source
- MDCG issues guidance on clinical evidence for orphan in-vitro diagnosticsThe Medical Device Coordination Group (MDCG) has published new guidance that explains how clinical evidence requirements apply to orphan in-vitro diagnostics (IVDs). The document is intended to he…
- Compact Medical issues recall and updated instructions for ButterflyBVM bag-valve-mask resuscitators due to bellows holesThe FDA's Center for Devices and Radiological Health has issued an early alert about a potential high‑risk problem with certain Compact Medical ButterflyBVM bag‑valve‑mask devices. Compact Medical…