McDermott and Bull executive Search
 

Other News

FastWave Medical Reports 96.4% Procedural Success in First-in-Human Study of Sola™ Coronary Laser IVL System

30-patient feasibility study demonstrated calcium fracture in every treated lesion and 49% acute lumen gain prior to stenting. MINNEAPOLIS, Sept. 29, 2026 /PRNewswire/ — FastWave Medical, which is developing next-generation intravascular lithotripsy (IVL) technology, today announced positive interim results from the first-in-human (FIH) feasibility study of its Sola™ laser IVL […]

KARL STORZ Receives FDA Clearance for TIPCAM1 Rubina in Select Cardiac Surgical Procedures

EL SEGUNDO, Calif.–(BUSINESS WIRE)–KARL STORZ, a global leader in advanced surgical visualization and integrated operating room solutions, today announced that the U.S. Food and Drug Administration (FDA) has cleared expanded indications for the TIPCAM1™ Rubina™ video endoscope for use in selected cardiac surgical procedures. TIPCAM1™ Rubina™ combines 4K visualization, stereoscopic 3D imaging, and near-infrared fluorescence imaging (NIR/ICG) in a single video endoscope, helping surgeons visual

Elucid Appoints Mark Miller as Chief Revenue Officer to Lead Commercial Expansion Ahead of BioIntegrated FFR-CT Launch

BOSTON–(BUSINESS WIRE)– #YesCCT–Elucid, a medical technology company using AI-powered, clinically validated software to advance precision diagnosis of cardiovascular disease, today announced that Mark Miller has joined the company as chief revenue officer (CRO). Miller will sit on Elucid’s leadership team and report directly to CEO Kelly Huang, PhD. He joins the company ahead of the launch of its comprehensive cardiovascular platform, which is comprised of its FDA-cleared Plaque-IQ™ and its BioIntegra

Novo’s Ozempic® (semaglutide) 2 mg associated with lower risk of major adverse cardiovascular events (death, heart attack, and stroke) in adults with type 2 diabetes compared to switching to Mounjaro® (tirzepatide), in real-world analysis at EASD

Adults with type 2 diabetes on semaglutide injection 1 mg, whose dose was increased to 2 mg, were associated with a statistically significant 6% lower risk of major adverse cardiovascular events (MACE), compared to switching to tirzepatide (up to 15 mg)1 Retrospective real-world analysis…

Route 92 Medical Announces U.S. FDA Clearance for the FreeClimb® 46 Catheter with Tenzing® 4

Expands Company’s Portfolio of Advanced Neurovascular Catheters to Support Treatment in Smaller and More Distal Anatomies WEST JORDAN, Utah, Sept. 28, 2026 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced U.S. Food and Drug Administration 510(k) clearance for the FreeClimb® 46 catheter with Tenzing® 4. The two components are engineered as an integrated system to provide neurovascular access. FreeClimb® 46 and Tenzing® 4 are the newest offerings in Route 92’s portfolio of advanced neurovascular catheters. The FreeClimb 46 system joins FreeClimb 54, 70 and 88, and complements the HiPoint® 70 and HiPoint 88 systems, which also feature the company’s proprietary Monopoint® single-operator system. All Route 92 access and aspiration catheters are powered by custom-sized Tenzing delivery catheters. The navigational capabilities of Tenzing enable atraumatic, precise, and controlled access through neurovascular anatomy, establishing stable access for the treatment of complex neurovascular diseases. “In neurovascular intervention, access is critical,” said Matthew D. Alexander, M.D., Medical Director of Neurointerventional Radiology at Sutter Medical Center in Sacramento, California. “Tenzing supports consistent navigation through even the most challenging cases, allowing us to reach the anatomy we need to treat. The FreeClimb 46 with Tenzing 4 expands Route 92’s catheter technologies to smaller and more distal vessels, where the clinical need is large and accurate delivery is critical to achieving the best outcomes for my patients. I look forward to bringing this next level of neurovascular access into my practice.” The FreeClimb 46 catheter system, including Tenzing 4, and all Route 92 catheters and systems are covered by a portfolio of more than 200 issued patents in the U.S. and international jurisdictions.About Route 92 Medical, Inc.Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention through cutting-edge engineering, innovative product design and revolutionary procedural change. Founded by physicians, the company collaborates with leading neurovascular clinicians to solve the biggest challenges in neurointervention and deliver meaningful, differentiated solutions that promote clinical success. For more information, visit www.r92m.com or follow the company on LinkedIn. CONTACT: Contacts:
For media:
Gwen Gordon
Gwen@gwengordonpr.com

Tempus Receives FDA Clearance for its ECG-MR AI Product Designed to Identify Undiagnosed Mitral Regurgitation

