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How Boston Scientific Got the Watchman Back on Track
How Boston Scientific Got the Watchman Back on Track
Medical Devices and Diagnostics Industry
Boston Scientific
Medtech
devices
WATCHMAN
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Abbott’s Biowearable Performs Well In U.K. Ahead Of U.S. Launch
Abbott’s Biowearable Performs Well In U.K. Ahead Of U.S. Launch
Forbes
Abbott Labs
biowearables
UK
diabetes
Lingo
devices
Medtech
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FDA details switch to electronic filings for 510(k), de novo submissions
FDA details switch to electronic filings for 510(k), de novo submissions
Medtech Dive
FDA
Medtech
de novo pathway
devices
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FDA Finalizes Human Factors Guidance in Combination Medical Devices
FDA Finalizes Human Factors Guidance in Combination Medical Devices
Medical Devices and Diagnostics Industry
Medtech
devices
FDA
regulatory
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Hopes dim for Medtronic hypertension treatment after FDA panel rebuff
Hopes dim for Medtronic hypertension treatment after FDA panel rebuff
Medtech Dive
Medtronic
Medtech
hypertension
devices
FDA
Symplicity Spyral
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Magenta Medical completes enrolment for world’s smallest heart pump trial
Magenta Medical completes enrolment for world’s smallest heart pump trial
Clinical Trials Arena
Magenta Medical
devices
Medtech
heart pumps
clinical trials
percutaneous coronary intervention
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FDA greenlights medical device to combat bladder issues
FDA greenlights medical device to combat bladder issues
Stat
Medtech
overactive bladder
BlueWind Medical
FDA
devices
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Median lag between FDA authorization and Medicare coverage hits 6 years: study
Median lag between FDA authorization and Medicare coverage hits 6 years: study
Medtech Dive
devices
Medtech
FDA
Medicare
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Capitalizing on 3D-Printing for Medical Device Manufacturing
Capitalizing on 3D-Printing for Medical Device Manufacturing
Medical Devices and Diagnostics Industry
devices
Medtech
3D printing
innovation
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FDA by the Numbers: 2023 Mid-Year Review
FDA by the Numbers: 2023 Mid-Year Review
Medical Devices and Diagnostics Industry
Medtech
FDA
devices
510(k)
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More, but slower, medtech approvals
More, but slower, medtech approvals
EP Vantage
FDA
Medtech
devices
device approvals
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Restor3d inks Conformis buyout, adding hip and knee implants to portfolio
Restor3d inks Conformis buyout, adding hip and knee implants to portfolio
Medtech Dive
Restor#d
M&A
ConforMIS
knee replacements
hip replacements
Medtech
devices
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CMS proposes new pathway for reimbursing breakthrough devices
CMS proposes new pathway for reimbursing breakthrough devices
Stat
devices
Medtech
CMS
breakthrough devices
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Medtronic Takes a Hard Look in the Mirror
Medtronic Takes a Hard Look in the Mirror
Medical Devices and Diagnostics Industry
Medtronic
devices
Medtech
transparency
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Abiomed heart pump recall labeled Class I by FDA, no deaths reported
Abiomed heart pump recall labeled Class I by FDA, no deaths reported
Medtech Dive
JNJ
Abiomed
devices
Medtech
Impella 5.5
product recalls
device recalls
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Black men were likely underdiagnosed with lung problems because of bias in software, study suggests
Black men were likely underdiagnosed with lung problems because of bias in software, study suggests
Stat
racial disparity
lung function
Medtech
devices
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The Effect of Climate Change on Medical Device Manufacturing
The Effect of Climate Change on Medical Device Manufacturing
Medical Devices and Diagnostics Industry
climate change
devices
Medtech
supply chain disruption
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Integra recalls all devices made at Boston facility in the past 5 years, pauses production
Integra recalls all devices made at Boston facility in the past 5 years, pauses production
Medtech Dive
Integra LifeSciences
devices
Medtech
device recalls
postoperative fever
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Cook Set to Layoff 500 Employees
Cook Set to Layoff 500 Employees
Medical Devices and Diagnostics Industry
Cook Medical
layoffs
Medtech
devices
device manufacturing
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Report names connected medical devices with the biggest cybersecurity risks
Report names connected medical devices with the biggest cybersecurity risks
Medtech Dive
Medtech
cybersecurity
devices
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