Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, June 2, 2023. Fast Five by MassDevice · Bayer is making a big digital health play, startup Ezra wants to make a 15-minute MRI using AI […]
Medtronic names former Amazon consumer robotics VP as chief technology and innovation officer
Medtronic today announced it appointed former Amazon executive Ken Washington as chief technology and innovation officer. In this newly created role, Washington will leverage his extensive experience leading technology development and execution across industries, including robotics, consumer products, automotive and space. He will also become a member of the Medtronic Executive Committee. “This new leadership […]
B. Braun launches DoseTrac Enterprise infusion management software
B. Braun today announced it launched its next generation of infusion management software, called DoseTrac Enterprise. The new software allows organizations to receive a mix of real-time views and retrospective reporting features better to understand their infusion pump fleet and associated data. DoseTrac Enterprise can connect up to 40,000 pumps at an unlimited number of […]
Startup Ezra wins FDA clearance for AI that enhances MRIs
Ezra today announced it received FDA 510(k) clearance for its Ezra Flash AI platform that enhances the quality of MR images. New York-based Ezra designed Ezra Flash to reduce the time needed to complete a high-quality scan with the hopes of reducing MRI costs. The company plans to use the technology to launch what it […]
New FDA clearance will boost Philips and Masimo partnership
Philips and Masimo today announced an FDA clearance that allows the incorporation of Masimo’s advanced monitoring tech into Philips’ existing high-acuity patient monitors. The FDA clearance allows the companies to use SedLine brain function monitoring, Regional Oximetry and CO2 measurements in Philips’ patient monitors, IntelliVue MX750 and MX850. This is the latest extension of Masimo […]
Teleflex signs purchasing agreements with Premier
Teleflex today announced it was awarded two group purchasing agreements with Premier, effective July 1. The new agreements allow Premier members, at their discretion, to use special pricing and terms pre-negotiated by Premier for Teleflex’s central venous and arterial vascular access products. Premier also awarded Teleflex a national agreement for hemodynamic monitoring products and accessories, […]
ABK Biomedical receives FDA IDE for tumor-treating microspheres
ABK Biomedical this week announced it received FDA investigational device exemption approval for its Eye90 microspheres yttrium 90 radioembolization therapy. The FDA IDE approval allows the Halifax, Nova Scotia–based company to commence a multi-center pivotal clinical study in the U.S. involving patients with an especially tough-to-treat form of liver cancer. “FDA approval of this pivotal […]
Fast Five: iRhythm’s FDA warning letter, Masimo management and activist investor trade blows
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, June 1, 2023. Fast Five by MassDevice · iRhythm’s FDA warning letter, Masimo management and activist investor trade blows The global release of Exactech’s next-generation […]
CardioRenal receives FDA breakthrough designation for Tenor at-home blood potassium measuring device
CardioRenal today announced it received FDA breakthrough device designation for its Tenor at-home blood potassium measuring device. Tenor is a connected medical device that combines multiple technologies to assist patients with chronic illnesses, including chronic kidney disease, in measuring their blood potassium levels from the comfort of their homes. Patients can collect blood for testing […]
Establishment Labs wins CE mark for minimally invasive surgical tools
Establishment Labs this week announced it received CE mark approval for its Motiva Injector, Motiva Inflatable Balloon and Motiva Channel Dissector. The company designed the three devices for its next-generation minimally invasive aesthetic procedures. “The approval in Europe of our minimally invasive tools is an important step in the evolution of plastic surgery,” Founder and […]
Sanuwave appoints new CEO
Sanuwave recently announced it appointed Morgan Frank as chief executive officer, effective immediately. Frank has served 19 years as founder and principal of Manchester Management, Sanuwave’s largest outside shareholder, and has served as chair of the Sanuwave board of directors since August 2022. Former CEO Kevin Richardson will remain on the board of directors of […]