Top Tweets for #FDABreakthrough
FDA designation fast-tracks a promising therapy for MASH, a silent liver disease tied to metabolic aging and long-term health.
https://t.co/ecHNz1Q9qC
#longevity #FDABreakthrough #Altimmune #Pemvidutide #ObesityTreatment #MetabolicHealth #DrugDevelopment #HealthInnovation
"Congrats @neuralink
! A game-changer for ALS patients to speak again. #Neuralink #FDAbreakthrough #NeuroTech #HealthInnovation"
SCI members Matthew Frank, David Miklos & others were awarded #FDAbreakthrough designation for their early study on #CARTCell therapy for high-risk #lymphoma. Early results show improved responses by modifying the therapy’s molecular target. https://t.co/Tn1TURLCWe
#regulatory #news
~@Roche MS test secures #FDABreakthrough device designation
~@MicrobotMedical granted registered trademark from @uspto
~@hearsoundwave receives 510(k) clearance for self-fitting #OTC #HearingAids
Portfolio company INBRAIN Neuroelectronics achieves #FDABreakthrough designation for their #graphene based Intelligent Network decoding and modulation platform, bringing it closer to patients. https://t.co/1Zim4GPvjD
September is #hydrocephalus awareness month. As a hydrocephalus dedicated company, @rhaeos aims to improve the lives of those affected by this chronic condition. #HAM2023 #neurosurgery #FDAbreakthrough #completelywireless #wearable
We are happy to announce that our #μFR® system receives #FDABreakthrough Device Designation!!!
See more details:
https://t.co/RsKZXFdU5x
#money #news
~@Protalix_Bio announces $20M milestone payment from @ChiesiGRD
~#CadenceNeuroscience raises $26M in #SeriesB #financing
~@paradromics raises $33M, wins #FDABreakthrough nod for #BCI #tech
#regulatory #news
~@LuxuanX receives #FDABreakthrough for PDACatch, #liquidbiopsy assay for #PancreaticCancer
~#OmeqMedical secures FDA approval for #epidural injection device
~@TempusLabs clocks #FDAApproval for 648-gene cancer test
#regulatory #news
~@AvingerInc receives clearance for Tigereye ST #ImageGuided CTO crossing system
~@ultromics granted #FDABreakthrough for #AI-enhanced #CardiacAmyloidosis detection
~@innoblative wins #FDAbreakthrough nod for #ablation device
more #regulatory wins
~@ultromics granted #FDABreakthrough for #AI-enhanced #CardiacAmyloidosis detection
~@galderma recieves approval for Sculptra® for cheek wrinkles
~@MawiDNA receives clearance for iSWAB-respiratory tract sample collection for #COVID
#regulatory #news
~#liberDi receives #FDA clearance for digital #dialysis system
~@DatarCancer wins #breakthrough designation for #BloodTest diagnosis #BrainTumors
@BurningRock2014 wins #FDABreakthrough nod for multi-cancer #bloodtest
#FDA #news
~@BrandInstitute partners on #brand name development for #FDAApproved treatment for active benign #gastric #ulcer
~#Sklip approved to test #skincancer triage at home using #AI
~@CeribellEEG receives #FDABreakthrough designation for #delirium indication
#HAConnect is almost here! Come visit our booth to learn about our solutions for #hydrocephalus!
@hydroassoc #noninvasive #wearables #platformtech #digitalhealth #fdabreakthrough #neurosurgery #brainhealth #austin #haconnect2022
#regulatory #news
~@TravereRare scores #FDA priority review of drug application for treatment of IgA #nephropathy
~@unmc, @AnandaScience snag #FDAApproval, IND for #PTSD #clinicaltrial
~@Exactechinc nabs #FDABreakthrough for @Jointmedica's Hip Resurfacing System
FDA gives Breakthrough designation for relapsing-remitting MS test
https://t.co/UpIyug1uWA
@QuanterixSimoa #medtech #diagnostics #FDABreakthrough #RRMS
#medicaldevices #regulation
@CookMedical wins #FDABreakthrough for #Thoraco+ #endovascular system
@aidocmed's #AI-powered #XRay system cleared to detect collapsed lungs
@BielCorp's #RecoveryRx #PainRelief device nabs clearance from @COFEPRIS, to launch distribution in Mexico
Manus receives FDA Breakthrough Designation for NMP device
https://t.co/4lVUuT5cVI
@Manusneuro #medtech #FDABreakthrough #neuromotorpen #medicaldevices #parkinsons
#RegulatoryUpdates :
~#CEMark win for @Fluxergy’s 1-hr #COVID19 test
~@JNJNews gains Japan approval for first drug-releasing combination contact lenses $JNJ
~@IceCureMedical wins #FDABreakthrough designation for #cryoablation system #Afib
The FDA has granted a Breakthrough Device Designation for the RA-DTx product of the Arthronica platform!
#FDAbreakthrough #healthcaresolution #digitalhealthcare #ai #arthritis #rheumatoidarthritis #rheumatology #rheumatoidarthritis
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