Cerebriu is required by the FDA to review a change control plan for an AI-enabled device in the US.
Public source
Publisher name
Public post
๐ฅ๐ฎ๐ฑ๐ถ๐ผ๐น๐ผ๐ด๐ ๐ฎ๐น๐ฟ๐ฒ๐ฎ๐ฑ๐ ๐ต๐ฎ๐ ๐ฎ ๐พ๐๐ฎ๐น๐ถ๐๐ ๐ฐ๐ผ๐ป๐๐ฟ๐ผ๐น ๐๐๐๐๐ฒ๐บ ๐ณ๐ผ๐ฟ ๐ต๐๐บ๐ฎ๐ป ๐ฟ๐ฒ๐ฎ๐ฑ๐ฒ๐ฟ๐. ๐ฑ๐ฐ% ๐ผ๐ณ ๐๐ต๐ฒ ๐ฟ๐ฎ๐ฑ๐ถ๐ผ๐น๐ผ๐ด๐ถ๐๐๐ ๐ถ๐ป๏ฟฝโฆ
Company
Cerebriu
Every Patient Diagnosed In Time
- Industry
- Software Development
- Location
- Copenhagen, DK
- Company size
- 51โ200 employees
About Cerebriu
Cerebriuโs proven radiology AI solutions detect findings during the initial scan and enable the most appropriate procedures while the patient is still in the scanner. This leads to a simpler, faster MR image acquisition and creates tangible clinical value: Improving technologistsโ confidence and freeing up radiologistsโ time by ensuring the right data the first time the patient is in the scanner Timely diagnosis of critical findings by prioritizing radiologistsโ worklists Improving patient experience and reducing patient recalls
See moreLatest activity
Latest activity from Cerebriu
2 signals
Discover more
Similar signals
Similar public activity from other companies.
Legal & Regulatory
CergenX
CergenX Wave, the first product of CergenX, achieved CE Mark certification under EU MDR 2017/745.
Legal & Regulatory
enginius.ai
enginius.ai notes that the FDA issued an early alert on the same device in 2025 for 184 serious injuries.
Legal & Regulatory
Shen AI
Shen AI's Medical SDK is certified as a Class IIa software as a medical device under MDR, covering heart rate, HRV, breathing rate, and blood pressure through a contactless, one-minute face scan.
Legal & Regulatory
Veeva Systems
Veeva Systems reported that the FDA granted four AI-powered devices, including TEMPO: the Technology-Enabled Meaningful Patient Outcomes pilot, reach Medicare patients before any held full marketing authorization.
Legal & Regulatory
Elevate MedTech