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Dymax expands TPO-free solutions for sustainable adhesives
The new release addresses regulatory and marketplace demands.
Coated implants for surgery; Next-gen film-cast PTFE liners
OSTAGUARD is positioned to address the need for bacteria control in medical devices; Zeus can produce StreamLiner NG with significantly improved consistency when compared to existing film-cast liners.
Recent U.S. Food and Drug Administration (FDA) approvals
Medtronic earns approval for Adaptive deep brain stimulation system; OrthoNovis gets clearance to market wrist fracture system
Birk Manufacturing achieves ISO 13485 recertification
ISO 13485 recertification reinforces Birk’s commitment to excellence in medical device manufacturing.
AdvaMed’s Medical Innovation Agenda for the 119th Congress
Top medtech priorities from AdvaMed for the 119th Congress: Igniting a new era of innovation for every American patient.
Zimmer Biomet and Pentax Medical recent FDA approvals.
Medtech approvals around the industry.
Ferrocene becomes first Rust toolchain to achieve IEC 62304 qualification
Enables medical device developers to leverage the unmatched safety and reliability of Rust while streamlining compliance.
How new executive orders may affect US FDA medical device operations
These executive orders may, for example, delay pending regulations, create uncertainty for FDA’s prior guidance related to artificial intelligence, and adversely impact FDA staffing and resources.
AdvaMed seeks medical technology exemption from all tariffs
The increased costs posed by tariffs, and their functioning essentially as an excise tax in practice, could resurrect the climate of concern the medical device excise tax created for nearly a decade.
Risk management as an innovation catalyst
Unlocking the potential of ISO 14971 in medical device development.
