FDA Archives - News Center

Paradromics Receives FDA Approval to Expand BCI Access to Personal Computing Devices in Clinical Study

Август 27, 2026 BCI, FDA

Paradromics has received FDA approval to expand the types of computing devices that may be used with its investigational brain-computer interface (BCI) system in the Connect-One clinical study, enabling compatibility with personal laptops, tablets, and phones through its Convey user interface.

Abbott Receives FDA Authorization for World’s First Dual Glucose-Ketone Biowearable for Diabetes

Август 27, 2026 Диабет, FDA

Abbott has received FDA De Novo authorization for its Libre Duo 10 Day system, the world’s first dual glucose-ketone sensing technology designed to monitor glucose and detect rising ketone levels that can lead to diabetic ketoacidosis in people with diabetes.

Roche Receives FDA Clearance for Elecsys pTau217 Blood Test to Advance Alzheimer’s Diagnosis

Август 24, 2026 Alzheimer’s, FDA

Roche has received FDA clearance for its Elecsys pTau217 blood test, the first and only FDA-cleared single-biomarker test supporting both rule-in and rule-out assessment of amyloid pathology. Quest Diagnostics and Labcorp will offer the test to clinicians nationwide.

C2N Diagnostics Receives FDA Clearance for PrecivityAD2 Alzheimer’s Blood Test for Adults as Young as 40

Август 21, 2026 Alzheimer’s, FDA

C2N Diagnostics has received FDA clearance for its PrecivityAD2 blood test, the first Alzheimer’s diagnostic aid cleared for use in symptomatic adults aged 40 and older, delivering high diagnostic performance to help clinicians rule in or rule out clinical Alzheimer’s disease.

Empatica Receives FDA 510(k) Clearance for Parkinson’s Health Monitoring Platform

Август 20, 2026 Alzheimer’s, FDA

Empatica has received FDA 510(k) clearance for its Health Monitoring Platform for Parkinson’s, enabling continuous symptom monitoring through clinical-grade wearables to support personalized care and clinical research.

GE HealthCare Expands Breast Imaging Portfolio with Invenia ABUS Prime and ABUS StreamVue

Август 3, 2026 FDA, GE HealthCare, Ultrasound

GE HealthCare запустила Invenia ABUS Prime и ABUS StreamVue, расширяя свой портфель маммографии решениями, предназначенными для поддержки дополнительного скрининга для женщин с плотной тканью молочных желез и обеспечения удаленного просмотра исследований через корпоративные сети визуализации.

DeepHealth Receives FDA Clearance for AI-Powered Breast Ultrasound Solution

Июль 31, 2026 AI, FDA, Ultrasound

DeepHealth получила разрешение FDA 510(k) на свое решение для ультразвукового исследования молочных желез на основе ИИ, которое автоматизирует обнаружение, характеристику и составление отчетов о поражениях для повышения стандартизации, точности и эффективности визуализации молочных желез.

Smith+Nephew Receives FDA De Novo Classification for TESSA Spatial Surgery System

Июль 30, 2026 FDA, Smith+Nephew

Smith+Nephew получила классификацию De Novo FDA для своей системы пространственной хирургии TESSA – платформы на основе ИИ, сочетающей дополненную реальность, навигацию и пациент-специфическое 3D-моделирование для артроскопических процедур, с первым показанием для реконструкции передней крестообразной связки.

FDA Clears Momentis Surgical’s Anovo System for Multiport Surgery

Июль 23, 2026 FDA, Robotics

The FDA has granted 510(k) clearance for the multiport configuration of Momentis Surgical’s Anovo System, making it the first robotic platform capable of supporting natural orifice, single-port, and multiport procedures on a single system.

Johnson & Johnson Receives FDA De Novo Authorization for OTTAVA Robotic Surgical System

Июль 23, 2026 FDA, Johnson & Johnson, Robotics

Johnson & Johnson has received FDA De Novo authorization for its OTTAVA Robotic Surgical System, the world’s first table-integrated soft tissue robotic system, for multiple general surgery procedures including gastric bypass, cholecystectomy, and splenectomy.

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