Abbott ramps up Libre 3 production amid shortages
2024年9月20日 · 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.
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.
What’s next at Masimo after CEO Kiani’s exit? | MedTech Dive
2024年9月30日 · 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.
FDA finalizes guidance on device shortage reporting rules
2025年1月8日 · Dive Insight: Industry groups pushed back against the first draft in 2022, warning that the scope of the document may cause overreporting. The FDA responded in 2023 by proposing a list of product codes that would be subject to the reporting requirements.
Establishment Labs wins FDA approval for Motiva breast implants
2024年9月30日 · Dive Brief: Establishment Labs received Food and Drug Administration approval for its Motiva breast implants for primary and revision breast augmentation.; Motiva is the first new breast implant to receive U.S. premarket approval since 2013, according to Establishment Labs’ Thursday announcement.
BD receives FDA warning letter over quality system violations
2024年12月20日 · 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.
Dexcom prices first over-the-counter glucose monitor
2024年8月26日 · Dive Brief: Diabetes technology company Dexcom began sales of its first over-the-counter continuous glucose monitor (CGM) on Monday.; The device, called Stelo, will cost $89 for a monthly subscription or $99 for a one-time order of two sensors.
FDA plan would alert public sooner on high-risk device recalls
2024年11月22日 · The Food and Drug Administration’s medical device center unveiled Thursday a pilot program meant to speed up notices to the public about potentially high-risk product recalls.. The pilot aims to improve the time between when the FDA first knows about certain corrective actions on products and when the public and healthcare providers are notified.
Boston Scientific resumes PFA trial in new patient group after …
2024年11月12日 · Dive Brief: Boston Scientific has resumed a study of pulsed field ablation (PFA) as a first-line treatment for persistent atrial fibrillation (AFib), after pausing the trial to assess unspecified observations.; The Avant Guard clinical trial compares PFA against anti-arrhythmic drugs to treat patients who have AFib lasting more than a week, called persistent AFib, a dangerous form of irregular ...
Top medtech conferences in 2025 | MedTech Dive
2024年10月1日 · J.P. Morgan Healthcare Conference. Jan. 13-16 San Francisco. The J.P. Morgan Healthcare Conference is one of the industry’s biggest events. Executives from medical device, hospital and pharmaceutical companies provide insights on their recent financial performance and developments to watch in the year ahead.