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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

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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

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

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

overactive bladder

BlueWind Medical

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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

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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

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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

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More, but slower, medtech approvals

More, but slower, medtech approvals

EP Vantage

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

knee replacements

hip replacements

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CMS proposes new pathway for reimbursing breakthrough devices

CMS proposes new pathway for reimbursing breakthrough devices

Stat

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

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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

product 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

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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

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

postoperative fever

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Cook Set to Layoff 500 Employees

Cook Set to Layoff 500 Employees

Medical Devices and Diagnostics Industry

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

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Post-approval modification of high-risk devices linked to 30% jump in recall risk: study

Post-approval modification of high-risk devices linked to 30% jump in recall risk: study

Medtech Dive

high-risk devices

product recalls

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EPA proposes limits on carcinogenic gas used to sterilize medical devices

EPA proposes limits on carcinogenic gas used to sterilize medical devices

Stat

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Are ICU Medical & GE HealthCare Competing to Acquire 2 Units from Medtronic?

Are ICU Medical & GE HealthCare Competing to Acquire 2 Units from Medtronic?

Medical Devices and Diagnostics Industry

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