FDA

MHRA, FDA, & Health Canada Release 5 Guiding Principles to Simplify MLMD Regulations October 27, 2023 Predetermined change control plans (PCCP) principles aim to ease regulatory hurdles for machine-learning-enabled medical devices (MLMD) developers, freeing resources to enhance patient-focused product performance.

Indian MedTech Startup SigTuple Receives FDA Clearance for AI100 with Shonit October 4, 2023 SigTuple's AI100 with Shonit represents AI-assisted digital pathology. In this process, a physical sample undergoes digital imaging through a microscopic lens, and AI models are employed to extract individual cells and categorise them into more than 30 distinct cell types.

Qure.ai Receives FDA Clearance for qXR-CTR AI Solution to Assess Cardiomegaly October 3, 2023 Qure.ai, a Mumbai-based medical imaging AI company, has received FDA clearance for qXR-CTR, its artificial intelligence-enabled chest X-ray solution.

Pharma Giant Zydus Gets EIR for Formulations Facility in Ahmedabad September 21, 2023 Ahmedabad's Zydus Lifesciences Limited has received an Establishment Inspection Report (EIR) approval from the US Food and Drug Administration (FDA) for its manufacturing facility near Ahmedabad.

Qure.ai's AI-Enabled Chest X-Ray Solution qXR Receives FDA Clearance for Critical Conditions September 16, 2023 The solution is capable of triaging pneumothorax (PTX) and pleural effusion (PE), both posing formidable challenges in emergency medical settings.

Alveofit's Alveoair Spirometer Receives US FDA Clearance for Expansion in the United States September 7, 2023 With the recent U.S. FDA approval and strategic partnerships, such as the one with AstraZeneca, Alveofit is prepared for global expansion.

GE Healthcare's Wireless Monitoring for Early Patient Deterioration Detection Gets FDA Clearance  August 17, 2023