KP Biomedical Engineering - Issue #10

-Agilent Revolutionizes HPLC with the Launch of the Agilent Infinity III LC Series SANTA CLARA, Calif.--(BUSINESS WIRE)

--Agilent Technologies Inc. (NYSE: A) announced the release of its next generation Agilent InfinityLab LC Series portfolio, which includes the 1290 Infinity III LC, 1260 Infinity III Prime LC, and 1260 Infinity III LC systems, all including the biocompatible versions. These are the first HPLC systems on the market to feature the new Agilent InfinityLab Assist Technology, offering enhanced, built-in system assistance capabilities.

-NUCLIDIUM Announces First Patient Imaged in Phase 1 Study Evaluating 61Cu-based Radiotracer in Patients with PSMA-positive Prostate Cancer BASEL, Switzerland--(BUSINESS WIRE)

--NUCLIDIUM today announced that the first patient has been successfully imaged in a phase 1 clinical trial evaluating the company’s radiotracer candidate as a safe and accurate diagnostic and disease-staging imaging agent in prostate cancer patients.

-Bruker Announces One-Hundred Dollar, Deep, High-Accuracy Plasma Proteome; Advances Glycoproteomics and Metaproteomics DRESDEN, Germany--(BUSINESS WIRE)

--At the 23rd Human Proteome Organization World Congress, Bruker Corporation (Nasdaq: BRKR) announces advances in deep, unbiased and high-sensitivity 4D-Proteomics for robust, high- fidelity, large-scale studies - avoiding inherent cross-talk of affinity high-plex technologies.

-Endospan Completes Enrollment of Primary Arm in NEXUS® Aortic Arch Stent Graft TRIOMPHE IDE Clinical Study HERZLIA, Israel--(BUSINESS WIRE)

--Endospan, a pioneer in endovascular solutions for the Aortic Arch, announced the completion of enrollment for the primary arm of its TRIOMPHE Investigational Device Exemption (IDE) clinical study for the NEXUS® Aortic Arch Stent Graft. The study is evaluating the safety and efficacy of the device for the treatment of aortic arch disease.

-Augurex Announces Agreement with ARUP Laboratories to Expand Access to Advanced Rheumatoid Arthritis Diagnosis with the Launch of 14-3-3η (eta) Test VANCOUVER, British Columbia--(BUSINESS WIRE)

--Augurex Life Sciences Corp., a leader in autoimmune biomarker-based diagnostics, announced that ARUP Laboratories, a leading national reference laboratory in the U.S., has launched the 14-3-3η test as part of their diagnostic testing portfolio. This agreement is poised to significantly enhance the early detection and management of rheumatoid arthritis (RA), providing clinicians with an important tool to improve patient care and outcomes.

-ENDRA Life Sciences Activates TAEUS System to Initiate Clinical Study at LMU University Hospital in Germany ANN ARBOR, Mich.--(BUSINESS WIRE)

--ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), announces the activation of a post market clinical study and first patient scanned with the TAEUS liver system at LMU University Hospital in Munich, one of the leading medical research centers in Europe.

-Revvity Highlights its Strong Progress on Sustainability and Workplace Culture in 2024 Impact Report WALTHAM, Mass.--(BUSINESS WIRE)

--Revvity, Inc. (NYSE: RVTY) unveils its annual Impact Report, a declaration of the Company’s sustainability, social and governance strategy, initiatives and performance. The report showcases Revvity’s continued evolution and strengthened commitments to creating a lasting, positive impact on the world.

-Peli BioThermal Unveils Crēdo Vault™: A Revolutionary Solution for Bulk Pharma Shipments MAPLE GROVE, Minn.--(BUSINESS WIRE)

--Peli BioThermal, a global leader in temperature-controlled packaging, proudly announces the launch of Crēdo Vault™, an advanced bulk shipper that offers thermal reliability and real-time monitoring for pharmaceutical and life sciences shipments.

-Introducing Avandra: The World’s Largest Federated Network for Medical Imaging and Clinical Data IRVINE, Calif.--(BUSINESS WIRE)

--Avandra, the world’s largest federated network for medical imaging and clinical data, launched out of stealth. Avandra’s network aims to organize global medical images and create a data ecosystem for research and innovation. It utilizes industry-leading de-identification and tokenization solutions to securely deliver aggregated, multimodal data to power the future of health.

