Latest news with #SaMD
Miami Herald
20 hours ago
- Health
- Miami Herald
JBA AI Earns FDA SaMD Recognition
A New Era of Accessible Health Monitoring GARDEN GROVE, CALIFORNIA / ACCESS Newswire / June 9, 2025 / JBA AI, the flagship health-tech division under AQ Pharmaceuticals, Inc. and JBA Brands, proudly announces several major global milestones in its mission to make preventive healthcare more accessible, intelligent, and affordable. JBA AI has been officially recognized by the United States Food and Drug Administration (FDA) as a Software as a Medical Device (SaMD). In addition, the platform has now received Class B Medical Device approval from Vietnam's Ministry of Health. These achievements affirm the platform's safety, clinical effectiveness, and international credibility. The JBA AI mobile application is already available globally for Android users and will soon be released on iOS. It enables contactless, non-invasive vital signs monitoring directly through smartphones or tablets. In just 60 seconds, the app delivers insights on over nine key health metrics. These include heart rate, heart rate variability, blood oxygen saturation, respiratory rate, stress index, and estimated glucose and blood pressure trends. This is achieved using AI-powered facial signal analysis through camera-based remote photoplethysmography technology. Expanding its impact even further, JBA AI has partnered with one of Vietnam's largest financial institutions, which serves more than 30 millions members. Together, they are preparing to launch JBA AI nationwide, making preventive health monitoring more accessible through a trusted and widespread digital network. "JBA AI is more than a health app - it's a certified medical device. Recognized by both the FDA and Vietnam's Ministry of Health," said Tracy Trang Nguyen, founder and CEO of JBA AI. "We're proud to deliver trusted, clinically guided tools for daily health monitoring worldwide." Nguyen is a Vietnamese American engineer and wellness industry leader who developed JBA AI after surviving cancer. Her personal health journey inspired her to combine advanced artificial intelligence with affordable wellness solutions. Under her leadership, JBA AI complements other products within the JBA Brands portfolio, such as GlucoTrojan, Joint Revive Fucoidan, and Vegan Collagen, to form a fully integrated health ecosystem. JBA AI is already gaining traction and is starting to expand into pharmacies, corporate wellness programs, public health campaigns, and family clinics across the United States, Vietnam, and other countries. The platform's franchise-ready model supports rapid local deployment while keeping costs low and impact high. It is designed to help people monitor their health in real-time, without the need for needles, wearable devices or clinic visits. JBA AI is currently welcoming franchisees, affiliates, and institutional partners to help bring this technology to communities around the world. Whether at home or in partnership with healthcare providers, JBA AI is redefining preventive care through data-driven technology and a compassionate approach to well-being. Contact Information Catherine Marino Marketing Managercat@ 714 903 1009 SOURCE: AQP One, Inc. press release
Yahoo
27-05-2025
- Business
- Yahoo
Median Technologies to Showcase iCRO's Central and AI-Powered Imaging Services for Oncology Clinical Trials at ASCO 2025
Median is a leading provider of imaging services to the world's top oncology pharma companies ASCO abstracts position Median as highly differentiated provider of AI-imaging services for oncology trials Median will host two presentation sessions to introduce its new solution for radiopharmaceutical image processing for oncology research at booth #11046 SOPHIA ANTIPOLIS, France, May 27, 2025--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, "Median" or the "Company"), manufacturer of eyonis®, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, announced today that the Company will be participating in the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place from May 30 to June 2, McCormick Place, Chicago, IL, USA. Median's team will be hosting interested parties at booth #11046, South Building, Hall A, McCormick Place, from May 31 to June 2 (exhibit dates), from 9:00 am to 5:00 pm CT, where it will share the most recent advances for its central and AI-powered imaging services for oncology clinical trials. Median Technologies' abstracts selected for online publication are available on the ASCO platform: Abstract e24073: Technical Performance of the L3 Skeletal Muscle Index in CT Abstract e13590: Using tumor growth modeling and informed neural networks as early predictive clinical endpoints Median will host two 30-minute presentation sessions on how the Company's new solution for radiopharmaceutical image processing is advancing oncology research. Sessions will take place at booth #11046 on Saturday, May 31 and Sunday, June 1, 11:30 am -12:00 pm CT. The ASCO Annual Meeting is the world's premier oncology conference, organized by the American Society of Clinical Oncology, the largest oncology society in the world. Each year, the ASCO conference brings together more than 35,000 oncologists from all around the globe, and is attended by all medical, educational and industrial stakeholders involved in the field of oncology worldwide. More about the ASCO Annual Meeting: About Median Technologies: Pioneering innovative software as a medical device and imaging services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and treatments. Median's offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis®, an AI/ML tech-based suite of software as a medical device (SaMD). Median empowers biopharmaceutical entities and clinicians to advance patient care and expedite the development of novel therapies. The French-based company, with a presence in the U.S. and China, trades on the Euronext Growth market (ISIN: FR0011049824, ticker: ALMDT). Median is also eligible for the French SME equity savings plan scheme (PEA-PME). For more information, visit View source version on Contacts MEDIAN TECHNOLOGIES Emmanuelle LeyguesVP, Corporate Marketing & Financial Communications+33 6 10 93 58 Investors - SEITOSEI ACTIFIN Ghislaine Gasparetto+33 6 21 10 49 U.S. media & investors - COHESION BUREAU Chris Maggos+41 79 367 Press – ULYSSE COMMUNICATION Bruno Arabian+33 6 87 88 47 26barabian@ Nicolas Entz+33 6 33 67 31 54nentz@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
