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Comments close on FDA's generative AI device framework 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 Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework 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 Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets
The Directory // Manufacturing, Components & Supply

Manufacturing, Components & Supply

Contract manufacturers, components, materials and packaging. 6 companies listed.

Singapore  ·  Unknown  ·  Submission pending

Makes Bioactiv Matrix, a synthetic animal-free regenerative wound dressing produced by 3D printing. Approved by Singapore's HSA for end-use medical implants, with submissions pending in the US, EU, Australia and ASEAN.

St. Paul, MN  ·  Est. 2025  ·  Unknown  ·  Not a regulated device

Contract developer and manufacturer of finished devices and subassemblies, formed in October 2025 by the merger of Intricon and Minnetronix Medical. Runs six plants across North America, Singapore, Indonesia and Costa Rica.

San Francisco, CA  ·  Series A  ·  $22.5M raised  ·  Not a regulated device

Vertically integrated durable medical equipment company. It handles insurance approval, point-of-care scanning and ordering, and 3D-printed manufacturing of custom orthotics and prosthetics in its own lab.

London, UK  ·  Est. 2022  ·  Seed  ·  In development

Designs application-specific semiconductor chips for neural sensing, signal processing and stimulation, sold to companies building implants, brain-computer interfaces and sensory prostheses.

Minnesota  ·  Est. 2025  ·  Growth  ·  Not a regulated device

Contract development and manufacturing organization for device OEMs, covering design, precision machining, metal injection molding and finished assembly. SK Capital created it in November 2025 by carving out LISI Group's medical division.

Norwich, VT  ·  Est. 2025  ·  Series A  ·  Not a regulated device

Wireless power transfer platforms for implantable devices, spun out of Resonant Link in November 2025. Its Aurion platform targets neuromodulation, cardiac rhythm management and brain-computer interfaces.

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