-Artera Receives California Lab License, Expanding Access to its ArteraAI Prostate Test SAN FRANCISCO--(BUSINESS WIRE)

--Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced it has received its California laboratory license from the California Department of Public Health (CDPH). This licensure allows Artera to offer its innovative ArteraAI Prostate Test to one of the largest healthcare markets in the United States.

-Revvity Introduces Transcribe AI: Revolutionizing Data Entry in Clinical Laboratories WALTHAM, Mass.--(BUSINESS WIRE)

--Revvity, Inc. (NYSE: RVTY) announced the launch of Revvity Transcribe AI, an innovative optical character recognition (OCR) service designed to convert handwritten text on test request forms into a digitized format. This cutting-edge solution is now available to clinical laboratories, aiming to streamline workflows and reduce manual data entry tasks.

-Hesperos, Inc. Appoints Lawrence Florin as Chief Executive Officer to Lead Company Growth ORLANDO, Fla.--(BUSINESS WIRE)

--Hesperos, Inc., a pioneer in recreating human biology for drug development with its Human-on-a-Chip® technology, is pleased to announce the appointment of Lawrence (Larry) Florin as Chief Executive Officer. Mr. Florin brings over two decades of leadership experience in the bio / clinical technology arenas, with a proven track record in clinical development, business growth, and strategic innovation.

-United Therapeutics Corporation Announces the 500th Lung Transplant Utilizing its Centralized Ex Vivo Lung Perfusion Service SILVER SPRING, Md. & JACKSONVILLE, Fla.--(BUSINESS WIRE)

--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, and its subsidiary Lung Bioengineering Inc. (LBE) announced that the 500th lung transplant utilizing LBE’s centralized ex vivo lung perfusion (EVLP) service was completed last month. These 500 transplants were the result of evaluating over 800 donated lungs using centralized EVLP since 2014.

-Allurion Announces Submission of First Three Modules of Premarket Approval Application to the U.S. Food and Drug Administration for the Allurion Balloon NATICK, Mass.--(BUSINESS WIRE)

--Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, announced the submission of the first three modules of its premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for the Allurion Balloon. The Company expects to file the fourth and final module of the PMA containing the clinical data from its AUDACITY trial early next year.

-Flosonics Medical Earns Best In Class Digital Health Award for World’s First Wearable Doppler Ultrasound Patch LAS VEGAS--(BUSINESS WIRE)

--Flosonics Medical, a leader in wearable medical ultrasound, was selected as a Best in Class of the Digital Health Awards, presented by the Digital Health Hub Foundation in a ceremony Monday afternoon in Las Vegas at HLTH, the global healthcare conference. One year after being named a Rising Star in the awards program, Flosonics was named Best in Class within the Provider Diagnostics category.

-AMRA® Profiler 4 Pilot Study Demonstrates Feasible Assessment of Muscle Composition in Liver Transplant Candidates LINKÖPING, Sweden--(BUSINESS WIRE)

--A recent publication in the Annals of Hepatology utilizing the AMRA® MAsS Scan, a body-composition analysis service powered by the FDA 510(k) cleared AMRA® Profiler 4 device, explored the feasibility of using AMRA’s specialized MRI-based analysis for generating muscle composition assessments in patients with end-stage liver disease (ESLD).

-Sinaptica Therapeutics to Present Results of 52-week Phase 2 Study of Precision Neuromodulation for Alzheimer’s Diseases in Oral Presentation at Clinical Trials on Alzheimer’s Disease (CTAD) Conference CAMBRIDGE, 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, today announced that the company will present an oral presentation with results of a 52-week Phase 2 study in Mild-to-Moderate Alzheimer’s disease at the Clinical Trials on Alzheimer’s Disease (CTAD) conference being held October 29-November 1, 2024.

