Author: Ken Dropiewski

R3 Vascular Expands Management Team with Two Senior Executives

Appointments Support Accelerated Trial Enrollment, Market Development, Scalability, and Future CommercializationMOUNTAIN VIEW, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce the appointment of two senior executives as it accelerates trial enrollment, market development, scalability, and future commercialization. Robert Spanos has been appointed as Vice President, Global Market Development and Katie Segreto has been appointed as Vice President, Finance and Corporate Controller. Commenting on the appointments, Christopher M. Owens, President and CEO of R3 Vascular said, “On behalf of the R3 management team, I am very pleased to welcome Bob Spanos and Katie Segreto. Both bring exceptional expertise and proven leadership that will be instrumental as we advance the clinical development of MAGNITUDE®, accelerate our market presence, and build the infrastructure needed to support future commercialization. Bob’s deep experience in peripheral vascular markets and successful product launches will strengthen our commercial strategy and market expansion efforts, while Katie’s extensive finance leadership experience will help us scale our organization and position R3 Vascular for long-term growth. We are excited to have them join our team at this important stage for the company, including the recent rapid acceleration of our ELITE Clinical Trial enrollment, finalizing the advances in scaffold product line extensions, driving elite margin structure and setting the foundation throughout the organization to prepare for commercialization.” Robert Spanos is a seasoned cardiovascular medical device executive with more than 20 years of experience leading commercial strategy, clinical execution, and successful product launches across the endovascular and peripheral vascular markets. Throughout his career, he has built and led high-performance sales organizations while driving market adoption and revenue growth for innovative, first-to-market technologies. Prior to joining R3 Vascular, Robert held senior leadership roles including Executive Vice President of Corporate Operations for Emblok Inc., Vice President of Commercial Development at AngioDynamics, and Vice President of U.S. Sales Accounts at Eximo Medical, where he played a critical role in IDE trials, FDA 510(k) submissions, global commercial launches, and acquisition integrations. He has also served in key leadership positions at IDev Technologies, Mercator MedSystems, FoxHollow Technologies, and Guidant Endovascular Solutions, contributing to multiple successful product launches and strategic exits.   He holds a Bachelor of Business Administration in Marketing from the University of St. Thomas. Robert Spanos said, “I’m excited to join the R3 Vascular team and contribute to the advancement of MAGNITUDE, a remarkable next-generational bioresorbable platform. Its ultra-high molecular weight polymer delivers strength and flexibility needed to address the unique demands of tibial vessels in patients with critical limb ischemia (CLTI), while offering potential applications in other vascular beds, including the superficial femoral and coronary arteries.   I look forward to helping drive the successful execution of the company’s clinical, regulatory and commercial objectives.” Katie Segreto brings more than 18 years of finance leadership experience building and scaling high-performing finance organizations across the medical device, biotechnology, and technology sectors. She has guided both public and private companies through periods of substantial growth and transformation.   Prior to joining R3 Vascular, Katie served as Vice President of Finance for Kronos Bio, a publicly traded clinical-stage biotechnology company, where she led the finance organization through the company’s post-IPO expansion. Previously, Katie served as Vice President of Finance at K Health, a venture-backed health technology company, where she built the finance function from the ground up, enabling the company’s growth from $0 to $20M in sales and through its Series C and D financings. Earlier in her career, Katie held finance leadership roles at Bonobos, a high-growth ecommerce company acquired by Walmart, and spent eight years in the Life Science audit practice at PwC, advising biotech and med tech companies on audit and accounting strategy.   Katie holds a Bachelor of Arts in Business Management Economics from the University of California, Santa Cruz and is a Certified Public Accountant (inactive). Katie Segreto added, “I am thrilled to join the R3 Vascular team at such an important point in the company’s growth and to help advance this innovative bioresorbable technology. The platform’s potential to address important unmet needs and improve outcomes in vascular care is particularly compelling. I look forward to supporting the advancement of the company’s clinical and commercial objectives to ultimately bring this technology to the patients who need it most.” About R3 Vascular Inc.R3 Vascular is a privately-held medical device company that develops a novel technology platform for the next generation of fully bioresorbable drug eluting sirolimus coated vascular scaffolds. These are designed to deliver the ‘stent-like’ support of a scaffold along with the anti-inflammatory and anti-proliferative result of sirolimus, but ‘disappearing’ over time as the vessel heals. R3 Vascular is headquartered in Mountain View, California. More information can be found at www.r3vascular.com. Media Contact:David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com

