FDA– tag –
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Intelligent Bio Solutions Clears Cybersecurity and Software Review Items Ahead of FDA 510(k) Submission, Advancing US Market Entry
Intelligent Bio Solutions (INBS) News and Media USA Overview Intelligent Bio Solutions Inc. announced it has addressed all cybersecurity and software-related review items for its upcoming FDA 510(k) submission. This milestone, achieved a... -
Biolinq’s Needle-Free Autonomous Wearable Biosensor, Shine™, Receives FDA De Novo Classification, Establishing New Device Category
EvoNexus USA Overview Biolinq, an EvoNexus graduate company, announced that its Shine™ device, a needle-free autonomous wearable biosensor, has received FDA De Novo classification. This classification creates a new regulatory category fo... -
Roche Secures EU CE Mark for Elecsys pTau217 Alzheimer’s and Elecsys IGRA TB Blood Tests
GlobeNewswire Switzerland Overview Roche announced that its Elecsys pTau217 blood test for Alzheimer's disease diagnosis and Elecsys IGRA TB test for latent tuberculosis infection have received EU CE mark certification. This approval, pa... -
FDA Clears Dexcom’s Stelo OTC Continuous Glucose Monitor for Non-Insulin Users Aged Two and Up
Prime Therapeutics - Portal USA Overview The FDA has granted over-the-counter (OTC) marketing authorization for Dexcom's Stelo Glucose Biosensor System, expanding its use to non-insulin users aged two and older. This marks the first OTC ... -
FDA Selects Dexcom as Inaugural Participant in Digital Health Pilot to Accelerate AI-Integrated Glucose Management
Healthcare Dive USA Overview The U.S. FDA has named Dexcom as the first participant in its new digital health pilot program, designed to streamline regulatory pathways for innovative devices. This initiative will exempt certain Dexcom di... -
FDA Bestows RMAT Status on iPSC-Derived Cell Therapy for Intractable Disease, Poised to Accelerate Clinical Development
Company Announcement / Specialized Media USA Overview A regenerative medicine firm has announced its iPSC-derived cell therapy program for an intractable disease has received Regenerative Medicine Advanced Therapy (RMAT) designation from... -
FDA Issues Draft Guidance for Long-Term Follow-Up of Gene Therapies, Establishing Industry Standards for Safety and Efficacy
STAT News USA Overview The U.S. Food and Drug Administration (FDA) has released new draft guidance for the long-term safety and efficacy follow-up of approved gene therapy products. This guidance aims to establish industry standards for ... -
FDA Details Regenerative Medicine Advanced Therapy (RMAT) Designation Framework, Offering Fast Track and Breakthrough Therapy Benefits
Global MedTech Expert USA Overview Global MedTech Expert details the FDA's regulatory framework for 351/361 HCT/P classification and Regenerative Medicine Advanced Therapy (RMAT) designation. RMAT offers significant benefits, including F... -
FDA Flags Unapproved Exosome Therapies, Citing Safety Concerns and International Regulatory Gaps
PLANEW Clinic South Korea Overview Exosome therapy is attracting significant attention for its regenerative potential, particularly in skin treatments, yet currently lacks U.S. FDA approval. The FDA has issued public safety warnings agai... -
CHOC Shapes Future of Pediatric Gene Therapy: Driving Early Intervention with CRISPR Editing and Strict Quality Control
Children's Hospital of Orange County (CHOC) Pediatrica USA Overview Rady Children's Health Orange County is focusing on in vivo gene replacement, ex vivo gene therapy (e.g., CAR T-cell therapy), and CRISPR-based genome editing to shape t...
