$30 million Series B financing led by InClin, Inc., a global contract research organization, with continued support from existing investors ASPIRE-HF, a Phase 2a study of THRV-1268 in heart failure with reduced ejection fraction and QTc prolongation, opens for enrollment in early 2027…
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Conavi Medical Presents Data Demonstrating Feasibility of Saline-Based Hybrid IVUS–OCT Imaging with OCTIV™ at TCT 2026
Study demonstrates feasibility of saline-based hybrid IVUS-OCT imaging without iodinated contrast during image acquisitionFDA-cleared OCTIV system now in commercial clinical use, with patient cases ongoing TORONTO, Nov. 03, 2026 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a commercial-stage medical device company developing imaging technologies to guide cardiovascular procedures, today announced the presentation of data from its OCTIV™ hybrid IVUS–OCT imaging system at Transcatheter Cardiovascular Therapeutics (“TCT”) 2026. The study, conducted in an animal model before OCTIV’s use in patients, demonstrated the feasibility of using saline instead of iodinated contrast during image acquisition. The FDA-cleared system is now in commercial clinical use, with its first U.S. placement completed and patient cases ongoing. The findings were presented by Megha Prasad, MD, MS, in an abstract titled “Saline-Based Hybrid IVUS-OCT Imaging: Feasibility of Contrast-Free Dual-Modality Intracoronary Imaging in a Porcine Model.” “These findings highlight the potential of OCTIV to provide complementary ultrasound and optical images using saline, eliminating the need for iodinated contrast during image acquisition,” said Thomas Looby, President and Chief Executive Officer of Conavi Medical. “Since this study was conducted, OCTIV has advanced into commercial clinical use, with our first U.S. placement completed and patient cases ongoing. We are pleased to share these results as we build clinical experience with the system.” Study Results The prospective feasibility study evaluated hybrid intravascular ultrasound (“IVUS”) and optical coherence tomography (“OCT”) imaging of major coronary arteries in three swine, using saline as the sole OCT flushing medium. Investigators performed 26 imaging pullbacks in native vessels and following stent placement, assessing feasibility, safety, catheter performance and image quality. Key findings included: Interpretable images across all 26 pullbacks: Hybrid imaging was successfully performed in all targeted vessels without iodinated contrast during image acquisition.Complementary vessel assessment: OCT provided high-resolution visualization of luminal morphology and stent architecture, while IVUS enabled assessment of vessel dimensions and deeper wall structures within the same pullback.Continuous IVUS imaging: IVUS assessment remained available independently of blood clearance, with high-resolution OCT visualization achieved when saline flushing was adequate.No observed device-related complications: No device-related complications, coronary injury, sustained arrhythmia or procedural mortality occurred.Potential to eliminate iodinated contrast during image acquisition: The findings support further clinical evaluation of saline-based hybrid imaging, which could be particularly relevant for patients at risk of contrast-associated acute kidney injury. About Conavi MedicalConavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented OCTIV hybrid imaging system is the first system to co-register and co-align intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging beams to enable simultaneous hybrid imaging of coronary arteries. The hybrid imaging system has 510(k) clearance from the U.S. Food and Drug Administration. For more information, visit http://www.conavi.com/. Forward-Looking StatementsThis press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding the Company and its business, which may include, but are not limited to, statements with respect to the anticipated clinical benefits and performance of OCTIV, continued clinical use, placements at additional U.S. institutions, participation in TCT 2026, the commercialization and commercial launch of Conavi’s hybrid imaging system and the timing thereof, the sufficiency of Conavi’s resources to achieve such commercial launch, the global market opportunity for coronary intravascular imaging (including for IVUS and OCT), the continued growth in adoption of and in the clinical validation and guideline support for intravascular imaging and the ability of Conavi’s hybrid imaging system to meet market needs. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking information or statements”. Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate” or any variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, those listed in the “Risk Factors” section of the annual information form of the Company dated February 26, 2026 (available on the Company’s profile at www.sedarplus.ca). Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. ContactMark Quick, Chief Financial Officer | 416-483-0100Christina Cameron, Investor Relations | 416-483-0100 ext. 121 | IR@conavi.comSusan Thomas, Media | 619-540-9195
