November 17, 2025Innovation uses AI to track and visualize tiny repair devices* through the beating heart, helping clinicians navigate in 3D with enhanced clarity and confidence**Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today introduced DeviceGuide, an AI-powered device tracking* solution that assists physicians during one of interventional cardiology’s most technically demanding procedures: repairing leaking heart valves through a minimally invasive approach. Built on Philips’ EchoNavigator platform, this software brings AI directly into the procedure room, translating complex imaging into intuitive, real-time visual guidance that helps clinicians navigate the beating heart with greater clarity and confidence. It will be previewed at London Valves 2025 (November 16-18), one of the world’s leading meetings for structural heart specialists.“With DeviceGuide, we’re bringing AI into the heart of the procedure room, and into the heart itself,” said Dr. Atul Gupta, Chief Medical Officer, Diagnosis & Treatment at Philips. “This is Philips’ first AI assisting physicians in real time to visualize and guide heart valve treatment devices* as they navigate the beating heart. It’s helping doctors in the moment as they are helping their patients with structural heart disease.”Minimally invasive treatment of the mitral valveA leaking heart valve, known as mitral valve regurgitation, is a condition in which blood leaks backward through the heart’s mitral valve. It affects more than 35 million [1] adults worldwide, leaving many short of breath, fatigued, and struggling with everyday activities like climbing stairs or walking short distances. Many also live with anxiety or fear, knowing their heart isn’t pumping efficiently. If left untreated, severe cases can lead to heart failure and other serious complications.For patients who are too frail for open-heart surgery, minimally invasive transcatheter repair techniques such as mitral transcatheter edge-to-edge repair (M-TEER) offer a vital treatment option. During these procedures, physicians repair a leaking valve through a tiny incision in the top of the leg in the groin area, guiding long, flexible instruments through the blood veins and navigating a miniature repair device into the beating heart.Clinicians must view and interpret both X-ray and ultrasound images on multiple screens, coordinate movements between two operators, and make precise adjustments to grasp the moving valve leaflets, position the repair device, and confirm the result in real time. The process demands accuracy, coordination, and experience from the team. This is where DeviceGuide can help with its 3D navigation support.How AI is helpingDeviceGuide uses an AI algorithm to automatically track the tiny repair device as it moves through the beating heart, intelligently combining live echo and X-ray images. It creates a virtual 3D model of the treatment device in real time, superimposed on the live images of the beating heart. This allows clinicians to see where the device is and in which direction it is pointing, providing a clear view of the procedure and potentially enabling them to navigate the device more easily to effectively seal the leak.“The AI software serves as an assistive tool, with the physician always remaining in control. This isn’t about replacing expertise – it’s about amplifying it,” added Dr. Atul Gupta. “By embedding AI into the procedure, DeviceGuide gives physicians an extra pair of eyes, effectively bionic vision, helping them treat more patients safely and confidently.”Collaboration with Edwards LifesciencesThis innovation was developed in close collaboration with Edwards Lifesciences, the manufacturer of these repair devices. The solution combines Philips’ expertise in medical imaging and AI technologies with Edwards’ global leadership in structural heart innovation. Together, the companies have reimagined key parts of the mitral TEER procedural workflow.“DeviceGuide demonstrates the impact of combining leading imaging and therapy expertise to develop solutions designed around the procedural workflow, a model that will shape the future of AI-enabled image-guided structural interventions,” said Mark Stoffels, Business Leader, Image Guided Therapy Systems.This solution illustrates how Philips’ imaging and AI expertise can merge with the insights of leading therapy companies to innovate procedural workflows. This kind of collaboration is a model for developing the next generation of AI-enabled, image-guided innovations, centered on the needs of clinicians and their patients.Read more on how Philips DeviceGuide works here.
