December 22, 2025 | The Singapore-MIT Alliance for Research and Technology launches a new collaborative research project; Cleveland Diagnostics receives FDA approval of their IsoPSA in vitro diagnostic kit; Roche announces that its first point-of-care test for the detection of Bordetella infections has been granted FDA 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 waiver; and more.
Researchers at Sanford Burnham Prebys Medical Discovery Institute plan to develop computational models to predict human toxicity thanks to a grant from the Advanced Research Projects Agency for Health (ARPA-H). The multi-institution, $31.7 million contract funds a project called Pharmacological Research and Evaluation through Digital Integration and Clinical Trial Simulation (PREDICTS). In addition to reducing the long timeline usually associated with drug development, the goal is to also reduce the need for laboratory animal models and catch safety problems with new drugs before they are tested in people. Press release.
The Singapore-MIT Alliance for Research and Technology (SMART) launches a new collaborative research project: Wearable Imaging for Transforming Elderly Care (WITEC). WITEC marks a pioneering effort in wearable technology, medical imaging, research, and materials science. It is Singapore’s first center dedicated to foundational research and development of the world’s first wearable ultrasound imaging system capable of 48-hour intermittent cardiovascular imaging for continuous and real-time monitoring and diagnosis of chronic conditions, such as hypertension and heart failure. Press release.
Nanocrine has unveiled its RT-Chip technology, a next-generation biosensor platform that enables real time observation of tumor activity at the cellular level. Nancorine's biochip—initially developed by scientists at the U.S. Naval Research Laboratory—was advanced by collaborations with scientists at the National Institutes of Health and the Frederick Innovative Tech Center. The imaging platform will enable researchers and clinicians to diagnose cancer more quickly and accurately by uncovering the tumors spread at the molecular level, map drug responses in real time on a cellular level that traditional assays miss, and more. Press release.
Pangaea announces a multi‑year strategic collaboration with AstraZeneca to make AI-driven clinical decision-making available at scale, and improve how patients are identified, diagnosed, treated, and connected to existing therapies and clinical trials. As part of the collaboration, AstraZeneca and Pangaea will co‑develop an enterprise‑grade platform that fuses large‑scale clinical, imaging, genomic, pathology, and real‑world data using the latest breakthroughs in generative and predictive AI from Microsoft. Press release.
4D Path announces a collaboration with AMD and Oracle to advance predictive oncology and accelerate clinical trials. Using AMD EPYC CPUs on Oracle Cloud Infrastructure (OCI), 4D Path’s QPOR platform—a physics-informed, AI-driven, deterministic software engine—can convert routine biopsy images into interpretable biomarkers of tumor and immune response faster and at lower cost. By running natively on CPUs, QPOR achieves reproducibility, cost efficiency, and scalability at trial level. Clinicians, CROs, and sponsors benefit from explainable, regulatory-friendly insights, enabling faster clinical trial execution and more personalized cancer care. Press release.
A new study from Froedtert Hospital shows that patients with suspected infection who received the IntelliSep rapid sepsis test had a 42% lower mortality and spent fewer days in the hospital compared with those who were not tested. These findings are consistent with previously published peer-reviewed evidence performed at multiple health systems across diverse emergency department settings. The lab test delivers results in eight minutes, enabling clinicians to rapidly risk stratify patients at triage to accelerate care for high-risk patients and avoid unnecessary interventions in lower-risk cases. Press release.
Cleveland Diagnostics announces that the U.S. Food and Drug Administration has approved the company’s IsoPSA in vitro diagnostic kit through the Premarket Approval process. IsoPSA is a blood-based test indicated as an aid in the decision for prostate biopsy for men ≥ 50 years of age with elevated PSA levels. In the U.S., greater than one million men undergo prostate biopsies each year, yet up to 75% of those follow-up tests are negative for high-grade disease. This diagnostic gap subjects millions to invasive, costly procedures that can produce physical risks, emotional stress, and significant healthcare costs. IsoPSA helps close this gap, giving clinicians and patients a more accurate risk assessment and greater confidence in biopsy decision-making. Press release.
Roche announces that its first point-of-care test for the detection of Bordetella infections, including whooping cough (pertussis), has been granted U.S. Food and Drug Administration 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 waiver. The PCR test uses the cobas liat system to deliver results in just 15 minutes at the point of care. This speed enables physicians to diagnose patients during their consultation and take immediate action to provide appropriate antibiotics that can prevent severe complications and onward transmission. Press release.
