CE Certificate N4MRWire
CE Certificate N4MRWire
Invasive cardiovascular magnetic resonance…
Invasive cardiovascular magnetic resonance (iCMR) for diagnostic right and left heart catheterization using an MR-conditional guidewire and passive visualization in congenital heart disease.
The upside of lockdown
The upside of lockdown 2020 was a year when many things changed in the world and of course also to Nano4Imaging. We started the year with high hopes of successfully launching the EmeryGlide in the USA. However, the pandemic turned everything upside down. Just before that there was the [...]
CMR as routine diagnostic for PH
Routine diagnostic for PH A recent paper in JCMR (Knight et al, 2019) put online on september 9th shows the feasibility of CMR in routine screening for pulmonary hypertension. Fifty patients were investigated for suspected or known PH underwent right heart cath in the CMR. Durations of separate procedural [...]
Q4 2017 brings both FDA 510 and renewed CE label
December 15th 2017 Nano4Imaging received (renewed) CE label for its existing and new guidewire (EmeryGlide TM). Within the last quarter we have now obtained both FDA 510 K and CE labels and are eager to move forwards with our clinical and business partners to move more and more cathlab procedures [...]
FDA special 510K achieved
With a new energy boost we are now starting to prepare our participation at CMR in Barcelona (Jan 2018). FDA has approved the special 510K for our second generation MR compatible guide wire, and we are awaiting CE approval also soon. Next year you will see us at Barcelona CMR [...]
Next step in CMR guided cardiac procedures
On september 6th a paper was published by Ratnayka et al in JCMR in which CMR fluoroscopy guided right heart catheterization was shown to be feasible and safein 39 pediatric (12.7 ± 4.7 years) subjects. The group included subjects with previous metallic implants, those requiring continuous vasopressor medication infusions, and [...]
Pulmonary Hypertension- adult application
In 2018 several of our clinical users have initiated screening and diagnostic programs usinfg right heart cath to evaluate pulmonary artery pressure in CMR instead of using the cathlab. Royal Free Hospital (RF) in London is the center that want to move this into routine in 2019, based on their [...]
MRWire receives Health Canada license
On december 21st 2015 our MR conditional guide wire received a license (number 96312) from Health Canada. We will only start our sales in Canada, after completion of the post-market clinical follow-up (PMCF) which is ongoing in Europe. This is a great news at the end of an important year [...]
Animal testing at Johns Hopkins
To prepare for the USA market, Nano4Imaging has conducted studies in collaboration with Johns Hopkins Hospital in Baltimore (MA), being the leading hospital in the USA for the past 20 years. Our new guide wires are currently being investigated for visibility, steerability and reaching different targets in the central circulation. The [...]