U.S. FDA approves Supernus' drug-device combination for Parkinson's disease
The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals' drug-device combination to treat ...
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 ...
aha.org2d
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 ...
TCTMD2d
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 approves wearable infusion device for advanced Parkinson disease
The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only ...
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.
Sierra Sun Times1d
FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices
FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible ...
Monthly Prescribing Reference4d
FDA: Diabetes Device Alerts May Be Missed Due to Smartphone Settings
Health care providers are urged to inform patients to periodically check their smartphone settings and to confirm that they are able to receive alerts.
The Taipei Times7d
‘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 ...
Acrivon Therapeutics Announces FDA has Granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Endometrial Cancer
The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in Acrivon’s ongoing, registrational-intent, multicenter Phase 2b trial of ACR-368 in ...
Beckman Coulter Receives FDA Breakthrough Device Designation for Alzheimer's Disease Blood Test
Beckman Coulter Diagnostics, a global leader in clinical diagnostics, today announced the U.S. Food and Drug Administration ...