KP Biomedical Engineering - Issue #11

-AtriCure to Participate in the UBS Global Healthcare Conference MASON, Ohio--(BUSINESS WIRE)

--AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, announced that the company will be participating in the upcoming UBS Global Healthcare Conference.

-Heart Repair Technologies, Inc. Appoints David H. Chung as Chief Executive Officer SAN JOSE, Calif.--(BUSINESS WIRE)

--Heart Repair Technologies, Inc. (“HRT” or “Company”), a privately-held medical device company specializing in disruptive mitral and tricuspid valve repair technology to resolve heart valve regurgitation in heart failure patients, announced that David H. Chung has been appointed Chief Executive Officer (CEO), effective as of October 1, 2024.

-HeartFocus Unveils AI-powered Education App for Conducting Clinical-Grade Heart Scans, Available on Butterfly Network’s Handheld Ultrasound Devices BORDEAUX, France--(BUSINESS WIRE)

--HeartFocus, the revolutionary, AI-enabled heart echo software by data-driven medtech company, DESKi, is proud to announce the launch of the HeartFocus Education app in partnership with Butterfly Network, Inc., (“Butterfly”) (NYSE: BFLY) a digital health company transforming care with portable, semiconductor-based ultrasound technology and intuitive software.

-Scottish Tech Company Novosound Develops World’s First Ultrasound Blood Pressure Monitor GLASGOW, Scotland--(BUSINESS WIRE)

--Novosound, the pioneering Scottish tech company, has developed the world’s first ultrasonic blood pressure monitor. This breakthrough allows for the miniaturization of blood pressure monitoring in wearable devices, including smartwatches and smart rings, achieving accuracy levels comparable to conventional electronic cuff devices.

-HistoSonics? Awarded Exclusive Contract with Veterans Affairs for Tumor Destroying Histotripsy Systems MINNEAPOLIS--(BUSINESS WIRE)

--HistoSonics, (www.histosonics.com), the developer and manufacturer of the Edison Histotripsy System, announced today they have been awarded an exclusive contract to provide Veteran’s Affairs hospitals across the United States access to their novel non-invasive tumor liquefying platforms.

-Paragonix Technologies Receives FDA 510(k) Clearance for KidneyVault Portable Renal Perfusion System WALTHAM, Mass.--(BUSINESS WIRE)

--Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, received U.S. Food and Drug Administration (FDA) 510(k) clearance for its donor kidney preservation system, KidneyVault. The KidneyVault System is Paragonix’s first perfusion device, integrating its streamlined digital monitoring capabilities with portable hypothermic perfusion technology to protect donor kidneys during transport and expand the donor pool.

-Movemedical Partners with Resurgens Technology to Expand Innovation in the Medical Device Supply Chain SAN DIEGO--(BUSINESS WIRE)

--Movemedical, the enterprise software platform for medical device inventory management, is pleased to announce a strategic investment partnership with Resurgens Technology Partners. This investment provides capital for continued growth and expansion, fueling Movemedical’s mission to unite the medical device supply chain and drive continued innovation across the industry.

-Vaxxas Licenses Next-Generation Vaccine for Respiratory Syncytial Virus (RSV) from the United States National Institutes of Health (NIH) BRISBANE, Australia & CAMBRIDGE, Mass.--(BUSINESS WIRE)

--Vaxxas, a clinical-stage biotechnology company commercializing a novel high-density microarray patch (HD-MAP) vaccination platform, announced that the United States National Institutes of Health (NIH) has granted the company a license to a next-generation vaccine antigen (DS2), designed for use in prophylactic vaccines against Respiratory Syncytial Virus (RSV).

-Groundbreaking Data Demonstrate Superiority of EARLY TAVR in Asymptomatic Severe Aortic Stenosis Patients WASHINGTON--(BUSINESS WIRE)

--Edwards Lifesciences (NYSE: EW) announced results from the EARLY TAVR Trial, the first randomized, controlled trial designed to study the best strategy for treating asymptomatic severe aortic stenosis (AS) and the benefits of early intervention with transcatheter aortic valve replacement (TAVR).

-Elixir Medical’s DynamX Bioadaptor Demonstrates Significant Improvement Over Contemporary Drug-Eluting Stent in Patients with Acute Coronary Syndrome and Complex Lesion Subsets After Six Months WASHINGTON--(BUSINESS WIRE)

--Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, announced late-breaking data demonstrating significant benefit of the DynamX? Coronary Bioadaptor System compared to contemporary Resolute Onyx? zotarolimus drug-eluting stent (DES) for target lesion failure (TLF) in complex patient population subsets from the INFINITY-SWEDEHEART RCT.

