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Tag: FDA

13 articles

Industry News

Science Corp's PRIMA implant patients averaged a 29-letter vision gain at three years

Science Corporation reported on 5 October 2026 that the 18 patients still assessed for vision at 36 months in PRIMAvera, the pivotal trial of its PRIMA retinal implant for blindness from geographic atrophy in age-related macular degeneration, read on average 29 more letters on a standard eye chart than before surgery. At 12 months the 32 patients then assessed had gained 24.5 letters with PRIMA glasses. At 36 months, 14 of the 18 (78 percent) had gained at least 15 letters. No new safety signal appeared between months 12 and 36, and natural vision in the implanted eye stayed stable. The trial implanted 38 patients at 17 sites in five European countries; 27 were evaluable for safety and 18 for efficacy at 36 months. The results were presented at the EURETINA congress in Vienna and have not yet been peer reviewed. PRIMA went on sale in Europe in July 2026, is now also available in the UK, and is pending FDA approval in the United States.

Oct 6

Policy & Regulation

China issues a medical-device standard for AI processing of EEG data in brain-computer interfaces

China's National Medical Products Administration (NMPA) has issued what state news agency Xinhua characterises as the world's first medical-device standard covering AI-processed electroencephalogram (EEG) data in brain-computer interfaces, announced on 14 September 2026. The standard was drafted by the National Institutes for Food and Drug Control (NIFDC) under an expedited procedure and becomes effective on 1 September 2027. Scope: quality requirements and evaluation methods for EEG datasets used by AI algorithms in BCI medical devices, covering collection, processing, annotation, storage, and access across R&D, production, and quality-control stages. Named NMPA and NIFDC officials: Yuan Peng (Deputy Director, NMPA Department of Medical Device Registration), Li Shu (Deputy Director, NIFDC medical device institute), Zheng Jia (Deputy Director, NIFDC Institute for Medical Device Standardization). This is the third BCI-related medical-device standard issued by China in twelve months, following 2025 standards on BCI terminology and on test methods for implantable closed-loop neural stimulators. The US FDA has no BCI-specific AI/EEG data-quality standard. The EU has no BCI-specific standard, only horizontal AI Act coverage of medical BCI as high-risk. On the narrow AI-EEG-BCI slice, China's world-first framing holds up.

Sep 17

Industry News

Paradromics wins FDA approval to connect its Connexus BCI to personal laptops, tablets and phones inside Connect-One

Paradromics announced on 26 August 2026 that the US Food and Drug Administration has issued an approval letter expanding the types of computing devices that may be used with its Connexus brain-computer interface inside the Connect-One Early Feasibility Study. Compatible personal, internet-connected devices (laptops, tablets, phones) can now be added into the study without a per-device FDA approval. Paradromics also identified a second patient for the feasibility study, and its first patient has progressed to closed-loop stage.

Aug 26

Industry News

ANEUVO's spinal stimulator clears the FDA

The ExaStim system — a transcutaneous spinal cord stimulator for people with chronic spinal cord injury — has received FDA 510(k) clearance, making it the first device of its kind cleared for both clinical and home use in the United States.

Apr 16

Policy & Regulation

Medicare Has No Plan for Brain-Computer Interfaces

A Health Affairs analysis argues that CMS needs a dedicated coverage pathway for implantable BCIs before the technology outpaces the reimbursement system that patients depend on.

Mar 21