fda

Feb
16

Sunrise's sleep apnea detection tool receives FDA 510(k) clearance

Sunrise's sleep apnea detection tool receives FDA 510(k) clearance unknown Belgian sleep-focused digital health startup Sunrise received
1 min read
Feb
11

FDA Updates for the Week of Feb. 6, 2023

FDA Updates for the Week of Feb. 6, 2023 unknown FDA okays pediatric indication for Takeda’s Takhyzro The FDA
5 min read
Feb
08

Another FDA approval for Naviswiss

Another FDA approval for Naviswiss unknown Two of NaviSwiss' products are currently being used in the United States. The
1 min read
Feb
04

FDA Updates for the Week of Jan 30, 2023

FDA Updates for the Week of Jan 30, 2023 unknown FDA approves Trodelvy for HR+/HER2- breast cancer. The FDA
3 min read
Feb
02

FDA approves AI ultrasound application for musculoskeletal imaging

FDA approves AI ultrasound application for musculoskeletal imaging Andrea Fox Clarius Mobile Health, which first introduced wireless handheld imaging for
2 min read
Jan
31

Remote therapeutic monitoring is reimbursable

Ever since CMS released the new CPT codes for remote therapeutic monitoring last year, health systems have been eager to
6 min read
Jan
31

Former Oracle exec to lead digital health efforts at the FDA

Former Oracle exec to lead digital health efforts at the FDA unknown The Food and Drug Administration has tapped former
Jan
30

STAT+: FDA names former Oracle executive as new digital health leader

STAT+: FDA names former Oracle executive as new digital health leader Lizzy Lawrence The Food and Drug Administration has installed
Jan
28

FDA Updates for the Week of Jan. 23, 2023

FDA approves Lilly’s BTK inhibitor for rare blood cancer. The FDA has granted accelerated approval to Lilly’s Jaypirca
4 min read
Jan
27

How Will FDA Guidance Impact Decentralized Clinical Trials in 2023?

How Will FDA Guidance Impact Decentralized Clinical Trials in 2023? Jane Myles As we begin the new year, there is
5 min read