From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning.
1. Skyline Medical launches JV deal with Helomics
Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics. The agreement comes after a strategic collaboration between the companies that allows Skyline to reach more markets. The joint venture leverages the Helomics D-Chip platform to develop and market new approaches for personalized cancer diagnostics and care.
2. iReliev launches wearable arthritis-treatment EMS/Tens patch
iReliev recently introduced its PlayMakar Wireless EMS + TENS Unit that helps treat chronic pain from arthritis on the go, according to a Nov. 15 press release. The device features two functions that include transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS). TENS helps block pain signals from the brain to provide pain relief while EMS stimulates muscles for conditions, strengthening and recovery using gentle electrical impulses. It has two rechargeable receivers that connect to electrode pads to allow for it to work wirelessly. The device has 14 preset therapy mode for personalized treatment and additional receivers can be added on for treating bigger areas.
3. Mortise Medical gets FDA clearance
Mortise Medical announced in a Nov. 14 press release that it has received FDA 510(k) clearance for its SyndesMetrics Syndesmosis Repair System. The system addresses clinical needs for syndesmotic disruption injuries like predictable and repeatable anatomic reduction, restoration of physiological motion and restoration of ankle stability. The SyndesMetrics implant system has minimal hardware prominence, no suture prominence and a reversible locking mechanism that secures high strength suture that that connects tibial and fibular implant components.
4. InnerScope announces new distribution deal
InnerScope Hearing Technologies has announced that it has signed an exclusive distribution deal with Speechlab Advanced Technologies, according to a Nov. 14 press release. The deal allows for resell rights of InnerScope’s BlackCat Personal Sound Amplifier Product (PSAP). The BlackCat is a personal audio controller that is designed to help people understand speech better in noisy environments.
5. Mevion receives CE Mark for proton therapy system
Mevion announced in a Nov. 13 press release that it has achieved CE Marking clearance for its Mevion S250i Proton Therapy System. The system features Hyperscan technology and pencil beam scanning (PBS) for faster, sharper and more robust proton treatments. It also uses the fastest energy layer switching, optimized spot sizes and the Adaptive Aperture proton multi-leaf collimator system.
6. Nexstim wins FDA nod for NBT depression device
Nexstim has been cleared by the FDA to market and distribute its Nexstim NBT system, according to a Nov. 13 press release. The system is designed to treat major depressive disorder through stimulation of the brain using repetitive transcranial magnetic stimulation (TMS), which has been proven to be effective in treating depression. The company plans to begin to market and sell its system in early 2018.
7. Lensar gets FDA clearance, CE Mark for laser eye surgery marker
Lensar announced in a Nov. 10 press release that it has received FDA 510(k) clearance and CE Mark for its IntelliAxis-L. It is a unique reference mark that uses the company’s integrated pre-operative diagnostic capabilities, iris registration and intraoperative imaging to identify the location of steep corneal axis at the capsular plane for toxic IOL alignment.