FSS lands extended CE Mark for FlexStent | Regulatory Roundup

From Medical Design & Outsourcing

• Here are the top 5 medtech stories of mid-2017
  The middle of 2017 is shaping up to be a continued whirlwind of activity for medtech. FDA is getting used to its new leadership but is facing a continued lack of clarity on user fees and UDIs. Industry is seeing a deeper consolidation in medical supplies, exemplified in Cardinal Health’s purchase of patient recovery supplies from […]
• HP’s new 3D printers: Here’s why Proto Labs likes them
  Quick-turn manufacturer Proto Labs is among a number of companies testing the new HP Multi Jet Fusion technology for industrial-grade 3D printing. “As far as what we’re testing in, it is definitely becoming a faster way to build parts compared to [selective laser sintering],” Joe Cretella, an applications engineer at Proto Labs (Maple Plain, Minn.), told MDO […]
• Medtech stories we missed this week: June 23, 2017
  From Guardant suing Foundation Medicine to Interson receiving 510(k) clearance for ultrasound probes, here are medtech stories we missed this week but thought were still worth mentioning. 1. Guardant levels false advertising suit against Foundation Medicine Guardant Health announced in a June 22 press release that it has filed a lawsuit against Foundation Medicine for […]
• Clever catheter lets surgeons see inside arteries to trim plaque
  The Pantheris catheter developed by Avinger takes the physician out of the radiation field. A clever catheter design lets cardiologists see inside arteries and precisely remove plaque from diseased tissue. The Pantheris catheter is safer than conventional radiation-guided procedures because it takes the surgeon out of the radiation field, and along with on-board optics, it […]
• 5 secrets of contract manufacturing longevity
  Whether it’s a few decades or the better part of a century, there are important factors that enable a contract manufacturer to last for a long time – business traits that OEM customers should value. We asked top executives from long-lasting medical device industry suppliers to share their secrets.  Mike Ondercin started Cleveland-based Criterion as […]
• What startups need to succeed when selecting medical device materials
  Whether a startup targets an emerging category such as wearables or a more mature device market, a well-planned approach to medical device materials selection can make a significant difference in the product launch cycle, economic model and other variables. Deepak Prakash, Vancive Medical Technologies Materials selection can be a make-or-break issue for medical device startups. Even […]
• Brazilian medical device regulators change registration submission formats
  By Stewart Eisenhart, Emergo Group Brazilian medical device regulator ANVISA has adjusted its electronic submission policy for marketing authorization applications, now accepting both electronic and paper formats of documents. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
• How to grow your medical device business through its life cycle
  While every medical device business founder daydreams of pre-revenue exits and unicorn valuations, it is imperative to plan for the long and unpredictable haul. Richard F. Mattern, Bass, Berry & Sims PLC Despite the starting point being nearly universal (founder sees a clinical need, a promising market opportunity and a path to regulatory approval or […]
• What you need to know about heat shrink tubing
  Heat shrink tubing comes in a range of materials for many medical applications. Custom materials are also available. Justin Fry, TE Connectivity Medical There is a lot more to medical tubing than extruded polymers. Heat shrink tubing, for instance, provides a range of materials intended to improve designs and solve engineering and manufacturing problems. For instance, […]
• Fluid Metering offers new valveless transfer pump
  Fluid Metering is touting a new valveless, fluid transfer pump that can be used for analytical instrumentation. The new pump offers precision fluid control and integrates CeramPump pumping technology which has a brushless DC motor and integral driver electronics that can last a long time. The pump is powered with a 24V DC input power […]
• S&S Plastics teams with StarMed on endoscopy bottle top
  S&S Plastics has partnered with StarMed to develop a new endoscopy bottle top designed to reduce cross-contamination during gastroenterological investigations, according to a Medical Plastics News report. The device, designed by StarMed, is intended to keep endoscopes lenses clean and ensure a proper diagnosis and reduce procedure times. The final product reduces cross-contamination during procedures […]