22-05-2025
- Business
- Yahoo
Bayer Launches Centafore Imaging Core Lab to Support Imaging for Clinical Trials and Software as a Medical Device Development
Imaging Contract Research Organization (iCRO) from Bayer offering tailored services that will span the entire imaging study cycle from concept to completion Supporting early research through Phase IV trials and Software as a Medical Device (SaMD) development for pharmaceutical, biotech, medical device, and digital health companies 25+ years of expertise as the Imaging Core Lab for Bayer, supporting more than 200 clinical trials globally Bayer will be showcasing Centafore, its services and technology at this year's Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 30 till June 3 WHIPPANY, N.J., May 22, 2025--(BUSINESS WIRE)--Bayer today announced the launch of its Imaging Core Lab Services under the brand name Centafore. With over 25 years of experience supporting more than 200 clinical trials at Bayer and its arm's length companies globally, Centafore is now positioned as a distinct Imaging solution provider, offering tailored services for external customers to support their clinical trials and Software as a Medical Device (SaMD) development across diverse therapeutic areas and development phases. Attendees of the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) will get the chance to learn more about the Centafore team, technology and its services in Chicago from May 30 till June 3 (Booth #24152). Centafore provides technology and services for image management, processing, and interpretation, empowering study sponsors with expert project management and facilitating advanced analyses of imaging data. Its extensive network includes experienced imaging professionals like board-certified radiologists, enabling customers to effectively manage studies across more than 50 countries. "Centafore represents a significant leap forward in our commitment to enhancing the landscape of clinical trial imaging and advancing the development of new medicines and healthcare solutions," said Nelson Ambrogio, President of Radiology at Bayer. "By leveraging our extensive experience and expertise, we are dedicated to providing our customers with high quality imaging services that meet their specific needs in clinical research. Through Centafore, we aim to enhance the reliability of trial outcomes and support informed decision-making in the development of investigational medicines, ultimately benefiting patients and improving their quality of care." Centafore's services support a wide range of therapeutic areas, including oncology, cardiovascular, CNS, dermatology, women's health, pediatrics, and digital health. It aims to help pharmaceutical, biotech, medical device and digital health companies with early research through Phase IV trials and SaMD development, and adherence to regulatory and data privacy compliance standards. As part of Bayer's ongoing efforts to support global healthcare startups, the Imaging Core Lab Services of Bayer have been first presented at ECR 2024. Centafore is already collaborating with organizations such as OBIO® and Luxsonic Technologies to leverage clinical imaging as a critical tool for improving decision-making in clinical trials and software as a medical device (SaMD) development. About Centafore Centafore is an Imaging Contract Research Organization (iCRO) that supports early research through phase IV trials and Software as a Medical Device (SaMD) development for pharma, biotech, medical device and digital health companies. For over 25 years, it has been the primary, trusted iCRO for Bayer, playing a vital role in advancing the company's drug pipeline – and now, extended its expertise to external customers under the brand name Centafore, delivering high-quality support for imaging studies and research initiatives across the industry. About Bayer in Radiology Building on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET). Bayer's comprehensive offerings also include informatics solutions, a curated marketplace with digital and artificial intelligence (AI) enabled applications. In 2024, Bayer's radiology products generated €2.1 billion in global sales. Committed to research and innovation, Bayer continues to advance medical imaging with the ultimate goal to improve patient outcomes. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, "Health for all, Hunger for none," the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to Find more information at Follow us on LinkedIn: Bayer | Pharmaceuticals Follow us on Twitter: @BayerPharma Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. View source version on Contacts Global media contact: Simone Leyendecker, phone +49 174 9508190 Email: US media contact: Jennifer May, phone Email: Sign in to access your portfolio
Business Wire
22-05-2025
- Business
- Business Wire
Bayer Launches Centafore Imaging Core Lab to Support Imaging for Clinical Trials and Software as a Medical Device Development
WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced the launch of its Imaging Core Lab Services under the brand name Centafore. With over 25 years of experience supporting more than 200 clinical trials at Bayer and its arm's length companies globally, Centafore is now positioned as a distinct Imaging solution provider, offering tailored services for external customers to support their clinical trials and Software as a Medical Device (SaMD) development across diverse therapeutic areas and development phases. Attendees of the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) will get the chance to learn more about the Centafore team, technology and its services in Chicago from May 30 till June 3 (Booth #24152). Centafore provides technology and services for image management, processing, and interpretation, empowering study sponsors with expert project management and facilitating advanced analyses of imaging data. Its extensive network includes experienced imaging professionals like board-certified radiologists, enabling customers to effectively manage studies across more than 50 countries. 'Centafore represents a significant leap forward in our commitment to enhancing the landscape of clinical trial imaging and advancing the development of new medicines and healthcare solutions,' said Nelson Ambrogio, President of Radiology at Bayer. 'By leveraging our extensive experience and expertise, we are dedicated to providing our customers with high quality imaging services that meet their specific needs in clinical research. Through Centafore, we aim to enhance the reliability of trial outcomes and support informed decision-making in the development of investigational medicines, ultimately benefiting patients and improving their quality of care.' Centafore's services support a wide range of therapeutic areas, including oncology, cardiovascular, CNS, dermatology, women's health, pediatrics, and digital health. It aims to help pharmaceutical, biotech, medical device and digital health companies with early research through Phase IV trials and SaMD development, and adherence to regulatory and data privacy compliance standards. As part of Bayer's ongoing efforts to support global healthcare startups, the Imaging Core Lab Services of Bayer have been first presented at ECR 2024. Centafore is already collaborating with organizations such as OBIO® and Luxsonic Technologies to leverage clinical imaging as a critical tool for improving decision-making in clinical trials and software as a medical device (SaMD) development. About Centafore Centafore is an Imaging Contract Research Organization (iCRO) that supports early research through phase IV trials and Software as a Medical Device (SaMD) development for pharma, biotech, medical device and digital health companies. For over 25 years, it has been the primary, trusted iCRO for Bayer, playing a vital role in advancing the company's drug pipeline – and now, extended its expertise to external customers under the brand name Centafore, delivering high-quality support for imaging studies and research initiatives across the industry. About Bayer in Radiology Building on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET). Bayer's comprehensive offerings also include informatics solutions, a curated marketplace with digital and artificial intelligence (AI) enabled applications. In 2024, Bayer's radiology products generated €2.1 billion in global sales. Committed to research and innovation, Bayer continues to advance medical imaging with the ultimate goal to improve patient outcomes. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 'Health for all, Hunger for none,' the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Associated Press
20-05-2025
- Business
- Associated Press
Petros Pharmaceuticals Partners with Innolitics, a Leading Software-as-a-Medical-Device Developer
With more than $10m in cash, and a significantly reduced burn rate, the Company is positioned to fully fund the development of its technology platform. NEW YORK, NY / ACCESS Newswire / May 20, 2025 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) ('Petros' or the 'Company'), a company focused on expanding consumer access to medication through over the counter ('OTC') drug development programs, today announces its partnership with Innolitics, a leading developer in the Software-as-a-Medical Device space. The collaboration is intended to integrate many of the Company's emerging capabilities in the ongoing development of its first-in-industry SaaS platform designed to complement its proprietary web application (also known as a Software as a Medical Device, or 'SaMD'). Utilizing the same knowledge management system as multiple Fortune 100 companies and having developed software for more than 70 medical devices, Innolitics is expected to be integrating many of the Company's recently announced cloud-based components. These enhancements include AI, cybersecurity, and others to provide potential prescription treatments and pharmaceutical sponsors with a commercially viable and enterprise scaled platform. Innolitics specializes in medical device software development, cybersecurity, and FDA regulatory submissions. It is expected to be integral to integrations with the Company's Big Data partner and consumer user interface experience. Their team comprises a multi-faceted array of talent including software engineers, cybersecurity experts, regulatory consultants, and AI and machine learning processing experts. Fady Boctor, Petros' President and Chief Commercial Officer, commented, 'We continue to make incremental progress in the development of our enterprise system designed to take advantage of what we believe represents a significant shift in the pharmaceutical industry. We believe that our $10 million cash position, coupled with a significantly reduced burn rate compared to Q4 2024, puts us in good stead to complete this development and create a much-needed resource for the pharmaceutical industry in an age where new alternatives to expand access are in demand. 