MedTech Industry Dynamics
MedTech Industry Dynamics
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.
詳細情報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.
詳細情報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.
詳細情報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.
詳細情報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.
詳細情報GE HealthCareは、Invenia ABUS PrimeとABUS StreamVueを発表し、高濃度乳房の女性に対する補足スクリーニングをサポートし、エンタープライズイメージングネットワーク全体でのリモート検査レビューを可能にするソリューションで乳房イメージングポートフォリオを拡張した。
詳細情報DeepHealthは、病変の検出、特性評価、レポート作成を自動化し、乳房イメージングの標準化、精度、効率を向上させるAI搭載乳房超音波ソリューションについてFDA 510(k)承認を取得した。
詳細情報Smith+Nephewは、関節鏡手術向けに拡張現実、ナビゲーション、患者固有の3Dモデリングを組み合わせたAI搭載プラットフォームであるTESSA Spatial Surgery SystemについてFDAデノノボ分類を取得した。最初の適応症はACL再建術である。
詳細情報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.
詳細情報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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