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EssilorLuxottica receives FDA clearance and EU certifications for Nuance Audio, making it available to consumers in the U.S. and Europe Paris, France (3 February 2025) – EssilorLuxottica announced ...

This certification allows the company to market ... CEO Desmond Wheatley emphasized the importance of the CE mark in validating the safety and quality of their offerings as the company aims ...

Leveraging gold-standard PCR technology, the cobas liat system claims to deliver outcomes in under 20 minutes.

The Amsterdam-based biotech firm said that its melt curve analysis-based test is used as a first-tier genetic screening tool to aid the diagnosis of SMA.

“CE-IVDR certification is setting a new benchmark for quality and safety in medical devices, including those powered by AI,” said Wouter Bulten, Chief Operating and Product Officer at Aiosyn.

Unique dense breast tissue focus to drive expedited recruitment rates; modular clinical study design reduces time to PMA ...

Once satisfied, the Notified Body issues the EU/UKCA type-examination certificate, valid for five years. The manufacturer can then affix the CE and/or UKCA mark and place the product on the market.

Henceforth, we expect the company’s CE Mark Certification for HFX iQ to positively impact NVRO stock in the coming days. Meanwhile, NVRO currently has a market capitalization of $152.5 million.