Boston Scientific recently issued an urgent field safety notice for certain Vercise Genus deep brain stimulation (DBS) implantable pulse generators. In the urgent field safety notice released in the United Kingdom, the company warned about the potential for Vercise Genus DBS IPG stimulation therapy to be transiently suspended during charging due to a device reset. […]
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Fresenius Medical Care recalls more than 2 million catheter components
The FDA says a recall of Fresenius Medical Care catheter extension sets and luer lock adapters is Class I, the most serious kind. Fresenius Medical Care initiated the recall of a number of its Stay-Safe luer lock adapters and catheter extensions on Jan. 23, 2024. It extends to nearly 2.2 million devices distributed between March […]
BD warns on some neXus V700 infusion pumps outside the U.S.
BD issued an urgent field safety notice in the UK to warn of potential issues with its Alaris neXus V700 infusion pump system. According to the notice, BD identified that the anti-free flow clamp may not activate when the system door opens. This allows for the potential uncontrolled flow of medication. The issue does not […]
FDA says InfuTronix infusion pump recall includes 1 death
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 […]
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. The news comes only weeks after analysts expressed optimism that the company was moving ahead of previous regulatory challenges with the FDA. Outset Medical recalled certain Tablo hemodialysis systems after non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) leaching […]
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 […]