FDA premarket approval

The SoftVue 3D Whole Breast Ultrasound Tomography System
Delphinus receives FDA clearance for ultrasound breast cancer screening tech
By Mallory Hackett | 12:55 pm | October 12, 2021
The SoftVue system is intended to be used in addition to digital mammograms to screen for cancer among patients with dense breast tissue.
Cochlear receives FDA clearance for three new hearing devices
By Mallory Hackett | 10:18 am | July 07, 2020
Cochlear Limited announced yesterday the U.
In-Depth: Consumer genomics furthers healthcare foothold but privacy, resource concerns persist
By Laura Lovett | 06:16 pm | June 15, 2018
In the last few years consumer genomics has grown in both its offerings and legitimacy.
FDA makes premarket exemption official for genetic risk assessments
By Jonah Comstock | 02:20 pm | June 04, 2018
As of tomorrow, individual genetic risk tests are officially exempt from requiring 510(k) premarket approval, provided the company offering the test has gone through a one-time premarket review of its testing apparatus and at least one test.