CardioFocus wins FDA nod for HeartLight AF balloon

From Medical Design & Outsourcing

• Smith & Nephew launches portable negative pressure wound therapy system
  Smith & Nephew announced today that it has launched its Pico 7Y single-use negative pressure wound therapy system (sNPWT) in Europe. The system features AirLock technology and includes an integrated Y extension that allows for two dressings to be used from one pump to allow for two wounds to be treated at the same time.… […]
• What is the difference between DC brushed and brushless motors?
  Here is an overview of the factors you’ll need to consider when deciding between a DC brushed or brushless motor. By Carsten Horn, Maxon Motor The key difference between brushed and brushless motors is service life. The service life of a brush motor is shorter and limited by wear of the brushes, while a brushless… […]
• Teleflex, Arcis enter agreement for cancer diagnostics
  Cancer-detection company Arcis Biotechnology said today it has signed an agreement allowing Teleflex (NYSE:TFX) to use Arcis’ advanced nucleic acid sample preparation chemistry in the development of a novel technology. Daresbury, England-based Arcis’ diagnostics use a two-step nucleic acid extraction and preservation technology. The company said it has an extensive patent portfolio covering DNA and RNA extraction… […]
• Neovasc touts Tiara TMVR success rate in study
  A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation. Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study had had a previous… […]
• Bard’s peripheral artery stent exceeds acceptable restenosis rate
  C.R. Bard (NYSE:BCR) has notified buyers of its LifeStream covered iliac stent of a higher-than-anticipated restenosis rate among patients. The field notice issued by Bard, parent company BD and Irish catheter-maker ClearStream Technologies said the restenosis rate of 0.04% exceeds the acceptable failure rate of 0.01%. An unspecified number of restenosis complaints was reported following implantation of… […]
• Interrad inks French distribution deal for SecurAcath
  Interrad Medical recently signed a distribution agreement with Vygon to distribute the company’s SecureAcath Subcutaneous Catheter Securement Device in France. “As we continue to expand global distribution, we are very excited to be able to enter the French market with Vygon as a partner,” Joe Goldberger, president and CEO of Interrad Medical, said in a… […]
• Strata Skin Sciences launches Xtrac S3 laser
  Strata Skin Sciences has launched its Xtrac S3 309nm laser at this year’s American Society for Dermatologic Surgery. The new laser has a smaller footprint with a vertical configuration that helps increase floor space. It is also 20% faster than earlier laser models, allowing clinicians to treat more patients in the same amount of time.… […]
• U.S. regulators to overhaul third-party 510(k) review program
  By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has set a goal of obviating the need to re-review 85% or more of 510(k) applications that have undergone third-party review by the agency’s 2021 fiscal year. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post… […]
• 3 ways HHS can help medtech innovators
  The U.S. Department of Health and Human Services (HHS) is doing everything from sharing more data to cultivating entrepreneurial talent and engaging in partnerships in order to support medical device innovators, the department’s CTO Ed Simcox told than 100 industry insiders in the Twin Cities today. A major goal at HHS is to build an innovation-focused… […]
• OKW launches in-series charging stations for Body-Case
  OKW recently launched new mountable stations for its Body-Case wearable enclosures that are designed to allow for multiple units to be charged at once. The company’s Body-Case is designed to fit a standard size watch straps. It can be used for data recording and transmission, tracking and monitoring, emergency call and notification and as bio-feedback… […]
• FDA clears Medacta’s Mpact 3D Metal hip implants
  Medacta recently received FDA clearance for its Mpact 3D metal implants and Augments 3D metal to enhance its Impact system for hip revision procedures. The new Mpact 3D Metal Acetabular Two-Hole and Multi-Hole Shells are hemispherical porous shells that feature multiple cross-linked polyethylene liner options. Its ultra-porous material makes the implants ideal for more demanding primary… […]