Neural Noise

Precision Neuroscience

2 min read

  • Precision Neuroscience received FDA clearance for its minimally invasive brain-computer interface implant (April 2025).1
  • The company is described in press as a rival to Musk-backed Neuralink in the cortical interface space.1

Weekly enrichment (2026-07-20)

  • The FDA cleared Precision’s Layer 7 Cortical Interface (device name Layer 7-T) via the 510(k) pathway under submission K242618, with a decision date of 30 March 2025 (classified as Class II, product code GYC, 21 CFR 882.1310).23
  • The array packs 1,024 microelectrodes into a flexible thin-film thinner than a human hair that conforms to the brain surface without penetrating tissue, and can be inserted through a cranial micro-slit smaller than 1 mm.45
  • Clearance covers temporary use of up to 30 days for recording, monitoring, and stimulating electrical activity on the cortical surface, in either open or burr-hole procedures with optional intraoperative imaging (X-ray, fluoroscopy, CT).24
  • The FDA granted the clearance on the basis of substantial equivalence to Ad-Tech’s subdural electrode system (predicate K191186), with the same temporary indication and safety profile.23
  • Precision describes this as the first full FDA clearance for a company developing a next-generation wireless BCI, and the Layer 7 array is a core component of its fully implantable wireless system still in development.45
  • The device had been temporarily implanted in 37 clinical-study participants through partnerships with Mount Sinai Health System, UPenn’s Perelman School of Medicine, West Virginia University’s Rockefeller Neuroscience Institute, and Beth Israel Deaconess Medical Center.45
  • Precision Neuroscience was founded in 2021 by Benjamin Rapoport (Chief Science Officer and a former Neuralink founding-team member), CEO Michael Mager, Demetrios Papageorgiou, and Mark Hettick.6
  • In December 2024 the company closed a $102 million Series C led by General Equity Holdings (with B Capital, Stanley Druckenmiller’s Duquesne Family Office, and Steadview Capital), bringing total funding to about $155 million at a roughly $500 million post-money valuation; earlier rounds included a $12M Series A (2021) and a $41M Series B (2023).6
  • Company leadership frames near-term value in intraoperative brain mapping while the clearance expands access to high-quality neural data for training decoding algorithms, targeting conditions such as spinal cord injury, stroke, and ALS.45

Footnotes

  1. https://news.google.com/rss/articles/CBMiqgFBVV95cUxOOVVESWJ4VXhoVWJEMVN1dzhvMm93bDNKencyci01SVUyNkxyMWdtTVI2dmdnSW5oTU9Sb1k0WGtKdkNZcmtPQ0VaNlVtX1JCWmVwQU1MdXg2U01yNlVuci1CanlVRXFVLXNLdlEtTEctaDNmajYyb1MwdnhUYmdQWTFzcTJDSE9JaDRYWDZ6NUw0VmwwNTNLamJoUDNwcWo0SWxnOTU0QTBKQdIBrwFBVV95cUxONHB3ZzZXLWhWV3NGcDJhOXRScnlDYTY5OVJGTERINllyNml1VGhtcUR4a0Rtdmo0aXN0anB0aGNLZDc2R2FFa3Z1aFV4eVJLN29QZ05LcnRXWHNTUzFaVTNWc1hDclhOVk5RR3ZEVlRxZ2dVUUNnWFhYSmtVN1lJdVYwUHVLa1BKNkhXOHlyRURRTzdrTHZBR29ydklzbk5WaVprbFhMZjRvZzMwWHM4?oc=5 ↩ ↩2

  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242618 ↩ ↩2 ↩3

  3. https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242618.pdf ↩ ↩2

  4. https://www.precisionneuro.io/articles/company-news/precision-neuroscience-receives-fda-clearance-for-high-resolution-cortical-electrode-array ↩ ↩2 ↩3 ↩4 ↩5

  5. https://practicalneurology.com/news/fda-clears-braincomputer-interface-device-for-the-measurement-and-stimulation-of-cortical-brain-activity/2474229/ ↩ ↩2 ↩3 ↩4

  6. https://en.wikipedia.org/wiki/Precision_Neuroscience ↩ ↩2

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