Medical Device – Talk Bio

EDAP Receives FDA 510(k) Clearance for Advanced Focal One Robotic HIFU System Enhancements

5 days ago talkbio0Tagged algorithm, Clearance, Edap, Malignant neoplasm of prostate, Medical Devices, robotic HIFU, United States Food and Drug Administration

EDAP; FDA 510(k) clearance; Focal One; robotic HIFU; high intensity focused ultrasound; ultrasound imaging; prostate cancer treatment; AI algorithms; medical devices

ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use

1 week ago talkbio0Tagged ARC-EX System, CE Mark, Clearance, hand sensation, Hand Strength, Home Use, Medical Devices, Medical service, neurotechnology, ONWARD, Spinal Cord Injuries, United States Food and Drug Administration

ONWARD Medical; FDA 510(k) clearance; ARC-EX System; home use; spinal cord injury; hand strength; hand sensation; neurotechnology; CE Mark; medical device

Microsoft and INBRAIN Collaborate to Explore Agentic AI for Next-Generation Brain Therapies

2 weeks ago talkbio0Tagged agentic AI, Brain-Computer Interfaces, closed-loop interventions, INBRAIN, Microsoft, nervous system disorder, next-gen brain therapies, precision neurology, real-time monitoring

Microsoft; INBRAIN; agentic AI; brain-computer interfaces; precision neurology; next-gen brain therapies; real-time monitoring; neurological disorders; closed-loop interventions

Spotlight On: What to Watch at AHA 2025 – Key Science and Trends

2 weeks ago talkbio0Tagged 2025, Autoimmune hemolytic anemia, Cardiology discipline, cardiometabolic, Cardiopulmonary Resuscitation, Clinical Trials, coronary trials, gene editing therapies, Guidelines, Hypertensive disease, Interventional procedure, lipid management, Medical Valves, polypill, Science

AHA 2025; late-breaking science; clinical trials; cardiology; gene-editing therapies; polypill; lipid management; valve and coronary trials; cardiometabolic intervention; hypertension; CPR guidelines

Altanine Strengthens Scientific Advisory Board with Appointment of Dr. Bruce D. Forrest

4 weeks ago talkbio0Tagged Altanine, biopharmaceutical development, Bruce D. Forrest, clinical strategy, Drug Delivery Systems, pharmaceutical innovation, Regulatory Expertise, Scientific Advisory Board, Vaccine Development

Altanine; Scientific Advisory Board; Bruce D. Forrest; drug delivery; clinical strategy; regulatory expertise; biopharmaceutical development; vaccine development; pharmaceutical innovation

Halozyme to Acquire Elektrofi for $750 Million, Expanding Drug Delivery Capabilities

2 months ago talkbio0Tagged Acquisition, Biological Factors, Drug Delivery Systems, Elektrofi, Halozyme, Hypercon, microparticle technology, milestone payments, subcutaneous delivery

Halozyme Therapeutics; Elektrofi; acquisition; drug delivery; Hypercon; biologics; subcutaneous delivery; milestone payments; microparticle technology; Q4 2025

Trump Administration Launches Tariff Probe into Medtech and Pharmaceutical Industries

2 months ago talkbio0Tagged Evaluation, Manufacturing, Medical Devices, medtech industry, National Security, pharmaceutical imports, Sectioning technique, semiconductor tariffs, supply chain, tariffs, Transplant Registry Unified Management Program

Trump administration; tariffs; medtech industry; pharmaceutical imports; Section 232 investigation; semiconductor tariffs; national security; supply chain; manufacturing; medical devices

Acadia Halts Development of Nasal Prader-Willi Drug After Phase 3 Failure

2 months ago talkbio0Tagged Acadia, carbetocin, Clinical trial failure, Compass, Hyperphagia, Nasal Spray, Prader-Willi Syndrome

Acadia Pharmaceuticals; carbetocin; Prader-Willi syndrome; Phase 3 trial; COMPASS PWS study; clinical trial failure; nasal spray; hyperphagia

J&J’s Inlexzo Bladder Cancer Therapy Wins ‘Practice-Changing’ FDA Approval

3 months ago talkbio0Tagged Approved, BCG-Unresponsive, Carcinoma, Drug Delivery Systems, gemcitabine intravesical system, in situ, Inlexzo, Johnson & Johnson, Malignant neoplasm of urinary bladder, New, Non-Muscle Invasive Bladder Neoplasms, SunRISe-1 trial, United States Food and Drug Administration

Inlexzo; FDA approval; bladder cancer; Johnson & Johnson; gemcitabine intravesical system; BCG-unresponsive; non-muscle invasive bladder cancer; SunRISe-1 trial; novel drug delivery; carcinoma in situ

Eisai Secures FDA Approval for Leqembi Autoinjector for Maintenance Dosing in Alzheimer’s Patients

3 months ago talkbio0Tagged Alzheimer 's disease, Approved, at-home, AutoInjector, Biogen, dosing, Eisai, Lecanemab, Leqembi, Maintenance, Subcutaneous Injections, United States Food and Drug Administration

Eisai; Leqembi; lecanemab; FDA approval; autoinjector; subcutaneous injection; maintenance dosing; Alzheimer’s disease; at-home treatment; Biogen