-Insulcloud Receives FDA Clearance to Expand Proprietary Diabetes Management Solution Insulclock? CAP into U.S. Market MADRID--(BUSINESS WIRE)

--Insulcloud, a pioneering healthtech company revolutionizing diabetes management, announced its strategic expansion into the U.S. market following the FDA's clearance of its award-winning Insulclock CAP smart device, designed to monitor patient use of disposable insulin pens in real time and increase patient adherence to prescribed therapy.

-MedLumics New CEO and Board Member Announces 10 Patients Treated in First in Man (FIM) Clinical Trial With the Real-Time Visually Guided AblaView PFA System MADRID--(BUSINESS WIRE)

--MedLumics, a medical device company developing fiber optically guided platform technologies for the treatment, initially, of Atrial fibrillation (AF), announced 10 patients treated in the company’s First in Man clinical trial. The AblaView Unipolar Pulsed Field (PF) Ablation System, used in this trial, features MedLumics unique, real-time, fiber optic, visually guided AF ablation technology.

-Qbtech Reaches 1 Millionth Patient Milestone with FDA-Cleared ADHD Tests HOUSTON--(BUSINESS WIRE)

--Qbtech, the global leader in objective ADHD testing, announced its one millionth patient milestone, amassing one of the most extensive data sets of patients tested for ADHD. Adopted by more than 12,000 healthcare providers worldwide, including 44 U.S. states, the company’s industry-leading tests provide evidence-based data for unbiased decision-making and enhanced patient care.

-Dassault Systèmes Collaboration Yields Breakthrough Guide for Using Virtual Twins in Clinical Trials VELIZY-VILLACOUBLAY, France--(BUSINESS WIRE)

--Dassault Systèmes (Euronext Paris: FR0014003TT8, DSY.PA) announced the availability of the world’s first guide for the medical device industry that outlines how to use virtual twins to accelerate clinical trials. This guide was published following the successful completion of a five-year collaboration with the U.S. Food and Drug Administration.

-GE HealthCare reports third quarter 2024 financial results CHICAGO--(BUSINESS WIRE)

--GE HealthCare (Nasdaq: GEHC) reported financial results for the third quarter ended September 30, 2024. GE HealthCare President and CEO Peter Arduini said, “In the third quarter, we reported sales and orders growth of 1% globally. Both sales and orders grew in the mid-single digits excluding China, with particular strength in the U.S. across all segments.

-BioIVT Launches LEUKOMAX? XL to Provide Researchers with More Cells from a Single Donor Collection per Volume WESTBURY, N.Y.--(BUSINESS WIRE)

--BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, launched LEUKOMAX XL, a new leukopak product that provides researchers with a minimum of 15 billion TNC. LEUKOMAX XL features the most cells from a single donor collection per volume, including over 50% more cells per bag than the standard Leukopak Full Paks, and is available through U.S. and U.K. collection sites.

-OSI Systems Receives $6 Million Award for Patient Monitoring Solutions HAWTHORNE, Calif.--(BUSINESS WIRE)

--OSI Systems, Inc. (the “Company” or “OSI Systems”) (NASDAQ: OSIS) announced that its Healthcare division, Spacelabs Healthcare?, has received an order valued at approximately $6 million to provide patient monitoring solutions and related supplies and accessories to a U.S. based hospital system.

-Personalized Neuromodulation Treatment Significantly Slowed Alzheimer’s Progression in 12-month Phase 2 Study, Meeting Primary and Key Secondary EndpointsCAMBRIDGE, Mass.--(BUSINESS WIRE)

--Sinaptica Therapeutics, Inc., a clinical-stage company leading the development of a new class of personalized neuromodulation therapeutics to treat Alzheimer’s and other primary neurodegenerative diseases, announced results of a 52-week Phase 2 study in Mild-to -Moderate Alzheimer’s disease patients showing that non-invasive personalized neuromodulation of the Default Mode Network (DMN).

-Ventus Therapeutics Announces Successful Completion of Phase 1 Clinical Trial of VENT-03, a First-in-Class, Orally Administered cGAS Inhibitor WALTHAM, Mass. & MONTREAL--(BUSINESS WIRE)

--Ventus Therapeutics, a clinical-stage biopharmaceutical company utilizing its proprietary ReSOLVE? platform to discover and develop differentiated small-molecule therapeutics, announced results from its Phase 1 clinical trial of VENT-03, the first cyclic GMP-AMP synthase (cGAS) inhibitor to successfully complete a first-in-human study.