FSS lands extended CE Mark for FlexStent | Regulatory Roundup

From Medical Design & Outsourcing

• Cretex breaks ground on new plant north of Minneapolis
  Cretex Cos. last week broke ground on a new 245,000 ft2 medical device contract manufacturing plant in Brooklyn Park, Minn. Elk River, Minn.–based Cretex plans to complete facility construction by the end of the year. The company expects the facility by the end of 2022 to house its stamping, molding and tool design — and… […]
• Resonetics to expand manufacturing in Costa Rica
  Resonetics announced today it has leased new manufacturing space in Costa Rica to more than double its production there. The space, in a building near its current site in the Coyol Free Zone business park in Alajuela, will be expanded and reconfigured to create a 45,000 ft² production site. The move comes after the company… […]
• Are Black patients not getting LVADs as quickly as white patients?
  Researchers from the University of Missouri conducted a study that found disparities in treating Black and white patients with advanced heart failure. According to a news release, the study found that Black patients with advanced heart failure were more likely to receive a left ventricular assist device (LVAD) — a pump implanted into the chest… […]
• Viant expands factory in Costa Rica
  Viant announced today that it has completed a major expansion of its medical device manufacturing facility in Heredia, Costa Rica. The company said it invested in the additional capacity to meet market demand for minimally invasive surgical devices, including energy-based devices. Begun in fall 2020, the expansion adds 14,000 ft² of ISO Class 8 cleanroom… […]
• St. Jude Medical founder and his Medical 21 raise $3M
  Raising money for a startup company during a pandemic is no cakewalk, according to Manny Villafaña. But he did it. Medical 21, the latest venture for the founder of St. Jude Medical, has raised another $3 million in an equity offering, according to an SEC filing. The most recent round brings the Minneapolis-based startup’s total funding… […]
• How can patient input improve clinical trials?
  The Medical Device Innovation Consortium (MDIC) has laid out some recommendations for improving medical device clinical trials with increased patient input. Having observed that clinical trial sponsors seldom refer to patient input — something the FDA issued guidance for in September 2019 — MDIC offered its view on increasing and using patient input to improve… […]
• Orchid names new CFO
  Orchid Orthopedic Solutions (Holt, Mich.) announced this week that Matt Tharp has joined the company as chief financial officer. Tharp comes to Orchid from Ammega, where he held the role of CFO – Americas. He has more than 20 years of experience in supply chain, operations and finance and has held leadership roles at Midwest… […]
• ICS establishes dedicated medical device practice
  Integrated Computer Solutions (ICS) is establishing a dedicated medical device practice amid increased demand for complex medtech. ICS said its work in the medical and life sciences markets has nearly doubled year-over-year as connected technologies drive innovation and transform healthcare. “There has been extraordinary innovation and growth in the medtech sector in recent years which… […]
• SMC is expanding its Costa Rica facility
  SMC (Somerset, Wis.) recently announced that it will double the size of its Alajuela, Costa Rica facility to 120,000 ft2 this year. The additional space will enable SMC Costa Rica to provide increased contract manufacturing solutions, including assembly, injection molding and secondary operations. SMC plans to double the number of workers it has in the Central… […]
• Sandia Labs seeks partners to make reusable masks
  Sandia National Laboratories has come up with its own version of a reusable respirator for frontline workers. Sandia has filed for patent protection, is testing prototypes, and seeking NIOSH approval and potential manufacturing partners for its elastomeric half-mask N95 respirator. It’s the latest entry to a small but growing category of reusable masks designed to… […]
• Evco Plastics adds Ga. plant for medtech production
  Evco Plastics (DeForest, Wis.) announced today that it recently purchased a new facility for white room and liquid silicone rubber molding near Calhoun, Ga. The CAL 2 facility has room for 20 injection molding machines of up to 500 tons, and there will be a separate room for new LSR machines. Other features of CAL… […]