From Zetta getting FDA clearance to Prescient Medical receiving CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning.
1. Zetta wins FDA clearance for Zoom MRI software
Zetta announced in a June 25 press release that its MRI software has received FDA 510(k) clearance. The software, known as Zoom, features an algorithm for image quality enhancement and image optimization of short scanning techniques. It works with all MRI models from all major manufacturers, according to the company. Zoom’s algorithm was designed to help MRI imaging departments automatically process MRI imaging techniques.
2. MIM Software, Spectrum Dynamics Medical ink software deal for Veriton scanner
MIM Software and Spectrum Dynamics Medical have partnered to provide MIM-SD advanced visualization and quantitative processing software for the Veriton, according to a June 24 press release. Veriton is a 12 detector CZT multi-organ scanner that has unparalleled sensitivity, image quality and diagnostic accuracy. The detectors are configured for each organ and offers high resolution, lower dose and shorter acquisition times.
3. LumiThera wins CE Mark for LT-300 device for macular degeneration
LumiThera announced in a June 21 press release that it has received CE Mark for its LT-300 device that treats dry advanced macular degeneration. The device is a light delivery system. The CE Mark approval allows the company to commercialize the device in Europe.
4. RTI Surgical launches Fortilink IBF systems
RTI Surgical has launched its Fortilink-TS and -L IBF Systems, according to a June 12 press release. The systems are designed to be used in lumbar interbody fusion procedures at one or two adjoining levels in patients who have degenerative disc disease. Both systems feature the company’s TetraFuse 3D technology that is a 3D printed polymer-based interbody fusion device that uses a nano-rough surface to create more notable trabecular bone ingrowth.
5. Prescient Medical wins CE Mark for CleanCision
Prescient Surgical announced in a June 12 press release that it has received CE Mark approval for its CleanCision system. CleanCision fights and defends against surgical site infection sources. The approval allows for the commercialization of the system throughout Europe. In addition to the CE Mark approval, Prescient Surgical also received ISO 134385:2016 certification for its quality management system.
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