You are here

devices

Trump’s Second Term Could Turn LDT Regulation on its Head

Medical Devices and Diagnostics Industry

Sun, 11/17/24 - 09:32 pm

Are Medical Device CEOs Worried About Trump’s Proposed Tariffs?

Medical Devices and Diagnostics Industry

Mon, 11/11/24 - 11:37 am

device manufacturing

FDA’s new device chief faces challenges. Patient groups, industry are still optimistic.

BioPharma Dive

Thu, 10/31/24 - 10:43 pm

patient advocacy groups

FDA names Tarver as new head of device center

Biopharma Reporter

Tue, 10/22/24 - 11:26 pm

Michelle Tarver

Abbott bumps up profit forecast on strong medical device sales

Reuters

Wed, 10/16/24 - 12:29 pm

FDA seeks feedback on predetermined change control plans

Medtech Dive

Mon, 08/26/24 - 10:34 pm

FDA’s plan to expand device surveillance faces challenges, GAO finds

Medtech Dive

Wed, 08/21/24 - 10:30 pm

How Will FDA’s New QMSR Affect Medical Device Companies?

Medical Devices and Diagnostics Industry

Sun, 03/24/24 - 10:23 pm

FDA warns of potential risk from Hologic's devices implanted in soft tissue

Reuters

Tue, 02/27/24 - 11:15 pm

FDA creates ‘super office’ to oversee device cybersecurity, digital health and supply chain

Medtech Dive

Mon, 01/29/24 - 10:55 am

GAO Urges FDA, CISA to Update Medical Device Cybersecurity Guidance

Medical Devices and Diagnostics Industry

Wed, 01/3/24 - 09:31 am

How Boston Scientific Got the Watchman Back on Track

Medical Devices and Diagnostics Industry

Wed, 10/11/23 - 10:24 am

Boston Scientific

Abbott’s Biowearable Performs Well In U.K. Ahead Of U.S. Launch

Forbes

Tue, 10/10/23 - 11:55 pm

FDA details switch to electronic filings for 510(k), de novo submissions

Medtech Dive

Wed, 10/4/23 - 09:46 am

de novo pathway

FDA Finalizes Human Factors Guidance in Combination Medical Devices

Medical Devices and Diagnostics Industry

Wed, 09/13/23 - 11:21 am

Hopes dim for Medtronic hypertension treatment after FDA panel rebuff

Medtech Dive

Tue, 08/29/23 - 11:20 am

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

clinical trials

percutaneous coronary intervention

FDA greenlights medical device to combat bladder issues

Stat

Tue, 08/22/23 - 11:29 pm

overactive bladder

BlueWind Medical

Median lag between FDA authorization and Medicare coverage hits 6 years: study

Medtech Dive

Sun, 08/13/23 - 02:31 pm

Capitalizing on 3D-Printing for Medical Device Manufacturing

Medical Devices and Diagnostics Industry

Tue, 07/25/23 - 09:10 pm

Pages