Author: Ken Dropiewski
Poll Finds Concerns Among Vascular and Cardiac Specialists About Radiation Exposure
FLAGSTAFF, Ariz. and MINNEAPOLIS, Nov. 17, 2025 /PRNewswire/ — A new national poll1 announced today by W. L. Gore & Associates’ medical business (Gore) and Egg Medical sheds light on the growing concern for radiation exposure in operating rooms and cath labs across the country. The…
ViTAA Medical Secures FDA 510(k) Clearance for AiORTA™ Plan — Marking the First Step in Its Hyper-Precise Aortic Care Platform
MONTREAL–(BUSINESS WIRE)–ViTAA Medical Solutions Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for AiORTA™ Plan, the company’s fully automated, hyper-precise aortic surgery planning solution. This clearance represents a key milestone in the evolution of ViTAA’s broader AiORTA™ platform, built to support physicians across the full continuum of […]
HeartBeam Reports Third Quarter 2025 Results
Commercial Readiness Plans Accelerating in Anticipation of FDA 510(k) Clearance for Groundbreaking 12-lead Electrocardiogram (ECG) Synthesis Software for Arrhythmia Assessment Anticipated FDA Clearance in Q4 2025 is a Major Inflection Point as HeartBeam Evolves into a Commercial-Stage Company Focused on Growth Announced Partnership with HeartNexus to Provide On-Demand Cardiologist Reviews […]
Medtronic Aurora EV-ICD™ system demonstrates exceptional results at six months in the Enlighten real-world post-market study while the OmniaSecure™ defibrillation lead sustains performance at three years in the LEADR Pivotal Trial
APHRS.25: Medtronic showcases breadth of defibrillation portfolio with outcomes from extravascular and transvenous defibrillation studies for the treatment of dangerous heart rhythm episodes Cardiac Rhythm Management Researchers presented results from two late-breaking presentations at the Asia Pacific Heart Rhythm Society (APHRS) Scientific Session 2025 held in Yokohama, Japan. The six-month […]
Windtree Therapeutics Announces More Strengthening of Its Istaroxime and Next Generation SERCA2a activator Patent Estate
Windtree has a total of 59 issued or allowed patents and 17 pending patents for Istaroxime and its SERCA2a activators Windtree received recent notification of allowed Istaroxime patents for acute heart failure in Canada and Mexico The pure SERCA2a activators patent for acute heart failure was granted in Isreal WARRINGTON, Pa., Nov. 14, 2025 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (OTCID: WINT), a diversified company with several divisions and focused on becoming a revenue generating company, announced that acute heart failure patents are allowed in Canada (Patent Application No. 3,130,261) and Mexico (Patent Application No. MX/a/2021/010483). Additionally, the next generation pure SERCA2a activator patent for heart failure was granted in Isreal (Patent Application No. 291412). This latest news for Windtree’s cardiovascular pipeline makes a total of 58 patents issued or allowed, with 17 pending. The cardiovascular patent estate includes istaroxime, the dual mechanism SERCA2a activators and the pure SERCA2a activators for the treatment of heart failure, prevention of arrhythmias and treatment of cardiogenic shock. Heart failure affects 60 million people globally of which approximately 20 million are admitted annually due to Acute HF, 1.5 million in the US. In patients with systolic blood pressure BP < 120 mmHg, in-hospital and 6-month mortality can reach double digit percentages. Additionally, hospital readmission after discharge and/or worsening heart failure and/or death are areas that need drug innovation. Current treatment options for acute heart failure patients are limited and can have side effects such as arrythmias and problems with renal function. “We are very pleased to be strengthening our cardiovascular patent estate,” said Jed Latkin, Chief Executive Officer of Windtree. “We believe that istaroxime has a unique profile to effectively treat acute heart failure patients with low blood pressure, who are most in need. Further, istaroxime has demonstrated favorable results in renal function and no increase in arrythmias that is lacking with currently available drugs. We are pursuing partnership for development and believe that the clinical studies to date are very encouraging in considering a Phase 3 program for istaroxime.” About Windtree Therapeutics, Inc.Windtree Therapeutics, Inc. is a diversified company with several divisions and focused on becoming a revenue generating company with future profitability. About IstaroximeIstaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that istaroxime infused intravenously can significantly improve cardiac function and blood pressure without increasing heart rate or the incidence of clinically significant cardiac rhythm disturbances. About Pure SERCA2a ActivatorsThese compounds activate SERCA2a and Windtree Therapeutic’s research and development program is evaluating these preclinical product candidates, including oral and intravenous SERCA2a activator heart failure compounds. Forward Looking StatementsThe Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include, among other things: risks related to the Company’s ability to begin its environmental services business, and manage costs and execute on its operational and budget plans. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events, or otherwise, after the date of this press release. Contact Information:Eric Curtisecurtis@windtreetx.com
