company reported that the technology was supported by more than 20 peer-reviewed studies, including randomized controlled trials involving more than 40,000 patients across four continents. Published research cited by the company reported higher sensitivity than conventional interpretation approaches, fewer false-positive results, and faster treatment pathways. These performance claims were reported by Powerful Medical and should be distinguished from the FDA’s regulatory authorization itself. The company had previously deployed its technology in Europe following CE marking. According to Powerful Medical, the system had been used to identify more than 120,000 heart attacks during 2025 in Europe and had contributed to shorter treatment times in a substantial proportion of those cases.

Following the U.S. authorization, Powerful Medical accelerated plans to deploy PMcardio across U.S. healthcare systems. The platform was intended to provide AI-assisted ECG assessment from the first point of patient contact and facilitate information transfer between emergency and cardiology teams. Overall, the FDA authorization represented a regulatory development for the AI-based cardiac diagnostics market, particularly AI-enabled ECG interpretation for acute coronary syndrome and heart attack detection. It also expanded the regulatory pathway for artificial-intelligence technologies designed to assist clinicians with rapid cardiovascular diagnosis and triage.

“This milestone reflects our mission to ensure every patient has access to fast, accurate heart attack diagnosis, regardless of where they present,” said Martin Herman, CEO and Co-founder of Powerful Medical. “With FDA De Novo authorization in place, we can scale adoption and bring this technology into routine clinical care across the United States.”

As per DelveInsight’s “Cardiovascular Imaging Equipment Market Report,” the cardiovascular imaging equipment market is estimated to grow at a CAGR of 6.71% during the forecast period from 2024 to 2030. The incidence of cardiovascular diseases (CVDs) is rising due to lifestyle changes, smoking, lack of physical activity, excessive alcohol consumption, obesity, and other factors that are escalating the global market of cardiovascular imaging equipment. Additionally, public health campaigns and initiatives aimed at raising awareness about cardiovascular health encourage individuals to undergo regular check-ups and screenings. Increased public knowledge about the importance of early detection and management of heart diseases leads to higher utilization of cardiovascular imaging services. Furthermore, key cardiovascular imaging equipment manufacturers are continuously investing in research and development to introduce innovative cardiovascular imaging technologies; increased partnerships and collaborations, product launches, and approvals ensure that the market remains dynamic and innovative during the forecast period from 2024 to 2030.

ZEISS Introduced AT LUCIA toric 721P for Cataract Surgery and Astigmatism Correction 

On 10 September 2026, ZEISS Medical Technology announced the commercial availability of the ZEISS AT LUCIA toric 721P, a hydrophobic monofocal toric intraocular lens designed for cataract surgery with simultaneous correction of astigmatism. The product was officially introduced during the European Society of Cataract and Refractive Surgeons (ESCRS) Congress in London. The AT LUCIA toric 721P incorporated a bitoric optic design and a non-constant asphericity profile. These optical features were developed to address astigmatism while maintaining the characteristics of the ZEISS LUCIA family of hydrophobic monofocal IOLs.

The IOL was developed to account for variations in pupil size, corneal spherical aberration, and the natural position of the lens within the eye. Its optical design was intended to provide consistent visual performance across different patient eye conditions. The product received CE marking and became commercially available in selected European markets, including Germany, Italy, Spain, Portugal, and France. Its launch expanded the ZEISS LUCIA IOL portfolio and provided an additional option for surgeons managing cataract patients with astigmatism.

ZEISS also highlighted early clinical experience with the IOL at the ESCRS Congress. Several ophthalmic surgeons who participated in initial implantations presented their clinical experiences with the new lens during the launch activities. The introduction of the AT LUCIA toric 721P represented an expansion of ZEISS’s anterior-segment ophthalmology portfolio, particularly in the area of premium and toric IOL technologies. The product combined cataract treatment with astigmatism correction within a single monofocal IOL platform. Overall, the commercial launch supported continued technological development in the Toric IOL Market, particularly for hydrophobic monofocal IOLs used in cataract surgery and astigmatism correction. It also strengthened the availability of advanced IOL options for surgeons seeking to address both cataract-related lens replacement and pre-existing corneal astigmatism.

“This collaboration bolsters our broader array of offerings to the shoulder surgical care market and importantly helps address a real unmet need for patients and surgeons facing these complex cases,” said Rob Ball, CEO of Shoulder Innovations. “We look forward to working with ALM Ortho with this new capability in the marketplace, which we expect will drive improved patient outcomes and yield strategic advantages for SI as our commercial engine continues to grow.”  

As per DelveInsight’s “Intraocular Lens Market Report,” the global intraocular lens market was valued at USD 4,648.96 million in 2024, growing at a CAGR of 6.12% during the forecast period from 2025 to 2032 to reach USD 7,414.66 million by 2032. The intraocular lens market is being significantly boosted by the growing cases of eye-related disorders such as cataracts, presbyopia, and astigmatism, which are increasing the demand for corrective surgical interventions. This rising disease burden is complemented by improved awareness and accessibility to eye care services, especially in developing regions, enabling more patients to seek treatment. Additionally, ongoing technological advancements in lens materials and designs such as the development of multifocal, toric, and extended depth-of-focus lenses are enhancing visual outcomes and patient satisfaction. Furthermore, increased product development activities by key market players are leading to the introduction of innovative and customized IOL solutions, collectively accelerating the growth of the global intraocular lens market during the forecast period from 2025 to 2032.

