1. EOI wins FDA nod for FLXfit15 expandable cage
EOI announced in a Sept. 28 press release that it has received FDA 510(k) clearance for its FLXfit 15. The clearance will help enhance the company’s FLXfir 3D expandable cage system and help expand the surgeon’s flexibility and capability by offering different length options.
2. ivWatch inks distribution deal with Terumo
ivWatch has recently signed a licensing and distribution agreement with Terumo to improve patient safety, according to a Sept. 21 press release. Terumo will become the exclusive distributor of the ivWatch Model 400 and ivWatch OEM board in Japan. ivWatch technology can be integrated with other patient monitoring systems, infusion pumps and other devices easily with the ivWatch OEM board. The agreement also allows Terumo to exclusively integrate ivWatch into existing and future Terumo products in Japan.
3. FDA clears Mortise Medical’s LigaMetrics suture anchor system
Mortise Medical announced in a Sept. 26 press release that it has received FDA 510(k) clearance for its LigaMetrics Suture Anchor System. The LigaMetrics Suture Anchor System is the first and only knotless suture anchor that allows for precise, measured tension control of the suture repair construct. The system is designed to connect to and lock suture tape that is attached to soft tissue or a conventional suture anchor.
4. Lombard Medical launches Aorfix delivery device in Japan
Lombard Medical has commercially launched its new delivery system for the Aorfix AAA system, according to a Sept. 26 press release. The new delivery system is marketed in Japan by Medico’s Hirata and is used to deliver Lombard’s Aorfix AAA stent graph.
5. FDA expands clearance for Cefaly migraine device
Cefaly announced in a Sept. 21 press release that the FDA has expanded its clearance for Cefaly Acute migraine treatment. The device is used for the acute treatment of migraines in patients 18 years or older. The Cefaly Acute allows migraine sufferers to use the device during a migraine attack which makes it more than a preventative measure.
6. Varian touts first use of Halcyon oncology system
Varian Medical System has announced that the first patient in the world has been treated using Varian’s Halcyon system, according to a Sept. 21 press release. The patient had head and neck cancer. The system is suited to offer advanced treatments for prostate, breast, head and neck and other forms of cancer.
7. Sanuwave inks JV deal with Brazil’s Mundimed
Sanuwave announced in a Sept. 28 press release that it has signed a joint venture agreement with Mundimed in Brazil. The agreement states that the companies will split profits in the wound care industry while using the dermaPACE technology. The net present value is expected to exceed $25M. Sanuwave will also receive an undisclosed amount of cash payments beginning Sept. 30 and the payments will continue through 2019.