EBM’s vendor neutral system gets FDA nod for diagnostic reading of radiological images
The US Food and Drug Administration (FDA) has granted Class II FDA clearance for EBM Technologies' vendor neutral,…
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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.
16 Jan 19
iSchemaView announced that the FDA has cleared the RAPID neuroimaging platform for use in selecting stroke patients who…
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…