1. Cytosorbents opens new U.S. manufacturing facility
CytoSorbents announced in a June 12 press release that it has opened a new manufacturing facility in Monmouth Junction, N.J. with the company’s ISO 13485:2003 certification. The new facility is expected to quadruple production capacity and will accelerate margin expansion and drive operating profitability. CytoSorbents currently manufactures its CytoSorb Blood purification technology that treats deadly inflammation in critically-ill and cardiac surgery patients.
2. Centinel Spine wins 510(k) clearance
Centinel Spine has won FDA 510(k) clearance for its FLX Platform of Integrated Interbody and non-integrated interbody fusion device, according to a June 7 press release. The FLX devices are 3D printed, all-titanium devices that feature solid and porous radiolucent sections designed to reduce mechanical stiffness and improve visibility. The devices also use a Fuse-Thru trabecular scaffold that is designed to promote bony in-growth and on-growth throughout the implant.
3. Prescient Surgical gets CE Mark approval
Prescient Surgical announced in a June 12 press release that it has received CE Mark approval for its CleanCision technology. CleanCision fights and defends against the sources of surgical site infections. The approval allows the company to be available to European hospital systems. CleanCision received FDA 510(k) clearance in the U.S. in October last year and is ISO 134385:2016 certified.
4. Globus Medical launches cement-augmented pedicle screw system
Globus Medical has launched its CREO Fenestrated Screw System that is designed to be used in patients who have advanced stage tumors of the thoracolumbar spine, according to a June 13 press release. The CREO fenestrated screws are designed to restore the structural integrity of the spine at a vertebral level that have been affected by metastatic bone disease. The CREO Fenestrated Screw System comes with threaded, non-threaded and MIS screw head options to accommodate surgeon preferences for complex tumor procedures. The screws in the system are cannulated with fenestrations along the shank for cement dispersion.
5. OptoVue wins expanded FDA clearance for epithelial mapping system
OptoVue announced in a June 14 press release that it has received FDA 510(k) clearance for its non-contact, quantitative measurements of the epithelial and stromal layers of the cornea, or epithelial thickness mapping system. The expanded clearance allows for an additional 9mm ETM scan to the previous 6mm map, which will allow for the detection of epithelial irregularities in an area of the eye that is about t.25 times the area covered by a 6mm scan. The ETM is available on the Avanti Widefield OCT system and is the only FDA-cleared product that provides corneal epithelial and stromal measurements, according to OptoVue.
6. Summit Medical launches InstruSafe da Vinci trays
InstruSafe Instrument Protection Tray by Summit Medical has released eight new trays that were designed with Intuitive Surgical to accommodate the newest da Vinci Surgical System Instrumentation, according to a June 13 press release. The new da Vinci SP Surgical System was launched on May 31. InstruSafe trays have 360 degrees of protection for instruments during sterilization, transportation and storage. They are also validated for steam sterilization in the sterile wrap configuration for the da Vinci SP instrumentation.
7. DyAnsys wins FDA nod for auricular neurostimulation device for opioid addiction
DyAnsys announced in a June 12 press release that it has received FDA clearance for its auricular neurostimulation device Drug Relief. Drug Relief is designed to be used as an aid to reduce the symptoms of opioid withdrawal without narcotics. It is a wearable device that sends electrical pulses through tiny needles that are inserted in the ear to alleviate opioid withdrawal symptoms like anxiety, agitation, depression, nausea, opiate cravings and more. Drug Relief available for providers to prescribe for use during opioid detoxification.