Positron Corp. touts regulatory wins in U.S., U.K.

From Medical Design & Outsourcing

• Resonetics acquires STI Laser Industries
  Resonetics (Nashua, N.H.) said today that it has purchased STI Laser Industries (Or Akiva, Israel), a medical device industry supplier of laser processing, nitinol shape setting and electropolishing, and cleanroom assembly and packaging. Financial terms of the deal were not disclosed. Founded in 1998 by its president and CEO Tovy Sivan, STI has a worldwide business, with… […]
• Civco Radiotherapy wins 510(k), CE Mark for Solstice SRS immobilization system
  Civco Radiotherapy recently received FDA 510(k) clearance and CE Mark approval for its Solstice SRS Immobilization System. The Solstice SRS Immobilization System has a unique corrective pitch capability and positioning flexibility. It also features customizable components that are able to create a comfortable head and neck immobilization system for radiotherapy treatments. “The Solstice SRS Immobilization… […]
• Adaptiiv teams with University of Hong Kong on software use, research
  Adaptiiv said that the University of Hong Kong will begin using the company’s 3D bolus software and that it will partner with the university’s clinical oncology department to develop new applications. Adaptiiv (Halifax, Nova Scotia) designed its software to convert cancer patient CT scan data into a digital model that can be used to print a… […]
• Pulse Systems expands CNC machining capabilities and facilities
  Precision metal fabricator Pulse Systems said it has acquired additional computer numerical control (CNC) machine tools and has expanded its facilities space to accommodate the new equipment. The recent CNC equipment acquisitions include a second Tsugami LaserSwiss machine, as well as several conventional Star Swiss screw machines, bringing to 11 the total number of CNC… […]
• Changes to ISO 14155 standard for medical device clinical investigations expected in 2019
  By Dietmar Falke Aleksandra Klimaszewski and Stewart Eisenhart, Emergo Group Revisions to the ISO 14155 standard covering pre- and post-market clinical investigations for medical devices are set to take effect in 2019. Manufacturers and clinical trial sponsors should consider ramifications of the updated standard for risk management and related issues if they have not already… […]
• Nordson snaps up Clada Medical
  Nordson (NSDQ: NDSN) said it has acquired Clada Medical Devices, a Galway, Ireland-based design and development contract manufacturer primarily focused on balloons and balloon catheters. The purchase will expand Nordson’s (Westlake, Ohio) balloon and balloon catheter capabilities with broader design, development and manufacturing capabilities, Nordson said in a statement. Terms of the deal were not… […]
• Digital Manufacturing Case Studies
  Medtech Startup Gets to Market Faster, Cost-Effectively with On-Demand Molding MEDTECH STARTUP INVOY TECHNOLOGIES is on a mission to disrupt the weight-loss industry. Its novel solution combines patented technology—a handheld breath analyzer that instantly measures fat burning—and a data-driven coaching app to help users reach their goals. In launching its second-generation device, Invoy is relying… […]
• U.S. military to adopt Adaptiiv’s 3D bolus cancer software
    Adaptiiv Medical Technologies said that the U.S. military will use its 3D bolus software to treat American veterans with cancer at Walter Reed National Military Medical Center. Adaptiiv designed its software to convert patient CT scan data into a digital model that can be used to print a bolus that conforms to patient anatomy, according… […]
• Feinstein researchers study what the body is telling the brain
  A 2014 study showed that inflammation-causing proteins known as cytokines were present in the plasma of lupus patients up to several weeks before their disease flared up. Conversely, these Oklahoma researchers found that inflammation regulators are present during periods when the disease is stable. Now, researchers at The Feinstein Institute for Medical Research (Manhasset, N.Y.)… […]
• FDA clears MC3 Cardiopulmonary’s Crescent ECMO catheter
  MC3 recently received FDA clearance for its Crescent Jugular Dual Lumen Catheter designed for extracorporeal membrane oxygenation. The catheter is a single-use, dual lumen catheter that is placed through the jugular vein and connected to an ECMO system that removed carbon dioxide and reinfuses oxygenated blood. Its design minimizes recirculation while allowing for smooth insertion,… […]
• FDA announces key guidance publication plans for 2019
  By Stewart Eisenhart, Emergo Group Updated cybersecurity requirements for medical device premarket submissions, Abbreviated and Special 510(k) program refinements, and medical software policy changes stemming from the 21st Century Cures Act rank highly among topics for a new list of guidance documents the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH)… […]