Koning Health Achieves MDSAP Certification
August 4, 2026
Certification strengthens Koning’s global regulatory foundation as two new Vera Breast CT systems expand patient access in key U.S. markets
Certification strengthens Koning’s global regulatory foundation as two new Vera Breast CT systems expand patient access in key U.S. markets
Cortechs.ai, a San Diego, CA-based provider of AI-powered quantitative imaging solutions, has announced the expansion of its European CE Marking under the European Union Medical Device Regulation (EU MDR) for its latest imaging products.
Galaxy Therapeutics, a privately held medical device company focused on the treatment of intracranial aneurysms, today announced that it has received CE mark for its SEAL Embolization System
The DeepHealth Breast Ultrasound system automates the detection, characterisation, and reporting of breast lesions.
Ceribell (Nasdaq:CBLL) announced today that CMS granted a New Technology Add-on Payment (NTAP) for its Delirium Monitor System.
GE HealthCare (Nasdaq:GEHC) announced today that it launched its new Invenia ABUS Prime and ABUS StreamVue platforms.
enVVeno Medical (Nasdaq:NVNO) announced today that it received FDA investigational device exemption (IDE) for its enVVe system.
New medium-cutoff Dialyzer with a Super High-flux membrane brings NIPRO’s approach to expanded hemodialysis to United States healthcare providers.
Total Flow Medical announced today that it received FDA 510(k) clearance for its TFA femoral arterial cannula device.
Medical Microinstruments (MMI) announced today that the FDA approved a supplement to a study of its surgical robot in Alzheimer’s.