- Imricor Medical Systems aimed to have popular European product approval, the CE mark, applied to its catheter product this quarter of 2019
- TÜV SÜD, the institution in charge of giving out the CE approval, has faced an increased workload lately and will reach Imricor’s request at a later stage, per announcement today
- Imricor’s product is a modern twist on the staple medical instrument, boasting fibre optics for mixed reality vision
- The company says all is well if the approval is granted by early October, but a later date could impose issues on its 2019 financial year round up
Med-tech company Imricor was hoping to have its catheter product slapped with a CE approval this quarter, but delays have postponed that goal.
TÜV SÜD, the institution in charge of giving out the CE approval, is facing a particularly stressful work load and Imricor will reportedly have to wait.
CE approval is the certification of health and consumer standards slapped onto almost every product, subject from a European body of approval. TÜV SÜD is the German product inspector that frequently oversees CE certification.
Imricor’s product, labelled the Vision-MR Ablation Catheter, features modern solutions to a staple tool in the medical sector — including fibre optic temperature sensors and mixed reality tracking.
“While we are disappointed with this delay, we are encouraged by our engagement with TÜV SÜD and that the certification process is moving forward at a steady pace,” Imricor CEO Steve Wedan said.
TÜV SÜD’s increased workload comes from a reduction in notified bodies and the institution adopting a new medical device regulatory system.
Imricor management states today the company has no knowledge on an expected CE approval date for its catheter product.
If approval is granted by early October, the company said no impacts will take place on its 2019 financial year forecasts.
Shareholders bit back at the delays as well, with Imricor’s shares on the ASX buckling 1.59 per cent to $1.24 per share.
The company’s market cap is currently valued at $117 million.