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Frontier signal stream

22 Jul 2026 00:00
⚖️ Regulatory & Approvals

FDA grants PRIMA two Humanitarian Use Device designations, covering advanced geographic atrophy and Stargardt disease

Science Corporation disclosed on 22 July 2026 that its PRIMA implant has received two Humanitarian Use Device (HUD) designations from the US Food and Drug Administration. The first covers patients blinded by advanced geographic atrophy secondary to age-related macular degeneration; because geographic atrophy itself is not a rare disease, the FDA approved the advanced bilateral-blindness form as an 'orphan subset' of the broader condition. The second covers patients who have lost vision to Stargardt disease, a rare inherited retinal disease. The company notes the HUD programme offers expedited review, but that a device must still be reviewed and approved by the FDA via a Humanitarian Device Exemption before it can be marketed - so this establishes a regulatory path rather than authorising US sales. The disclosure states that over two decades of research and clinical work, including nearly 50 patients across four clinical trials worldwide, led to the designations. The post is authored by Frank Brodie, Medical Director for Vision and PRIMA at Science. PRIMA had previously received FDA Breakthrough Device designation.

Science Corporation (company press release)COMPANYA
01 Jul 2026 00:00
🔬 Breakthroughs & Milestones

Neuralink performs its first transdural implant, inserting electrode threads straight through the dura

Neuralink disclosed that it had carried out its first transdural procedure, inserting the implant's electrode threads through the dura and into the cortex rather than removing the dura first. The company frames it as a step toward scalability, since eliminating the durotomy simplifies the surgery; the procedure was performed in May 2026 in the Canadian CAN-PRIME trial at Toronto Western Hospital.

Neuralink company update, via Yahoo News and Road to VRUNLISTED SOURCEC
04 Jun 2026 00:00
🏛️ Government & Policy

Conflicts of Interest Policy

Paradromics has published its Conflicts of Interest policy, which implements U.S. federal requirements for objectivity in research.

ParadromicsCOMPANYA
22 Jul 2026 00:00
🚀 Product Launches

PRIMA retinal implant receives EU MDR CE mark and goes commercially available across 30 European countries

On 22 July 2026 Science Corporation announced the European commercial launch of PRIMA, stating it is the first and only treatment shown in clinical trials to restore functional central vision to patients with geographic atrophy caused by age-related macular degeneration. PRIMA received a CE mark under the EU Medical Device Regulation from notified body DEKRA, authorising commercial availability across 30 European countries, and the company states it is the first brain-computer-interface device to receive CE marking for form vision restoration - reading letters, numbers and words. Country-specific reimbursement applications and clinical site activations are described as underway, with the first commercial implant expected in Germany. The company cites its New England Journal of Medicine publication covering 38 patients across 17 clinical sites in five countries: mean improvement of 25.5 letters on the ETDRS chart, 84% of patients reporting the ability to read letters, numbers and words, and 80% achieving prosthetic visual acuity improvement of at least logMAR 0.2 at 12 months (p<0.001). The implant is a 2x2mm subretinal photovoltaic device paired with near-infrared projecting glasses. AMD-associated geographic atrophy is stated to affect more than five million people globally.

Science Corporation (company press release)COMPANYA
10 Jul 2026 00:00
🚀 Product Launches

Kernel Flow reaches paying clinics with published subscription pricing from $2,500 per system per month

Business Insider reported hands-on testing of Kernel Flow at a longevity clinic, describing the non-invasive fNIRS headset as now available to try at about half a dozen longevity-focused clinics after ten years of development and more than $150 million invested. Kernel's own clinics page corroborates a live commercial subscription offer built on Flow 2 hardware across three tiers — Starter at $2,500 per system per month, Plus at $5,750 and Unlimited at $10,500, with annual-commitment discounts — delivering a 7-minute passive Brain Age report and a 30-minute active Cognition report. Kernel continues to state that its systems are for research use only and are not intended to diagnose, treat or manage any disease, so the commercial rollout sits alongside an explicit non-clinical disclaimer.

Business InsiderUNLISTED SOURCEC
17 Jun 2026 00:00
🚀 Product Launches

Precision Neuroscience wins 2026 Webby Award and back-to-back Fast Company World Changing Ideas honour; says device implanted in more than 90 patients

Precision Neuroscience announced it won a 2026 Webby Award and was named to Fast Company's World Changing Ideas list for a second consecutive year, both citing its Layer 7 cortical interface and its potential to restore communication for people living with paralysis. The release states Precision has implanted the device in more than 90 patients across multiple health systems — the substantive datapoint in the announcement, and an increase on the 'more than 80' figure stated in its 30 April release. No funding figures were stated. NOT flagged as a big event: this is third-party recognition with no disclosed economics and no clinical or commercial milestone. Recorded on the same basis as Island's CNBC Disruptor 50 placement (run 48) and Chainguard's Gartner Magic Quadrant placement (run 35) — logged as recognition, explicitly not as a valuation or performance event.

Precision Neuroscience (GlobeNewswire)PRESSA