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OcuMet is positioned as a device to identify eye pathologies like glaucoma, the leading cause of irreversible blindness worldwide. Credit: muratart/Shutterstock.
OcuMet被定位为一种识别青光眼等眼部疾病的设备,青光眼是全球不可逆失明的主要原因。来源:muratart/Shutterstock。
The US Food and Drug Administration (FDA) has cleared OcuSciences’ retinal health assessment device, OcuMet Beacon.
美国食品和药物管理局 (FDA) 已批准 OcuSciences 的视网膜健康评估设备 OcuMet Beacon。
The non-invasive device is indicated for ophthalmoscope scanning for infrared and autofluorescence imaging of the retina, with or without the use of a mydriatic agent.
该非侵入性设备适用于使用或不使用散瞳剂的情况下,进行视网膜的红外和自发荧光成像的眼底镜扫描。
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OcuMet measures flavoprotein fluorescence (FPF), which can serve as a biomarker of mitochondrial dysfunction in retinal diseases such as glaucoma. According to the company, scans with the device are typically completed within minutes, with the in-built screen providing analyses upon completion.
OcuMet测量黄素蛋白荧光(FPF),这可以作为青光眼等视网膜疾病中线粒体功能障碍的生物标志物。据公司称,使用该设备的扫描通常在几分钟内完成,内置屏幕在完成后提供分析结果。
Ahead of the FDA clearance, OcuMet has been variously assessed, with a study evaluating the device at New York’s Mount Sinai hospital finding that FPF was significantly higher in glaucoma eyes versus normal eyes,
在FDA批准之前,OcuMet接受了多项评估,其中纽约西奈山医院进行的一项研究发现,青光眼患者的眼部FPF显著高于正常眼睛。
especially in early-stage glaucoma cases
尤其是在早期青光眼病例中
in which damage is often hard to detect. Early detection of the condition is viewed as critical in
其中损伤往往难以检测。早期发现这种情况被认为是至关重要的。
maximising the benefits of treatment
最大化治疗的益处
for patients.
对于患者来说。
With the marketing clearance, Michigan-based OcuSciences said OcuMet would “soon be available” for use in clinics and healthcare institutions across the US.
密歇根州的OcuSciences公司表示,随着市场许可的通过,OcuMet将“很快在美国各地的诊所和医疗机构中投入使用”。
OcuSciences CEO Kurt Riegger commented: “With our collaborators, we are extending the depth of understanding for retinal diseases.
OcuSciences 首席执行官 Kurt Riegger 表示:“通过与我们的合作伙伴共同努力,我们正在加深对视网膜疾病的理解。
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“This is a game-changer for the many patients and ophthalmologists who stand to benefit from more precise and deeper insight.”
“这对许多患者和眼科医生来说是一个改变游戏规则的进展,他们将受益于更精确和更深入的洞察。”
Left untreated, glaucoma is the leading cause of irreversible blindness worldwide. Research indicates that the optic degenerative neuropathy will affect more than
如果不进行治疗,青光眼是全球不可逆失明的主要原因。研究表明,这种视神经退行性病变将影响超过
110 million people globally by 2040.
到 2040 年,全球将有 1.1 亿人。
Glaucoma can be treated with eye drops, medication, surgery or with femtosecond lasers that treat the condition by creating microscopic channels in the trabecular meshwork, improving fluid drainage and reducing eye pressure. In 2024,
青光眼可以通过眼药水、药物、手术或使用飞秒激光治疗,这种激光通过在小梁网中创建微小通道来改善液体引流并降低眼压。在2024年,
ViaLase secured a European CE Mark
ViaLase 获得了欧洲 CE 认证
approval for its ViaLase femtosecond laser for glaucoma treatment.
批准其用于青光眼治疗的ViaLase飞秒激光。
Biopharma company Perfuse recently announced data from a
生物制药公司Perfuse近日宣布了来自一项研究的数据,
Phase I/IIa trial of its intravitreal implant for glaucoma
青光眼玻璃体内植入物的I/IIa期试验
. Subjects treated with the implant registered a mean increase in optic nerve head blood flow of a minimum of 10% from baseline as early as week one, a benefit that persisted through week 24.
接受植入物治疗的受试者在第一周时视神经头血流量就比基线水平平均增加了至少10%,这种益处一直持续到第24周。
In other eye health developments, in March 2025,
在其他眼部健康进展方面,2025年3月,
Pantheon inked a deal with Eyedeal Medical
万神殿与Eyedeal Medical签订了协议。
to advance the manufacture of its bioengineered corneal implants for treating corneal blindness.
为了推进其用于治疗角膜盲症的生物工程角膜植入物的制造。
According to the World Health Organization, corneal blindness is the fourth-leading cause of blindness globally, behind cataracts, glaucoma and age-related macular degeneration.
根据世界卫生组织的数据,角膜盲是全球第四大失明原因,仅次于白内障、青光眼和老年性黄斑变性。