Posted inMedical Technology
FDA slams ExThera with warning letter over controversial blood filter device
The FDA slammed ExThera with a warning letter for deviating from the regulatory agency’s guidelines by promoting and selling its…
Posted inMedical Technology
Thermo Fisher unveils test to aid in dosing of antirejection drug
Thermo Fisher Scientific is launching a new test it says can help doctors avoid the “trial-and-error” approach typically used to…
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Quantum Surgical snaps up J&J’s NeuWave Medical for its microwave ablation technology
Quantum Surgical is looking to become the “leader in the interventional radiology industry” with its buyout of Johnson & Johnson’s…
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Medtronic’s diabetes business MiniMed eyes $784M IPO
Less than a year after announcing the spinout of its diabetes division, Medtronic says it is seeking $784 million in…
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Labcorp, PathAI expand partnership to offer AI tech for digital pathology diagnostics
Labcorp expanded its partnership with PathAI to offer its FDA-cleared digital pathology platform at the life science giant’s U.S. network…
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Organon pays $27.5M upfront to license Sebela’s hormone-free copper IUD
Women’s-health-focused pharma Organon is grabbing exclusive global licensing rights to Sebela Pharmaceuticals’ newly approved hormone-free copper intrauterine device in a…
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Allurion stock balloons as FDA signs off on its weight loss gastric system
Allurion saw its shares jump roughly 60% on Monday, Feb. 23, as the FDA signed off on the medtech’s premarket…
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FDA issues safety alert on Trividia blood glucose monitors
The FDA is flagging a high-risk issue with blood glucose monitors manufactured by Trividia Health that the company says is tied…
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Mainz Biomed looks to shed ColoAlert, shifts focus in US
Mainz Biomed, maker of the ColoAlert test, inked a private placement deal for $6 million and is looking to shed…
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Grail stock craters as key NHS-Galleri trial fails to hit primary endpoint
Grail’s shares plummeted more than 45% after-hours Thursday as the medtech revealed a major National Health Service (NHS) trial of…