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Philips receives FDA 510(k) clearance for Verida, the world’s first AI-powered detector-based spectral CT*, advancing diagnostic precision across clinical applications

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Philips Verida detector-based spectral CT – 01

Philips Verida detector-based spectral CT

Philips Verida detector-based spectral CT – 02

Philips Verida detector-based spectral CT

Philips Verida detector-based spectral CT – 03

Philips Verida detector-based spectral CT

April 16, 2026 Combining always-on spectral imaging with AI reconstruction to deliver enhanced levels of image quality, efficiency, and clinical insight across radiology, cardiology, and oncology Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced it has received U.S. Food and Drug Administration 510(k) clearance for the Philips Spectral CT Verida system, bringing its next-generation, AI-powered spectral CT innovation to the United States. AI-based reconstruction integrated into the imaging chain Verida incorporates Spectral Precise Image, with a third-generation Nano-panel Precise dual-layer detector with intrinsic noise reduction, along with an AI-based deep learning reconstruction engine, designed to reduce noise and enhance image quality across CT applications [1]. Clinicians are able to customize optimal image de-noising according to their preferences. “With FDA clearance for Verida, we are bringing the next evolution of spectral CT to more markets,” said Dan Xu, Business Leader of CT at Philips. “By combining always-on spectral imaging with AI-powered reconstruction, Verida enables clinicians to see more, first time right, supporting faster, more informed decisions and expanding the role of CT across clinical pathways.” Always-on detector-based spectral CT for clinical versatility Built on Philips’ industry-leading detector-based spectral CT technology, Verida enables always-on spectral imaging without requiring separate scans or workflow changes. It includes system and software enhancements designed to support clinical workflow, including improvements to the spectral result generation pipeline and updated computing infrastructure to support performance and usability. Verida reconstructs 145 images per second, so entire exams automatically appear in less than 30 seconds – 2× faster than previously, enabling up to 270 exams every day [2]. By capturing both high- and low-energy data in a single acquisition, clinicians can access conventional and spectral results simultaneously, supporting enhanced tissue characterization and material differentiation. This approach eliminates the need for pre-selection or repeat scans, enabling first-time-right imaging and deeper clinical insight across a broad range of applications [3]. Verida is a Computed Tomography X-ray system intended for diagnostic imaging in radiology, interventional radiology, and cardiology, and in oncology as part of treatment preparation and radiation therapy planning. It is indicated for head, whole body, cardiac, and vascular CT applications in patients of all ages [1]. The system is also intended to be used for low dose CT lung cancer screening when performed within established screening protocols [4]. Extended field-of-view images and respiratory correlated scanning (4DCT) are for treatment preparation and radiation therapy planning/simulation use only [3]. For more information about the Philips Spectral CT Verida system, visit the Philips website. *Data on file[1] Spectral Precise Image is an AI-based reconstruction feature with supplemental data for clinical interpretation and does not replace professional clinical judgement. SPI has been clinically evaluated in adults (≥22 years); pediatric use has not been clinically validated.[2] Spectral CT Verida Premium up to 270 (4 CIRS config) exams a day (16 hours dual shift working day) meeting the needs of radiology departments with extended work hours and very high patient throughput.[3] See Instructions for Use for complete indications, limitations, and feature-specific restrictions.[4] Please refer to clinical literature, including the results of the National Lung Screening Trial (NEngl. J Med 2011; 365:395-409) and subsequent literature, for further information. For further information, please contact:Jayme Maniatis Philips Global External Relations  Tel.: +1 617 804 8368E-mail: Jayme.maniatis@philips.com About Royal PhilipsRoyal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home.Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2025 sales of EUR 18 billion and employs approximately 64,800 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter. 
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Philips Verida detector-based spectral CT – 01

Philips Verida detector-based spectral CT – 02

Philips Verida detector-based spectral CT – 03

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ACHIEVE-4, the longest Phase 3 study of Lilly’s Foundayo (orforglipron) to date, reaffirmed its cardiovascular and overall safety profile as well as consistent improvements across key measures of cardiometabolic health