Majority of Patients with Moderate Aortic Stenosis Carry Features Linked to Twice the Risk of Death, egnite Registry Study Finds
The analysis, published simultaneously in JACC, found that moderate AS patients with at least one at-risk feature had a two-fold increase in mortality and hospitalization with heart failure compared with moderate AS patients with no at-risk features over two years. Dr. Philippe Généreux…
SIMPLAAFY study of the WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device meets primary endpoints
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Progress Trial Demonstrates Edwards TAVR Is Superior to Clinical Surveillance for Moderate AS Patients With At-Risk Features
SAN DIEGO–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced results from the PROGRESS Trial, marking a turning point in the management of moderate aortic stenosis (AS). The trial demonstrated that transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance in the primary composite endpoint of death or heart failure events at two years in moderate AS patients with at-risk features. The late-breaking results were presented at Transcatheter Cardiovascular Th
Inquis Medical Launches a Large Multicenter Post-Market Registry to Build on Positive AVENTUS™ Pivotal Trial Results with Real-World Evidence in Pulmonary Embolism
MENLO PARK, Calif.–(BUSINESS WIRE)– #AVENTUSThrombectomy–Inquis Medical, the leading innovator in the treatment of venous thromboembolic disease, today announced the launch of SENSE-PE, an all-comer post-market registry evaluating the safety and efficacy of the AVENTUS™ Thrombectomy System in patients treated for acute pulmonary embolism (PE). Cleared by the FDA for the treatment of PE in June 2025, AVENTUS is the only thrombectomy platform combining integrated tissue-sensing technology and directional aspiration
Late-breaking one-year data show Abbott’s next-generation Amulet 360™ device continues to demonstrate high rates of left atrial appendage closure and low incidence of stroke
Late-breaking one-year VERITAS study results were presented at the Transcatheter Cardiovascular Therapeutics conference and simultaneously published in JACC: Cardiovascular Interventions; data show the device achieved high closure rates of the left atrial appendage (LAA) and a low…
First-in-Human Coronary Intervention Study Results of Robocath’s Next-Generation Robotic System Highlighted at TCT
100% clinical success and no device-related adverse events in 20 First-in-Human Percutaneous Coronary Intervention procedures with next-generation robotic systemRobocath system demonstrates ability to efficiently and effectively support the full range of coronary interventions including in complex coronary artery disease patientsPrincipal investigator, Dr. Nejjari, shared the findings during the “Innovations in Robotics for Transcatheter Heart Interventions” session at TCT on November 1, 2026 ST. LOUIS and ROUEN, France, Nov. 02, 2026 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced the findings from the first-in-human clinical results for Robocath’s next-generation robotic system during the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego. The findings support a favorable performance profile for the system, with 100% clinical success rate and no device-related complications. The study was conducted by Dr. Mohammed Nejjari and Dr. Franck Digne, Interventional Cardiologists at Centre Cardiologique du Nord (CCN) in Saint-Denis, France. This prospective pilot clinical study enrolled twenty patients undergoing PCI for coronary artery disease. Key findings from the study include: 100% clinical success and 95% technical success: All 20 patients met the study’s clinical success criteria of minimal residual stenosis post PCI. In all but one procedure the physician was able to complete the procedure entirely robotically without conversion to manual.No device-related adverse events: Clean safety profile with no intra-procedural vascular complications, major adverse events, or device related adverse events through 30-day follow-upNo physician radiation exposure: Operating physicians performed the procedures entirely protected from fluoroscopy radiation, supporting the system’s potential to reduce occupational risk in interventional cardiology.Performance across lesion complexity: The study included A/B1, B2, and C-type lesions, representing three levels of procedural complexity, including in complex coronary disease in tortuous distal vasculature. Dr. Nejjari discussed these findings during the November 1, 2026 scientific session “Innovations in Robotics for Transcatheter Heart Interventions” that took place at TCT. A manuscript documenting these findings has been submitted for publication and is under review. “These initial findings mark an important milestone in the advance of robotic technology in interventional cardiology,” said Dr. Nejjari. “The results are very encouraging, particularly the clinical success and safety observed across the patient cohort including in complex PCI. We are excited for the potential of this robotic innovation to improve care for patients and benefit