FDA clears more Chocolate PTA balloon catheters | Regulatory Roundup

From Medical Design & Outsourcing

• DTW Podcast: 10 ways medtech is finding its footing amid COVID-19
  When COVID-19 set upon the U.S. in March, medtech executives had a month at most to tell Wall Street analysts how the pandemic had hit the industry’s largest companies. We heard about short-term hits in revenues, procedures and employee headcounts, but uncertainty clearly ruled the day. Over the past few weeks, medtech executives from several… […]
• 3M lays off another 1,700 workers, many related to former drug delivery business
  3M (NYSE:MMM) laid off another 1,700 workers during its second-quarter — with many of the jobs related to the company’s divested drug delivery business. The layoff — announced as part of an SEC filing on July 28 — comes after the Maplewood, Minn.–based manufacturing conglomerate said early this year that it would lay off 1,500 workers — though… […]
• Millstone Medical completes headquarters expansion
  Millstone Medical Outsourcing has completed its previously announced headquarters expansion in Fall River, Mass. The expansion includes 60,000 square feet of state-of-the-art warehouse and office space that expands capacity in Fall River to 120,000 square feet of production space. The expansion includes 4,500 square feet of mechanical inspection, 31,000 square feet of warehouse area, and… […]
• Confluent Medical opens catheter development center in Austin, Texas
  Confluent Medical this week announced it has opened a Complex Catheter Design and Development Center in Austin, Texas. The facility is a rapid-prototyping, development and pilot facility that expands the company’s ability to provide customers with electrophysiology and neuromuscular catheters and complex delivery systems for structural heart and vascular applications. Confluent Medical also said its […]
• J&J’s Ethicon touts surgical stapler study
  Ethicon — part of Johnson & Johnson (NYSE:JNJ) — is highlighting new study results in which its Echelon powered stapler with gripping surface technology (GST) had a lower rate of bleeding-related complications than a competing Medtronic product. Ethicon funded the peer-reviewed study, which appears online in Medical Devices: Evidence and Research. The study compared the Echelon… […]
• Instron to hold virtual biomedical testing open house
  Instron (Norwood, Mass.) plans to hold its first-ever virtual Biomedical Testing Open House, August 24–27. Register on Instron’s website. The online event will bring together materials testing experts for a mix of presentations and Q&A sessions. Topics will include  PPE and medical device testing, understanding regulatory standards, ensuring data integrity and traceability, and more. Experts… […]
• Nolato Group acquires GW Plastics
  GW Plastics (Bethel, Vt.) announced today that the Nolato Group (Torekov, Sweden) has acquired it. Financial terms of the deal were not disclosed. GW Plastics’ seven global manufacturing facilities will join Nolato’s more than 25 facilities worldwide — creating a solid position for the newly merged company in North America, Asia and Europe. Officials at… […]
• Abbott launches study of next-gen ablation catheter
  Abbott today announced it has enrolled the first participants in its TactiFlex PAF IDE study to evaluate the performance of the TactiFlex Ablation Catheter, Sensor-Enabled. The catheter is designed to treat people suffering from paroxysmal atrial fibrillation (PAF) with symptoms that are unable to be managed by medication. TactiFlex combines Abbott’s contact force-sensing technology within… […]
• This implantable transmitter could provide a wireless option for biomedical devices
  The Purdue University research team is touting a fully implantable radio-frequency transmitter chip they developed for wireless sensor nodes and biomedical devices. The transmitter chip consumes the lowest amount of energy per digital bit among similar technologies published to date, according to the researchers, who published their results in the journal IEEE Transactions on Circuits… […]
• How a Mars rover is enabling better surgical robots
  From the Perseverance Mars Rover on its way to Mars to race cars, maxon (Taunton, Mass.) credits the aerospace and automotive industries with presenting demanding design challenges that are bearing fruit in other spaces such as surgical robotics. The company’s GPX UP planetary gearbox, for example, is well-suited to provide haptic feedback for surgeons because it… […]
• Australian researchers think they’ve found a way to attach hydrogels to medical implants
  A research team at the University of Sydney said that it developed a plasma technology to attach hydrogels to polymeric materials. In a paper published in Advanced Functional Materials, the team of biomedical engineers said the plasma technology attaches the jelly-like hydrogel substances that are structurally similar to human soft tissue to the polymeric materials,… […]