🧠 ⚙ 𝐍𝐞𝐮𝐫𝐨𝐭𝐞𝐜𝐡 𝐍𝐨𝐭𝐚𝐛𝐥𝐞𝐬 #𝟐𝟑: 𝐉𝐚𝐧 𝟐𝟎𝟐𝟓
💼 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 & 𝐀𝐠𝐞𝐧𝐜𝐲 𝐔𝐩𝐝𝐚𝐭𝐞𝐬 𝐢𝐧 𝐍𝐞𝐮𝐫𝐨𝐭𝐞𝐜𝐡 💼
📄 The FDA has released a draft guidance about AI-enabled device software functions with a compilation of insights from over 1,000 AI-enabled device authorizations. For those interested: A webinar is scheduled for February 18, with comments due by April 7, offering an opportunity for stakeholders to impact future policies.
📝 The Advanced Research Projects Agency for Health (ARPA-H)’s Network Survey will help accelerate med device and diagnostic reimbursement strategies to bridge gaps in bringing devices to market efficiently. Responses due by February 21, 2025.
🔌 The FDA Breakthrough Device Designation was granted for closed-loop transcranial alternating current stimulation to treat major depressive disorder.
📢 Comphya has received the FDA IDE approval to begin U.S. trials for CaverSTIM, the first implantable neuromodulator for erectile dysfunction.
🚀 ONWARD Medical has earned the FDA De Novo classification and a U.S. market authorization for its non-invasive spinal cord stimulation system for chronic spinal cord injury, the first in neurorehabilitation that's accessible.
✅ Medtronic has won the CE mark approval for its adaptive deep brain stimulation technology for Parkinson’s disease.
🎉 Abbott’s Liberta RC™ DBS System has received the CE mark approval, adding next-generation deep brain stimulation to the toolkit for managing neurological conditions.
🔬 ARPA-H has launched the PROSPR program to build on NIA’s work accelerating the development of therapeutics for enhancing healthspan.
📚 The American College of Surgeons released new Traumatic Brain Injury (TBI) care guidelines.
🛡️ The Defense Bill has mandated new military actions on brain injury, a crucial development in neurohealth for service members and veterans.
💰 The U.S. Senate has passed an act tripling funding for state and local dementia programs.
👩⚕️ Director of the FDA CDRH, Dr. Michelle Tarver, has shared their vision for neurotech and device regulation.
🏡 The FDA’s "Home as a Health Care Hub" Idea Lab details how remote monitoring & home-based care models can seamlessly integrate into healthcare ecosystems.
🤔 The GAO has released a report on "BCI: Applications, Challenges, and Policy Options," with insights into ethical, regulatory, and technical considerations of BCIs.
#Neurotech #BrainHealth #Neuromodulation #AIinHealthcare #MentalHealthTech #BrainComputerInterface #WearableTech #MedicalDevices #Neuroscience #DigitalHealth
Zeto’s Marketing Manager: Bringing EEG Innovation to Everyone, Everywhere.
6moThank you, Hollie!