Regulation Archives - Page 95 of 108

EBM’s vendor neutral system gets FDA nod for diagnostic reading of radiological images

18 Jan 19

The US Food and Drug Administration (FDA) has granted Class II FDA clearance for EBM Technologies' vendor neutral,…

17 Jan 19

Qiagen, a provider of sample and assay technologies for molecular diagnostics, has secured approval for EGFR test in…

16 Jan 19

TransEnterix has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Senhance ultrasonic system.

11 Jan 19

TELA Bio and Aroa Biosurgery have secured 510(k) clearance from the US Food and Drug Administration (USFDA) to…

11 Jan 19

Global contract research organization (CRO) Factory-CRO Group has merged with Boston Biomedical Associates (BBA) to form a global…

09 Jan 19

Embrace by Empatica has received 510(k) clearance from the US Food and Drug Administration (FDA) for use in…

03 Jan 19

Restoration Robotics has completed its ISO 13485:2016 audit and is compliant with CE Mark requirements for the sale…

03 Jan 19

Cardiovascular Systems (CSI) has secured approval from the Japan’s Ministry of Health, Labor and Welfare (MHLW) to use…

03 Jan 19

Neuro-technology company BrainScope has secured clearance from the US Food and Drug Administration (FDA) to include new indication…