FSS lands extended CE Mark for FlexStent | Regulatory Roundup

From Medical Design & Outsourcing

• How Minnesota got a Pediatric Device Innovation Consortium
  FDA funds a handful of pediatric device innovation groups around the United States. But Dr. Gwenyth Fischer, director of The Pediatric Device Innovation Consortium at the University of Minnesota, thinks there’s something that sets the seven-year-old group apart. The Minnesota group, Fischer said, is focused not only on funding but on getting doctors and other academics […]
• Zeiss adds Xradia Context microCT to X-ray portfolio
  Zeiss has launched its new X-ray imaging instrument the Xradia Context microCT, which is a large field-of-view, non-destructive 3D X-ray microcomputed tomography system. The new Zeiss system is a tomographic imaging solution for 3D characterization and inspection needs for a variety of applications. The system allows users to easily adjust the system to enable imaging […]
• Medtech stories we missed this week: April 20, 2018
  From CHF Solutions’ new Italian distribution deal to Masimo’s CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning. 1. CHF Solutions signs Italian distribution deal CHF Solutions announced in an April 17 press release that it has signed a new distribution agreement with TRX Italy to distribute […]
• FDA OKs Opus breast implant line from Sientra, with Lubrizol manufacturing
  The FDA this week granted a pre-market approval supplement to Sientra (NSDQ:SIEN) for its Opus line of silicone breast implants. The implants are made in Wisconsin by Lubrizol LifeSciences subsidiary Vesta, which inked a contract manufacturing deal with Sientra back in August 2016. Sales of Sientra’s silicone breast implants ground to a halt in the autumn of 2015, when […]
• Icon and Intel forge partnership for pharmaceutical analytics platform for clinical trials
  Icon and Intel have struck an deal that allows Icon to offer the Intel Pharma Analytics Platform in clinical trials. The financial details of the deal were not disclosed. The Intel platform is an edge-to-cloud artificial intelligence platform that allows clinical data to be remotely monitored while it continuously captures data for study participants who […]
• OCTANe announces partnership with Small Cap Nation
  Orange County, Calif.–based life sciences accelerator organization OCTANe recently announced a strategic partnership with Small Cap Nation (SCN), a New York City–based financial media content distribution platform. SCN delivers breaking, on-demand news and information related to the domestic and international small-cap sector. It recently opened a Silicon Valley office. “This partnership will open an important source of capital […]
• Cadence snapped up by private equity firm Kohlberg & Co.
  Officials at high-precision components and finished devices maker Cadence are selling the Staunton, Va.–based company to private equity outfit Kohlberg & Co. Financial terms of the definitive agreement, announced yesterday, were not disclosed. Cadence makes components and devices for advanced surgical and specialty industrial applications. Cadence CEO Alan Connor will continue to lead the company, and […]
• Turns out graphene can fight bacteria on implants
  Graphene flakes that are arranged like spikes can kill bacteria and stop infections during implant surgery procedures, according to new research from Chalmers University of Technology in Göteborg, Sweden. Bacteria moves around the body in fluids like blood looking for an area to stick to. Once they find a place, the bacteria starts to grow […]
• How augmented reality and virtual reality devices are boosting medicine
  Augmented reality (AR) and virtual reality (VR) devices have immense disruptive potential, with the capacity to change how the healthcare industry delivers patient care and provider training. These technologies are helping to take medicine outside clinical spaces and will present a wide range of opportunities for innovators as professionals continue to adapt. Tim Jennings,  Custom […]
• TT Electonics wraps up acquisition of Stadium Group
  TT Electronics (Woking, U.K.) said today that it has completed its purchase of Stadium Group, a Reading, U.K.–based supplier of connectivity products and services, power supplies, human-machine interface (HMI) and electronic assemblies. Financial terms of the deal were not disclosed. Stadium products are used in applications including medical equipment, smart home, industrial robotics and aircraft cabin controls […]
• Excelitas Technologies touts OmniCure at InPrint Industrial Inkjet Conference
  Excelitas Technologies is touting its OmniCure OV LED curing solutions at this year’s InPrint Industrial Inkjet Conference at The Palmer House Hilton in Chicago, May 1-2. The company will showcase its new OmniCure AC8-HD (high dose) series of UV LED curing systems that offer higher optical power and enhanced performance in the same air-cooled mechanical […]