Tempus Receives FDA Clearance for its AI Product Intended to Detect Signs of Pulmonary Hypertension From Standard ECGs

CHICAGO–(BUSINESS WIRE)–Tempus AI, Inc. (NASDAQ: TEM) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus ECG-PH (pulmonary hypertension), an AI-enabled software device that analyzes standard 12-lead electrocardiograms (ECGs) for signs associated with pulmonary hypertension. Tempus ECG-PH is the third FDA-cleared device in Tempus’ growing cardiovascular portfolio, expanding the company’s suite of next-generation AI products aimed at ide

Pulnovo Medical Announces First Two U.S. Patients Enrolled in PULSE-LHD IDE Clinical Trial of Pulmonary Artery Denervation in Treating Pulmonary Hypertension Associated with Left Heart Disease

NEW YORK, Aug. 23, 2026 /PRNewswire/ — Pulnovo Medical, a globally recognized pioneer in medical devices for pulmonary hypertension (PH) and heart failure (HF), today announced the enrollment of the first two patients in its PULSE-LHD clinical trial, conducted under a U.S. Food and Drug…

Shape Memory Medical Secures $10 Million Financing Led by August Global Partners to Advance Aortic Clinical Programs

SAN JOSE, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of proprietary shape memory polymer technology for endovascular embolization, today announced the closing of a $10 million convertible note financing led by new investor August Global Partners (AGP), joined by fellow new investor Taiwania Capital. The financing provides capital to support continued clinical development of the company’s aortic portfolio, including patient follow-up and data collection in the AAA-SHAPE Pivota

Renowned radiology innovator and longtime Subtle Medical advisor expands role to help advance the company’s next generation of AI-powered imaging solutions

MENLO PARK, Calif., Aug. 20, 2026 /PRNewswire/ — Subtle Medical, a leading provider of AI-powered medical imaging solutions, today announced the appointment of Lawrence N. Tanenbaum, MD, FACR, as Executive Medical Director and Chair of the company’s Medical Advisory Board. A nationally…

New Study Demonstrates AliveCor’s KardiaMobile 6L Significantly Increases Arrhythmia Detection Beyond Traditional Ambulatory Monitoring

