The FDA today shared new information on an infusion pump recall from InfuTronix that included one report of death. Following a voluntary removal, the FDA deemed the recall Class I, the most serious kind, earlier this month. It affects 52,328 devices in the U.S. in total. Today, the agency shared that a slew of issues […]
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FDA labels Outset Medical recall of Tablo hemodialysis system as Class I
The FDA today labeled Outset Medical’s recall of some Tablo hemodialysis devices as Class I, the most serious kind. Outset Medical recalled certain Tablo hemodialysis systems after non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) leaching was identified at levels above allowable safety limits. Peroxide-cured silicone tubing in the machines’ hydraulics and dialysate lines caused the unsafe NDL-PCBAs […]
ICU Medical’s Smiths Medical is reportedly closing a New Hampshire plant, cutting 220 jobs
ICU Medical’s Smiths Medical unit reportedly plans to close a New Hampshire manufacturing facility that houses about 220 employees. The infusion technology maker plans to close the plant in Keene, New Hampshire, next year, according to the Keene Sentinel. The outlet said VP of Global Marketing, Tom McCall, confirmed the decision to close today after […]
Conmed appoints new chief operating officer
Conmed announced that it promoted Patrick Beyer to the newly created role of COO. Beyer previously served as president of international and global orthopedics at the Largo, Florida-based company. In his new role, his responsibilities include leading commercial businesses, plus operations, distribution, regulatory/quality and customer excellence. “Pat has been invaluable in driving Conmed’s above-market growth […]
Study highlights benefits of automated insulin delivery for children in UK
A study in the UK demonstrated significant improvements in HbA1c for users of automated insulin delivery technologies. This comes on the heels of a UK NHS initiative to provide tens of thousands of children and adults with type 1 diabetes in the country with an artificial pancreas. The study aimed to assess the efficacy of […]
AtaCor Medical closes $28M Series C extension
AtaCor Medical announced today that it completed a $28 million Series C financing round to support its cardiac pacing and defibrillator technology. Arboretum Ventures led the financing round. Existing investors Longview Ventures, Hatteras Venture Partners, Catalyst Health Ventures and BayMed Venture Partners participated, too. San Clemente, California-based AtaCor plans to use the funds to support […]
FDA wants to advance health equity through home-based care
The FDA has announced an initiative to reimagine the home environment as an integral part of the healthcare system and promote health equity for all Americans. The new initiative, called “Home as a Health Care Hub,” seeks to address the longstanding disparities in healthcare access and outcomes using home-based care. FDA’s Center for Devices and […]
Blue Arbor wins FDA breakthrough nod for neuromuscular interface
Blue Arbor Technologies announced today that it received FDA breakthrough device designation for its Restore neuromuscular interface system. The FDA also accepted the system into its Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread […]
Boston Scientific stock is up as Farapulse drives Q1 beat, raised guidance
Boston Scientific shares got a boost this morning on first-quarter results that came in ahead of the consensus forecast. Shares of Boston Scientific ticked up nearly 7% to $73.66 apiece in early-morning trading today. They got as high as $74.39 during the day, marking a 52-week best for the company. MassDevice’s MedTech 100 Index — […]
FDA clears Sail Fusion’s BowTie Sacroiliac Fusion System
Sail Fusion today announced it received FDA 510(k) clearance for its BowTie Sacroiliac Fusion System. The Del Mar, California-based sacroiliac device company designed the device to incorporate intra-articular and transfixing components. BowTie minimizes tissue disruption, thoroughly prepares the joint, and provides rigid fixation to enable robust arthrodesis. “There hasn’t been meaningful differentiation in the SI […]
Medtronic names new chief regulatory officer
Medtronic officials today shared that the medtech giant named Yarmela Pavlovic as its new chief regulatory officer. Pavlovic posted the news on LinkedIn: “I’m excited to share that I’ve recently been named chief regulatory officer for Medtronic. Medtronic products touch the lives of 74 million patients per year, and I’m honored to continue to support […]