A brain implant that could rival Neuralink's enters clinical trials (www.nature.com)

Paradromics has won FDA approval for a first long-term clinical trial of its implanted brain–computer interface (BCI), planning early next year to place electrode arrays into two volunteers who have lost the ability to speak. The device uses a roughly 7.5 mm-diameter patch of thin, stiff platinum‑iridium electrodes that penetrate about 1.5 mm into cortex and are wired to a chest‑implanted power source and wireless transceiver. Arrays will target the motor cortex region controlling lips, tongue and larynx; participants will imagine speaking prompted sentences while the system learns neural patterns tied to speech sounds and converts them to on‑screen text or a real‑time synthetic voice reconstructed from prior recordings of the user. The trial will also probe imagined hand movements for cursor control, and could expand to up to ten volunteers with dual implants to access richer signals. This is the first BCI clinical trial formally aimed at synthetic‑voice generation and marks a milestone in fully implantable, high‑resolution neural interfaces — positioning Paradromics as a direct rival to Neuralink and complementary to population‑level approaches like Synchron’s Stentrode. Technically, it emphasizes single‑neuron penetration for higher bandwidth decoding, and its outcomes will be watched closely for safety, decoding accuracy, and real‑world communication improvements. The field will be looking for open data and independent validation as companies push implanted BCIs toward clinical use.