KP Biomedical Engineering - Issue #37

-EU Regulations for Digital Medical Devices with AI Components Specialist Course | A Basket Full of Requirements - What Does a Manufacturer Need to Consider? DUBLIN--(BUSINESS WIRE)

--The "The EU Regulations for Digital Medical Devices with AI Components - A Basket Full of Requirements - What Does a Manufacturer Need to Consider?" training has been added to ResearchAndMarkets.com's offering. This compact 4-hour specialist course provides manufacturers, developers and quality managers with a systematic overview of the regulatory requirements that must be observed when developing and placing AI-based medical software on the market in Europe. In addition to EU MDR 2017/745, numerous other EU regulations and national regulations apply to the development, approval and documentation of digital medical devices with AI components, the sheer number of which can make even well-informed manufacturers and developers lose track. In addition, various legal deadlines expire or have already expired by 2031, with further requirements to be met with each deadline. For example, the AI Act is already legally binding and applicable, while the regulations on the European Health Data Space (EHDS) have several transitional periods.

-Syncell Announces Strategic Co-Marketing Agreement to Advance High-Resolution Spatial Proteomics LIVERMORE, Calif., & TAIPEI, Taiwan--(BUSINESS WIRE)

--Syncell, Inc., a pioneer in subcellular spatial proteomics, announced a strategic co-marketing agreement with Thermo Fisher Scientific to bring a fully integrated, high-resolution spatial proteomics workflow to the market. The collaboration highlights the power of integrating Syncell’s proprietary Microscoop® technology for spatial protein purification with Thermo Fisher’s ultra-sensitive Orbitrap™ Astral™ mass spectrometer and newly released Orbitrap™ Astral™ Zoom mass spectrometer.

-Apreo Health Announces First Patient Treated in BREATHE-3, Pivotal Clinical Trial of Company’s BREATHE Airway Scaffold MENLO PARK, Calif.--(BUSINESS WIRE)

--Apreo Health, a clinical-stage medical device company pioneering a novel, tissue-sparing approach for treating severe emphysema, announced that the first patient has been treated in its pivotal clinical trial, BREATHE-3 (Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung—Study 3). The trial is evaluating the safety and efficacy of the Apreo BREATHE Airway Scaffold, a bronchoscopically delivered, self-expanding implant designed to relieve emphysema-related lung hyperinflation in patients who continue to have difficulty breathing despite optimal medical management.

-bioAffinity Technologies Reports Second Quarter 2025 Results SAN ANTONIO--(BUSINESS WIRE)

--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on providing noninvasive, accurate detection of early-stage lung cancer and other lung diseases, reported financial results for the three months ended June 30, 2025.“Our second quarter results reflect the continued acceleration of our CyPath® Lung commercialization strategy, with testing revenue up 62% for the first half of the year,” Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies said.

-BioTools Innovator Begins VANGUARD Program with Inaugural Accelerator Track Cohort and Nearly $1M in Funding Awards LOS ANGELES--(BUSINESS WIRE)

--BioTools Innovator (BTI) VANGUARD has selected five companies for up to $200,000 in non-dilutive funding contracts and 10 companies for the 2025 Accelerator Track. Through the two arms of the program, BTI VANGUARD aims to support the development and commercialization of innovative enabling technologies that could be readily deployed as medical countermeasures in the event of a health emergency.“I’m very excited to welcome the inaugural companies selected for the BTI VANGUARD Accelerator Track and DEV projects,” said Kathryn Zavala, Managing Director of BioTools Innovator.

-RenovoRx Reports Commercial Revenue Growth in the Second Quarter 2025 MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)

--RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, announced its financial results and business update to shareholders for the second quarter ended June 30, 2025.

-Tivic Health Advances Discussions on Use of Entolimod as a Radiation Countermeasure at Military Health System Research Symposium 2025 FREMONT, Calif.--(BUSINESS WIRE)

--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, is proud to announce that it has advanced discussions with key US Government agencies through its participation in the 2025 Military Health System Research Symposium (MHSRS), held August 4-7, 2025, in Kissimmee, Florida. The MHSRS is the Department of Defense’s premier scientific meeting that brings together military, academic, and industry experts to discuss medical research and innovation in support of warfighter health and readiness.