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-MR, an AI product that analyzes standard 12-lead resting electrocardiograms (ECGs) to detect signs associated with undiagnosed moderate or severe mitral regurgitation (MR). MR is a common form of heart valve disease where blood leaks backward through the mitral valve. Because early stages are often asymptomatic or manifest as no

GuideAI Health Corp. and vRad Renew Data Exclusivity Agreement to Develop AI Models for the Detection and Characterization of Multiple Vascular Diseases

Company holds exclusive access to imaging data from 2,100+ U.S. hospitals through its ongoing data partnership with vRad, the largest teleradiology provider in the United StatesBOSTON, Sept. 28, 2026 (GLOBE NEWSWIRE) — GuideAI Health Corp. (Cboe CA: GDAI) (FSE: ZN0) (“GuideAI” or the “Company”) is pleased to announce the renewal of its data exclusivity agreement with vRad (Virtual Radiologic), which aims to develop artificial intelligence models for the detection and characterization of multiple vascular diseases. The renewed collaboration provides GuideAI with exclusive access to imaging data from more than 2,100 hospitals across the United States, which the Company believes to be one of the largest and most diverse real-world imaging datasets of its kind. Under the renewed partnership, GuideAI retains exclusive rights to develop AI models using de-identified imaging data generated across vRad’s national network of more than 2,100 hospitals and healthcare facilities. GuideAI’s technology is currently deployed within the workflow of vRad’s approximately 500 radiologists, where it supports the identification of vascular disease at the point of care. The scale and diversity of vRad’s dataset provide GuideAI with a durable foundation on which to train and validate its algorithms. Building on its work in peripheral arterial disease, the Company intends to expand its platform to the detection and characterization of multiple vascular diseases, with the goal of surfacing disease earlier and supporting more precise, more comprehensive treatment decisions for patients nationwide. GuideAI Health CEO, Raj Shah, commented, “Renewing our exclusive data collaboration with vRad is a defining moment for GuideAI. Access to imaging data from more than 2,100 hospitals, combined with the trust of the 500 radiologists who already have access to our technology in their daily workflow, gives us an exceptional foundation to build clinically meaningful AI, furthering our aim of helping clinicians catch disease earlier and improve outcomes for patients.” About GuideAI Health Corp. GuideAI Health Corp. is a healthcare technology company using artificial intelligence to enable the early detection of vascular disease and support more precise treatment decisions. Its platform analyzes routine CT scans to identify peripheral vascular disease. By surfacing disease earlier, GuideAI aims to improve patient outcomes while helping hospitals and radiology groups deliver more comprehensive vascular care. For more information, please visit www.guideaihealth.com. On Behalf of the Board of Directors: Raj Shah CEO Contact: Phone: (416) 309-3583Email: info@guideaihealth.com Cautionary Note Regarding Forward-Looking Statements This news release contains certain “forward-looking statements” and “forward-looking information” within the meaning of applicable Canadian securities laws (collectively, “forward-looking information”). Forward-looking information in this news release includes, but is not limited to, statements regarding: the continuation and anticipated benefits of the Company’s renewed data exclusivity agreement and collaboration with vRad; the Company’s continued exclusive access to, and ability to use, de-identified imaging data generated across vRad’s network; the scope, scale, diversity and anticipated value of that dataset; the continued deployment and use of GuideAI’s technology within vRad’s radiology workflow; the Company’s ability to train, develop, validate and commercialize artificial intelligence models for the detection and characterization of vascular diseases; the expansion of the Company’s platform beyond peripheral arterial disease; the potential for the Company’s technology to identify disease earlier, support more precise and comprehensive treatment decisions and improve patient outcomes; and the Company’s business plans, objectives and future activities. Forward-looking information is often, but not always, identified by words or phrases such as “anticipates”, “believes”, “expects”, “intends”, “plans”, “aims”, “goal”, “may”, “will”, “would”, “could”, “should”, “potential”, “continue” and similar expressions.  Forward-looking information is based on management’s estimates, assumptions and expectations as of the date of this news release, including assumptions regarding: the continued validity and enforceability of, and performance by the parties under, the renewed agreement; the Company’s continued ability to access and lawfully use sufficient quantities of de-identified imaging data; the quality, completeness, diversity and representativeness of the available data; the continued availability, performance and integration of the Company’s technology within vRad’s workflow; the Company’s ability to retain qualified personnel, secure required financing and other resources, protect its intellectual property and data rights, and complete development, testing and validation activities; and the receipt of any required regulatory, clinical, commercial or third-party approvals. Although the Company considers these assumptions reasonable, they may prove to be incorrect.  Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially from those expressed or implied, including risks relating to: the termination, non-renewal, amendment, breach or unenforceability of the renewed agreement; interruptions, restrictions or loss of access to imaging data or the vRad network; limitations in the quantity, quality, completeness, diversity or representativeness of available data; privacy, data protection, cybersecurity, data de-identification, consent and regulatory compliance; the accuracy, reliability, generalizability, validation and clinical utility of artificial intelligence models; development delays, technical failures, integration challenges and the inability to achieve expected performance or commercial objectives; changes in laws, regulations, standards of care or regulatory requirements applicable to artificial intelligence, medical devices, healthcare or data use; failure to obtain or maintain required approvals; intellectual property disputes and the inability to protect proprietary rights; competition and technological change; dependence on key personnel, collaborators, service providers and third parties; the availability of capital and other resources; and the possibility that the anticipated clinical, operational or commercial benefits of the collaboration and the Company’s technology will not be realized. Additional risks are described in the Company’s public disclosure documents available under its profile on SEDAR+ at www.sedarplus.ca. Readers are cautioned not to place undue reliance on forward-looking information. The Company undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law. 

