The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Medtronic advises of problems with Interstim leads; Palmetto eyes coverage of CT for cerebral perfusion.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Bio-Techne, Foldax, Foundation Medicine, Helix, Kantaro, Perkinelmer, Siemens Healthineers, Theranica.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeglea, Bayer, Bioinvent, Bioxcel, Forte, Janssen, Nicox, Nitric Oxide Innovations, Passage, Santen, Sesen, Spectrum, Tracon, Y-mabs.
The latest global regulatory news, changes and updates affecting biopharma, including: MOU to help with compounding oversight; MHRA advises on MA transition; CMS delays date for radiation oncology bundle; NRC issues advisory letter to INIS.
Aidoc Inc., a provider of artificial intelligence (AI) solutions in radiology, has won U.S. FDA clearance to market the first software solution for flagging and triaging incidental pulmonary embolism (PE). The AI technology, which includes triaging and notification algorithms, is an “always on” technology that analyzes chest CT scans in real time and alerts the radiologist to any potentially abnormal findings – possibly speeding up diagnosis by hours.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Nuclear Regulatory Commission issues advisory letter to INIS; HHS authorizes pharmacy interns to test for COVID-19.
Drug and medical device manufacturers have several compliance matters to deal with under the False Claims Act (FCA), only one of which is the Anti-Kickback Statute (AKS). Nonetheless, the AKS might be a good area for members of industry to emphasize, given that it accounted for the vast majority of federal enforcement actions in fiscal year (FY) 2019, according to a new report by Gibson, Dunn & Crutcher LLP.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascendis, Astrazeneca, Evgen, Kezar.
Patient engagement is increasingly the order of the day in the device development process as the U.S. FDA has made clear, a consideration that drove the Oct. 22 FDA advisory hearing. A patient representative said patients want to take part as early as possible in the development process for software as a medical device (SaMD), and Pat Baird, director of global software standards for Royal Pillips NV, said industry is very much open to ideas about bringing the patient perspective on board earlier in that process.
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