Peer-reviewed research in JACC Advances reveals patient-initiated, symptom-triggered 6-lead ECG monitoring nearly doubles the diagnostic yield of conventional continuous monitoring modalitiesMOUNTAIN VIEW, Calif., Aug. 20, 2026 (GLOBE NEWSWIRE) — AliveCor, the global leader in AI-powered cardiology, today announced a new prospective cohort study (the M-KEEPS study) conducted by researchers at the University of Rochester Clinical Cardiovascular Research Center and published in JACC Advances. The study, titled “Symptom-Triggered 6-Lead ECG Monitoring Significantly Increases Arrhythmia Detection Beyond Traditional Ambulatory Monitoring,” establishes that 30-day use of the handheld KardiaMobile 6L (KM6L) device outperforms traditional short-duration ambulatory ECG monitoring alone in detecting clinically significant arrhythmias.  By empowering patients to capture medical-grade recordings on-demand during symptomatic episodes, the KM6L device achieved an overall diagnostic yield nearly double that of standard clinical monitoring modalities. Key Clinical Findings & Diagnostic YieldThe study evaluated 350 adult patients presenting with unexplained palpitations, dizziness, or lightheadedness who were concurrently tracked using both a physician-ordered standard ambulatory monitor (24/48-hour Holter or an extended patch ECG monitor) and a KM6L device for 30 days.  Doubling the Diagnostic Capture: Clinically significant arrhythmias were detected in 66 patients (18.9%) overall across both monitoring types. Traditional ambulatory monitors identified arrhythmias in only 27 patients (7.7%), whereas the KM6L device detected arrhythmias in 52 patients (14.9%) (P < 0.001). Exclusive Arrhythmia Detection: A total of 39 arrhythmia episodes (11.1%) were captured exclusively by the KM6L device and completely missed by conventional continuous monitoring options (p = 0.0008). Outperforming Prolonged Patch Monitors: In an exploratory analysis of patients wearing extended patch ECG monitors for 7 days or longer, the patch devices documented arrhythmias in 9.8% of patients (9 out of 93), while the KM6L device detected arrhythmias in 23.9% of those same patients (22 out of 93) (p 130 bpm)0202Pause1001Total13391466      Redefining the Standard of Care”The M-KEEPS study showed that the KardiaMobile 6L hand-held device enabled patient-initiated ECG recordings with 88% of participants—across a broad range of ages and with two-thirds being women—evaluating the device as easy to use,” said Wojciech Zareba, MD, PhD, of the Clinical Cardiovascular Research Center at the University of Rochester. “Symptom-triggered ECG recordings obtained over 30 days were superior to standard 24- or 48-hour Holter recordings and to prolonged multiday recordings in detecting clinically significant arrhythmias. KM6L might be considered as the first line of diagnostic process in individuals with uncertain causes of cardiac symptoms.” The research team also highlighted how real-world clinical paradigms are shifting toward patient-activated technology to address these exact workflow bottlenecks.  “Traditional short-duration monitoring simply misses too many transient events, creating a costly diagnostic blind spot for clinicians,” said Dr. Dave Albert, Chief Medical Officer and Co-founder of AliveCor. “This landmark study from the University of Rochester proves that putting our medical-grade, 6-lead device directly into patients’ hands nearly doubles the diagnostic yield. By empowering patients to capture arrhythmias the moment symptoms occur, we can accelerate accurate diagnoses, optimize clinical workflows, and get patients to life-saving treatment faster—ultimately preventing critical cardiac episodes and the compounding costs of undetected conditions.” High Data Quality and Exceptional Patient UsabilityA critical element of deploying consumer-facing medical technology is patient adherence and signal reliability. Across 6,251 total KM6L recordings collected during the study, 92.3% of the total recordings were deemed clinically interpretable by research technicians. In direct head-to-head temporal alignments, 88.3% of KM6L recordings were classified as top-tier, readable ECGs compared to 86.7% of traditional Holter recordings.  Patient survey results at the end of the 30-day testing period indicated massive compliance and clinical satisfaction across a diverse demographic, where two-thirds of study participants were female: 88% of surveyed participants strongly agreed that the KM6L smartphone application was easy to use. 70% strongly agreed that obtaining a 6-lead ECG recording utilizing the left leg electrode was easy to complete. 88% strongly agreed that they felt more confident using the device to actively document their heart rhythms.  In practice, the KM6L device functions seamlessly as an adjunct early in the cardiac diagnostic pathway. By reducing repeated short-term monitoring loops, the technology speeds up symptom-rhythm correlation, easing patient anxiety and minimizing unnecessary healthcare expenditures associated with an extended diagnostic search.  AliveCor remains deeply committed to anchoring its innovations in rigorous clinical evidence, a dedication backed by more than 250 peer-reviewed articles. The company’s extensive research library, ranging from validation studies in JAMA to landmark trials in The Lancet, consistently proves that its medical-grade AI and hardware improve arrhythmia detection, streamline clinical workflows, and optimize patient outcomes. By continually subjecting its technology to independent scientific scrutiny, AliveCor provides physicians and patients with unmatched, data-driven confidence in remote cardiac care. For clinicians looking for more information on how to integrate Kardia devices into their workflow, visit: https://alivecor.com/health-systems. 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 MathisDirector of Corporate Communications, AliveCorpress@alivecor.com