From Medical Design & Outsourcing

• January 2020 Issue: The Leadership in Medical Technology Issue
  The next Roaring ’20s The medtech industry received one of the best holiday gifts it could have hoped for just before Congress adjourned for its year-end break: the repeal of the 2.3% medical device excise tax. The tax was part of the Affordable Care Act of 2010 and was one of a number of funding… […]
• Integer adds IPG manufacturing and testing tech to Mexico plant
  Integer Holdings (NYSE:ITGR) announced it has added implantable pulse generator (IPG) cleanroom assembly and testing capabilities at its Tijuana-North facility The plant is the first Class III active-implantable medtech manufacturing site in Mexico to receive FDA approval, according to the Plano, Texas-based company. Integer has added Class 7 and 8 cleanrooms, and manufacturing and capital… […]
• FDA issues draft guidance on multi-use arthroscopy tubing sets
  The FDA has issued draft guidance on arthroscopy pump tubing sets intended for multiple-patient use. Clinicians often use a single source of irrigation fluid for multiple patients without replacing the source of irrigation fluid or replacing/reprocessing the irrigation tubing system between patients.  These devices are designed to deliver irrigation to the surgical site, these devices… […]
• How LED light can break down ingestible medical devices
  Researchers at the Massachusetts Institute of Technology have developed an approach to break down ingestible medical devices in the gastrointestinal tract. Medical devices can be inserted in the gastrointestinal tract to treat, diagnose or monitor a number of GI disorders. However, the devices have to removed through endoscopic surgery once completed. The MIT researchers developed… […]
• New 510(k) boosts iRhythm, Verily efforts for AFib screening
  The latest 510(k) clearance for the Verily Study Watch will further the efforts of the Google sister company and iRhythm Technologies (NSDQ:IRTC)  to improve atrial fibrillation treatment. Verily — a life science company under Alphabet (NSDQ:GOOGL) — recently received an FDA 510(k) clearance to include an irregular pulse monitor in its Study Watch wearable. “We’ve worked carefully to meet the FDA’s stringent… […]
• Argon Medical debuts IVC filter retrieval kits
  Argon Medical Devices (Frisco, Texas) said this week that it has launched single-loop and triple-loop retrieval kits for percutaneous removal of inferior vena cava (IVC) filters that are no longer medically required. The kits are indicated for use via a jugular approach and offer the following features: A coil-reinforced outer sheath with the strength needed… […]
• NANS 2020: Neuromodulation news you need to know
  Neuromodulation devices from companies including Medtronic (NYSE:MDT), Abbott (NYSE:ABT) and SPR Therapeutics are showing promise treating pain. That’s one of the initial takeaways from study results that medical device companies in the neuromodulation space are touting this weekend at NANS 2020 in Las Vegas. NANS is a joint conference of Congress of Neurological Surgeons and the North American Neuromodulation… […]
• Injection Molding Principles
  Optimizing custom part designs for injection molding requires a thorough understanding of the process and outcomes. In this e-book, you’ll learn about common molding resins, special molding terms you should know, and most importantly, how to optimize your part with undercuts, even walls, drafts, and more. Download this e-book from Xometry to learn more… The […]
• GW Plastics expands Vermont manufacturing and tech center
  GW Plastics announced that it has completed a $10 million expansion of its Royalton, Vt., manufacturing and technology center. The company said it has added a 30,000 ft2 to the building to accommodate the growth of its thermoplastic injection molding and medical device contract assembly business. The expansion includes a new 13,000 ft2, Class 8… […]
• Certain GE Healthcare patient-monitoring devices vulnerable to cyberattack
  The federal government and GE Healthcare (NYSE:GE) announced today that the certain of the company’s patient monitoring devices are vulnerable to cyberattack. If attacked, some versions of the Carescape and ApexPro telemetry servers, the Carescape Central Station version 1 and Central Information Center systems could stop monitoring patients, silence alarms or produce unnecessary alarms during… […]
• Cardinal Health recalls 9 million surgical gowns, sends hospitals scrambling
  Cardinal Health (NYSE:CAH) announced that it is voluntarily recalling 9.1 million surgical gowns produced by an unnamed contract manufacturer after discovering quality issues with the product. The Dublin, Ohio-based company said that some gowns were produced in unapproved locations that did not maintain proper environmental conditions as required by law. Some of the gowns were also… […]