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SinglePass Device Achieves 100% Technical Success and Zero Clinically Significant Bleeding Events in Multicenter Study Published in the Journal of Vascular and Interventional Radiology

LAKE FOREST, Calif.–(BUSINESS WIRE)–SinglePass, Inc., developer of the SinglePass biopsy closure device, today announced the publication of a multicenter (Hoag Health System, Newport Beach and Irvine, California) retrospective clinical data study in the Journal of Vascular and Interventional Radiology (JVIR). Across 120 consecutive patients followed for 30 days, the SinglePass device achieved a 100% technical success rate with zero clinically significant bleeding events.1 Percutaneous biopsy

Philips advances women’s health ultrasound with new single-transducer solution

Philips eV14-2v transducer

Philips eV14-2v transvaginal transducer, designed to support a broad range of gynecology and early obstetrics exams.

Clinician holding Philips eV14-2v transducer

A clinician holds the Philips eV14-2v transvaginal transducer.

Patient consultation with Philips Alturion ultrasound

A clinician consults with a patient alongside the Philips Alturion ultrasound system and eV14-2v transducer during a women’s health appointment.

September 3, 2026   FDA 510(k) cleared and CE marked, the eV14-2v combines exceptional image quality and broad clinical capabilities in one lightweight transducer, helping streamline exams, support diagnostic confidence, and improve the patient experience Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today introduced the eV14-2v transvaginal transducer, expanding its obstetrics and gynecology ultrasound portfolio. FDA 510(k) cleared and CE marked, the eV14-2v is designed to support a broad range of gynecology and early obstetrics exams by combining image quality and broad clinical capabilities in a single lightweight transducer. The new transducer will be showcased at the 36th International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) World Congress. Across obstetrics and gynecology, clinicians care for women with diverse clinical needs, from routine gynecologic exams to early pregnancy assessments and more complex cases. Achieving the desired balance of penetration and image resolution may require switching between transducers, which can interrupt workflow and extend exam times. The eV14-2v is designed to address these challenges by providing enhanced penetration, improved resolution, and a wider field of view in a lightweight, ergonomic design. The transducer delivers a 41.7% increase in penetration, a 10% increase in 2D resolution, a 15.8% improvement in field of view, and a 22% lighter design, supporting imaging across routine and complex gynecology and early obstetrics exams [1]. “Advancing women’s health is a priority for Philips ultrasound, and we are committed to developing innovations that make women’s healthcare more accessible and more comfortable for patients,” said Ajay Gannerkote, Ultrasound Business Leader at Philips. “At Philips, we’re focused on bringing together high-quality imaging, intelligent workflows and connected capabilities to simplify the ultrasound experience for clinicians and patients. The eV14-2v transducer reflects that approach, giving clinicians greater versatility in a single transducer and helping support high-quality care for women.” Built specifically for gynecology and obstetrics imaging, the eV14-2v leverages PureWave crystal technology, first introduced by Philips, and features a lightweight ergonomic design that supports user comfort during exams. This gives clinicians detailed visualization of anatomy relevant to evaluating infertility and pelvic pain associated with conditions such as endometriosis and fibroids. Philips technology, including 2D and color resolution, supports the detection of fetal abnormalities, with the ability to delineate the cardiac chambers in a fetus as early as 13 weeks when the heart is the size of a single corn kernel [2]. “Reducing transducer changes during exams has a meaningful impact, not just on efficiency, but on the patient experience as well,” said Dr. Michael S. Ruma, MD, MPH, Perinatal Associates of New Mexico. “With the eV14-2v, we’re able to complete more exams with a single transducer while maintaining excellent image quality, which helps streamline our workflow and improve patient comfort.” The eV14-2v transducer can be used with Philips Collaboration Live, supporting real-time remote consultation during ultrasound exams. Clinicians can view live imaging, provide guidance during exams, and consult with care teams without requiring patient travel. This approach can help expand access to specialty care in underserved communities while supporting more efficient care delivery. In addition to the eV14-2v transducer, attendees at ISUOG 2026 will have the opportunity to experience Philips’ latest women’s healthcare ultrasound innovations firsthand, including the newly launched Alturion ultrasound system, EPIQ Elite, Lumify, and Flash with Collaboration Live, and learn more about the company’s ongoing efforts to advance ultrasound solutions for women worldwide. For further information on the eV14-2v transducer, please visit: Philips – eV14-2v Transducer FUS0929 – Philips. [1] Compared to the 3D9-3v transducer[2] Video image on file For further information, please contact:    Jayme Maniatis  Philips Global External Relations   Tel.: 617-894-8368  E-mail: jayme.maniatis@philips.com    About Royal Philips Royal 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 image-guided therapy, diagnostic imaging, ultrasound, monitoring, enterprise informatics and personal health. Philips generated 2025 sales of approximately EUR 18 billion and employs approximately 63,700 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 eV14-2v transducer

Clinician holding Philips eV14-2v transducer

Patient consultation with Philips Alturion ultrasound

Heartvue.ai and Innolitics Achieve FDA 510(k) Clearance for Heartvue.Proton, an AI-Powered Cardiac MRI Analysis Platform

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Cleerly Announces New Findings on How AI-QCT Plaque Measurements Relate to Long-Term Cardiovascular Risk

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Texas Cardiac Arrhythmia Institute at St. David’s Medical Center first in U.S. to participate in trial for innovative mapping and pulsed field ablation system

AUSTIN, Texas, Sept. 2, 2026 /PRNewswire/ — The Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center recently became the first facility in the nation to participate in a clinical trial to evaluate the safety and effectiveness of a next-generation mapping and pulsed…

