Top Tweets for #FDABreakthroughDeviceDesignation
PreveCol®, our #bloodtest for early cancer detection, has proven to have better diagnostic efficacy than currently approved #colorectalcancer screening tests in the US, which brings a significant benefit to patients.🔬🎗️🧬
#FDABreakthroughDeviceDesignation
The FoundationOne® Liquid CDx by @FoundationATCG is the only FDA-approved liquid #biopsy that is designed to help guide #treatment strategies and predict #patient benefit across multiple #cancer indications.
https://t.co/LM0eWYhb84
#FDABreakthroughDeviceDesignation #healthcare
The Guardant360® CDx by @GuardantHealth is the first FDA-approved #bloodtest for complete #genomic testing option for solid #cancers that has been approved by the #FDA.
https://t.co/IiSWLrtt6l
#FDABreakthroughDeviceDesignation #healthcare #healthcareIT
The @MDT_Diabetes MiniMed™ 770G system is a device that aims to aid #diabetes management. It automatically adjusts #insulin delivery every 5 minutes, to help prevent highs and lows.
https://t.co/hcAOQrO1Be
#FDABreakthroughDeviceDesignation #insulindelivery #diabetes #innovation
The @ShockwaveIVL intravascular lithotripsy system with the Shockwave C2 coronary intravascular lithotripsy catheter is a new standard of #care for safe calcium modification by reducing the #risk of perforations.
https://t.co/r1srf71bnS
#FDABreakthroughDeviceDesignation
The INTERCEPT Blood System for Plasma by Cerus is a #pathogen reduction system that has been designed to reduce the #risk of transfusion-transmitted infections and transfusion-associated graft-versus-host disease.
https://t.co/YjTPk0YVgc
#FDABreakthroughDeviceDesignation
The @MDT_Diabetes MiniMed™ 770G system is a device that aims to aid #diabetes management. It automatically adjusts #insulin delivery every 5 minutes, to help prevent highs and lows.
https://t.co/hcAOQrO1Be
#FDABreakthroughDeviceDesignation #insulindelivery #diabetes #innovation
The FoundationOne® Liquid CDx by @FoundationATCG is the only FDA-approved liquid #biopsy that is designed to help guide #treatment strategies and predict #patient benefit across multiple #cancer indications.
https://t.co/LM0eWYgDiw
#FDABreakthroughDeviceDesignation #healthcare
The Guardant360® CDx by @GuardantHealth is the first FDA-approved #bloodtest for complete #genomic testing option for solid #cancers that has been approved by the #FDA.
https://t.co/IiSWLrsVgN
#FDABreakthroughDeviceDesignation #healthcare #healthcareIT
#regulatory #news
~@T2Bio receives #FDABreakthroughDeviceDesignation for the T2Lyme Panel
~#Renovia receives #FDA clearance for leva® Pelvic Health System as first-line treatment for #chronic #fecalincontinence
~@Nyxoah receives FDA IDE approval to Initiate study of Genio®
#medicaldevice #regulatory #news
~@wysabuddy receives #FDABreakthroughDeviceDesignation for #AI-led #MentalHealth conversational agent
~@Accelus1 receives #FDAClearance for Interbody Fusion System
~#Breakthrough designation to @RemedeeLabs' #endorphinstimulation solution
#FDABreakthroughs!
~@spinex_ receives #FDA #BreakthroughDesignation for SCiP
~@X_Therma - #FDABreakthroughDeviceDesignation for XT-ViVo® Preservation Solution & TimeSeal® Organ Transport Device
~@MirvieDx - #Breakthrough Designation for 1st #Preeclampsia risk test
#Regulatory #news
@T2Bio submission for #FDABreakthroughDeviceDesignation for #T2Biothreat Panel
#FranklinMountainMedical recieves clearance of #patented #UltraNav Transseptal #catheter system
@NAVX_software's Dynamic Navigation receives clearance for #endodontic procedures
More regulatory news:
~@Implandata obtains CE mark for  #remote #glaucoma monitoring device

~@sensome_ Receives #FDABreakthroughDeviceDesignation for #AI-powered #stroke guidewire
~@radiobotics, an #XRAY analysis firm, receives #ISO 13485 & EU #MDR certification
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