Array from Precision Neuroscience.

来自Precision Neuroscience的阵列。

Source: Precision Neuroscience

来源：Precision Neuroscience

Neurotech startup

神经科技初创公司

Precision Neuroscience

精准神经科学

on Thursday announced that a core component of its brain implant system has been

周四宣布其脑植入系统的核心组件已经

approved

批准

by the U.S. Food and Drug Administration, a major win for the four-year-old company.

美国食品药品监督管理局（FDA）批准，这对于这家成立四年的公司而言是一次重大胜利。

Precision is building a brain-computer interface, or a BCI, which is a system that decodes neural signals and translates them into commands for external technologies. The company's BCI will initially be used to help patients with severe paralysis restore functions like speech and movement, according to its .

Precision公司正在构建一个脑机接口（BCI），这是一种解码神经信号并将其转化为对外部技术的指令的系统。该公司表示，其脑机接口最初将用于帮助严重瘫痪患者恢复语言和运动等功能。

website

网站

.

。

Only part of Precision's system was approved by the FDA on Thursday, but it marks the first full regulatory clearance granted to a company developing a wireless BCI, Precision said in

Precision 表示，其系统的部分组件于周四获得 FDA 批准，但这是首家开发无线脑机接口（BCI）的公司获得完整的监管许可。

a release

一个版本

. Other prominent startups in the space include

。该领域其他突出的初创公司包括

Elon Musk's

埃隆·马斯克的

Neuralink, and

Neuralink，以及

Synchron

同步

, which is backed by

，得到了...的支持

Amazon

亚马逊

founder

创始人

Jeff Bezos

杰夫·贝索斯

and

和

Microsoft

微软

co-founder

联合创始人

Bill Gates

比尔·盖茨

.

。

'This is a foundational moment for Precision,' Dr. Benjamin Rapoport, Precision's co-founder and chief science officer, said in a statement. Rapoport also helped co-found Musk's Neuralink in 2017 before departing the following year.

“这是Precision的一个关键时刻，”Precision的联合创始人兼首席科学官本杰明·拉波波特博士在一份声明中表示。拉波波特还曾在2017年帮助共同创立了马斯克的Neuralink，但在次年离开。

Stephanie Rider of Precision Neuroscience inspects the company's microelectrode array

Precision Neuroscience公司的斯蒂芬妮·莱德正在检查公司的微电极阵列。

Source: Precision Neuroscience

来源：Precision Neuroscience

The piece of Precision's system that the FDA approved is called the Layer 7 Cortical Interface. The microelectrode array is thinner than a human hair and resembles a piece of yellow scotch tape. Each array is made up of 1,024 electrodes.

FDA 批准的 Precision 公司系统的部分被称为 Layer 7 皮层接口。这款微电极阵列比人类头发还细，类似于一块黄色的透明胶带。每个阵列由 1,024 个电极组成。

When it's placed on the brain, Precision says it can conform to the surface without damaging any tissue.

当放置在大脑上时，Precision 表示它可以贴合表面，而不会损伤任何组织。

The FDA authorized Layer 7 to be implanted in patients for up to 30 days, and Precision will be able to market the technology for use in clinical settings. This means surgeons will be able to use the array during procedures to map brain signals, for instance. It's not Precision's end goal for the technology, but it will help the company generate revenue in the near term..

FDA批准了Layer 7可以植入患者体内最长30天，Precision将能够在临床环境中推广该技术。这意味着外科医生将能够在手术过程中使用该设备来绘制脑信号图。虽然这不是Precision对该技术的最终目标，但将有助于公司在短期内获得收入。

Precision has temporarily implanted the Layer 7 in 37 patients so far, and

迄今为止，Precision 已经在 37 名患者身上暂时植入了第 7 层，

CNBC observed

CNBC观察到

one case at The Mount Sinai Hospital in New York last April. Until this point, the implementations have taken place for short periods, often a matter of minutes or hours, on patients who were already undergoing brain surgery for a medical reason.

去年四月，纽约西奈山医院发生了一起案例。截至目前，这些实施过程持续时间较短，通常为几分钟或几小时，且是在因医疗原因已接受脑部手术的患者身上进行的。

Now, thanks to the FDA clearance, the company will be able to collect data for much longer periods of time.

现在，由于获得了FDA的批准，该公司将能够收集更长时间的数据。

'This regulatory clearance will exponentially increase our access to diverse, high-quality data, which will help us to build BCI systems that work more effectively,' Rapoport said.

“这一监管批准将使我们获得多样化、高质量数据的能力呈指数级增长，这将有助于我们构建更有效的脑机接口系统，”拉波波特说。

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辉瑞因一名患者出现肝损伤而放弃每日一次的减肥药

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数字健康初创公司 Transcarent 以 6.21 亿美元收购 Accolade 私有化