-IMvigor011 Bladder Cancer Trial Achieves Positive Results, with Signatera™ Strongly Predicting Adjuvant Immunotherapy Benefit AUSTIN, Texas--(BUSINESS WIRE)

--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, announced positive topline results from the randomized, phase III IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC). The trial is sponsored by Genentech, a member of the Roche Group. IMvigor011 utilizes the Signatera ctDNA test in patients with MIBC to detect molecular residual disease (MRD) in the bloodstream after surgery and predict who will benefit from adjuvant treatment with the cancer immunotherapy atezolizumab (Tecentriq®). Approximately 760 patients were enrolled in the surveillance phase of the trial and underwent serial Signatera testing for up to 12 months post surgery. Patients were randomized to treatment with atezolizumab or placebo if they tested Signatera-positive and remained free of cancer recurrence on imaging with treatment administered every 4 weeks for 12 cycles or up to one year. Patients who consistently tested Signatera-negative were not randomized to treatment but continued to be followed up with radiographic imaging and ctDNA MRD testing.

-Cohesys Announces First-in-Human Use of Investigational BoneTape™ in Craniofacial Fracture Repair TORONTO--(BUSINESS WIRE)

--Cohesys Inc., a Toronto-based medical device developer of resorbable fixation technologies, announced that the first participants have undergone treatment with BoneTape™, an investigational device designed for the fixation of non-load-bearing craniofacial fractures. The procedures were completed as planned and mark the first clinical use of this drill- and screw-free fixation system. "Reaching this milestone is significant for Cohesys as we evaluate BoneTape’s potential to offer a simpler, patient-friendly approach to fracture repair,” said Dr. Michael Floros, CEO of Cohesys. “The data from this study will inform our regulatory strategy and commercialization pathway.”

-Harrison.ai's Foundation Model Achieves Breakthrough Results in Independent US Healthcare AI Challenge SYDNEY--(BUSINESS WIRE)

--Harrison.ai, a leading healthtech company, announced that its radiology-specific foundation model, Harrison.rad.1, delivered exceptional preliminary results in an independent, large-scale evaluation by Mass General Brigham (MGB) and the American College of Radiology. Harrison.rad.1 was released last year and outperformed foundation models from OpenAI, Anthropic, Google and others on VQA-Rad, one of the most widely used benchmarks to evaluate and compare the performance of multimodal foundational models on medical tasks. Harrison.rad.1 achieved 82% accuracy and precision on closed questions filtered for plain radiographs. The results of the Healthcare AI Challenge are just now reaffirming these impressive results.

-EU MDR and FDA Clinical Evaluation of Medical Device Software and Software as a Medical Device Training Course (ONLINE EVENT: October 1, 2025) - ResearchAndMarkets.com DUBLIN--(BUSINESS WIRE)

--The "Clinical Evaluation of Medical Device Software and Software as a Medical Device Training Course" training has been added to ResearchAndMarkets.com's offering. This course will provide a clear understanding of the clinical evaluation requirements and their practical application for software products, including AI/ML-based devices. It will also provide advice on how to determine the type and amount of data needed to sufficiently support the intended medical purpose and (individual) clinical claims, with many practical examples and analysis of differences between the EU MDR and FDA approach.

-LivaNova Launches Essenz Perfusion System in China LONDON--(BUSINESS WIRE)

--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, announced it initiated the commercial launch of the Essenz™ Perfusion System in China, the second-largest market for LivaNova heart-lung machines (HLMs) after the United States. The Essenz Perfusion System, which recently received regulatory approval from China’s National Medical Products Administration (NMPA), enables a patient-tailored perfusion approach rooted in data-driven decision-making that improves both clinical workflows and quality of patient care during life-saving cardiopulmonary bypass (CPB) procedures.

-Cynosure Lutronic Announces U.S. Clearance of the XERF™ Device, Redefining the Future of Non-Invasive Skin Tightening WESTFORD, Mass.--(BUSINESS WIRE)

--Cynosure Lutronic, a global leader in energy-based medical aesthetic devices, is proud to announce that its XERF™ system, an innovative radiofrequency (RF) technology for skin tightening, has received clearance from the U.S. Food and Drug Administration. The XERF system is a groundbreaking, non-invasive solution for skin revitalization that tightens skin without the need for numbing, needles, or downtime, and is safe for all skin types.

