From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning.
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.