Do this for devices also. @VivosIncUSA @RadioGel $RDGL #BreakthroughDevice already designated

$105 million for the next frontier of Alzheimer’s treatment - and it’s not another monoclonal antibody. Cognito Therapeutics announced the close of an oversubscribed $105 million Series C, bringing its total funding to $233 million. The round was led by Morningside Ventures, IAG Capital Partners, and Starbloom Capital, with strong participation from new investors including New Vintage Partners, Apollo Health Ventures, and Benvolio Group. At the center of this momentum is Spectris, a physician-prescribed, at-home wearable neurostimulation device that looks like sleek sunglasses connected to over-ear headphones. Patients simply wear it for one hour per day while it delivers precisely synchronized 40 Hz gamma-frequency light and sound stimulation. By non-invasively restoring disrupted gamma brain rhythms that decline early in Alzheimer’s, the therapy drives meaningful downstream effects. It reduces amyloid and tau pathology, helps preserve brain structure such as the corpus callosum, and meaningfully slows neurodegeneration. In the completed OVERTURE Phase 2 randomized, sham-controlled study and its open-label extension, patients using Spectris experienced a 77 percent reduction in the decline of daily function on the ADCS-ADL scale, a 76 percent reduction in cognitive decline on the MMSE, a 69 percent reduction on the integrated Alzheimer’s Disease Rating Scale, and a 56 percent lower Alzheimer’s Dependence Score. These benefits were sustained through the 18-month open-label extension, all with excellent safety and no serious device-related adverse events. The device carries FDA Breakthrough Device Designation for cognitive and functional symptoms in Alzheimer’s. A non-pharmacological, disease-modifying therapy that patients can use comfortably at home, with the potential for fewer side effects and far broader accessibility than today’s anti-amyloid infusions. It also opens the door for future expansion into other neurodegenerative diseases. #AlzheimersDisease #Neurotechnology #Neurodegeneration #DigitalHealth #Biopharma #Neuroscience #BreakthroughDevice #Longevity

Exciting milestone for @HemexHealth 🚀 Our Gazelle® Hb Variant Test just received FDA Breakthrough Device Designation, recognizing its potential to improve sickle cell disease monitoring with rapid, point-of-care quantitative hemoglobin results. This FDA designation accelerates the review for devices addressing life-threatening conditions like sickle cell disease. It provides more interactive FDA engagement, prioritized submissions, and expedited pathways, while maintaining strict safety and effectiveness standards, to help bring innovative, decentralized diagnostics to patients faster and advance health equity for underserved communities. Proud to be part of this innovation, developed with my team at Case Western Reserve University (@cwru) bringing decentralized diagnostics closer to patients. As Hemex Health CEO Patti White said: “The Breakthrough Device Designation reflects the FDA’s recognition of the need for improved tools to support the management of sickle cell disease.” Full press release: d27xuvt8nttd87.cloudfront.ne… #SickleCell #FDA #BreakthroughDevice #HemexHealth #Gazelle #HealthInnovation

The @US_FDA has granted #BreakthroughDevice Designation to the M.scio System, a unique implant that monitors #intracranialpressure long-term for people with #hydrocephalus. practicalneurology.com/news/… @Miethke @bbraun_com @Child_Neurology @childNeuroSoc @hydrocephalusso @hydroassoc @AANSneuro

🚀 Only a few days left for $MYNZ as the FDA decision on their Breakthrough Device application approaches! If approved, this could be a game-changer. Meanwhile, $NVDA , $AAPL and $GOOGL are leading the market with strong gains today! Could $MYNZ be the next big winner with %%%% big numbers (investopedia.com/stocks-to-w…) #Stocks #Biotech #BreakthroughDevice #FDA #TechStocks #Growth" This version highlights the urgency and potential impact of the FDA decision for $MYNZ, while also mentioning the strong performance of other major stocks. The link provides a source for further information

Excited to announce Breakthrough Device Designation for the eShunt System! #breakthroughdevice #hydrocephalus #NPH #endovascular prnewswire.com/news-releases…

$RDGL #BreakthroughDevice #FDA #revolutionarycancerdestroyer

$RDGL Must read! #BreakthroughDevice #IDEsubmissionSoon HUGE Market!!! radiogel.com/radiogel/precis…

@FDA awards #BreakthroughDevice designation to #AI-powered #tuberculosis diagnostic tool. #AI #FDA #TBTest @qure_ai ow.ly/gO3650Qy6Hz

$icu #medical #biotech #stockstobuy #undervalued #StockMarketToday #Breakout #CytokineStorm #Recovery #ICU #Breakthroughdevice #BillionsClub

#PCBCommunity | #InBrainNeuroelectronics, based in #BarcelonaSciencePark, receives #BreakthroughDevice Designation from @US_FDA for its intelligent #graphene-neural platform Congrats @carolainaguilar & team!👏 ▶️bwnews.pr/44X7SHc @FDADeviceInfo #MedicalDevices #Parkinson

📣 Exciting news! Anumana has received @US_FDA Breakthrough Device Designation for our ECG-AI algorithm to aid early identification of cardiac #amyloidosis. #AIforhealth #breakthroughdevice. Read the update 👉🏽 anumana.ai/newsroom/ZJLQeREA…

👏Congrats👏 MTI'22 alumn Prapela on the $3.5M NIH Blueprint MedTech grant in collaboration w @TuftsMedicalCtr & @UABNews tinyurl.com/3j6j5z4a #medtech #apneaofprematurity #infanthealth #neonates #pediatricdevices #pediatricinnovation #clinicaltrials #nicu #breakthroughdevice

What is going beyond CES? WHIM is! Not everything shiny and new will be at #CES2023 this year - WHIM is leading the charge in digital visual innovation. #digitalcanvas #onawhim #breakthroughdevice #digitaltransformation #tech

AVITA Medical Announces FDA Breakthrough Device Designations for the RECELL® System ir.avitamedical.com/news-rel… #FDA #BreakthroughDevice #skinrestoration #softtissue #vitiligo #RECELL $RCEL $AVH

What were our #healthtech readers clicking on the most this week? Take a look at our #FridayFive #TopReads firstwordhealthtech.com/stor… .@GoogleHealth .@US_FDA #Cerebral #Wysa #peoplemoves #breakthroughdevice #pharmapartners #digitaltherapeutics #mentalhealth #chronicpain #ALS

#FDA's #BreakthroughDevices Program was meant to speed the development, review of cutting-edge and potentially lifesaving #medicaldevices. However, the program is delivering the biggest benefits for companies, not patients. bit.ly/3uQuRVi #medtech #BreakthroughDevice

#Neurological devices, #diagnostics dominate latest #FDA #breakthroughdevice designations bit.ly/3zV38DP #autism #Parkinsons #medtech #DTx #vagusnerve #breakthroughdevices #medicaldevices #Parkinsonsdisease #cardiovascular #digitaltherapeutics #autismspectrumdisorder

Proud to see the announcement of MOWOOT's Breakthrough Device Designation featured in FDANews! fdanews.com/articles/205961-… #FDAnews #breakthroughdevice #medicaldevice

Latest #FDA #breakthroughdevice designations go to #braincomputerinterface, exo-suit bit.ly/3CIWArP #BCI #stroke #brainimplant #breakthroughdevices #medtech #medicaldevices #Alzheimers #concussion #chronicclusterheadache #breastcancer #spinalfusion #neuromodulation