Coronary/Structural Heart by 0 comments

In ACHIEVE-4, Foundayo met the primary objective of non-inferiority vs. insulin glargine with a 16% lower risk of MACE-4 events and a 23% lower risk of MACE-3 events In a pre-planned analysis, the risk of all-cause death was 57% lower for Foundayo vs. insulin glargine, showing the…

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Amarin to Report First Quarter 2026 Financial Results and Host Conference Call on April 29, 2026

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DUBLIN and BRIDGEWATER, N.J., April 15, 2026 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ: AMRN), a company advancing the science of cardiovascular therapeutics worldwide, today announced that it will report first quarter 2026 financial results and conduct a conference call on Wednesday, April 29, 2026. The Company will issue a press release detailing its first quarter 2026 financial results in the pre-market hours, followed by a conference call with senior management at 8:00 a.m. ET. Information on how to participate is as follows. Access to the live call:Via telephone: Dial in within the United States: 888-506-0062 International dial in: 973-528-0011Access Code: 543818 Via online: A webcast of the call will be available on the Investor Relations section of the Company’s website at www.amarincorp.com.Access to the replay:Via telephone: Dial in within the United States: 877-481-4010International dial in: 919-882-2331Replay Code: 53836 Via online: A replay of the webcast will be accessible through the Investor Relations section of the Company’s website at www.amarincorp.com, beginning shortly after the end of the live call and available until 10/29/26. About AmarinAmarin is a global pharmaceutical company committed to reducing the cardiovascular disease (CVD) burden for patients and communities and to advancing the science of cardiovascular care around the world. We own and support a global branded product approved by multiple regulatory authorities based on a track record of proven efficacy and safety and backed by robust clinical trial evidence. Our commercialization model includes a direct sales approach in the U.S. and an indirect distribution strategy internationally, through a syndicate of reputable and well-established partners with significant geographic expertise, covering close to 100 markets worldwide. Our success is driven by a dedicated, talented, and highly skilled team of experts passionate about the fight against the world’s leading cause of death, CVD. Availability of Other Information About Amarin Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (http://www.amarincorp.com/investor-relations), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.  Amarin Contact InformationMedia Inquiries: Tegan Berry Amarin Corporation plc PR@amarincorp.com Investor Inquiries:Devin Sullivan & Conor RodriguezThe Equity Group on Behalf of Amarin dsullivan@theequitygroup.com or crodriguez@theequitygroup.com Investor.relations@amarincorp.com

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Picard Medical / SynCardia Highlights Total Artificial Heart Bridge to Transplant Case at Texas Children’s Hospital

