Medical, Legal, And Practice
Medimaps receives certification for bone imaging software
Image processing AI software developer Medimaps Group has received Medical Device Regulation certification from its notified body BSI for its management system and product portfolio.
September 7, 2023
Renew Europe group highlights AI Act adoption
The Renew Europe group is applauding the adoption of the Europe Union's Artificial Intelligence Act (AI Act) in the committees of civil liberties and of consumer protection.
May 10, 2023
Advantis gets clearance for MRI analysis software
Dutch-based imaging software developer Advantis Medical Imaging has garnered U.S. Food and Drug Administration clearance for its Advantis Platform brain and prostate MRI analysis software.
April 16, 2023
Annalise.ai receives approval for extra AI CT, x-ray indications
Australian-based artificial intelligence (AI) software developer Annalise.ai has secured clearances from the U.S. Food and Drug Administration (FDA) that cover additional indications for use of its CT and x-ray triage and notification software.
April 13, 2023
New draft guidance becomes available for AI devices
The U.S. Food and Drug Administration has issued draft guidance and requested feedback on regulatory approaches for medical devices enabled by artificial intelligence (AI) and machine learning.
April 6, 2023
Brainomix secures FDA clearance for stroke AI software
Artificial intelligence (AI) software developer Brainomix has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its flagship e-ASPECTS stroke imaging software.
March 20, 2023
Varian secures FDA clearance for Halcyon, Ethos radiotherapy systems
Varian, a Siemens Healthineers company, has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as the CE mark, for its Halcyon and Ethos radiotherapy systems featuring its HyperSight technology.
February 1, 2023
Caption Health secures CE Mark for Caption AI
Ultrasound artificial intelligence (AI) software developer Caption Health has received the CE Mark for its Caption AI technology.
July 19, 2022
FDA patient committee to discuss virtual reality technology
A committee of the U.S. Food and Drug Administration (FDA) that represents the interests of patients plans to meet in July to discuss medical devices that use augmented reality and virtual reality.
April 14, 2022
FDA issues new draft cybersecurity guidance
The U.S. Food and Drug Administration (FDA) has issued a new draft guidance addressing cybersecurity in medical devices.
April 10, 2022
Oxipit secures CE Mark for autonomous imaging AI
Artificial intelligence (AI) software developer Oxipit's ChestLink software for chest x-rays has received the CE Mark.
March 28, 2022
MedTrace Pharma prepares phase III trial for O-15 PET
Danish PET technology developer MedTrace Pharma has received an investigational new drug exemption from the U.S. Food and Drug Administration, paving the way for a clinical trial to assess the firm's radioactive water (oxygen-15 water) PET imaging technique in detecting coronary artery disease.
March 21, 2022
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