Tag: medtech

Abbott Laboratories has officially submitted its application to the U.S. Food and Drug Administration (FDA) for the Libre Duo, a first-of-its-kind dual-analyte sensor designed to monitor both glucose and ketone levels simultaneously. This regulatory milestone follows the company’s receipt of the CE (Conformité Européenne) mark in early 2024, which cleared the device for use in…

The U.S. Food and Drug Administration (FDA) has officially granted De Novo authorization to Vitestro, a Dutch medical robotics company, for its Aletta autonomous blood-drawing device. This landmark decision marks the first time the agency has cleared a robotic system designed to perform end-to-end venipuncture, a procedure that has remained largely manual since the inception…

Baxter International Inc., a global leader in medical technology, officially announced on Wednesday the appointment of John Rogers as its new Executive Vice President and Chief Financial Officer. Rogers, a seasoned finance executive with a background in driving large-scale organizational transformations, is slated to join the Deerfield, Illinois-based company on October 1. His arrival marks…

GE HealthCare Technologies Inc. has officially announced the appointment of William Grogan as its new Chief Financial Officer, a move that signals a strategic pivot toward lean operational efficiency and aggressive margin expansion for the medical technology giant. Grogan, who most recently served as the CFO of Xylem Inc., a leading global water technology provider,…

The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has released a comprehensive discussion paper outlining a proposed regulatory approach for generative artificial intelligence (AI) in the medical field. This move signals a pivotal shift in how the federal government intends to oversee a technology that is rapidly transforming clinical workflows,…

In a move that signals a continued shift toward the "Make America Healthy Again" agenda, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has officially announced the nomination of Dr. Heidi Overton to serve as the Commissioner of the Food and Drug Administration (FDA). Dr. Overton, a physician with deep ties to conservative…

The global adhesives giant H.B. Fuller has reached a definitive milestone in its strategic pivot toward high-margin healthcare markets following the overwhelming support from shareholders of Advanced Medical Solutions (AMS) for a 715 million pound acquisition. This move, which is expected to close before the end of the current fiscal year, represents the largest and…

The landscape of clinical oncology is undergoing a fundamental transformation as healthcare providers move beyond traditional software procurement toward internal technological innovation. In a landmark collaboration, NYU Langone Health and the Dana-Farber Cancer Institute have announced the launch and commercialization of the Solavia Decision Suite, a homegrown digital oncology tool designed to streamline the complex…

The medical technology landscape is witnessing a significant consolidation as iRhythm Technologies moves to acquire VitalConnect, a move designed to cement its leadership in the rapidly evolving cardiac monitoring sector. This acquisition is not merely a tactical expansion but a strategic pivot aimed at capturing a $1 billion market opportunity that has remained partially out…

The United States Food and Drug Administration (FDA) and representatives from the medical device industry have reached a preliminary agreement on the sixth iteration of the Medical Device User Fee Amendments (MDUFA VI), a framework that will govern the agency’s device review funding and performance goals from 2028 through 2032. While the agreement promises stability…