Singulex Gains CE Mark for Sgx Clarity System
California–based Singulex received a CE mark for its Sgx Clarity system, an automated, in vitro diagnostics platform that can count single molecules of biomarkers and distinguish individuals who have disease from those who do not, before symptoms are apparent, leading to improved outcomes.
Singulex will submit data for regulatory clearance of the Sgx Clarity system in the United States, and it anticipates FDA clearance in 2018.
NICO Wins CE Mark for BrainPath Cranial Access Tech
Indianapolis–based Nico has been awarded a CE mark for BrainPath — a technology that provides non-disruptive access to the brain by using both a parafascicular and trans-sulcal surgical approach.
BrainPath uses the folds of the brain as a path to the surgical site. It displaces brain tissue to create a corridor to a tumor or hemorrhage site, through an opening the size of a dime.
ETS Wound Care Wins FDA Clearance for Mirragen
Montana–based ETS Wound Care received FDA clearance for its Mirragen advanced wound matrix for treatment of acute and chronic wounds.
The device consists of a resorbable borate glass matrix comprised of fibers and beads. Mirragen is designed to be packed into wounds to control wound fluids.
The company plans to make the device commercially available via a controlled domestic market release in early second quarter of 2017 and to release it to the broader domestic market in 2018.
Australia Clears Milestone’s Epidural and Intra-Articular Instruments
New Jersey–based Milestone Scientific has received marketing clearance in Australia for its CompuFlo epidural and intra-articular instruments.
CompuFlo’s dynamic pressure sensing provides feedback that allows anesthesiologists to identify the epidural space.
The DPS technology is also incorporated into the CompuFlo intra-articular instrument to provide computerized drug injections into intra-articular joint spaces in osteoarthritis patients.
AirXpanders Receives FDA Clearance for AeroForm Tissue Expander
The company has received FDA marketing clearance for an enhanced film material used to contain carbon dioxide within the device.
AeroForm is activated by a handheld wireless controller that administers small amounts of CO2 up to three times a day, to gradually stretch the tissue to prepare for a breast implant.
AeroForm received de novo clearance from the FDA in December 2016.
Occlutech Obtains CE Mark for its PmVSD Occluder
Swiss device maker Occlutech has gained a CE mark for its perimembranous ventricular septal defect (PmVSD) occluder used in treating the congenital heart condition.
The implantable device is indicated for minimally invasive closure of perimembranous ventricular septal defects. The occluder consists of a flexible nitinol wire mesh with “shape-memory” properties.