1. Mauna Kea wins FDA nod for neurosurgery indication
Mauna Kea announced in a May 24 press release that it has received FDA 510(k) clearance for its Celivizio 100 series F400 and F800 with new Confocal Miniprobe, the CranioFlex. The clearance allows the device to be used during neurosurgical procedures. The Cellvizio 100 with CranioFlex gives allows for imaging of tissue internal microstructures and allows for identification of cells and vessels and their organization in the central nervous system during cranial diagnostic and therapeutic procedures. The F400 series operates at 488 nm and the F800 model operates at 800 nm.
2. Bonesupport, Collagen Matrix ink deal
Bonesupport has signed a strategic agreement with Collagen Matrix to expand its product offering to the U.S., according to a May 24 press release. The agreement states that Bonesupport will start selling and marketing some of the Collagen Matrix bone graft substitute products under its own brand and through its own distribution network in the fourth quarter of this year.
3. Implanet launches Jazz Evo spine implant
Implanet announced in a May 23 press release that it has launched its Jazz Evo implant that is designed to respond to the constraints of vertebral fusion indications in adults. The implant is designed to facilitate the treatment of degenerative pathologies in adults and is part of the company’s Jazz range of products that block the braid with a single screw to ensure optimum clamping on the rod without damaging the braid.
4. MC10 wins FDA nod for BioStamp nPoint wireless patient monitor
MC10 recently received FDA 510(k) clearance for its BioStamp nPoint System, according to a May 16 press release. The system is a wireless, biometric data collection platform that is designed to be used by healthcare professionals and researchers for collecting physiological data continuously in the home or in traditional healthcare settings. It is specifically designed for clinical trials or research studies where continuous collective data is needed. It features flexible, body-conforming rechargeable sensor patches that are reusable and can record data for up to 24 hours. It can be configured to measure, record and display general activity, postural classifications, vital signs and sleep metric with clinical validated accuracy.
5. FDA clears second XableCath peripheral catheter
XableCath announced in a May 24 press release that it has received FDA clearance for its XableCath abrasion tip support catheter. This clearance marks the second clearance for the company after its blunt tip catheter was cleared at the end of 2017. Both XableCath’s designs are designed to easily slide past occluding atheroma through the true lumen of the vessel.
6. CrossRoads Extremity Systems launches DynaForce foot implant
CrossRoads Extremity Systems has launched its Active Stabilization MPJ Implant System, according to a May 22 press release. The company launched the product after it received FDA clearance for its DynaForce system. The DynaForce Active Stabilization MPJ Implant System combines stability and an anatomic plate with active compression of a nitinol clip that is delivered to the operating room in a sterile package.
7. FDA clears Medacta pedicle screw guide
Medacta announced in a May 23 press release that it has received FDA clearance for its MySpine Midline Cortical Pedicle Screw Placement Guide. The MySpine MC system allows surgeons to optimize procedures for both outpatient and inpatient settings for a more rapid patient recovery through accurate and reliable muscle-sparing approaches to posterior lumbar surgery. The system guides the screw to a trajectory in the pedicle that has evolved from a cortical bone trajectory. The system also avoids interference with cranial facet joins and can accommodate larger screw diameters and lengths with four points of cortical bone purchase.