The U.S. FDA’s device center posted a report on the TAP program, stating that the metrics available to date suggest the program is a rousing success. Still, there are a few key indicators that have not yet had time to emerge – such as product approvals and clearances, but those data points won’t emerge for another year or two at the inside.
New hires and promotions in the med-tech industry, including: Cyrex Medical, Cleveland Diagnostics, Nucleic AI, Pixelgen, Prollenium, Qiagen, Quibim, Voxcell.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bluejay Diagnostics, Burl Concepts, Imagine Devices, Neotech, Robocath, Siemens Healthineers.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abanza, Outset Medical, Spine Innovation.
In a lawsuit that’s been bouncing through the courts for years, the U.S. Court of Appeals for the District of Columbia once again cleared the way for several biopharma and medical device companies to potentially be held liable, under the Anti-Terrorism Act, for terrorist attacks against hundreds of Americans in Iraq.
Medtronic plc's Sphere-360 secured a CE mark – the second catheter in its Affera PFA franchise – as it announced completion of the first cases in its investigational device exemption HORIZON trial for the Sphere-360 in the U.S. The device is indicated for treatment of paroxysmal atrial fibrillation (AF), an intermittent erratic heartbeat that can progress to persistent AF. Atrial fibrillation affects more than 10.5 million people in the U.S. and 60 million globally.
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