Biocoat (Horsham, Pa.) announced today that is has received a certification of registration for the ISO 13485:2016 quality management system. Company officials described the certification as reflecting an ongoing commitment to quality. Biocoat specializes in supplying lubricious hydrophilic coatings for medical devices used in a range of … [Read more...] about Biocoat achieves ISO 13485:2016 certification
Catheters
Could this old-school manufacturing technology enable better catheter designs?
Excimer lasers have taken a back seat to femtosecond and picosecond lasers when it came to catheter manufacturing, but it may be time for medical device creators to give this decades-old technology a second look. A serial medical device manufacturing entrepreneur in the Twin Cities, Brady Hatcher still remembers the moment years ago when he first … [Read more...] about Could this old-school manufacturing technology enable better catheter designs?
How innovative pump designs power intelligent balloon catheters
The next generation of intelligent balloon catheters depends on novel designs of ball-screw-driven pumps. Bruce Gretz, Steinmeyer Balloon catheters have long seen widespread use in cardiovascular applications. One of the first, decades ago, was intra-aortic. A balloon was implanted into the descending aorta and pressurized via a percutaneous … [Read more...] about How innovative pump designs power intelligent balloon catheters
MD&M West: Here are 4 things you may have missed
From 3M's adhesive-finding tool to help wearable designers to OnRobot's energy-efficient vacuum gripper, there were plenty of useful tools for medical device creators to discover at this year's MD&M West in Anaheim, Calif. As managing editor of Medical Design & Outsourcing, I toured the show floor to point out some of the highlights, which … [Read more...] about MD&M West: Here are 4 things you may have missed
FDA clears Safe Medical Design’s urethral catheter
Safe Medical Design (San Francisco) said that FDA has cleared its Signal Catheter for commercialization in the United States. The 100% silicone foley catheter features a novel hub design allowing the catheter to reduce excessive balloon pressure in the event the catheter is improperly placed. Each year in the United States there are as many as … [Read more...] about FDA clears Safe Medical Design’s urethral catheter
FDA clears Imperative Care’s stroke treatment catheters
Stroke-treatment startup Imperative Care (Campbell, Calif.) said it has landed FDA approval for its first line of access catheters. Access to brain blood vessels can be challenging because of the brain’s highly complex and twisted vascular structure. The catheters were designed to deliver interventional treatments during minimally invasive … [Read more...] about FDA clears Imperative Care’s stroke treatment catheters
How to ensure the structural integrity of multi-layer polymer tubing
When designing a co-extruded multi-layer tube for an intravascular application, the final physical properties of the polymers used are not the only factor. For optimal extrusion, it is also important to consider the effects of the viscosity, the polymers’ melt temperatures, and their placement in the structure. Steve Maxson, Spectrum Plastics … [Read more...] about How to ensure the structural integrity of multi-layer polymer tubing
Freudenberg Medical touts catheter handle platform and steerable introducers
Freudenberg Medical is touting its new catheter handle platform and its steerable introducer products. The Composer XL Deflectable Catheter Handle Platform gives users a commercialization-ready interface that is designed to give integrated control, according to the company. It is sized for large bore structural heart and endovascular devices like … [Read more...] about Freudenberg Medical touts catheter handle platform and steerable introducers