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SynCardia Total Artificial Heart supports patient through complex re-transplant journeyTUCSON, Ariz., April 15, 2026 (GLOBE NEWSWIRE) — Picard Medical, Inc. (NYSE American: PMI) (“Picard Medical” or the “Company”), parent company of SynCardia Systems, LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and Health Canada, today highlighted the successful use of the SynCardia Total Artificial Heart (“STAH”) as a bridge to heart transplantation at Texas Children’s Hospital (“Texas Children’s”), supporting a 21-year-old patient through a complex re-transplant journey. Texas Children’s recently featured the case of Gregory, a now 21-year-old patient who had received his first heart transplant at Texas Children’s in 2017 at the age of 13 following multiple congenital heart defects. In early 2025, Gregory was admitted to Texas Children’s after presenting with chest pain and was diagnosed with rejection of his first transplanted heart. With his original transplant no longer viable and a donor heart unavailable, surgeons implanted the STAH to provide full circulatory support. Gregory was supported on the STAH for approximately two and a half months before a suitable donor heart became available. He subsequently underwent successful heart transplantation and, following an extended recovery, was discharged from the hospital. The STAH is designed to replace the function of both ventricles in patients with end-stage biventricular failure, enabling stabilization, organ recovery, and improved candidacy for transplantation. Its use in complex clinical scenarios, including re-transplantation in young adults with congenital heart disease, demonstrates the flexibility and durability of the therapy in supporting some of the most critically ill patients. Patrick NJ Schnegelsberg, Chief Executive Officer of Picard Medical, commented, “Performing a successful re-transplantation in a young adult with congenital heart disease is among the most complex scenarios in cardiac surgery. In this instance at Texas Children’s, the STAH allowed the clinical team to stabilize the patient and effectively buy time following the diagnosis of rejection until a suitable donor organ became available. Although the support period in this case was relatively short compared with many other cases, the immediate availability of the STAH was essential in enabling a successful outcome. Experiences like this also reinforce why we are developing the Emperor Total Artificial Heart, our next generation fully implantable total artificial heart, designed to remove the external driver and ultimately serve as a potential alternative to heart transplantation for certain patients.” Picard Medical continues to support leading transplant centers across the United States and globally, advancing the use of the STAH to improve outcomes for patients with advanced heart failure. Picard is also advancing development of the Emperor Total Artificial Heart, a fully implantable next-generation device designed to expand access to long-term mechanical circulatory support without the need for external pneumatic drivers. About Texas Children’s Hospital Texas Children’s, a nonprofit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children’s hospital in Texas and among the top in the nation, Texas Children’s has garnered widespread recognition for its expertise and breakthroughs in pediatric and women’s health. The system includes the Texas Children’s Duncan NRI; the Feigin Tower for pediatric research; Texas Children’s Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children’s Hospital West Campus, a community hospital in suburban West Houston; Texas Children’s Hospital The Woodlands, the first hospital devoted to children’s care for communities north of Houston; and Texas Children’s Hospital North Austin, the new state-of-the-art facility providing world-class pediatric and maternal care to Austin families. The organization also created Texas Children’s Health Plan, the nation’s first HMO focused on children; Texas Children’s Pediatrics, the largest pediatric primary care network in the country; Texas Children’s Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that is channeling care to children and women all over the world. Texas Children’s Hospital is affiliated with Baylor College of Medicine. For more information, visit www.texaschildrens.org. About Picard Medical and SynCardia Picard Medical, Inc. is the parent company of SynCardia Systems, LLC (“SynCardia”), the Tucson, Arizona–based leader with the only commercially available total artificial heart technology for patients with end-stage heart failure. SynCardia develops, manufactures, and commercializes the SynCardia Total Artificial Heart (“STAH”), an implantable system that assumes the full functions of a failing or failed human heart. It is the first artificial heart approved by both the FDA and Health Canada, and it remains the only commercially available artificial heart in the United States and Canada. With more than 2,100 implants performed at hospitals across 27 countries, the STAH is the most widely used and extensively studied artificial heart in the world. For additional information about Picard Medical, please visit www.picardmedical.com or review the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”) at www.sec.gov. Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. Additional information about the Company, including risk factors that may affect the Company’s business, financial condition, and results of operations, is contained in the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available free of charge on the SEC’s website at http://www.sec.gov and on the Company’s investor relations website at https://picardmedical.com/. Contact: Investors Eric Ribner Managing Director LifeSci Advisors LLC eric@lifesciadvisors.com Picard Medical, Inc./SynCardia Systems, LLC IR@picardmedical.com General/Media Brittany Lanza blanza@syncardia.com

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Stereotaxis Announces Definitive Agreement to Acquire Robocath

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ST. LOUIS and ROUEN, France, April 15, 2026 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has entered into a definitive agreement to acquire Robocath, a venture-backed innovator of robotic technologies for interventional cardiology and neurointerventions.

