Tag: FDA Approval

Bicaval Valve Gains FDA Trial Approval.

As of December 15, 2025, the medical technology landscape has witnessed a pivotal development with meaningful implications for cardiovascular...

Lungpacer Approval Marks Respiratory Care Breakthrough.

The medical device industry witnessed a transformative milestone on December 5, 2024, as Lungpacer Medical secured premarket approval from...

RapidAI FDA Clearance Expands AI Medical Platform.

RapidAI Secures FDA Clearance for Five Advanced Medical AI Imaging Modules San Mateo-based medical artificial intelligence company RapidAI announced on...

Amgen Approval Boosts Lung Cancer Therapy.

Amgen Approval Signals New Momentum in Oncology Treatment Amgen Approval has become a central talking point across global biotechnology circles...

FDA Approval: At-Home Blood Pressure Device.

FDA Approves First-Ever At-Home Blood Pressure Monitoring Device for Hypertension ManagementIn a groundbreaking move, the U.S. Food and Drug...

Nitinotes Receives FDA Approval to Launch Pivotal U.S. Trial for EndoZip™ System EndoZip™ Aims to Transform Endoscopic Obesity Treatment.

Caesarea, Israel – July 2025: Nitinotes has announced that it has received Investigational Device Exemption (IDE) approval from the...

AI Steps In: Clarity’s New Tool Seeks to Forecast Breast Cancer Risk with Accuracy.

A New Move in Breast Cancer Screening. (Clarity Mammography Risk Score) Breast cancer is still one of the most prevalent...

FDA Approves Vutrisiran to Treat ATTR-CM- New Treatment Seeks to Minimize Risks of Heart Failure in Patients.

FDA approval Vutrisiran ATTR-CM treatment for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) in adults This is a significant milestone...

Journey Medical Corporation Showcased Emrosi™ at 2025 American Academy of Dermatology Annual Meeting.

Journey Medical Corporation (Nasdaq: DERM) exhibited at the 2025 American Academy of Dermatology (AAD) Annual Meeting. The event was...