Medical Device News
Latest industry news, regulatory updates, and announcements from trusted sources.
Reshoring prompts crucial decisions for medical device manufacturers
For medical device manufacturers, reshoring has been discussed for years. Now, many are putting it into action and hitting familiar capacity challenges along the way.
Read Full Article →RunStar introduces new wireless blood pressure monitor
RunStar has launched a tube-free upper-arm device, the LoopGo Wireless BP-202, to expand its domestic medical monitoring portfolio. The post RunStar introduces new wireless blood pressure monitor appe…
Read Full Article →FDA clears Coreline Soft’s AVIEW Aorta Metrics software
Coreline Soft has secured 510(k) clearance from the US FDA for its aortic quantitative analysis tool, AVIEW Aorta Metrics. The post FDA clears Coreline Soft’s AVIEW Aorta Metrics software appeared fir…
Read Full Article →Developers, not doctors, should be held accountable for generative AI medical devices, providers say
Provider groups are lobbying the Food and Drug Administration to make tech companies responsible for the safety and performance of generative AI-backed medical devices, arguing the tools’ makers are b…
Read Full Article →Qiagen agrees to private equity takeover
EQT Private Equity has agreed to pay about $12.1 billion, including debt, for the diagnostics company, which has long been the subject of takeover speculation.
Read Full Article →Edwards wins FDA approval for tricuspid valve repair device
Edwards’ approval should “strengthen the company’s position in the large and underpenetrated transcatheter tricuspid market,” analysts said.
Read Full Article →GE HealthCare’s SOFIE deal deepens a complicated relationship with Lantheus
GE HealthCare’s planned $945m acquisition of SOFIE Biosciences has been read as a move to protect supply for Flyrcado, its cardiac PET agent The post GE HealthCare’s SOFIE deal deepens a complicated r…
Read Full Article →FDA grants breakthrough device status to Teleflex’s coronary scaffold
Teleflex has received breakthrough device designation from the FDA for its Freesolve RMS, designed for use in PCI. The post FDA grants breakthrough device status to Teleflex’s coronary scaffold appear…
Read Full Article →Medtronic reports real-world findings for cardiac ablation systems
Medtronic has reported positive real-world registry findings for its cardiac ablation technologies in patients treated for AFib and VT. The post Medtronic reports real-world findings for cardiac ablat…
Read Full Article →Quest Diagnostics hit by cyberattack
The testing company believes an unauthorized third party accessed patient records.
Read Full Article →