From Medical Design & Outsourcing

• “Maybe we’re overthinking it” — A tough call was the right call for this medtech developer
  The challenges of developing the LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) went beyond engineering and anatomical obstacles. One of the biggest hurdles was downright emotional, Limflow leaders said in an interview with Medical Design & Outsourcing. Vein-to-artery crossing is key to LimFlow’s unique FDA-approved system for chronic limb-threatening ischemia (CLTI) patients who have… […]
• FDA proposes boosted regulations of lab-developed tests
  The FDA today announced a proposed rule that would make it explicit that in vitro diagnostics are medical devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. The agency is publishing the full rule proposal in the Federal Register. “A growing number of clinical diagnostic… […]
• Navigating thermally induced dynamics when developing miniaturized medical devices
  Understanding and managing thermally induced dynamics during assembly and use is essential as devices become increasingly integrated and miniaturized. By Dave Fromm, Promex Some complexities of integrating miniaturized components, such as microelectronics, into increasingly small medical devices are obvious. Examples include the precision required to position and align components with the requisite accuracy, or the… […]
• The Future of Medical Device Development: Honeywell’s Spectra UF BIO Fiber Solution for Cardiovascular Applications
  By Zachary Murnane, Medical Fiber Global Business Manager, Honeywell The rise in heart valve disease and other cardiovascular conditions has led to a growing demand for minimally invasive devices and technologies. In addition, medical devices need to meet specific tissue response and durability criteria for the biomedical structures to elicit proper biologic responses. This means… […]
• How Ambu seeks to hold its top spot in single-use scopes
  Ambu’s CEO seeks to “Zoom In” on what the Danish company has done best. More than a year after she took over the corner office at Ambu, Britt Meelby Jensen recalls what brought her into leadership. She already had a seat on the board at the maker of single-use endoscopes, anesthesia and airway management devices,… […]
• Qosina introduces RondelO stopcock manifolds
  NEWS RELEASE: Qosina Introduces RondelO™ Stopcock Manifolds Ronkonkoma, NY, USA, September 21, 2023—Qosina, a global supplier of OEM single-use components to the medical and pharmaceutical industries, is pleased to introduce the RondelO™ stopcock manifold. The RondelO modernizes drug infusion protocols through an innovative, patented design. The RondelO is the world’s first medical stopcock manifold that… […]
• Superior Sensor expands CPAP pressure sensor family
  NEWS RELEASE: Superior Sensor Technology Expands CPAP Pressure Sensor Family to Drive Better Patient Synchrony New CP Series Sensors Offer Faster System Response Time and New Safety Measures for PAP Devices, Providing a Higher Quality Patient Experience Los Gatos, CA,  September 27, 2023 – Superior Sensor Technology today announced two new CP Series pressure sensors for Positive Airway Pressure (PAP)… […]
• CUI releases medical grade dc-dc converter with 2:1 input voltage and extended temperature range
  NEWS RELEASE: CUI Releases Medical Grade DC-DC Converter with 2:1 Input Voltage and Extended Temperature Range Tualatin, OR. [September 27, 2023] CUI Inc, a Bel group company, today announced the release of its PTP15 Series—a 15 W, 5 Pin DIP isolated dc-dc converter, specialized for medical instrumentation and home medical supplies. Offering 4000 Vac isolation… […]
• Surface Solutions Group introduces sustainable, compliant GlideMed medical device coating
  NEWS RELEASE: Surface Solutions Group to Introduce Sustainable, Compliant GlideMed™ Medical Device Coating at MD&M Minneapolis CHICAGO, September 26, 2023 – ISO 13485 certified Surface Solutions Group, LLC (SSG), a leading provider of coating technologies for the medical device industry, today announced that it will be showcasing its GlideMed™ sustainable, compliant coating along with its… […]
• RWE tips from Boston Scientific Peripheral Interventions CMO Dr. Michael Jaff
  Real-world evidence (RWE) is a transformational concept for medical device design and engineering, says Dr. Michael Jaff, the chief medical officer and VP of the Boston Scientific Peripheral Interventions business. “Every really great technological advancement in the vascular space has come from a physician’s recognition that they would like to be able to do something… […]
• Resonant Link and Cirtec partner on implantable medical devices
  Resonant Link and Cirtec Medical have entered into a strategic partnership to serve developers of implantable medical devices. The two medtech suppliers said today that the partnership will combine Resonant Link’s next-generation wireless power technology with Cirtec Medical’s product design, development and manufacturing expertise to “offer medical device makers the best technology, fully integrated components,… […]