Medical Device News - MedTech Dive
2024年11月26日 · From SpaceTech to MedTech: What medical device engineering teams can learn from aerospace High-stakes industries like aerospace and MedTech face similar challenges with outdated workflows. Streamlined, cloud-based systems are driving change. Nov. 25, 2024
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.
As cyberattacks on healthcare persist, can the FDA’s new device …
2024年4月3日 · Medical device cybersecurity was an afterthought for the industry and regulators for years, even as hackers continually targeted the healthcare sector. That changed last year when Congress codified stricter medical device cybersecurity requirements and the Food and Drug Administration finalized souped-up guidance for manufacturers.
The number of AI medical devices has spiked in the past decade
2024年10月9日 · The FDA has authorized nearly 1,000 AI or machine learning-enabled devices since 1995, with a sharp increase in recent years. The majority of AI devices are in radiology, but companies are expanding into other specialties such as cardiovascular and robotics.
The top medtech trends in 2024 | MedTech Dive
2024年1月31日 · Learn about the key factors shaping the medical device industry in 2024, such as M&A, product safety, pulsed field ablation and procedure volumes. Read articles from experts and executives on the outlook for orthopedics, cardiac and other markets.
5 steps to navigate the FDA’s new lab developed test rule
2024年10月21日 · The FDA final rule expands regulatory oversight of LDTs, which are tests designed by individual labs for in-house use. Learn how labs can comply with the phased-in requirements, such as adverse event reporting, premarket review, registration and labeling.
Medtechs are boosting DTC investment, but industry still years …
2021年9月14日 · Unlike drugmakers, medical device companies do not need to submit promotional materials to the FDA in a premarket application, according to Friedman. However, ads or other promotional materials cannot go beyond language and claims that are part of a product's labeling, which is reviewed by the agency as part of product applications.
Medical Device News - MedTech Dive
2024年11月13日 · Kamen and Sequel Med Tech CEO Alan Lotvin say they are offering greater precision in insulin delivery with new pump technology in the Twiist device. Leerink analysts said the results were largely in line with outcomes in a trial of Inspire Medical’s rival device but cautioned that Livanova may ...
Survey Shows Growing Dependence on Contracts Among Medical …
2024年10月21日 · “Unequal information distribution creates major challenges for medical device sales teams,” said Alex McLachlan, U.S. Commercial Director at Intellijoint Surgical. “Reps aren’t necessarily going to a spreadsheet somewhere on a shared drive when they’re thinking about an opportunity with an individual surgeon who is right in front of them.
Johner Institute Launches “EUSTAR” Regulatory ... - MedTech Dive
2024年8月21日 · With the medical device industry evolving rapidly due to technological advancements and regulatory changes, companies must build a well-prepared and knowledgeable workforce. The Johner Institute’s free nine-day course offers a glimpse into the extensive training and resources available through the MDU, helping professionals stay …