Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bonesupport, Corista, Glaukos, Medtronic.
The U.S. FDA’s draft guidance for selection of a predicate device in 510(k) submissions is part of a larger effort to overhaul the 510(k) program, but industry’s response is that this draft guidance goes too far.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ion Beam, CMI, Life Molecular, Rapid Medical, Xpan.
The U.K. National Institute for Health and Care Excellence is not utterly opposed to the use of mechanical thrombectomy as a treatment for pulmonary embolism, but the agency believes that the outcomes data for high-risk patients are lacking.
Artificial intelligence has morphed from a buzzword referencing a popular curiosity to a series of national security and competitiveness considerations, which was reflected in the tone of a recent hearing in the U.S. House of Representatives.
The qui tam or whistleblower lawsuit under the U.S. False Claims Act (FCA) has driven a large volume of litigation against life science companies, but three Supreme Court justices expressed misgivings about the constitutionality of the qui tam relator in the Court’s hearing of Polansky. Should a fourth Supreme Court justice harbor similar misgivings, the matter could be ripe for a hearing at the Supreme Court with the possibility that the qui tam relator would then be declared unconstitutional.
The European Union’s Artificial Intelligence Act (AI Act) is widely seen as a groundbreaking piece of legislative handiwork, but companies in the life sciences may see it as a groundbreaker with negative consequences. The latest edition of the AI Act continues to treat medical AI software as a high-risk product, which would make these products exceptionally expensive and burdensome to bring to market in the EU and convince some companies in the medical AI business to skip the European market altogether.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Belkin Vision, Cryofocus, Zimvie.
After a nine-month review, the Biden administration is preparing to go where all other U.S. administrations have refused to trod. In releasing a draft framework to help federal agencies decide whether to exercise a federal march-in on patent rights protecting taxpayer-supported drugs and other inventions, including medical devices.
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