-CroíValve Announces First Implant of a Novel Minimally Invasive Device for Tricuspid Regurgitation in US Early Feasibility Study DUBLIN--(BUSINESS WIRE)

--CroíValve, a pioneering medical device company focused on the development of a novel transcatheter device for the treatment of severe+ tricuspid regurgitation (TR), announced the first patient treated with the DUO™ System as part of the TANDEM II Early Feasibility Study in the U.S. The DUO™ System is a transcatheter valve that works in tandem with the native tricuspid valve to restore valve function while preserving the native valve apparatus.

-Edmonton MedTech Start-Up MACH32 Awarded Research and Development Contract From BARDA To Develop Life-Saving Bleeding Control Intervention EDMONTON, Alberta--(BUSINESS WIRE)

--MACH32 announced that it has been awarded an EZ-BAA Advanced Research and Development contract from Biomedical Advanced Research and Development Authority (BARDA). The contract supports MACH32’s development of an intramuscular formulation of tranexamic acid (TXA) formulation designed to treat life-threatening bleeding after traumatic injury. Uncontrolled bleeding is a leading cause of preventable death worldwide.

-Adagio Medical Announces Completion of First Procedures in FULCRUM-VT U.S. FDA Pivotal IDE of Ventricular Tachycardia Cryoablation System LAGUNA HILLS, Calif.--(BUSINESS WIRE)

--Adagio Medical Holdings, Inc. (Nasdaq: ADGM; “Adagio Medical”, “Adagio” or the “Company”), a leading innovator in catheter ablation technologies, announced the completion of the first procedures in FULCRUM-VT U.S. Food and Drug Administration (FDA) Pivotal IDE study of Adagio’s VT Cryoablation System.

-Groundbreaking GUARDIAN Study Shows Benefits of Adding Genome Sequencing to Newborn Screening; Augments and Improves Standard Newborn Screening STAMFORD, Conn.--(BUSINESS WIRE)

--GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, announced that JAMA, the Journal of the American Medical Association, published peer-reviewed research from the GUARDIAN (Genomic Uniform-screening Against Rare Diseases In All Newborns) study, the largest study of its kind to explore the utility of whole genome sequencing (WGS) to identify 255 early onset genetic conditions in newborns from a diverse population.

-Finalists Announced in 2024 Create the Future Design Contest Sponsored by Mouser Electronics DALLAS & FORT WORTH, Texas--(BUSINESS WIRE)

--Mouser Electronics, Inc., the New Product Introduction (NPI) leader™ empowering innovation, congratulates the finalists for the 2024 Create the Future Design Contest, a global challenge to engineers and innovators around the world to design the next great thing. The competition is produced by SAE Media Group, an SAE International Company, and Tech Briefs magazine. COMSOL is also a principal sponsor of the contest.

-Elucid Announces Fifth Medicare Administrative Contractor to Cover AI Coronary Plaque Analysis BOSTON--(BUSINESS WIRE)

--Elucid has announced that Noridian will extend coverage for AI-enabled quantitative coronary plaque analysis, including its FDA-cleared PlaqueIQ™ image analysis software, beginning December 8, 2024. With this decision, five of the seven Medicare Administrative Contractors (MACs) will soon provide coverage for AI-enabled quantitative coronary plaque analysis, expanding accessibility to over 70 percent of eligible Medicare patients across the United States.

-WellSky® Acquires Leading Durable/Home Medical Equipment Software Provider Bonafide®, Enhancing Home Care Solutions OVERLAND PARK, Kan.--(BUSINESS WIRE)

--WellSky, a leading health and community care technology company, announced that it has acquired Bonafide, an enterprise software solution for durable medical equipment (DME) and home medical equipment (HME) companies. With the addition of Bonafide, WellSky expands its footprint in DME/HME and will serve more providers with an integrated software platform that allows them to run their businesses compliantly, efficiently, and profitably.

-Exact Sciences Presents Multiple Studies at ACG 2024 Demonstrating Leadership in Noninvasive Colorectal Cancer Screening and Patient Engagement MADISON, Wis.--(BUSINESS WIRE)

--Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, announced the company will present modeling data evaluating the simulated benefit and burden of established CRC screening strategies, including the Cologuard Plus™ test during the American College of Gastroenterology (ACG) Annual Meeting.