North America

BiVACOR Total Artificial Heart Accepted into FDA’s TAP Program

This milestone further solidifies BiVACOR’s collaboration with the FDA following the TAH’s earlier recognition this year as a Breakthrough Device...

BD Becomes First MedTech Company to Earn Diamond-Level Resiliency Badge Across All HIRC Supply Chain Domains

BD’s Urology and Critical Care and Surgery units achieve top-tier recognition from the Healthcare Industry Resilience Collaborative, affirming its leadership in supply chain transparency, risk mitigation, and operational excellence...

Synchron Enables First Thought-Controlled iPad Experience

Synchron Debuts First Thought-Controlled iPad Experience Using Apple’s New BCI Human Interface Device Protocol ...

BMI OrganBank Secures FDA Breakthrough Device Designation for Innovative Kidney Transplant Technology

BMI OrganBank is developing novel medical devices with potential to significantly reduce the waitlist for lifesaving organ transplants, beginning with kidneys...

BD Invests $35M to Expand U.S. Production of PosiFlush™ Prefilled Syringes

The expansion at its Nebraska facility will boost syringe output by hundreds of millions annually, enhancing supply resilience and supporting safe, high-quality patient care across U.S. hospitals....

Concept Medical Launches Major U.S. Trial for Sirolimus-Coated Balloon in Small Vessels

Concept Medical Announces First Patient Enrollment in MAGICAL-SV IDE Trial, Expanding its Coronary Clinical Program Across the U.S. and Europe...

The FDA Is Phasing Out Animal Testing. Our Replacements Must Catch Up Fast.

In April, Health Secretary Robert F. Kennedy Jr. announced plans to dramatically reduce animal testing at U.S. health agencies. The FDA followed with a commitment to phase out animal studies in areas like monoclonal antibody development, favoring in vitro systems and artificial intelligence instead. ...

BD Submits FDA Application for First At-Home HPV Test with Advanced Self-Collection and Robotic Lab Processing

Designed to detect more high-risk HPV strains than any test on the market, the BD Onclarity™ Assay empowers women with a discreet, non-invasive screening option and leverages full lab automation to ensure accuracy, efficiency, and expanded access to cervical cancer prevention. ...

Demetra Launches Global Spine Division Following Strategic Acquisition of OrthoFundamentals

With the formation of Demetra Spine and recent acquisitions in the US and Europe, Demetra accelerates its mission to revolutionise spinal surgery through infection-reducing, single-use technologies designed for minimally invasive, value-based care....

Galaxy Therapeutics Opens New 9,200 Sq. Ft. Facility to Support Global Scale-Up of Brain Aneurysm Solutions

Equipped with ISO Class 7 cleanrooms and expanded R&D capacity, the new site accelerates Galaxy’s path to commercial readiness and global distribution of its breakthrough neurovascular technologies. ...