Waters Launched BD FACSDiscover A7 Cell Analyzer for Standardized Spectral Flow Cytometry  

On 14 September 2026, Waters Corporation announced the global commercial launch of the BD FACSDiscover A7 Cell Analyzer, expanding its portfolio of advanced flow cytometry systems for academic institutions, pharmaceutical companies, and contract research organizations. The launch focused on improving the accessibility, standardization, and reproducibility of high-parameter spectral flow cytometry. The BD FACSDiscover A7 incorporated BD SpectralFX Technology, which combined full-spectrum optical capabilities, optimized hardware, and spectral analysis algorithms to provide high-resolution and sensitive cellular analysis. The system was designed to enable researchers to evaluate more than 50 characteristics of individual cells while maintaining consistent data quality.

The analyzer also incorporated FACSTruQ Technology, which provided automated instrument setup, calibration, and quality control. According to Waters, the technology supported reproducible performance across different instruments, users, and research sites, with company data showing a coefficient of variation below 10% across more than 50 fluorescent dyes. The system was further equipped with BD FACSChorus Software and an integrated autoloader. These features were intended to simplify experimental workflows, reduce manual setup requirements, and improve the consistency of flow cytometry experiments for both experienced and newer users.

The launch expanded access to high-parameter spectral flow cytometry for applications including immunology research, biomarker discovery, cell analysis, and drug development. The platform was therefore positioned for use across academic research laboratories, pharmaceutical organizations, and CROs.

The BD FACSDiscover A7 became commercially available globally through local representatives. Its launch strengthened the FACSDiscover platform by bringing advanced spectral analysis and standardized workflows to a broader range of research laboratories.

Overall, the development supported growth in the spectral flow cytometry and flow cytometry instruments markets by introducing a commercially available system capable of high-parameter single-cell analysis, automated quality control, and standardized data generation across research environments.

“The FACSDiscover A7 Cell Analyzer lowers the barrier to advanced spectral flow cytometry and will open up new possibilities for immunology research, enabling our core facility to help scientists uncover deeper biological insights with greater standardization and confidence,” said Cheryl Kim, Senior Director, Flow Cytometry Core, La Jolla Institute for Immunology. “We look forward to the FACSDiscover A7 Cell Analyzer being an integral instrument for our core, allowing our researchers to get the most out of spectral data to advance our important work of improving human health through the development of treatments and cures for immune system disorders.”

According to DelveInsight’s “Flow Cytometry Market Report”, the global flow cytometry market was valued at USD 4,942.02 million in 2023, growing at a CAGR of 7.52% during the forecast period from 2024 to 2030 to reach USD 7,587.63 million by 2030. The increase in demand for flow cytometry is primarily attributed to the rising research and development activities in the healthcare industry. Further, the rising prevalence of chronic and immunological ailments like HIV & AIDS and cancer due to gene mutations, such as smoking, radiation, viruses, cancer-causing chemicals (carcinogens), obesity, hormones, chronic inflammation, and a lack of exercise. The diagnosis of HIV & AIDS and cancer is done by flow cytometry, thereby increasing the demand for the device in the market. Additionally, rising advancements in stem cell research and recombinant DNA technology in the development of cancer and immunology drugs, and increasing advancements in flow cytometry software, such as providing high-resolution imaging, fluorescence and laser technology, and others across the world are anticipated to bolster the market, thereby contributing to the growth of the flow cytometry market during the forecast period from 2024-2030.

Nicklaus Children’s Hospital Performed One of the First Transcatheter Fontan Completions in the Country on a Two-Year-Old Child 

On 09 September 2026, Nicklaus Children’s Hospital reported that its Heart Institute had successfully performed one of the first transcatheter Fontan completions in the United States on a two-year-old child with complex congenital heart disease. The procedure used a catheter-based technique to complete the child’s Fontan circulation, avoiding the need for another open-heart surgery.

The child, who had been born with a double-outlet right ventricle, underwent the minimally invasive intervention using specialized equipment delivered through a blood vessel. Following the procedure, the child recovered well and was discharged home. The transcatheter approach was intended to provide eligible pediatric patients with benefits such as avoiding surgical incisions, reducing hospital stays, and supporting faster recovery compared with conventional surgery. The procedure was conducted by Nicklaus Children’s Hospital’s interventional cardiology and cardiovascular surgery teams and highlighted the growing use of less-invasive treatment approaches for children with complex congenital heart defects. The Fontan procedure represents the final planned stage of staged palliation for many children with single-ventricle heart defects by redirecting venous blood directly toward the lungs.

“This achievement reflects an extraordinary level of collaboration and coordination between our surgical and interventional cardiology team,” said Dr. Sathanandam. “It demonstrates what is possible when clinical expertise, innovation, and teamwork come together to expand treatment options for children with the most complex heart conditions.”

According to DelveInsight’s ”Congenital Heart Defect Devices Market Report,” the global congenital heart defect devices market size is estimated at USD 3.11 billion in 2025 and is projected to reach USD 5.91 billion by 2034, growing at a CAGR of 7.4% during the forecast period from 2026 to 2034. The demand for Congenital Heart Defect Devices is primarily being boosted owing to key factors such as the rising prevalence of congenital heart defects, increasing diagnosis and screening of congenital cardiac abnormalities, growing adoption of minimally invasive and transcatheter procedures, increasing demand for pediatric cardiac interventions, rising awareness regarding early diagnosis and treatment of congenital heart defects, expansion of specialized pediatric cardiac care centers, along with the growing focus on developing safer, smaller, and more effective cardiac devices for pediatric and adult patients. Furthermore, technological advancements in implantable cardiac devices, increasing adoption of catheter-based treatments, growing healthcare expenditure, rising access to advanced cardiac care in emerging markets, and continuous product innovation are expected to further support the growth of the Congenital Heart Defect Devices market during the forecast period from 2025 to 2030.