Wearable technology developer Biolinq has won FDA authorisation for a biosensor that can measure glucose levels continuously just beneath the skin's surface, without the need for a needle.

可穿戴技术开发商 Biolinq 已获得 FDA 批准，其生物传感器可以在皮肤表层下方持续测量葡萄糖水平，且无需使用针头。

The San Diego-based company claims a number of firsts for its coin-sized Biolinq Shine device, including that it is so far the only fully autonomous, needle-free glucose sensor that has an integrated display, so it does not need a linked smartphone to show its readings.

这家总部位于圣地亚哥的公司声称，其硬币大小的 Biolinq Shine 设备实现了多项首创，其中包括该设备是目前唯一一款完全自主、无针头的葡萄糖传感器，并且配备了集成显示屏，因此不需要连接智能手机即可显示读数。

The device, which is worn on the forearm, also monitors activity and sleep information via a smartphone app and provides users with real-time feedback if their blood glucose levels stray out of recommended ranges through an LED indicator light, according to Biolinq. A blue light means levels are in the target range, while a yellow indicates the user is hyperglycaemic..

据Biolinq介绍，这款戴在前臂上的设备还可以通过智能手机应用程序监测活动和睡眠信息，并通过LED指示灯实时反馈用户的血糖水平是否偏离了建议范围。蓝灯表示处于目标范围内，而黄灯则表示用户处于高血糖状态。

The privately-held firm

私营公司

raised $100 million

筹集了1亿美元

in a Series C earlier this year in preparation for a commercial rollout of the product, after completing $58 million and $100 million rounds in 2024 and 2021, respectively.

今年早些时候，在完成 2024 年和 2021 年分别进行的 5800 万美元和 1 亿美元融资后，该公司进行了 C 轮融资，为产品商业化推出做准备。

Biolinq Shine is being launched into a booming CGM market, which, according to presentations at the 2024 JP Morgan Healthcare Conference, is predicted to reach a value of $20 billion by 2028.

Biolinq Shine 正在进入一个蓬勃发展的 CGM 市场，根据 2024 年摩根大通医疗保健会议上的报告，该市场预计到 2028 年将达到 200 亿美元的价值。

It is operating in a space with some real giants – Abbott and Dexcom – which already report billions of dollars a year in sales of CGM products and have even launched

它正在一个有一些真正巨头——雅培和德康——的空间中运营，这些公司每年已经报告数十亿美元的CGM产品销售额，甚至已经推出新产品。

over-the-counter (OTC) devices

非处方（OTC）设备

for people with type 2 diabetes who don't need to use insulin.

对于不需要使用胰岛素的2型糖尿病患者。

In a statement, Biolinq said it is also planning to market the device initially to non-insulin-using type 2 diabetics who want a device that can go beyond simply measuring glucose and deliver insights into other aspects of their metabolic health.

Biolinq在一份声明中表示，该公司还计划将该设备首先推向不使用胰岛素的2型糖尿病患者，这些患者需要的设备不仅能够测量血糖，还能提供关于他们代谢健康的其他方面的见解。

Medtech round-up

医疗技术综述

Also this week in the medtech arena, Medtronic's

本周在医疗技术领域，美敦力公司的

Altaviva

阿尔塔维瓦

device – used to treat people living with urge urinary incontinence (UUI) – has been implanted into the first patient since its FDA approval last week. The implantable tibial neuromodulation (ITNM) device was inserted near the ankle of a patient using a minimally invasive procedure at Urology Partners in Dallas, Texas..

设备——用于治疗患有急迫性尿失禁（UUI）的人群——自上周获得FDA批准以来，已被植入首位患者体内。这种可植入的胫神经调节（ITNM）设备通过微创手术植入患者脚踝附近，手术在德克萨斯州达拉斯的泌尿科合作伙伴机构进行。

According to the company, it is the only therapy of its kind in the US to offer same-day activation, allowing patients to walk out of the doctor’s office with therapy turned on after a procedure that doesn't require sedation or medical imaging.

据该公司称，这是美国唯一一种提供当天激活的同类疗法，患者在接受无需镇静或医学成像的手术后，可以开启治疗并离开医生办公室。

French startup

法国初创公司

Sonomind

声诺心语

has raised €3 million (around $3.5 million) for a low-intensity ultrasound-based transcranial neuromodulation system that it is developing as a non-invasive, brain-stimulating treatment for depression.

已筹集了300万欧元（约合350万美元），用于开发一种基于低强度超声波的经颅神经调节系统，作为治疗抑郁症的非侵入性脑刺激疗法。

The Paris-based company plans to begin clinical trials within the next few months to evaluate its technology in the treatment of drug-resistant depression (TRD), which is seen in somewhere between a third and a half of the estimated 330 million people worldwide living with major depressive disorder (MDD)..

总部位于巴黎的公司计划在未来几个月内开始临床试验，以评估其技术在治疗难治性抑郁症（TRD）中的应用。据估计，全球约有3.3亿人患有重度抑郁症（MDD），其中三分之一到一半的人出现难治性抑郁症。

Researchers at Washington University in St Louis, Missouri, are developing a

密苏里州圣路易斯华盛顿大学的研究人员正在开发一种

wearable device that tracks blood loss

跟踪失血量的可穿戴设备

by measuring cardiovascular variables, such as haemoglobin levels and blood flow, using a novel light-based sensor. One application of the wrist-worn device will be the detection of postpartum haemorrhage, the leading cause of maternal death worldwide. At the moment, heart rate and blood pressure are used to warn of blood loss but can remain stable even if a patient has lost 1.5 litres of blood..

通过使用一种新型的基于光的传感器来测量心血管变量，如血红蛋白水平和血流量。这款佩戴在手腕上的设备的一个应用将是检测产后出血，这是全球导致孕产妇死亡的主要原因。目前，心率和血压被用来预警失血，但即使患者已失去1.5升血液，它们仍可能保持稳定。

The project is being supported with a five-year, $2.8 million grant from the US National Heart, Lung, and Blood Institute (NHLBI). The scientists behind the work predict that a more accurate and continuous early-warning system could potentially prevent 50% to 90% of bleeding-related maternal deaths if paired with adequate treatment..

该项目获得了美国国家心肺血液研究所（NHLBI）为期五年、金额达280万美元的资助。参与研究的科学家预测，如果能与适当的治疗相结合，一个更精确且持续的早期预警系统可能预防50%至90%与出血相关的孕产妇死亡。

Finally, Florida, US company

终于，美国佛罗里达州的公司

Smart Meter

智能仪表

has launched a new sensor that uses radar technology to passively track patient vital signs – such as heart rate, respiration, movement, and bed exits – without any need for wearables or camera-based monitoring systems.

推出了一种新的传感器，该传感器使用雷达技术被动追踪患者的生命体征——如心率、呼吸、活动和离床情况——而无需穿戴设备或基于摄像头的监控系统。

Called iAmbientHealth, the unintrusive system makes use of an AI algorithm that Smart Meter claims can predict a decline in overall health status and an emerging healthcare event up to seven days in advance, helping to reduce hospitalisations.

名为iAmbientHealth的非侵入式系统利用了Smart Meter公司声称可以预测整体健康状况下降和提前多达七天的新兴医疗事件的AI算法，有助于减少住院治疗。