Abbott ramps up Libre 3 production amid shortages
Sep 20, 2024 · MedTech industry news. “Essentially, some patients are seeing delays in their scripts getting filled at certain U.S. retail pharmacies due to a low on-shelf inventory, and while there are likely some minor supply issues causing these script delays, demand also has been very strong as Abbott continues to gain share in the U.S.,” Marcus wrote on Thursday.
What’s next at Masimo after CEO Kiani’s exit? | MedTech Dive
Sep 30, 2024 · Masimo’s leadership transition brings a two-year boardroom feud to a close, but questions remain about the path forward in the wake of CEO Joe Kiani’s exit.
Medical Technology News | MedTech Dive
MedTech Dive provides medical technology news and analysis for industry professionals. We cover medical devices, diagnostics, digital health, FDA regulation and compliance, imaging, and more.
BD receives FDA warning letter over quality system violations
Dec 20, 2024 · Dive Insight: The FDA sent the warning letter in November after inspecting a BD facility in San Diego. Carefusion 303, a business that BD acquired in a $12.2 billion deal in 2015, makes devices including Pyxis at the facility. Carefusion, then part of Cardinal Health, entered into a still-active consent decree with the FDA in 2007 in relation to Alaris pumps.
Medical device recalls under the spotlight in 2024
Dec 19, 2024 · More recently, the FDA has taken actions to speed up public notices about recalls that it believes could be high risk. Under new Center for Devices and Radiological Health Director Michelle Tarver, the agency launched a pilot program in November and issued its first early alert on a Fresenius infusion pump recall this month.. Several heart devices have also come under scrutiny this year ...
Zimmer pulls hip implant off the market due to fracture risk
Sep 18, 2024 · Dive Brief: Zimmer Biomet will phase out sales of its CPT Hip System by December due to concerns about the risk of thigh bone fractures, the Food and Drug Administration said in a Tuesday notice.; Despite plans to pull the device, the FDA said it is still concerned about the hip system being implanted in new patients, and it is “working with the manufacturer to address these concerns.”
Henry Schein to acquire medical supplier Acentus
Nov 21, 2024 · Dive Brief: Henry Schein said Wednesday it had agreed to acquire Acentus, a medical supplier specializing in delivering products to patients’ homes.; Henry Schein, a medical and dental supplies distributor, said the acquisition brings its homecare medical products platform’s annual revenue base to approximately $350 million.
The number of AI medical devices has spiked in the past decade
Oct 9, 2024 · The number of medical devices with artificial intelligence technology has risen sharply in the past decade. The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices as of Aug. 7, 2024, according to the agency’s database. While the FDA authorized the first AI-enabled device in 1995, the number of …
Top medtech conferences in 2025 | MedTech Dive
Oct 1, 2024 · J.P. Morgan Healthcare Conference. TBD San Francisco. The J.P. Morgan Healthcare Conference is one of the industry’s largest events. Executives from medical device, hospital and pharmaceutical companies provide insights on their recent financial performance and developments to watch in the year ahead.
Medtronic buys surgical instrument developer Fortimedix
Nov 22, 2024 · Dive Insight: Fortimedix has kept a low profile in recent years. The Dutch medtech company put out a series of press releases in 2016 and 2017, when it raised 11 million euros, received a CE mark and launched a single-port Symphonx surgery system in the U.S.. Physicians published a paper in 2020 about the learning curve for new users of the surgery system.