Nanox Partners with French Radiology Group Olympe Imagerie to Advance Clinical Validation in Europe
Olympe Imagerie to deploy Nanox.ARC at Paris-area Hospital Privé Jacques Cartier MASSY for lung cancer screening applications
Bioxodes presents BIOX-101 clinical data showing breakthrough potential for stroke in webcast with Prof Dr Robin Lemmens
Gosselies, Belgium, 14 November 2025 (08:30 am CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, has held a webcast on the breakthrough potential of its lead candidate BIOX101 to treat intracerebral hemorrhage (ICH) and discussed the data with Prof Dr Robin Lemmens, KU Leuven, the Principal Investigator of its Phase 2a BIRCH clinical trial. Prof Lemmens, a world-renowned stroke expert and head of the stroke unit at the University Hospital Leuven, underscored the urgent need to address the large unmet medical need in intracerebral hemorrhage, and provided his insights from the successful Phase 2a clinical study with BIOX-101. Bioxodes CEO Marc Dechamps presented the company’s strategy in bringing BIOX-101 to market, possibly as early as late 2030.
Nyxoah Secures Financing Commitments of up to U.S. $77 Million to Drive U.S. Commercialization of Genio
INSIDE INFORMATIONREGULATED INFORMATION Nyxoah Secures Financing Commitments of up to U.S. $77 Million to Drive U.S. Commercialization of Genio Financings are comprised of equity investments, including from Cochlear, Resmed and Nyxoah’s Chairman and Management, and a convertible bond. Mont-Saint-Guibert, Belgium – November 13, 2025, 2025, 10:11pm CET / 4:11 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA) through neuromodulation, today announced a €22 million private placement of equity, a U.S. $5.6 million registered direct offering, and a €17 million registered direct offering combined with a convertible bond financing of up to €45 million. The private placement consists of the issuance of 5,481,678 new ordinary shares at a subscription price per share of €4.00 (approximately U.S. $4.6304 at current exchange rates) with gross proceeds totaling €22 million (approximately U.S. $25 million at current exchange rates). The closing of the private placement is expected to occur on or about November 17, 2025, subject to customary closing conditions. Degroof Petercam acted as the sole book runner for this private placement. The ordinary shares are being sold in a private placement and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Additionally, the registered direct offering consists of the issuance of 1,215,964 new ordinary shares at a price per share of U.S. $4.6304 with gross proceeds totaling approximately U.S. $5,6 million. The closing of the registered direct offering is expected to occur on or about November 18, 2025, subject to customary closing conditions. The registered direct offering is being made pursuant to an effective shelf registration statement on Form F-3 (File No. 333- 268955) which was declared effective by the Securities and Exchange Commission (the “SEC”) on January 6, 2023. The offering is being made only by means of a prospectus which is part of the effective registration statement. A prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Additionally, the Company entered into a subscription agreement with an international financial services firm for the issuance of convertible bonds for an aggregate maximum principal amount of up to €45 million (approximately U.S. $52 million at current exchange rate). The financing consists of a first tranche of up to €22.5 million with an option to issue a second tranche of €22.5 million at Nyxoah’s discretion, during the 30 days beginning seven months from the closing date subject to certain conditions. The closing for the first tranche of bonds is expected to occur in December 2025, subject to customary closing conditions. The first tranche of bonds will be issued at 92 per cent of their principal amount and carry an interest rate of 6.5 per cent per annum, payable every quarter in arrears. The bonds have a three-year maturity from issuance with quarterly amortization payments of principal and interest. The default conversion price for the first tranche of bonds, which can be modified on a downward basis, shall be equal to EUR 5.00, which represents 125 per cent of the placement price of the Shares being issued pursuant to the