Welcome to your Daily Dose of Health Tech Innovation!
Stay ahead with the latest breakthroughs revolutionizing healthcare—from AI diagnostics to remote care solutions.
We bring you expert-curated insights, emerging trends, and must-know updates from the digital health frontier.
Whether you’re a clinician, innovator, or health tech enthusiast, this roundup delivers what matters most.
Let’s dive into the future of health, one innovation at a time.
Johnson & Johnson Gets EU Approval for IMAAVY to Treat Generalized MG
Johnson & Johnson announced that the European Commission has approved a Marketing Authorisation for IMAAVY (nipocalimab), a fully human FcRn-blocking monoclonal antibody, as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG). gMG is a chronic, incurable autoantibody disease that causes debilitating symptoms such as muscle weakness, difficulty chewing, swallowing and speaking. This approval is for the treatment of a broad population of people living with gMG including adults and adolescent patients 12 years of age and older who are anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody-positive.
HeartBeam Updates FDA Path for 12-Lead ECG Software
HeartBeam, Inc., a medical technology company focused on transforming cardiac care by providing powerful personalized insights, announced its regulatory strategy following receipt of a Not Substantially Equivalent (NSE) decision on the Company’s 510(k) submission for its 12-lead Electrocardiogram (ECG) Synthesis Software.
Celltrion Receives Health Canada Approval for Eydenzelt, a Biosimilar Referencing Eylea
Celltrion, Inc. announced that Health Canada has approved Eydenzelt, a biosimilar referencing Eylea, in both vial and pre-filled syringe format, for treatment of all indications approved for Eylea.
Samsung Bioepis Launches Denosumab Biosimilars in Europe
Samsung Bioepis Co., Ltd. announced the launch of OBODENCE™ (60 mg pre-filled syringe) and XBRYK™ (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva. The products will be commercially available in Europe in December 2025 and January 2026, respectively.
GE HealthCare Debuts Next-Gen SIGNA MRI System
GE HealthCare announced the 510(k) submissions to the U.S. Food and Drug Administration (FDA) seeking clearance for next-generation SIGNA™ MRI technology. Unveiled at the Radiological Society of North America’s 2025 Annual Meeting, these differentiated solutions are part of a wave of new GE HealthCare innovations aimed at tackling some of the most complex challenges in healthcare. Designed to enhance precision diagnosis for clinicians and help clinicians improve patient outcomes, the new technologies include GE HealthCare’s4 1.5T MRI system, both equipped with an AI-powered workflow platform designed for end-to-end exam efficiency.
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