17 Apr 2023
To Read - Pixium Vision S.A. in Fierce Biotech – Pixium Vision's bionic eye implant nets FDA breakthrough label in dry AMD
Read here: fiercebiotech.com/medtech/pi…
#breakthroughdevices #Pixium #Vision #ALPIX #dryAMD #AMD #implants #FDA #ophthalmology #bioniceye #artificialvision
ALT Pixium Vision's bionic eye implant nets FDA breakthrough label in dry AMD
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14 Apr 2023
To Read - Pixium Vision S.A. in MDDI – Pixium’s #AMD Implant Wins Breakthrough Device Designation
Read here: mddionline.com/implants/pixi…
#medicaldevices #healthcare #innovation #breakthroughdevices #implants #FDA #medtech #ophthalmology #visionrestoration #ALPIX #pixium #vision
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18 Apr 2022
#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
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16 Mar 2022
US replaces #EU as priority market for #medtech industry: survey bit.ly/3JuaUII #FDA #medicaldevice #MDR #EuropeanUnion #FDAregulation #Europe #medicaldevices #AI #machinelearning #digitalhealth #breakthroughdevices #medicaldeviceregulation #Brexit #MedTechEurope
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13 Jan 2022
#Neurological devices, #diagnostics dominate latest #FDA #breakthroughdevice designations bit.ly/3zV38DP #autism #Parkinsons #medtech #DTx #vagusnerve #breakthroughdevices #medicaldevices #Parkinsonsdisease #cardiovascular #digitaltherapeutics #autismspectrumdisorder
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22 Nov 2021
Latest #FDA #breakthroughdevice designations go to #braincomputerinterface, exo-suit bit.ly/3CIWArP #BCI #stroke #brainimplant #breakthroughdevices #medtech #medicaldevices #Alzheimers #concussion #chronicclusterheadache #breastcancer #spinalfusion #neuromodulation
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25 Mar 2021
Excellent article. Thanks @ChrisMedTech ! Seniors deserve access to novel therapies that treat severe diseases with no alternative treatment options, they are a vulnerable group. @CMSGov #MCIT #BreakthroughDevices
24 Mar 2021
Seniors Should Have Access to Breakthrough Medical Devices. Here’s Why: bit.ly/3vYkKwc
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16 Dec 2020
#FDA #BreakthroughDevice designations go to #renaldenervation devices in latest batch bit.ly/3p4fT8J #renalartery #resistanthypertension #ultrasound #medtech #BreakthroughDevices #meddevice #medicaldevices
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28 Oct 2020
#ALS patients implanted with #braincomputerinterface controlled their personal computers through direct thought bwnews.pr/35L1xC9 #paralysis #neuroprosthesis #BCI #medicaldevice #medicaldevices #medtech #meddevice #neuromodulation #breakthroughdevice #breakthroughdevices
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17 Sep 2020
Earlier this month, #CMS published a proposed rule that, if finalized, would expedite #Medicare coverage for #breakthroughdevices. Lauren Farruggia, @BruceArmon, and I discuss in our latest alert.
#FDA #Medicare #reimbursement #medicaldevices
17 Sep 2020
In the following alert, attorneys @RegulatoryAtty, @BruceArmon and Lauren Farruggia discuss a proposed rule that would provide Medicare beneficiaries with faster access to new and innovative medical devices. Read here... ow.ly/pbIK50Bu3uX #healthcare #medicare #medicaid
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9 Sep 2020
Medtronic #tricuspidvalvereplacement device wins #FDA breakthrough status bit.ly/35k8ueL #medtech #meddevice #medicaldevices #medicaldevice #FDAregulation #TTVR #breakthroughdevice #breakthroughdevices #cardiology #heartdevices #tricuspidvalveregurgitation
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14 Oct 2019
FDA's Safer Technologies Program is expected to significantly improve the safety of available treatments or diagnostic devices for diseases or conditions that are less serious than those eligible for the agency’s #BreakthroughDevices Program. Blog recap: wp.me/p8RFUE-1nh
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9 Jul 2019
Understanding The FDA's #BreakthroughDevices Program ow.ly/uSS550uWw04 #medicaldevice #medtechregulation
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26 Oct 2017
How does FDA's new draft guidance for breakthrough devices impact the industry? wp.me/p8RFUE-160 #FDA #breakthroughdevices
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25 Oct 2017
Our latest #RegulatoryRoundup post: #MedicalDevice Update: #FDA Releases Device Change Final Guidances and #BreakthroughDevices Draft Guidance, Qualifies First Device Development Tool #MDDT #21stcenturycures #clinicaltrials #innovation #software #MEDTECH
25 Oct 2017
Regulatory Roundup blog post by @regulatoryatty: "Medical Device Update: FDA Releases Device Change Final Guidances"
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