BY THE DIGITAL HEALTH LEADERS FOR THE DIGITAL HEALTH COMMUNITY
BY THE DIGITAL HEALTH LEADERS 
FDA Flags Cybersecurity Risks in Contec & Epsimed Patient Monitors January 31, 2025 The US Food and Drug Administration (FDA) has identified three significant cybersecurity vulnerabilities in certain patient monitors manufactured by Contec and Epsimed, urging healthcare facilities to take immediate mitigation measures.
FDA Issues Draft Guidance on AI in Drug & Biological Product Development January 8, 2025 The FDA introduces a new framework to validate AI models used in drug and biological product submissions, aiming to boost transparency, credibility, and efficiency in regulatory processes.
FDA Names Dr Michelle Tarver as New Chief of Medical Devices October 23, 2024 The FDA has appointed Dr Michelle Tarver as the new head of its medical device division, focusing on improving safety and transparency amid industry concerns.
Apple Receives FDA Approval for AirPods Pro 2 Hearing Aid Feature September 16, 2024 Apple has received FDA approval for a groundbreaking feature in its AirPods Pro 2, enabling them to function as over-the-counter hearing aids for individuals with mild-to-moderate hearing loss.
Qure.ai’s AI-Powered TB Solution Receives ‘Breakthrough Device’ Status from FDA February 7, 2024 This latest regulatory recognition for Qure.ai joins four FDA clearances and 61 EU Medical Device Regulation CE mark approvals over the last 18 months.
MH FDA Implements INR 24.59 Cr Worth Strategy to Strengthen Drug Regulatory System December 19, 2023 Commenced on May 1, 2017, this initiative undergoes reviews by the Union Health Ministry every two years. Scheduled for completion by March 31, 2025, the scheme symbolises a joint endeavour to enhance Maharashtra's drug regulatory capabilities.
FDA Recalls Stolen Medtronic Laryngoscopes Sold on Facebook Marketplace November 24, 2023 The FDA's recall underscores the vulnerability of essential medical equipment to exploitation in the widespread realm of online marketplaces, posing significant risks to patient safety and the integrity of medical procedures.
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.
