Israel-based medical device company Insightec has secured the US Food and Drug Administration (FDA) approval of its Exablate Neuro system to treat essential tremor (ET) in patients unresponsive to medication.
13 July 2016
29 June 2016
US-based medical device company SRS Medical Systems has secured the CE mark approval for its spanner temporary prostatic stent (STPS) in the European Economic Area (EEA).
2 June 2016
US-based medical device company Avenu Medical has secured the CE Mark approval to market its Ellipsys Vascular Access System to address the needs of vascular access for hemodialysis.
26 May 2016
US-based medical device company Respiratory Motion has secured the CE Mark for ExSpiron to facilitate a faster detection of life threatening respiratory depression.
12 April 2016
US-based developer of ultrasound tools Fujifilm SonoSite has secured CE mark and 510(k) clearance for its new mountable ultrasound system, the SonoSite SII.
20 December 2015
Luminex has secured approval from the US Food and Drug Administration (FDA) for its NxTAG respiratory pathogen panel that is capable of detecting simultaneously 20 clinically relevant viral and bacterial...
8 December 2015
US-based Allurion Technologies has received the CE Mark, allowing the sale of its Elipse gastric balloon in the European Union (EU).
9 November 2015
Ireland-based medical technology company Medtronic has launched the VenaSeal closure system in the US, which was developed to treat symptomatic venous reflux.
5 November 2015
The US Food and Drug Administration (FDA) has granted expedited access pathway (EAP) designation and priority processing status for ALung Technologies' Hemolung respiratory assist system (RAS).
20 October 2015
Luminex has secured CE-IVD Mark approval for its NxTAG respiratory pathogen panel that is capable of detecting 21 clinically relevant viral and bacterial respiratory pathogens.