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FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant

The Directory / Manufacturing, Components & Supply

Manufacturing, Components & Supply Cardiovascular

Zonova

London, UK · Seed · Not a regulated device

Licenses Z-ROS, an antimicrobial technology built into device polymers rather than applied as a surface coating, to device manufacturers. First target is vascular access catheters, with urology, womens health and orthopedics planned.

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