Regulatory Approvals

The Primary Relief neurostimulation device administers periodic low-level electrical pulses to the ear for more than 72 hours. DyAnsys has received approval from the US Food and...

The OptaBlate system allows physicians to easily customise their procedure and reduces ablation times by three minutes. Stryker has obtained 510(k) clearance from the US Food and Drug...

BIOCORP (FR0012788065 – ALCOR / Eligible PEA‐PME), a French company specialized in the design, development, and manufacturing of innovative medical devices, and SANOFI announced...

The CLASP IID randomized trial comparing the Pascal to the MitraClip will be presented Saturday at the TCT 2022 meeting. The US Food and Drug...

The company said the clearance will allow more pharma companies to use Tasso+ for decentralized clinical trials. Tasso received FDA 510(k) clearance for its patch-like blood...

CurveBeam AI, Ltd announced its medical diagnostic software, OssView™, has received US Food and Drug Administration (FDA) Breakthrough Device Designation. OssView calculates a Structural...

The system combines advanced imaging technologies, personalised targeting and new stimulation patterns. Magnus Medical has secured US Food and Drug Administration (FDA) 510(k) clearance for its SAINT...

The new tool measures the diameter of the ventricles of the heart to provide the ratio of the maximum right ventricle diameter compared with...

The miLab Cartridge CER stains and evaluates the cervical cells automatically to support the medical experts’ slide review. Biotech start-up Noul has received CE-IVD marks for its...