devices

FDA seeks feedback on predetermined change control plans
Medtech Dive
Mon, 08/26/24 - 10:34 pm
FDA
Medtech
PCCPs
regulatory
devices
FDA’s plan to expand device surveillance faces challenges, GAO finds
Medtech Dive
Wed, 08/21/24 - 10:30 pm
FDA
regulatory
GAO
medtehc
devices
How Will FDA’s New QMSR Affect Medical Device Companies?
Medical Devices and Diagnostics Industry
Sun, 03/24/24 - 10:23 pm
Medtech
devices
FDA
QMSR
FDA warns of potential risk from Hologic's devices implanted in soft tissue
Reuters
Tue, 02/27/24 - 11:15 pm
Medtech
FDA
Hologic
devices
implants
FDA creates ‘super office’ to oversee device cybersecurity, digital health and supply chain
Medtech Dive
Mon, 01/29/24 - 10:55 am
FDA
devices
Medtech
digital health
cybersecurity
GAO Urges FDA, CISA to Update Medical Device Cybersecurity Guidance
Medical Devices and Diagnostics Industry
Wed, 01/3/24 - 09:31 am
Medtech
cybersecurity
FDA
CISA
devices
GAO
How Boston Scientific Got the Watchman Back on Track
Medical Devices and Diagnostics Industry
Wed, 10/11/23 - 10:24 am
Boston Scientific
Medtech
devices
WATCHMAN
Abbott’s Biowearable Performs Well In U.K. Ahead Of U.S. Launch
Forbes
Tue, 10/10/23 - 11:55 pm
Abbott Labs
biowearables
UK
diabetes
Lingo
devices
Medtech
FDA details switch to electronic filings for 510(k), de novo submissions
Medtech Dive
Wed, 10/4/23 - 09:46 am
FDA
Medtech
de novo pathway
devices
FDA Finalizes Human Factors Guidance in Combination Medical Devices
Medical Devices and Diagnostics Industry
Wed, 09/13/23 - 11:21 am
Medtech
devices
FDA
regulatory
Hopes dim for Medtronic hypertension treatment after FDA panel rebuff
Medtech Dive
Tue, 08/29/23 - 11:20 am
Medtronic
Medtech
hypertension
devices
FDA
Symplicity Spyral
Magenta Medical completes enrolment for world’s smallest heart pump trial
Clinical Trials Arena
Wed, 08/23/23 - 09:56 am
Magenta Medical
devices
Medtech
heart pumps
clinical trials
percutaneous coronary intervention
FDA greenlights medical device to combat bladder issues
Stat
Tue, 08/22/23 - 11:29 pm
Medtech
overactive bladder
BlueWind Medical
FDA
devices
Median lag between FDA authorization and Medicare coverage hits 6 years: study
Medtech Dive
Sun, 08/13/23 - 02:31 pm
devices
Medtech
FDA
Medicare
Capitalizing on 3D-Printing for Medical Device Manufacturing
Medical Devices and Diagnostics Industry
Tue, 07/25/23 - 09:10 pm
devices
Medtech
3D printing
innovation
FDA by the Numbers: 2023 Mid-Year Review
Medical Devices and Diagnostics Industry
Thu, 07/13/23 - 10:12 am
Medtech
FDA
devices
510(k)
More, but slower, medtech approvals
EP Vantage
Tue, 07/11/23 - 10:08 am
FDA
Medtech
devices
device approvals
Restor3d inks Conformis buyout, adding hip and knee implants to portfolio
Medtech Dive
Wed, 06/28/23 - 10:51 am
Restor#d
M&A
ConforMIS
knee replacements
hip replacements
Medtech
devices
CMS proposes new pathway for reimbursing breakthrough devices
Stat
Thu, 06/22/23 - 10:48 pm
devices
Medtech
CMS
breakthrough devices
Medtronic Takes a Hard Look in the Mirror
Medical Devices and Diagnostics Industry
Mon, 06/12/23 - 09:55 am
Medtronic
devices
Medtech
transparency

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