December 27, 2024 | PathAI launches the AIM-IHC Breast Panel; electronRx plans purpleDx, a cardiopulmonary assessment app; and more.
Roche has received CE mark approval for its cobas mass spec solution, including the cobas i 601 analyzer and the first Ionify reagent pack of four assays for steroid hormones2. The CE mark is the first milestone in the global launch of the cobas mass spec solution, using in-house innovation to bring automated, integrated and standardized clinical mass spectrometry testing to routine laboratories worldwide. Following launch, the cobas mass spec solution will roll out a menu offering of more than 60 analytes for testing of steroid hormones, vitamin D metabolites, immunosuppressant drugs (ISD), therapeutic drug monitoring (TDM), and drugs of abuse testing (DAT). Press release.
Becton, Dickinson and Company (BD) and Babson Diagnostics announced an expansion of fingertip blood collection and testing technologies for use by US health systems and other large provider networks in settings like urgent cares, doctor offices and other ambulatory care settings. This blood testing process integrates BD's MiniDraw Capillary Blood Collection System with Babson's BetterWay technologies to enable test results from as few as six drops of capillary blood collected from a patient's finger. With this less-invasive alternative to venipuncture blood draws, samples can be collected and prepared by any trained health care worker, including those without prior phlebotomy experience. Press release.
electronRx will launch purpleDx, a cardiopulmonary assessment app built to medical device standards, in 2025. purpleDx enables chronic respiratory disease (CRD) patients to detect and monitor digital biomarkers of lung function at home, while providing clinicians with real-time data to customize treatment plans and help improve patient outcomes. The smartphone app comes with an accompanying clinical dashboard to support clinicians in detecting, monitoring, and treating pulmonary diseases, including asthma, chronic obstructive pulmonary disease, interstitial lung disease and pulmonary hypertension. It was developed in collaboration with several respiratory clinics and the company's recent charity partner, the European pulmonary hypertension association (PHA Europe). Press release.
MeMed announced that the FDA has granted Breakthrough Device Designation (BDD) to its innovative MeMed Severity test. This designation allows the opportunity for MeMed Severity to advance the management of patients with suspected acute infections and suspected sepsis by providing clinicians with timely, data-driven, clinical insights. The test is based on advanced host-response technology that measures multiple proteins from a blood sample and uses machine learning to stratify the risk of a patient with a suspected acute infection deteriorating to severe outcomes within 72 hours or death within 14 days. Designed for emergency department settings, it has the potential to support critical decisions on triage, treatment, and optimized patient disposition. For example, it can assist clinicians in identifying who could benefit from escalated care and who might be safely discharged from the hospital. Press release.
PathAI has launched the AIM-IHC Breast Panel, a set of advanced AI-assisted algorithms designed to quantify critical breast cancer biomarkers (HER2, ER, PR, and Ki-67). Available on the AISight Image Management System (IMS), this comprehensive panel provides partners with accurate, consistent scoring, enhancing precision, and streamlining workflow efficiency. Adding to the existing AIM-HER2 Breast solution, this consolidation of critical breast cancer biomarker algorithms into a single, pathologist-centric image management system directly addresses the need for standardized, reliable quantification assist tools to support pathologists. Press release.
Baylor College of Medicine has received a $3.5 million grant from the National Human Genome Research Institute for the Making Genomics Accessible to Newborns in Texas (MAGNET) program to study how to overcome challenges in the implementation of in-patient genomic medicine in neonatal intensive care units in under-resourced healthcare communities. Advances in genomic medicine have improved diagnoses and care of sick newborn babies in neonatal intensive care units, but many medical centers across Texas lack access to resources necessary to provide this care. The MAGNET program aims to improve genetic diagnoses of sick newborns in NICUs at hospitals across underserved regions of Texas using low-cost whole genome and RNA sequencing technologies. Press release.
Backed by a $22.5 million investment and support from the French government through the France 2030 initiative, Withings has launched Project DEEP (DEvice as a hEalth Prevention platform). This initiative aims to harness cutting-edge AI and medical device innovation to advance early detection and prevention of cardiometabolic diseases and accelerate the digital and prevention transition of healthcare systems around the world. Press release.
Capitainer played a key role in the international Artificial Intelligence Radiology (AIR) project aimed at improving the diagnostics and monitoring of lung diseases. The project’s goal is to create a model for more equal and accessible healthcare globally by combining AI-based image analysis and laboratory diagnostics through self-sampling. Through Capitainer’s technology, patients can easily collect blood samples at home and send them for laboratory analysis, increasing healthcare accessibility for those who struggle to reach traditional healthcare facilities. Press release.
QIAGEN has launched two new tools for designing and ordering custom solutions that can be used to support microbial analysis of bacterial, fungal and viral targets. The new tools are a design tool for Custom dPCR Microbial Assays, a first-of-its-kind custom assay design tool that enables users to design primers and probes for their specific microbial targets of interest and is tailored specifically for bacterial, fungal and viral targets. The second tool is QIAseq xHYB Custom Microbial Panels, where researchers can design their assays against many whole genomes at once, allowing them to achieve the highest possible resolution in applications such as microbial detection. Press release.
GE HealthCare announced the new Pristina Via mammography system designed to enhance the screening experience for both technologists and patients. This system provides mammography technologists with a suite of sophisticated tools that balance the demands of diagnostic accuracy and fast-paced workflows to facilitate more patient-centered breast care. Features include: zero-click acquisition, no wait time between exposures, vendor-neutral prior image comparison, and lowest radiation dose usage. Press release.