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.
FDA finalizes guidance on device shortage reporting rules
Jan 8, 2025 · 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.
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.
QuidelOrtho fires CEO Doug Bryant - MedTech Dive
Feb 21, 2024 · Dive Brief: QuidelOrtho’s board fired CEO Doug Bryant on Wednesday after nearly 15 years with the company. Bryant also resigned from the company’s board. The diagnostics firm made the decision after a challenging quarter in which its revenue and net income declined year over year. Analysts expressed disappointment with the company’s 2024 forecasts, and QuidelOrtho’s shares lost nearly ...
Artivion says cybersecurity incident has disrupted order, shipping ...
Dec 11, 2024 · Dive Brief: Artivion has taken certain systems offline in response to a cybersecurity incident, the company said Monday in a filing with the Securities and Exchange Commission.; The heart device manufacturer said the incident, which involved the acquisition and encryption of files, “has caused disruptions to some order and shipping processes, as well as to certain corporate operations.”
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.
4 takeaways from the FDA’s first digital health advisory committee
Dec 12, 2024 · 2. Health equity is at the heart of the debate around generative AI. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, discussed the promise of AI in extending care to people in communities with fewer resources — people who are older, are racial and ethnic minorities, and who live in small towns further away from healthcare facilities.
Dermtech files for Chapter 11, lays off 20% of staff
Jun 20, 2024 · Dive Brief: Dermtech has filed for Chapter 11 bankruptcy protection and laid off 20% of its staff to support its push to find a buyer for its cancer test technology, the company said Tuesday.; The San Diego-based company, which makes a skin patch to test for melanoma, began looking for a buyer in January as a mix of reimbursement challenges and costs related to R&D, facility leases and more ...
Medtech firms have cut thousands of jobs this year. Will layoffs ...
Dec 18, 2024 · Medtech firms have cut thousands of workers in the last two years, leaving employees wondering what’s to come in 2025. In the past two months, DNA testing company 23&Me announced plans to cut 200 jobs, orthopedics firm Smith & Nephew announced plans to cut 150 jobs and diabetes tech firm Embecta said it would cut 125 positions after discontinuing its insulin patch pump program.
Illumina CEO Francis deSouza resigns weeks after surviving Icahn …
Jun 12, 2023 · Francis deSouza has resigned as the CEO of Illumina weeks after surviving Carl Icahn’s attempt to oust him as a director of the company.. Late last month, deSouza chalked up a partial victory in a proxy vote that served as a referendum on his time as CEO and on the move to acquire liquid biopsy company Grail. Shareholders voted to retain deSouza as a director but elected to replace board ...