devices

Biohybrid Devices: Healthcare's Latest Game-changer
Medical Devices and Diagnostics Industry
Wed, 01/22/25 - 11:38 am
Medtech
devices
biohybrid devices
What the FDA’s Draft Guidance for AI-Enabled Medical Devices Means
Xtalks
Thu, 01/9/25 - 09:20 pm
FDA
Medtech
devices
artificial intelligence
6 Critical Developments That Could Define the Medical Device Industry in 2025
Medical Devices and Diagnostics Industry
Thu, 01/2/25 - 11:20 am
devices
Medtech
Europe
Medtronic
Abbott Labs
CGMs
JNJ
robotic surgery
Donald Trump
M&A
Trump’s Second Term Could Turn LDT Regulation on its Head
Medical Devices and Diagnostics Industry
Sun, 11/17/24 - 09:32 pm
LDTs
Medtech
devices
FDA
Donald Trump
Are Medical Device CEOs Worried About Trump’s Proposed Tariffs?
Medical Devices and Diagnostics Industry
Mon, 11/11/24 - 11:37 am
devices
Medtech
device manufacturing
Donald Trump
tarriffs
FDA’s new device chief faces challenges. Patient groups, industry are still optimistic.
BioPharma Dive
Thu, 10/31/24 - 10:43 pm
FDA
devices
Medtech
patients
patient advocacy groups
FDA names Tarver as new head of device center
Biopharma Reporter
Tue, 10/22/24 - 11:26 pm
Medtech
FDA
devices
Michelle Tarver
CDRH
Abbott bumps up profit forecast on strong medical device sales
Reuters
Wed, 10/16/24 - 12:29 pm
Abbott Labs
earnings
devices
Medtech
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

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