private placement. The net proceeds from the convertible bonds together with the net proceeds of the private placement, will be used (i) to support commercialization activities in the United States and advance the commercialization of the Genio system in the Company’s initial target markets outside the United States; (ii) to continue gathering clinical data and to support physician-initiated clinical research projects related to OSA patient treatments; (iii) to further finance research and development activities related to Genio system upgrades, re-designing the Company’s products for manufacturability and cost reduction initiatives; (iv) to continue to build a pipeline of new technologies and explore potential collaboration opportunities in the field of monitoring and diagnostics for OSA; and (v) for other general corporate purposes, including, but not limited to, working capital, capital expenditures, investments, acquisitions, should the Company choose to pursue any, and collaborations. This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. About NyxoahNyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65. Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device. ADDITIONAL INFORMATION The following information is provided pursuant to article 7:97 of the Belgian Code on companies and associations. The investors that have participated in the private placement include, among others, (either directly or through entities controlled by them) Robert Taub, who is the chairman of the board of directors, Jürgen Hambrecht and Daniel Wildman (permanent representative of Wildman Ventures LLC), who are independent directors, Olivier Taelman, CEO and director of the Company, John Landry, CFO of the Company and Scott Holstine, Chief Commercial Officer of the Company. Together, these investors have subscribed to 356,250 new shares for EUR 1.425 million in gross proceeds at an issue price equal to EUR 4.00. As Robert Taub, Jürgen Hambrecht, Daniel Wildman, Olivier Taelman, John Landry and Scott Holstine qualify as related parties of the Company, the board of directors applied the related parties procedure of article 7:97 of the Belgian Code on companies and associations in connection with the participation of the aforementioned related parties in the private placement. Within the context of the aforementioned procedure, prior to resolving on the private placement, a committee of three independent directors of the Company consisting of Rita Johnson-Mills, Virginia Kirby and Kevin Rakin (the “Committee”) issued an advice to the board of directors in which the Committee assessed the participation of the six aforementioned investors in the private placement. In its advice to the board of directors, the Committee concluded the following: “Based on the information provided, the Committee considers that the proposed Transaction is in line with the strategy pursued by the Company, will be done on market terms, and is unlikely to lead to disadvantages for the Company and its shareholders (in terms of dilution) that are not sufficiently compensated by the advantages that the Transaction offers the Company”. The Company’s board of directors approved the principle of the private placement and did not deviate from the Committee’s advice. IMPORTANT INFORMATION THIS ANNOUNCEMENT IS NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN ANY JURISDICTION WHERE TO DO SO WOULD BE PROHIBITED BY APPLICABLE LAW. THIS ANNOUNCEMENT IS FOR GENERAL INFORMATION ONLY AND DOES NOT FORM PART OF ANY OFFER TO SELL OR PURCHASE, OR THE SOLICITATION OF ANY OFFER TO SELL OR PURCHASE, ANY SECURITIES. THE DISTRIBUTION OF THIS ANNOUNCEMENT AND THE OFFER, SUBSCRIPTION, SALE AND PURCHASE OF SECURITIES DESCRIBED IN THIS ANNOUNCEMENT IN CERTAIN JURISDICTIONS MAY BE RESTRICTED BY LAW. ANY PERSONS READING THIS ANNOUNCEMENT SHOULD INFORM THEMSELVES OF AND OBSERVE ANY SUCH RESTRICTIONS. Forward-looking statements Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the closings of the private placement, the registered direct offering and the convertible bond financing; the Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the Company’s commercialization strategy and entrance to the U.S. market; and the Company’s results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the satisfaction of the closing conditions required for the closing of each of the private placement, the registered direct offering and the convertible bond financing and the consummation of the respective closings, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts: NyxoahJohn Landry, CFOIR@nyxoah.com
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Financing PR
Adagio Medical Reports Third Quarter 2025 Results
Continued Momentum Toward PMA Submission of ULTC Technologies Recent Financing Positions Company to Execute Growth Strategy LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the third quarter […]