'As manufacturers face critical lifecycle management decisions, and the federal government has mandated new and better solutions for access to medical care, we believe our SaaS program will be key to overcoming longstanding challenges such as retail integration, electronic health record interoperability and the commercial scalability necessary for a true over-the-counter experience. This collaboration with Innolitics represents continued progress in the development of this system, and we are confident in both our approach and its potential in the larger market,' concluded Mr. Boctor. Petros' enterprise platform is being designed within the United States Food and Drug Administration's (the 'FDA') Additional Conditions for Nonprescription Use ('ACNU') guidelines to facilitate bringing prescription products over the counter, and is intended to help industry comply with President Trump's recent Executive Order to expand access to medicines through OTC approvals under his Make America Healthy Again (MAHA) initiative. The Company is developing this intended licensable platform to provide a variety of services, including patient self-selection tools, electronic health records integration to support appropriate patient use, possible integration with retail pharmacies, and robust cybersecurity and privacy safeguards. The ACNU regulatory framework provides guidelines that are designed to expand access as pharmaceutical companies evaluate various potential switches from prescription to OTC availability. Petros' system is being designed to meet these stipulations in an efficient, commercially viable, licensable single framework. The Company believes there are multiple indications that may be appropriate for an Rx-to-OTC switch, including erectile dysfunction, hypercholesterolemia (high cholesterol), migraine, anxiety and urinary tract infection. The emerging self-care market is currently estimated to be valued at over $38 billion with an expected compounded annual growth rate of 5.6% over the next 10 years.1 About Petros Pharmaceuticals Petros Pharmaceuticals, Inc. is committed to the goal of becoming a leading innovator in the emerging $38 billion self-care market by providing expanded access to key prescription pharmaceuticals as OTC treatment options. The Company is currently developing a proprietary SaaS platform and a proprietary SaMD web application designed to assist pharmaceutical companies in meeting FDA standards to assist in the Rx-to-OTC switch. About the Pathway from Rx to OTC The process of switching a prescription medication to OTC first involves the design of a Drug Facts Label ('DFL') that is well understood by potential consumers. Then, data must show that consumers can make an appropriate informed decision to use or not to use the product based only upon the information on the DFL and their personal medical history. Consumers must then demonstrate that they can properly use the product based upon the information on the DFL. To accomplish this, the FDA ordinarily requires a consumer tested OTC DFL. Such testing includes conduct of iterative Label Comprehension Studies (LCS) in the general population, Self-Selection Studies (SSS) in a population interested in using the product and in specific populations who may be harmed if they use the product, and usually one Actual Use Trial (AUT) demonstrating safe and appropriate use by consumers in a simulated OTC setting. The regulation that the FDA recently finalized introduced Additional Conditions for Nonprescription Use ('ACNU') criteria that enable correct self-selection by consumers and may expand OTC access to medications that formerly could only be available by prescription. An ACNU may be an innovative computerized tool, or the additional conditions may use other approaches that support the switch process. Petros is developing a technology platform (SaaS) to assist companies in navigating this pathway. Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based upon the Company management's assumptions, expectations, projections, intentions, and beliefs about future events. In some cases, predictive, future-tense or forward-looking words such as 'intend,' 'develop,' 'goal,' 'plan,' 'predict', 'may,' 'will,' 'project,' 'estimate,' 'anticipate,' 'believe,' 'expect,' 'continue,' 'potential,' 'opportunity,' 'forecast,' 'should,' 'target,' 'strategy' and similar expressions, whether in the negative or affirmative, that reflect our current views with respect to future events and operational, economic and financial performance are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. Such forward-looking statements are only predictions, and actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of risks and uncertainties, Petros' ability to execute on its business strategy, including its plans to develop and commercialize its proprietary Rx-to-OTC switch technology Petros' ability to comply with obligations as a public reporting company; Petros' expectations related to the Company's partnership with Innolitics; Petros' ability to regain and maintain compliance with the Nasdaq Stock Market's listing standards; risks related to Petros' ability to continue as a going concern; risks related to Petros' history of incurring significant losses; and risks related to Petros' ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates, including its proprietary Rx-to-OTC switch technology. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in the Company's periodic reports and in other filings that the Company has filed, or may file, with the U.S. Securities and Exchange Commission (the 'SEC') under the headings 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' and elsewhere. The Company cautions readers that the forward-looking statements included in this press release represent our beliefs, expectations, estimates and assumptions only as of the date of hereof and are not intended to give any assurance as to future results. New factors emerge from time to time, and it is not possible for us to predict all these factors. Further, the Company cannot assess the effect of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement. Accordingly, you should not unduly rely on any forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events, a change in our views or expectations or otherwise, except as required by federal securities laws. Contacts Investors: CORE IR [email protected] Media: Jules Abraham CORE IR 917-885-7378 [email protected] SOURCE: Petros Pharmaceuticals, Inc. press release