physician safety and workflow. Robocath, a subsidiary of Stereotaxis, is a technology leader in pioneering advanced robotic innovations for interventional cardiology and neurointerventions. Robocath’s next-generation system builds on the clinical and technological experience of the first-generation R-One system, now used in centers worldwide. It adds advanced capabilities such as multi-device handling of up to five interventional devices simultaneously to support increasingly complex interventional procedures. “These first-in-human results support our confidence in our innovation strategy and reflect our commitment to advancing differentiated robotic technologies across endovascular interventions,” said David Fischel, Chairman and CEO of Stereotaxis. “We look forward to building on these initial findings, progressing Robocath’s technology towards regulatory submissions, and delivering this promising technology to interventional physicians and patients suffering from coronary disease and stroke.” About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.Stereotaxis.com. Cautionary Note Regarding Forward-Looking StatementsThis press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, our overall liquidity and our ability to fund operations, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, our ability to manage and integrate recent acquisitions, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company’s periodic and other filings with the SEC. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this press release. Stereotaxis Contacts: David L. FischelChairman and Chief Executive Officer Kimberly PeeryChief Financial Officer 314-678-6100Investors@Stereotaxis.com
HeartBeam Announces Positive Heart Attack Pilot Study Results at TCT 2026: Patient-Recorded 3D ECG Shown to Be as Accurate as Standard 12-Lead ECG
SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam Announces Positive Heart Attack Pilot Study Results at TCT 2026: Patient-Recorded 3D ECG Shown to be as Accurate as Standard 12-Lead ECG
TCT 2026 Clinical Data Reveals 84% Reporting Gap in Aortic Valve Calcification, Highlighting the Potential of Nanox.AI’s AVC Solution
TIME Best Inventions 2026
TIME Best Inventions 2026
Nanox.AI’s Investigational AVC Solution Demonstrated 98.3% Sensitivity and 96.6% Specificity in Evaluable CT Scans.Findings Highlight the Potential of AI to Identify Previously Unreported Aortic Valve Calcification Using Existing Routine CT Scans.Findings published in the peer-reviewed journal JACC: Advances. PETACH TIKVA, Israel, Nov. 2, 2026 (GLOBE NEWSWIRE) — Nanox Imaging Ltd. (“Nanox” or the “Company”, NASDAQ: NNOX), a leader in innovative medical imaging technology, today announced that updated clinical data on Nanox AI Ltd’s (“Nanox.AI”) aortic valve calcification (AVC) AI solution was presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference, taking place October 31 to November 3, 2026, in San Diego, California. Nanox.AI’s HealthAVC solution is intended to serve as a non-invasive, post-processing software application that detects and quantifies calcified plaques in the aortic valve. The software analyzes non-gated, non-contrast chest computed tomography (CT) images acquired during routine clinical care and provides a numeric aortic valve calcium score, a sex-based categorization, and a visual indication of the result. The HealthAVC device is being developed for the use by clinicians to assist in the detection and quantification of aortic valve calcification, supporting early identification of patients who may benefit from cardiovascular evaluation, ongoing monitoring, and potential consideration for TAVR. The solution is under development and is not yet cleared for clinical use or commercially available. “The low reporting rate may reflect the fact that most CT scans were performed for unrelated indications, alongside challenges in assessing aortic valve calcification and the lack of clearly defined clinical pathways for incidental findings,” said Ofir Koren, MD, FACC, FESC, Assistant Professor of Cardiology, Director, Cardiovascular Innovation Program of Cedars-Sinai Medical Center, consultant to Nanox.AI and lead author of the study. “AI-based clinical decision support could help address these challenges by providing consistent detection and quantitative assessment, potentially improving the recognition and reporting of AVC in routine practice. At the same time, we need to establish clearer, evidence-based recommendations for further evaluation and follow-up, particularly for patients with high calcium burden or findings suggestive of severe aortic stenosis.” The data was also published in the Journal of the American College of Cardiology (JACC). The TCT abstract, “AI-Detected Aortic Valve Calcification on Routine Chest CT Reveals a Large Hidden Population at Risk for Severe Aortic Stenosis,” was presented by Ofir Koren on Sunday, November 1, 2026. The study analyzed non-contrast chest CT from 440 evaluable adults aged 50 and older and compared AI findings with routine radiology reports. Key findings highlight an opportunity for AI-assisted detection A substantial documentation gap: 145 of 172 manually