breakthrough device

FDA proposes breakthrough status for devices that address health disparities
RAPS.org
Sun, 10/23/22 - 07:05 pm
FDA
CDRH
breakthrough device
regulatory
As FDA offers breakthrough designation to device makers, patients and providers are left with questions
Stat
Mon, 04/18/22 - 10:51 am
devices
Medtech
FDA
regulatory
breakthrough device
Pear claims breakthrough tag for alcohol use disorder DTx
Pharmaforum
Wed, 11/24/21 - 10:04 am
digital health
Pear Therapeutics
breakthrough device
devices
reSET-A
alcohol-use disorder
FDA
MCIT breakthrough device payment pathway included in Cures 2.0 bill
Medtech Dive
Thu, 11/18/21 - 10:42 am
devices
Medtech
legistlation
Cures 2.0
breakthrough device
MCIT
Medicare
CMS scraps coverage rule for breakthrough devices
MedCity News
Sun, 11/14/21 - 10:46 pm
devices
CMS
Medicare
breakthrough device
CMS moves to scrap MCIT rule due to clinical evidence concerns
Medtech Dive
Tue, 09/14/21 - 10:56 am
devices
Medtech
CMS
Medicare
breakthrough device
FDA ends summer with fresh batch of breakthrough device designations
Medtech Dive
Fri, 09/10/21 - 11:03 am
devices
Medtech
FDA
Novocure
liver cancer
CellMax Life
Endosound
ImpediMed
Auctus Surgical
Madorra
MicroTransponder
breakthrough device
CMS’ rule granting speedy coverage to FDA-designated ‘breakthrough’ devices delayed again
MedCity News
Tue, 05/18/21 - 10:57 am
CMS
Medicare
devices
breakthrough device
FDA
Locate Bio’s Osteomyelitis Implant Gets FDA Breakthrough Device Designation
Xtalks
Mon, 01/11/21 - 06:54 pm
Locate Bio
devices
FDA
breakthrough device
CognitOss
chronic osteomyelitis
FDA finalizes speedier medical device pathway alternative to breakthrough status
Medtech Dive
Fri, 01/8/21 - 09:28 am
devices
STeP
FDA
breakthrough device
Will Vectorious Be Victorious in Heart Failure?
Medical Devices and Diagnostics Industry
Wed, 12/2/20 - 10:47 am
devices
Vectorious Medical Technologicies
breakthrough device
FDA
left atrial pressure sensor
heart failure
Medtronic Wins Breakthrough Device Designation for TYRX
Medical Devices and Diagnostics Industry
Tue, 09/22/20 - 10:11 pm
Medtronic
devices
FDA
breakthrough device
Tyrx
ventricular assist devices
Medtronic Scores Breakthrough Designation for Transcatheter Tricuspid Valve
Medical Devices and Diagnostics Industry
Wed, 09/9/20 - 11:15 pm
Medtronic
devices
Intrepid TTVR
FDA
breakthrough device
Medtronic Scores Breakthrough Designation for Transcatheter Tricuspid Valve
Medical Devices and Diagnostics Industry
Wed, 09/9/20 - 11:15 pm
Medtronic
devices
Intrepid TTVR
FDA
breakthrough device
Startup using music to help stroke patients walk gets breakthrough designation
MedCity News
Tue, 06/16/20 - 10:50 am
MedRhythms
stroke
rehab
FDA
breakthrough device
devices
JenaValve raises $50m for TAVR tech
Mass Device
Thu, 02/13/20 - 11:25 pm
JenaValve
TAVR
aortic valve replacement
devices
breakthrough device
FDA