-Bausch + Lomb Announces Board Changes VAUGHAN, Ontario--(BUSINESS WIRE)

--Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, announced that the Amended and Restated Director Appointment and Nomination Agreement, dated as of June 21, 2022, by and among the company and Mr. Carl C. Icahn and certain of his affiliates, terminated pursuant to its terms when the Icahn group’s net long position in the common shares of Bausch + Lomb’s parent company, Bausch Health Companies Inc., fell below the required threshold. In connection with the termination, Brett M. Icahn and Gary Hu have resigned from the Bausch + Lomb Board of Directors.

-Capvidia brings MBD for Suppliers with browser-based 3D human-viewable models linked to QIF/STEP CHICAGO--(BUSINESS WIRE)

--Capvidia, a global leader in Model-Based Definition (MBD) and Model-Based Enterprise (MBE) software, announced a major milestone for MBDVidia: 3D human-viewable HTML models synchronized with QIF and STEP AP242. The result is OEM MBD that suppliers can use anywhere with no CAD required.

--Align Technology Initiates Patent Infringement Ligitation Against Angelalign Technology SAN JOSE, Calif. & TEMPE, Ariz.--(BUSINESS WIRE)

--Align Technology, Inc. (“Align”) (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign® System of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, today announced the filing of patent infringement lawsuits against Angelalign Technology, Inc. (“Angel”) (Hong Kong Stock Exchange: 6699.HK), a Shanghai-based manufacturer of clear aligners. The lawsuits allege that Angel’s products and associated software infringe Align patents, which encompass innovations such as multilayer aligner materials, cutting-edge treatment planning, and advanced aligner features.

-Alcon Underscores Benefits of Its IOLs and Cataract Surgical Equipment at APACRS AHMEDABAD, India--(BUSINESS WIRE)

--Alcon, the global leader in eye care dedicated to helping people see brilliantly, announced a strong presence at the 37th Asia-Pacific Association of Cataract and Refractive Surgeons (APACRS) Annual Meeting. APACRS will be held at Mahatma Mandir Convention and Exhibition Centre (MMCEC) in Ahmedabad, India, from August 21-23, 2025. The company will showcase four symposia, lead 10 medical affairs scientific exchange presentations, and offer a hands-on experience zone at booth #A1. These comprehensive activities, combined with new data, underscore Alcon's commitment to generating meaningful scientific evidence on the safety and efficacy of its innovations.

-Zai Lab Announces China National Medical Products Administration Grants Innovative Medical Device Designation for Tumor Treating Fields for Patients with Pancreatic Cancer SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)

--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced that the China National Medical Products Administration (NMPA) has granted Innovative Medical Device Designation for Tumor Treating Fields (TTFields) for patients with pancreatic cancer based on the positive results from the Phase 3 PANOVA-3 trial. The Innovative Medical Device Designation allows Zai Lab to take advantage of an expedited approval procedure for TTFields that offers opportunities for the NMPA to prioritize the allocation of review resources to expedite the regulatory review and approval process.

-Butterfly Network Joins Research Project Studying the Impact of AI-Assisted POCUS on Early Tuberculosis Detection in Sub-Saharan Africa BURLINGTON, Mass. & NEW YORK--(BUSINESS WIRE)

--Butterfly Network, Inc. (“Butterfly”, “the Company”) (NYSE: BFLY), a digital health company transforming care with handheld, whole-body ultrasound, today announced its role in the international research study CAD LUS4TB that will evaluate the impact of AI-assisted point-of-care ultrasound (POCUS) on tuberculosis (TB) triage in under-resourced settings.

-Masimo O3® Regional Oximetry Receives FDA Clearance for Expanded Indication of Its Unique Delta Hemoglobin ParametersIRVINE, Calif.--(BUSINESS WIRE)

--Masimo (NASDAQ: MASI) announced the FDA 510(k) clearance of expanded indications for the delta hemoglobin parameters provided with O3® Regional Oximetry. The parameters (ΔcHb, ΔHHb, and ΔO2Hb) display relative changes in hemoglobin that can help clinicians identify the underlying mechanisms responsible for changes in tissue oxygen saturation. With this latest clearance, this capability is now available for use in both cerebral and somatic applications as well as for all patient populations, including pediatric and neonatal patients.

-Synchron Expands Executive Team with Appointment of Andy Rasdal as Chief of Staff and Mark Brister as VP R&D NEW YORK--(BUSINESS WIRE)

--Synchron, a category-defining brain-computer interface (BCI) company, announced the appointment of Andy Rasdal as Chief of Staff and Mark Brister as VP R&D. The appointments bring deep experience in launching and scaling category-leading medical devices, positioning Synchron to advance its Stentrode® BCI through U.S. clinical trials and prepare for global market entry.