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AliveCor Launches AI-Powered Kardia 12L in Europe: The World’s First Handheld 12-Lead ECG with a Unique Single-Cable Design

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Now CE Marked, the Kardia 12L ECG System leverages AI to detect 35 cardiac determinations, simplifying the ECG process and expediting access to critical heart data
AliveCor’s Kardia 12L launches in Europe

AliveCor Launches AI-Powered Kardia 12L in Europe: The World’s First Handheld 12-Lead ECG with a Unique Single-Cable Design

MOUNTAIN VIEW, Calif., April 15, 2026 (GLOBE NEWSWIRE) — AliveCor, the global leader in AI-powered cardiology, today announced it has received CE Mark (Conformité Européenne) for the Kardia™ 12L electrocardiogram (ECG) System powered by KAI™ 12L AI technology. Kardia 12L is the world’s first AI-powered, portable 12-lead ECG system featuring a unique, single-cable design for Health Care Professionals (HCPs). Powered by KAI 12L, the system enables faster, easier detection of 35 cardiac determinations, including acute myocardial infarction (MI) and the most common types of cardiac ischemia. “Securing CE Mark for the Kardia 12L is a defining moment in our strategy to scale AliveCor’s global footprint,” said Simona Esposito, Senior Vice President of Sales, Global Markets at AliveCor. “Our priority is to get this life-saving technology into the hands of as many clinicians as possible, especially in settings where traditional, bulky ECG carts simply aren’t practical. By simplifying the hardware without sacrificing diagnostic depth, we are fundamentally improving access to high-quality cardiac care and reducing the burden of cardiovascular disease in the EU.” Technical Specifications and Capabilities of Kardia 12LKardia 12L is the portable, AI-guided, 12-lead ECG solution whose measurements and ECG interpretation are highly similar to standard 12-lead ECG solutions, right at the point of care, enabling rapid acquisition of complete ECG information and offering a better patient experience. 35 Cardiac Determinations: KAI 12L is the first AI of its kind to detect life-threatening cardiac conditions using a reduced leadset and can identify a comprehensive range of conditions. This includes 14 arrhythmias and 21 morphologies including serious conditions like acute MI and the most common types of cardiac ischemia.Rapid Detection: Specifically designed to expand access to accurate cardiac data across diverse healthcare and acute settings, the system allows for the rapid identification of life-threatening conditions like heart attack.Operational Efficiency: The device weighs just 0.13 kg (0.3 lbs) and is battery-operated, allowing it to be used by HCPs in primary care, urgent care, pharmacy, the home and rural clinics where traditional ECG machines may be impractical due to their size and complexity.Improved Patient and Clinician Experience: The simplified five-electrode setup makes it less invasive for patients, who do not need to fully disrobe during a reading, and typically allows for faster acquisition. Research has shown nearly a 30% reduction in ECG acquisition time compared to standard 12-lead setups. “In a fast-paced clinical environment, every second counts, but we cannot sacrifice accuracy for speed,” said Dr. Alejandro Barbagelata, Adjunct Assistant Professor of Medicine and Cardiology at Duke University. “Kardia 12L offers a unique combination of portability and diagnostic depth, allowing HCPs to make informed care decisions. By streamlining the acquisition process, it enables clinicians to identify life-threatening conditions like MI much faster, leading to better patient outcomes across the board.” Since its FDA clearance and subsequent launch in the United States in June 2024, Kardia 12L has seen growing global adoption including in India, Australia, New Zealand, Vietnam and Canada. The system has been adopted by clinicians across the globe capturing critical heart data on tens of thousands of patients. Most notably, the system has identified over 4,000 instances of MI and ischemia, facilitating life-saving care for those who need it most. This launch comes at a pivotal time, as the European Union reinforces its commitment to tackling cardiovascular diseases–the leading cause of mortality in Europe–through its EU Cardiovascular Health Plan, which prioritizes early detection, prevention, and improved access to care. Kardia 12L will be first available for healthcare providers in France, Germany, Italy, Spain, and the United Kingdom, and will be followed by additional European countries soon. For more information, please visit: https://alivecor.com/uk/products/kardia12l. Frequently Asked Questions Where is the Kardia 12L ECG System available in Europe? The Kardia 12L ECG System will be first available for healthcare providers in France, Germany, Italy, Spain, and the United Kingdom, followed by additional European countries soon. This follows the recent receipt of the CE Mark, allowing for its distribution across the European Economic Area. How does Kardia 12L compare to traditional ECG carts? Unlike traditional ECG carts that require 10 leads and bulky hardware, the Kardia 12L uses a unique single-cable, five-electrode design. It is pocket-sized, battery-operated, and uses AI to detect 35 cardiac determinations, making it significantly more portable and faster to deploy in a variety of healthcare facilities and acute settings, including primary and urgent care offices, mobile clinics, in pharmacies, by HCPs in home visits and other underserved or rural venues. How many and what cardiac conditions can the Kardia 12L detect? Powered by KAI 12L AI, the system is cleared to detect 35 cardiac determinations, including 14 arrhythmias (such as Atrial Fibrillation and Atrial Bigeminy) and 21 morphologies. Does the Kardia 12L require specialized training for clinicians? No. The device requires minimal self-guided training. Its simplified five-electrode placement is more intuitive than standard 10-lead setups, which can reduce the risk of lead reversal and shorten the time required for patient preparation. Is the Kardia 12L ECG System intended for home use? The Kardia 12L is intended for use by healthcare professionals in clinical environments including hospitals, urgent care centers, primary care practices, rural clinics, and pharmacy and home visits by an HCP. About AliveCorAliveCor, Inc., the leading provider of FDA-cleared personal electrocardiogram (ECG) devices, is transforming cardiology with its medical-grade AI solutions. The company was named to the inaugural TIME World’s Top Health Tech Companies 2025 list – recognition of its commitment to delivering innovative devices and services that empower patients and physicians with personalized, actionable heart data. With over 350 million ECGs recorded, the company’s Kardia devices are the most clinically validated personal ECGs in the world and can remotely detect six of the most common heart arrhythmias in just 30 seconds. The company’s latest offering, Kardia 12L ECG System, powered by KAI 12L cleared to detect 39 cardiac conditions (with determination availability varying by geography), was designed exclusively for use by healthcare providers. AliveCor’s enterprise platform allows third-party providers to manage their patients’ and customers’ heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies, addressing gaps in care and improving the treatment experience for patients across a range of disease areas. AliveCor is a privately held company headquartered in Mountain View, Calif. For more information, visit alivecor.com and follow us on LinkedIn, X, Instagram and Facebook. Media ContactMorgan Mathis Director of Corporate Communications, AliveCor press@alivecor.com Sales Contact OUSenquiries@alivecor.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d510c9dc-7eb1-45bd-ba22-aa01f14d3e40

