FDA urged to drop proposed rule change for Laboratory Developed Tests
A Salt Lake City Laboratory has urged to FDA to reverse course on its decision citing research that argues it will lead to a negative impact on patients.
30 November 2023
30 November 2023
A Salt Lake City Laboratory has urged to FDA to reverse course on its decision citing research that argues it will lead to a negative impact on patients.
The FDA-approved 3D-printed bone graft has made its clinical debut in jaw surgeries performed in the US and Germany.
Synaptive Medical debuts its Modus X robotic exoscope in Europe with the first installation in Italy.
The strategic partnership between Thermo Fisher Scientific and Flagship Pioneering will focus on creating platform companies to power the biotech ecosystem and accelerate the development of first-in-class therapies.
The FDA has received multiple reports of thermal issues with Philips Respironics' DreamStation 2 CPAP machines for obstructive sleep apnoea.
Damage to the device during manufacturing means the connector might detach, stopping insulin delivery and possibly causing hypoglycaemia.
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The rising number of older individuals globally is accompanied by increasing health concerns, presenting unique demand for the medical device industry. With rising pressure on governments, payers, and manufacturers to reduce healthcare costs, innovative medical technologies have tremendous potential to improve elder care. Advancements in medical device technology have resulted in a significant increase in the number of conditions that can be managed in a home care setting. To capitalize on this strong demand and growth, manufacturers are increasingly producing consumer-targeted equipment.
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