-Delcath Systems Announces First Patient Dosed in Phase 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic Colorectal Cancer QUEENSBURY, N.Y.--(BUSINESS WIRE)

--Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announced that the first patient has been dosed at the City of Hope National Medical Center in its global Phase 2 Clinical Trial evaluating HEPZATO™ in combination with standard of care (SOC) treatment for liver-dominant metastatic colorectal cancer (mCRC). The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with trifluridine-tipiracil and bevacizumab compared to trifluridine-tipiracil and bevacizumab alone in patients with liver-dominant mCRC receiving third-line treatment. Approximately 90 patients will be enrolled in this randomized, controlled trial. The study will be conducted at more than 20 sites across the United States and Europe. Results from the trial’s primary endpoint, hepatic progression-free survival (hPFS), are anticipated by mid-2028, while overall survival (OS), a secondary endpoint, is expected in late 2028.

-Propel Software Survey Reveals Medical Device Industry Lags in Adopting AI for Product Operations REDWOOD CITY, Calif.--(BUSINESS WIRE)

--Propel Software, creator of the first product value management (PVM) platform that transforms how businesses create, market, sell, and service products, today unveiled medical device industry findings from its State of Product Innovation 2025: AI Adoption and Collaboration Trends research. The survey, commissioned by Propel Software and conducted by Talker Research, found AI adoption in the medical device market trails all other industries surveyed, with a significant 50% lag versus high tech. Three quarters (76%) of medical device respondents don’t use AI in product operations and struggle with effectiveness as a result, highlighting the challenge the industry faces between adopting new technology and needing to remain compliant with global regulatory standards.

-Guided Therapeutics Receives $70,000 -- Its Second of Nine Payments Totaling $700,000 -- from New Chinese Distribution Partner that Provides Products for 2 Million Annual Cervical Cancer Screenings PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)

--Guided Therapeutics, Inc. (OTC:QB GTHP), the maker of the LuViva Advanced Cervical Scan, announced that on August 14th 2025, it had received a payment of $70,000 from its new distribution partner in China, Hangzhou Dongye Medical Technology Company, Ltd. (HDMT). This is the second scheduled payment in a series of nine payments that will total $700,000 in exchange for LuViva components and services. Thus far a total of $100,000 has been received by GTHP. The $70,000 payment received on August 14th 2025 triggers the shipment of three sets of components to HDMT and the manufacture of four additional sets of components. Once these four sets of components are assembled and tested, it will trigger the next payment of $80,000 from HDMT. Revenue from these sales is recognized once payments have been received and products are shipped. HDMT is in Hangzhou City, Zhejiang Province, where it is the exclusive provider of gynecology products for 42 hospitals that perform approximately two million cervical cancer screenings annually.

-Sequencing.com Announces Strategic Partnership with PGxAI to Drive Affordable Healthcare Through Advanced Pharmacogenomics PALO ALTO, Calif.--(BUSINESS WIRE)

--Sequencing.com, a biotech company offering the world’s largest platform for whole genome sequencing and personalized health insights, announced a strategic partnership with PGxAI, a leader in AI-driven pharmacogenomics. This collaboration will transform the pharmacogenomics field by combining cutting-edge genomic insights with real-world healthcare applications, ultimately enhancing patient outcomes and reducing adverse drug reactions.

-WHO and UNICEF to Launch Polio Vaccination Campaign in Afghanistan with PharmaJet® Tropis® ID Delivery System GOLDEN, Colo.--(BUSINESS WIRE)

--PharmaJet®, a company that strives to improve the performance and outcomes of injectables with its enabling needle-free injection technology, announced that the WHO prequalified Tropis ID delivery system will be used to support a polio eradication campaign sponsored by the National Emergency Operation Center (NEOC) Afghanistan, UNICEF, WHO, and other GPEI partners starting in August 2025. Focused on the Eastern region of Afghanistan, the campaign will deploy Tropis ID to administer 1.3 million fractional doses of inactivated polio vaccine (fIPV) to children ages 5 and under in parallel to oral polio vaccine (OPV) administration as part of a WHO-recommended strategy to boost humoral and mucosal immunity.