The Taipei Times11d
‘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 may not be resold, the Food and Drug Administration (FDA) said yesterday.
JD Supra10d
How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
TCTMD6d
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 ...
Monthly Prescribing Reference9d
FDA: Diabetes Device Alerts May Be Missed Due to Smartphone Settings
the settings within the mobile medical app connected to the diabetes device must be configured correctly with the settings within the smartphone itself. To mitigate this issue, the FDA is ...
Local 12 WKRC Cincinnati8d
FDA clears migraine device for children as young as 8
There, she was treated with an armband device made by Theranica, sold under the brand name Nerivio. The device was recently cleared by the FDA for use ... is covered by medical insurance plans.
Indiatimes6d
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. Issues arise from software configuration, hardware ...
FDA clears Outset Medical of previous warning issues
Inc. (NASDAQ:OM), a medical technology company focused on innovating dialysis treatment, has resolved all concerns raised in a Warning Letter from the U.S. Food and Drug Administration (FDA) dating ...
The American Journal of Managed Care10d
FDA Approves First Subcutaneous Apomorphine Device for Parkinson Disease
Onapgo, a subcutaneous apomorphine infusion device, is approved for advanced Parkinson's disease, offering continuous symptom management without surgery. The TOLEDO trial showed apomorphine ...
Yahoo Finance9d
Acrivon Therapeutics Announces FDA has Granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Endometrial Cancer
The designation reflects the FDA’s determination that the device is reasonably expected to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating ...
Forbes14d
2025 Medical Device Cybersecurity Trends: What Will Shape The Industry?
The future of medical devices has much potential, but they also have risks related to cybersecurity. In 2024, we saw the first full year of the Food and Drug Administration’s (FDA) new guidance ...
Business Wire3d
Reprieve Cardiovascular Builds Clinical Momentum with Positive Results from FASTR Pilot Trial and FDA Investigational Device Exemption Approval for Pivotal Trial
Reprieve Cardiovascular, Inc., a development-stage company focused on advancing acute decompensated heart failure (ADHF) ...
FierceBiotech28d
FDA's device chief calls for more authority to address supply chain shortages impacting pediatric, neonatal patients
While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are having greater impacts on the smallest patients—including in neonatal ...