fda

Jun
18

FDA Updates for the Week of June 12, 2023

FDA Updates for the Week of June 12, 2023 unknown FDA Approves Second Bispecific Antibody for Diffuse Large B-cell Lymphoma.
2 min read
Jun
15

Huma receives FDA clearance for digital health platform

Huma receives FDA clearance for digital health platform unknown Digital health company Huma Therapeutics has received Class II clearance from
2 min read
Jun
10

FDA Updates for the Week of June 5, 2023

FDA Updates for the Week of June 5, 2023 unknown FDA Approves Novel Cyclosporine for Dye Eye Disease The FDA
3 min read
Jun
09

FDA’s letter to medical device maker iRhythm is a warning for the industry

FDA’s letter to medical device maker iRhythm is a warning for the industry Lizzy Lawrence Heart monitoring company iRhythm
3 min read
Jun
08

FDA Announces Additional Steps to Modernize Clinical Trials

FDA Announces Additional Steps to Modernize Clinical Trials unknown     For Immediate Release:                  June 06, 2023 Today, the U.S. Food
3 min read
Jun
08

FDA Requests Public Input on Increasing Access to Home-Use Health Technologies

FDA Requests Public Input on Increasing Access to Home-Use Health Technologies Mintz The Center for Devices and Radiological Health (CDRH)
1 min read
May
25

iHealthScreen receives FDA 510(k) for AI-enabled eye screening system

iHealthScreen receives FDA 510(k) for AI-enabled eye screening system unknown iHealthScreen, maker of AI-enabled software for retinal imaging, received
1 min read
May
24

FDA has now cleared more than 500 healthcare AI algorithms

Dave Fornell | February 06, 2023 | Artificial Intelligence There are now more than 520 marker-cleared artificial intelligence (AI) medical algorithms available
5 min read
May
06

FDA Encourages the Use of Decentralized Clinical Trials in New Draft Guidance

FDA Encourages the Use of Decentralized Clinical Trials in New Draft Guidance Foley & Lardner LLP On May 2, 2023,
3 min read
May
06

Casana scores FDA clearance for health monitoring toilet seat

Casana scores FDA clearance for health monitoring toilet seat unknown Casana, maker of a health monitoring smart toilet seat, announced
1 min read