Author: Laila Zulfa

The landscape of neurological diagnostics underwent a transformative shift this week as Roche and Eli Lilly and Company announced that their co-developed Elecsys pTau217 plasma assay has received U.S. Food and Drug Administration (FDA) clearance. This regulatory milestone marks a significant leap forward in the quest for accessible, non-invasive tools to identify Alzheimer’s disease pathology.…

The U.S. Food and Drug Administration (FDA) has granted de novo authorization to Abbott for the Libre Duo 10 Day, the world’s first integrated dual-analyte sensor designed to continuously monitor both glucose and ketone levels. This regulatory milestone marks a significant shift in the management of diabetes, moving beyond traditional glucose-only tracking to provide a…

In a move that signals a definitive shift in its long-term corporate trajectory, Qiagen N.V., a global leader in molecular diagnostics and sample preparation technologies, announced on Monday the appointment of Jonathan Pratt as its new Chief Executive Officer. The appointment, effective September 1, 2024, concludes an exhaustive ten-month international search for a permanent successor…

The Advanced Research Projects Agency for Health, a federal funding body established to drive high-stakes breakthroughs in medicine, has announced a landmark investment of up to $175.3 million aimed at revolutionizing the treatment of acute ischemic strokes. Through its Autonomous Interventions and Robotics program, known as AIR, the agency is partnering with several leading medical…

The global landscape of diabetes management has reached a significant milestone as Medtronic officially commences the integrated shipping of its MiniMed Flex insulin pump alongside the Abbott-manufactured Instinct continuous glucose monitoring (CGM) sensor. This strategic rollout, which began in August, represents a pivotal shift in the company’s approach to interoperability and patient choice within the…

The economic partnership between the United States and Canada, long considered one of the most stable and productive bilateral relationships in the world, entered a period of profound uncertainty this Friday as high-stakes negotiations in Washington failed to avert the implementation of massive 50% tariffs. The collapse of the talks marks a significant escalation in…

The U.S. Food and Drug Administration (FDA) has finalized the selection of four participants for its Total Product Lifecycle Advisory Program (TAP) pilot, specifically within the TEMPO (Total Product Lifecycle Advisory Program) framework, marking a significant milestone in the integration of digital health technologies into the American clinical landscape. Among the final selections are two…

The landscape of oncology is currently undergoing a fundamental shift as blood-based screening tools, once the subject of speculative research, move decisively into the realm of standard clinical practice. At the center of this transition is Guardant Health, a precision oncology company that has secured a pivotal role in the early detection of colorectal cancer…

The global healthcare ecosystem has long occupied a precarious position in the crosshairs of cybercriminals, with hospitals and primary care providers frequently bearing the brunt of ransomware and data exfiltration campaigns. However, 2026 has marked a significant and alarming shift in the threat landscape, as the focus of these attacks has expanded aggressively into the…

The U.S. Food and Drug Administration (FDA) has issued a comprehensive set of recommendations aimed at standardizing the integration of digital health technologies (DHTs) into clinical investigations. In a move that signals a significant shift toward more decentralized and patient-centric research models, the agency emphasized that any digital tool used to collect data in clinical…