Profound Medical Further Strengthens Executive Leadership Team with Appointment of Richard Fabian as President

TORONTO, Sept. 01, 2026 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets innovative interventional MRI (iMRI) procedures, today announced the appointment of Richard Fabian as its new President, effective immediately. Mr. Fabian succeeds Mathieu Burtnyk, PhD, who has shifted to the newly created position of Chief Technology Officer. Mr. Fabian has an accomplished history of sales, marketing, operations, general and executive management success within the global healthcare industry, specifically in the medical imaging and medical device spaces. In a career spanning more than 29 years, he most recently served as Chief Executive Officer of FUJIFILM Sonosite, Inc. (“Sonosite”), an innovator and leader in point-of-care ultrasound. Before joining Sonosite in 2017, Mr. Fabian served in a variety of roles with Philips Healthcare (“Philips”), the primary healthcare and medical technology business segment and division of NYSE/AEX-listed Royal Philips. Starting in 2002 as a Senior Director in the Cardiovascular X-ray Business Unit, North America, he progressed to lead in several executive roles in sales, marketing, and global general management. Earlier in his career, Mr. Fabian was VP, Sales at Noetix Corporation (now Magnitude Angles) and VP, Operations at STERIS Corporation. Mr. Fabian received a Bachelor of Economics degree from the University of Michigan, where he was a two-time letterman on the varsity swim team, and a Master of Business Administration from the University of Pittsburgh Joseph M. Katz Graduate School of Business. “I am excited that we were able to recruit a medical device executive of Rich’s caliber to this key position,” said Arun Menawat, Profound’s CEO and Chairman. “Rich is a seasoned leader with a strong track record of delivering profitable growth to both established and emerging healthcare businesses. I have tremendous confidence in his ability to help us sharpen our overall execution. At the same time, I am pleased that our continuing clinical innovation and development will be in the capable hands of Mathieu, the inventor of the patented closed-loop temperature feedback control algorithm used by TULSA-PRO®, as well as the executive who has led the scientific design and execution of all of our clinical studies for the technology, including the ongoing Level 1 post-market CAPTAIN randomized controlled trial.” “I am incredibly energized to join Profound at such a transformative time in the evolutions of both robotic and incisionless surgeries,” commented Mr. Fabian. “By combining the unrivalled precision and patient-centered customization enabled by real-time MRI guidance and thermometry, artificial intelligence, and supervised autonomous robotics, Profound is truly changing the paradigm for patients facing prostate disease and other conditions – proving that effective treatment no longer requires compromising a patient’s quality of life. I am honored to be part of a team that is actively replacing uncertainty with clarity and expanding the boundaries of modern medicine.” About Profound Medical Corp. Profound is a commercial-stage medical device company and an innovator in interventional MRI (iMRI) procedures. The company’s flagship platform, TULSA-PRO®, enables MRI-guided, incision-free prostate ablation. Physicians use the TULSA Procedure™ to see, ablate, and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care—from whole-gland to subtotal, hemi, multifocal, and focal treatment. This approach enables individualized care using prostate tissue ablation, while minimizing the potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction. Profound also commercializes Sonalleve®, an MRI-guided therapy that provides a non-surgical treatment option for pain palliation of bone metastases, desmoid tumors, and osteoid osteoma, as well as for common gynecologic conditions including uterine fibroids and adenomyosis. Sonalleve delivers targeted therapy with no incisions, no blood loss during the procedure, no overnight hospital stay, and faster recovery — and, in gynecologic applications, enables uterine-sparing treatment that may help preserve fertility. Profound is also exploring additional clinical applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia-based cancer therapies. Profound Medical’s technologies are approved across major global markets. TULSA-PRO is cleared by the FDA in the United States for transurethral ultrasound ablation (TULSA) of prostate tissue. In addition, TULSA-PRO is cleared for use in various jurisdictions including Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE. Sonalleve is approved by the FDA as HDE in the United States for the treatment of osteoid osteomas in the extremities. Sonalleve is also cleared or approved in the Europe, Canada, China, and Saudi Arabia. Through real-time MRI guidance and data-driven innovation, Profound is advancing the future of MRI-guided therapy — expanding access to precise, personalized, and incision-free treatment options worldwide. Forward-Looking Statements This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technologies for disease conditions requiring MR-Guided ablation procedures for prostate, uterine fibroids, adenomyosis, palliative pain treatment, desmoid tumors, and osteoid osteoma; Profound’s expectations for future revenues/financial results; and the success of Profound’s commercialization strategy and activities for TULSA-PRO® and Sonalleve®. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound 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. No forward-looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward-looking statements are described in Profound’s Annual Report on Form 10-K and other filings made with U.S. and Canadian securities regulators, available at www.sedarplus.com and www.sec.gov. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law. For further information, please contact: Stephen KilmerInvestor Relationsskilmer@profoundmedical.com   T: 647.872.4849 Susan ThomasPublic Relationssthomas@profoundmedical.com T: 619.540.9195

Innova Vascular Completes Enrollment in Trust IDE Study Evaluating the Laguna Thrombectomy System for Pulmonary Embolism

IRVINE, CA, UNITED STATES, August 31, 2026 /EINPresswire.com/ — Innova Vascular, Inc., a medical technology company developing innovative endovascular solutions for the treatment of vascular thromboembolism, today announced the completion of patient enrollment in the TRUST pivotal Investigational Device Exemption (IDE) clinical study evaluating the safety and effectiveness of the Laguna® Thrombectomy […]