Device, drug makers seek tariff exemptions
Makers of drugs and medical devices say the tariffs on goods from Canada, Mexico and China could have an outsized impact on ...
FDA issues most serious type of recall for oxygen concentrators spontaneously bursting into flames
A line of oxygen concentrators from a China-based medical equipment company have apparently been spontaneously busting into ...
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FDA notifies veterinarians of animal burn risk linked to human medical devices
Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...
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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FDA warns of potential to miss notifications on smartphone-compatible diabetes devices
The Food and Drug Administration Feb. 5 released an alert notifying patients of a safety concern using diabetes devices such ...
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FDA Warns About Diabetes Device Smartphone Alert Settings
The US Food and Drug Administration (FDA) is cautioning patients and caregivers about the potential for not receiving blood ...
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FDA Issues Early Alert About Risks of Peripheral Atherectomy Device
Fractures and breakages of the helix on the Rotarex system has led to 30 serious injuries, four deaths, and 115 interventions ...
FDA clears migraine device for children as young as 8
A device long used by adults to manage migraines was now available for children as young as eight years old, offering new ...
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‘Medical devices’ cannot be resold, the FDA says
Some products bought in pharmacies, including tampons and adhesive bandages, are listed as “medical devices” in Taiwan and ...
Are smartphone diabetes devices putting lives in danger? US FDA sounds alarm
The US FDA warns users of smartphone-linked diabetes devices like CGMs and insulin pumps of potential health risks due to missed critical alerts. Issu ...
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Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
Backdoor uncovered in China-made patient monitors — Contec CMS8000 raises questions about healthcare device security
The CISA and FDA have released security warnings about the Contec CMS8000, which is used for patient monitoring.