Royal Philips launches Philips Image Management 15, the next generation of Philips Vue PACS, including a zero-footprint, web diagnostic viewer that transforms how radiologists access and interpret medical images. The new user interface provides access to a comprehensive suite of advanced clinical applications and accelerates interpretation by aligning images across modalities and time points, all seamlessly integrated with the interactive reporting application. Combined with the Philips Advanced Visualization Workspace, which embeds deeper analysis results directly into the reporting workflow, clinicians benefit from greater efficiency and productivity. Press release.
Quanterix Corporation, and its clinical diagnostics brand Lucent Diagnostics, together with Emocog Inc., a digital healthcare company based in Seoul, South Korea, have entered into an exclusive distribution agreement for the Korean market covering the Simoa (single molecule array) technology platform—including the ultra-sensitive HD-X immunoassay analyzer and blood-based Alzheimer’s biomarker reagents. This agreement marks the first introduction of the Simoa platform into Korea as a formally authorized in vitro diagnostic device rather than a research use only instrument, representing an important milestone in the development of Korea’s blood-based Alzheimer’s diagnostics ecosystem. Press release.
Yenos Analytical launches the Yenos cancer test, a new multi-cancer early detection (MCED) urine test that is now available as a laboratory-developed test (LDT) in the U.S. The Yenos test can detect signals from 6 cancer types responsible for about 50% of annual U.S. cancer diagnoses, including some with the highest mortality rates, such as pancreatic, ovarian, and lung cancers. The Yenos cancer urine kit with instructions will be shipped to a customer's home across the U.S. in places that are served by FedEx. FedEx will deliver the kit with the biospecimen to the Yenos Laboratory in California for analysis. The results report will be placed in the customer's portal, and the customer will be notified by email. Press release.
Seegene announces a new subsidiary in France to reinforce its European presence and support global sales expansion. The new subsidiary will strengthen local engagement with customers and partners through enhanced technical support, market development, and collaboration with healthcare stakeholders. Seegene aims to expand sales of these product lines while introducing a broader portfolio including cervical cancer and other multiplex diagnostic categories. Press release.
A researcher in Purdue University’s Weldon School of Biomedical Engineering is participating in a two-year research study evaluating approaches to monitor the health of pregnant women in Africa and inform future efforts to reduce maternal mortality. The study is funded as part of the Gates Foundation’s Grand Challenge awards to reduce the burden of preeclampsia, a major cause of maternal mortality, premature birth, stillbirth, and neonatal death worldwide. The solution uses a patented, noninvasive computer-vision method called mHealth conjunctiva AI imaging to analyze smartphone photographs of the eyeball to explore early prediction of preeclampsia. The method extracts microvascular patterns from photos of the conjunctiva, which is a thin and transparent membrane covering the inner eyelids and the white part of the eyeball. It will be used in collaboration with AMPATH in Kenya. Press release.
Raidium introduces its new AI-native PACS Viewer powered by Curia. This multimodal, multitask, multi-organ model, trained on a dataset of over one billion images, powers the viewer with unprecedented capabilities. It can interpret an entire imaging exam for any modality (e.g. CT, MRI, etc.), automatically contextualize information, and execute complete workflows much like a team of radiologists. The system has been developed in alignment with U.S. clinical expectations and is designed to support future regulatory pathways. This also marks Raidium’s entry into the U.S. market. Press release.
Macomics has validated its ENIGMAC platform in macrophage mediated antifibrotic therapy. Macomics’ ENIGMAC drug discovery platform is designed to discover therapeutic targets and unlock disease specific target biology. The platform enables identification and validation of novel targets and provides a translationally relevant path to the clinic through the development of more physiologically relevant human models combined with proprietary gene editing technology. Press release.
Ovation.io and PrecisionLife announce a collaboration to develop drug-response biomarkers for glucagon-like peptide-1 receptor agonist (GLP-1) therapies. The partnership combines Ovation’s longitudinal multiomic data from 25,000 US patients treated with GLP-1 therapies, and PrecisionLife’s AI-driven combinatorial analytics platform, uniquely capable of revealing the drivers of disease and identifying the patients most likely to respond to specific therapies. The first of its kind initiative will uncover the biological mechanisms that determine individual variation in response to GLP-1s and find biomarkers associated with their safety, efficacy, and tolerability. The goal is to help payors and providers achieve the best, most cost-effective outcomes for patients using GLP-1s. Press release.