Humacyte Expands Board Expertise with Appointment of Scott Coward and Paul Kuznik

DURHAM, N.C., Sept. 28, 2026 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the addition of life science industry veterans Scott Coward and Paul Kuznik to the Company’s Board of Directors, both of whom bring substantial experience in the areas of commercialization, enterprise leadership, and global operations. “We are delighted to welcome two distinguished commercialization and life science leaders to the Humacyte Board as we continue to expand our ongoing Symvess® launch and prepare for our planned commercial launch of the ATEV in the dialysis access indication,” said Dr. Laura Niklason, Founder, President, and Chief Executive Officer of Humacyte. “Scott Coward brings a track record of success through his leadership at Exact Sciences and has significant experience in board service and executive leadership within publicly traded life sciences companies. Paul Kuznik has extensive experience in vascular healthcare and cardiovascular devices, including extensive leadership roles in commercialization, enterprise leadership, manufacturing, strategic planning, and physician engagement. We look forward to their contributions as we work toward our anticipated U.S. market launch in dialysis.” Scott Coward served as Executive Vice President, Chief Legal Officer, Chief Administrative Officer and Secretary of Exact Sciences Corporation from January 2015 to December 2022. Mr. Coward led the integration of Genomic Health Corp. following its acquisition by Exact Sciences. He also served on the Exact Sciences board of directors from December 2022 to March 2026. Mr. Coward has been an attorney at K&L Gates since July 2026 and was previously a partner in the firm from 2008 through 2014. During that tenure, he served in different leadership roles, including as the managing partner of the Raleigh office. Mr. Coward brings significant experience in public company board service and corporate governance, executive leadership within publicly traded life sciences companies, mergers and acquisitions and post-acquisition integration, executive compensation, compliance and legal affairs, organizational leadership during periods of substantial growth and change, and has partnered with executive management teams and boards through transformational corporate events. Mr. Coward received his J.D. from Columbia Law School and his B.S. from the University of North Carolina at Chapel Hill. He has been appointed to the Company’s Audit Committee. “I am honored to join the Humacyte Board of Directors at such an exciting time for the Company,” said Mr. Coward. “Humacyte’s pioneering work in regenerative medicine has the potential to transform patient care, and I look forward to working with the Board and management team to support the Company’s continued growth and long-term success.” Paul Kuznik is a medical technology executive whose career spans more than three decades in vascular healthcare, cardiovascular devices, and medical diagnostics. Mr. Kuznik served as the Chief Executive Officer and a member of the Board of Directors from 2015 to 2018 at Bolton Medical, a developer of endovascular technologies for complex aortic disease, which was acquired by Terumo Corporation. Following the acquisition, Mr. Kuznik remained with Terumo Corporation, one of Japan’s leading global medical technology companies. He helped lead the integration of Bolton Medical with Vascutek to create Terumo Aortic and subsequently served as President of Terumo Aortic United States from 2019 to 2020 and as President of Terumo Aortic North America from 2020 to 2023. Mr. Kuznik brings extensive experience in commercialization, enterprise leadership, organizational integration, strategic planning, manufacturing, clinical affairs, regulatory oversight, quality systems, physician engagement and board governance. Mr. Kuznik is a graduate of the United States Military Academy at West Point and served as an officer in the United States Army. He has been appointed to the Company’s Commercial Committee. “I’m thrilled to join the Board of Directors at Humacyte as the Company’s regenerative medicine technologies have the potential to make a significant impact across numerous markets while benefiting patients throughout the world,” said Mr. Kuznik. “I’m excited to work with the Board of Directors and Humacyte in our efforts to expand both physician and patient access to the innovative regenerative vascular solutions offered by the Company.” About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com Photos accompanying this announcement are available athttps://www.globenewswire.com/NewsRoom/AttachmentNg/debe51f6-5e18-4813-9829-d8e85bd71f10https://www.globenewswire.com/NewsRoom/AttachmentNg/4e6163ac-4843-48ad-b0bb-76203e9bda00