Teleflex Receives Marketing Clearance For its Arrow VPS Rhythm Device
Wayne, Pennsylvania-based Teleflex has gained marketing clearance for its Arrow VPS Rhythm device with optional TipTracker technology.
The device assists in placement and confirmation of a catheter tip in the superior vena-cava-cavoatrial junction and can be used with a broad range of catheter types and brands.
When paired with the single-use TipTracker probe, the device provides real-time visual navigation.
Bayer Issues Recall for Medrad Intego PET Infusion System Administration Sets
Bayer has announced a recall for Medrad Intego PET infusion system source administration sets because of the possibility of injecting particulates into patients.
The device delivers medications from a chamber to a patient through a needle inserted into a vein during nuclear medicine procedures. The particulates may be formed when the tip of the needle pushes through the rubber top of the vial. If this occurs, the particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death.
The devices were distributed from Oct. 9, 2008 through Oct. 11, 2016.
FDA Grants Clearance to Roche’s Anti-Mullerian Hormone Test Elecsys
The FDA cleared Roche’s anti-mullerian hormone (AMH) assay Elecsys for use in the assessment of ovarian reserve, the reproductive potential based on the quality and quantity of egg cells in the ovaries.
The automated device measures the AMH levels in blood samples. The fertility test offers a more standardized method of measuring ovarian reserve compared to other options such as vaginal ultrasound.
Roche secured a CE mark to sell the device in all countries accepting the approval.
Globus Medical Earns CE Mark for Excelsius GPS in EU
Globus Medical received a CE mark for its robotic trajectory guidance and navigation system, the Excelsius GPS.
The system is designed to support minimally invasive and open orthopedic and neurosurgical procedures, including those related to the cervical spine, sacroilium, long bones and cranium. It integrates with instruments to guide the placement of implants.
Global Medical acquired the product’s developer, Excelsius Surgical, in January 2014.
FDA Issues Clearance to ivWATCH for Continuous Monitor
The medical device manufacturer ivWatch garnered an FDA 510(k) clearance for the use of its ivWatch Model 400 in pediatric patients under the age of 18.
The continuous monitoring device for a patient’s IV detects medication or fluid leaks outside the vein into surrounding tissue. The product uses a non-invasive sensor to collect near-infrared light and detect changes in the tissue. In February 2015, the FDA cleared the device for patients 18 years and older.
Orthofix Earns FDA Approval, CE Mark for Bone Growth Stimulators
Texas-based Orthofix received an FDA approval and CE mark for its CervicalStim and SpinalStim bone growth stimulators.
The Class III medical devices rely on low-level pulsed electromagnetic fields to stimulate spinal fusion and trigger the body’s natural healing process. The devices are designed for use in post-operative care following lumbar and cervical fusion surgical procedures.
Abionic Secures CE Marks for Sepsis and Iron Deficiency Diagnostics
Abionic garnered CE marks for two diagnostic tests intended for the company’s abioSCOPE device and designed for the assessment of sepsis risks and iron deficiency.