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[SITUATION] · [ACTIVE]
2 clusters · 12 sources · 5 days · First seen · Last updated
Categories: HEALTH
Science Corp PRIMA retinal implant rollout
Entities: Max Hodak · PRIMA retinal implant · European Union · Geographic atrophy · Science Corporation
Overview
Science Corporation’s PRIMA sub‑retinal photovoltaic implant received a CE mark under the EU Medical Device Regulation on 22 July 2026, clearing the way for commercial availability in roughly 30 European countries. The first surgical procedures were slated for Germany, with a broader EU/EEA rollout planned. A multi‑centre trial of 38 patients showed that 84 % regained the ability to read letters and numbers and 80 % achieved a clinically significant gain of at least 10 ETDRS letters, averaging a 25.5‑letter improvement.
A follow‑up notice on 27 July 2026 reiterated the EU clearance and added that the initial German implantations could begin as early as September. The report highlighted that PRIMA is the world’s first device approved to restore functional central vision in advanced geographic atrophy, the dry form of age‑related macular degeneration affecting over five million people worldwide. In parallel, the device had already earned FDA Breakthrough Device and Humanitarian Use Device designations in the United States, positioning it for a near‑term U.S. launch after the European launch progresses.
Timeline
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about 14 hours ago
[HEALTH] 3 sourcesScience Corporation's PRIMA retinal implant cleared for EU marketScience Corp's PRIMA retinal implant, the first approved to restore central vision in advanced AMD, cleared EU regulatory hurdle; launch expected in Germany, with US FDA designations also secured.
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5 days ago
[HEALTH] 9 sourcesScience Corp's PRIMA retinal implant gains EU approval and launches European rolloutScience Corp’s PRIMA retinal chip secured EU approval, showing 84% reading recovery in trials, and begins rollout across Europe, with U.S. FDA discussions underway.
Sources
alsadaranews.com · blocktempo.com · businessday.ng · europesays.com · exame.com · insightnews.com.au · netcost-security.fr · revistagalileu.globo.com · tctechcrunch2011.files.wordpress.com · techgear.gr · techjuice.pk · vetos.fr