confirmed AVC-positive scans (84.3%) did not explicitly mention AVC in the original radiology report. This is a reporting measure, not a radiologists’ diagnostic-error rate.Detection of undocumented AVC: HealthAVC V1.0 identified 142 of these 145 cases (97.9%). Across all 440 evaluable scans, sensitivity was 98.3% (169/172) and specificity was 96.6% (259/268).Important workflow limitation: 56 of 496 submitted scans (11.3%) were non-evaluable. Counting manually positive rejected scans as missed yielded end-to-end sensitivity of 89.9% (169/188).Broader clinical context: Expert manual scoring identified two cases meeting sex-specific severe AVC thresholds. Among 86 AI-positive patients with clinically obtained echocardiography within ±365 days, 10 had mild-or-greater aortic stenosis. These selected data do not establish clinical benefit or a need for intervention. Nanox.AI’s HealthAVC solution will be highlighted at the RSNA 2026 Annual Meeting on the Innovation Theater; Tuesday, December 1 | 11:00am Schedule a meeting with Nanox at RSNA 2026| Booth #1759: https://www.nanox.vision/rsna2026 About Nanox Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by delivering an integrated, end-to-end medical imaging and healthcare services platform. Nanox combines affordable imaging hardware, advanced AI-based solutions, cloud-based software, access to remote radiology, health IT solutions, and a marketplace to enable earlier detection, improved clinical efficiency, and broader access to care. Nanox’s vision is to expand the reach of medical imaging both within and beyond traditional hospital settings by providing a seamless solution from scan to interpretation and beyond. By leveraging proprietary digital X-ray technology, AI-driven analytics, and a clinically driven approach, Nanox aims to enhance the efficiency of routine imaging workflows, support early detection of disease, and improve patient outcomes. The Nanox ecosystem includes Nanox.ARC X, a multi-source digital tomosynthesis system designed to make advanced 3D imaging accessible in more clinical settings; Nanox.AI, a suite of AI-based algorithms that augment the interpretation of routine CT imaging to identify early signs often associated with chronic disease; Nanox.CLOUD, a cloud-based platform for secure data management, storage, and advanced imaging analytics; Nanox.MARKETPLACE and USARAD Holdings, which provides access to remote radiology and cardiology experts and comprehensive teleradiology services; and Nanox Health IT combines deep healthcare IT expertise with leading technology partners to deliver RIS, PACS, AI, dictation, and secure infrastructure solutions that streamline workflows and support safer, more efficient care delivery. The Nanox.ARC X was selected as one of TIME’s Best Inventions of 2026. By integrating imaging technology, AI, cloud infrastructure, clinical expertise, a marketplace, and health information technology, Nanox seeks to lower barriers to adoption, improve utilization, and advance preventive care worldwide. For more information, please visit https://www.nanox.vision. About Nanox.AI Nanox.AI is the deep-learning medical imaging analytics subsidiary of Nanox. Nanox.AI solutions are developed to target highly prevalent chronic and acute diseases affecting large populations around the world. Leveraging AI, Nanox.AI helps clinicians extract valuable and actionable clinical insights from medical imaging that otherwise may go unnoticed, potentially initiating further medical assessment to establish individual preventative care pathways for patients. For more information, please visit www.nanox.vision/ai. Forward-Looking Statements This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, any statements relating to the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to complete development of the Nanox System; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of Nanox’s liquidity to pursue its complete business objectives, and substantial doubt regarding its ability to continue as a going concern; (iv) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (v) Nanox’s ability to realize the anticipated benefits of the acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (vi) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vii) the market acceptance of the Nanox System and the proposed pay-per-scan business model; (viii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; (ix) Nanox’s ability to conduct business globally; (x) changes in global, political, economic, business, competitive, market and regulatory forces; (xi) risks related to the current war between Israel and Hamas and any worsening of the situation in Israel; (xii) risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises, among other things; and (xiii) potential litigation associated with our transactions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2025, and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations. Contacts Media Contact:Ben ShannonICR HealthcareNanoxPR@icrinc.com Investor Contact:Mike CavanaughICR Healthcaremike.cavanaugh@icrhealthcare.com
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TIME Best Inventions 2026



