Tag: FDA approval

Sonovein US FDA pivotal study treatments completed: Theraclion reaches key milestone...

Theraclion, a French MedTech company developing a robotic platform for non-invasive high-intensity focused ultrasound (HIFU) therapy, announces today that treatments in the US Food and...

Philips launches Duo venous stent system for treatment of symptomatic venous...

Royal Philips today announced the first implant of the Duo venous stent system, an implantable medical device indicated to treat symptomatic venous outflow obstruction...

Penumbra expands computer-aided thrombectomy offering with Lightning Bolt 7 launch

Penumbra has announced the US Food and Drug Administration (FDA) clearance and launch of Lightning Bolt 7, which the company claims is the most...

Swiss parliament votes to accept US FDA-approved medical devices

The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland. A motion...
The Geko device

Sky Medical Technology receives FDA clearance for (W3) geko device

Sky Medical Technology has announced it has achieved further US Food and Drug Administration (FDA) 510(k) clearance to market the new (W3) geko device...

NIH grant sets Mercator research underway for local anti-inflammatory DVT therapy

Mercator MedSystems has recently announced that the DEXTERITY trials research has begun under a technology transfer grant for approximately $300,000 funded by the National...
fist assist fa-1 device

Fist Assist device for focal arm massage and increased vein circulation...

Fist Assist Devices has received US Food and Drug Administration (FDA) 510(k) clearance for use of the Fist Assist FA-1 device in the USA...