Regulatory compliance management platform
Regulatory and quality consulting firm MethodSense launched a scalable, intelligent platform to help medtech companies navigate increasingly complex global regulatory requirements. The cloud-based LuminLogic Regulatory Compliance Management platform enables users to simplify documentation, streamline submissions such as FDA eSTAR, mitigate risk, and stay audit ready while executing an efficient, well-constructed regulatory roadmap.
LuminLogic helps medical device companies of any size adapt to artificial intelligence (AI) systems such as the U.S. Food and Drug Administration (FDA)’s Elsa, meet international market demands, and bring life-changing technologies to market faster and with greater confidence. The platform equips life science teams to adjust to a rapidly evolving regulatory landscape characterized by digital health, global market expansion, and trends such as AI, cybersecurity, and intelligent compliance systems.
MethodSense
https://methodsense.com
FDA clearance for 3D-printed nerve repair device
3D Systems and TISSIUM received U.S. Food and Drug Administration (FDA) approval for their jointly developed, fully bioabsorbable 3D-printed medical device for nerve repair. The device, called COAPTIUM CONNECT with TISSIUM Light, is an atraumatic, sutureless solution for the repair of peripheral nerves. It features a unique photopolymer enabling the production of high-resolution, elastomeric biodegradable implants.
COAPTIUM CONNECT was developed through the combination of TISSIUM’s proprietary biomorphic programmable polymers and 3D Systems’ regenerative medicine bioprinting technologies. It addresses the limitations of traditional microsutures, securely connecting nerve ends while eliminating stress at the coaptation site. The system includes a coaptation chamber to align nerve ends and support healing; a pre-filled syringe with the proprietary COAPTIUM polymer for a strong, reliable connection; a silicone applicator; and TISSIUM Light technology activating the viscous pre-polymer into a flexible bond. COAPTIUM CONNECT is now commercially available in the United States.
3D Systems, TISSIUM
https://www.3dsystems.com; https://tissium.com
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