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Reflow Medical Announces 12-Month Results from DEEPER REVEAL Trial: Sustained Outcomes with the Spur® Stent System in CLTI

Peripheral/Endo by 0 comments

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announces that 12-month results from the DEEPER REVEAL clinical trial (NCT05358353) were presented for the first time today at the Society of Interventional Radiology (SIR) 2026 Annual Scientific Meeting in Toronto, Canada. […]

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EHRA 2026 Studies Reveal Why False Positives Persist in AI-Equipped Implantable Cardiac Monitors

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Research identifies guideline-based interpretation gaps and signal-detection issues behind non-actionable alerts and shows how an additional cloud-based AI layer can significantly reduce clinician review burden while maintaining high sensitivity April 14, 2026 08:00 ET  | Source: Implicity CAMBRIDGE, Mass., April 14, 2026 (GLOBE NEWSWIRE) — Implicity, a leader in remote patient monitoring […]

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SCAI Reappoints JSCAI Founding Editor-in-Chief Alexandra J. Lansky, MD, MSCAI, for Second Term

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WASHINGTON—The Society for Cardiovascular Angiography & Interventions (SCAI) today announced that Alexandra J. Lansky, MD, MSCAI, has been reappointed to a second five-year term as Editor-in-Chief of JSCAI, the official peer-reviewed journal of SCAI. SCAI launched JSCAI in 2022 as a fully digital platform to advance interventional cardiology research and practice, appointing Dr. […]

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