2025 Medical Device Cybersecurity Trends: What Will Shape The Industry?
What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.
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HeartBeam submits 510(k) application to FDA for ECG software
HeartBeam has submitted a 510(k) application to the US Food and Drug Administration (FDA) for its 12-lead electrocardiogram ...
Hosted on MSN3d
FDA grants 510(k) clearance to GE HealthCare’s updated ultrasound systems
"FDA grants 510(k) clearance to GE HealthCare’s updated ultrasound systems" was originally created and published by Medical ...
JD Supra4d
FDA Dumps Trio of Device-Related Guidances Prior to Administration Change
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...
Medical Design and Outsourcing8d
FDA’s Tarver pushes for mandatory medical device shortage reporting
The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...
Becker's Spine Review16d
7 spine, orthopedic devices earning FDA clearance in 1 month
Here are seven orthopedic and spine devices and technologies that have recently ... Onward's Arc-Ex spinal cord stimulator earned the FDA's de novo classification and U.S. market authorization. 6.
IEEE16d
An Energy-Efficient Configurable 1-D CNN-Based Multi-Lead ECG Classification Coprocessor for Wearable Cardiac Monitoring Devices
However, most of them have relatively low energy efficiency, and lack configurability in classification leads number and inference algorithm models. A multi-lead ECG coprocessor is proposed in this ...
Canada16d
Drug and medical device establishment licence fees
Instructions for filling out the medical device establishment licence application. Information includes a calculation chart for the required fees and related guidance documents.
Forbes16d
FDA’s Red Dye No. 3 Ban, Explained—What It Means For Food And Trust
Red Dye No. 3, or erythrosine, is a synthetic red food dye once popular in candies and cakes. The ... [+] FDA bans Red Dye No. 3 under the Delaney Clause, citing cancer risks observed in lab ...
ScienceAlert17d
FDA Finally Outlaws Red Food Dye Banned Around The World
Outgoing US President Joe Biden's administration on Wednesday announced a ban on Red Dye No 3, a controversial food and drug coloring long known to cause cancer in animals. Decades after scientific ...
Time17d
FDA Bans Red Dye No. 3 From Foods
Food and Drug Administration officials granted a 2022 petition filed by two dozen food safety and health advocates, who urged the agency to revoke authorization for the substance that gives some ...
PBS17d
FDA bans red dye No. 3 from foods, nearly 35 years after it was barred from cosmetics because of potential cancer risk
Food and Drug Administration officials granted a 2022 petition filed by two dozen food safety and health advocates, who urged the agency to revoke authorization for the substance that gives some ...