Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes clear the FDA sees no compelling reason to issue such a report in every instance.
As the health care industry eagerly awaits the U.K. government’s 10-year plan to transform the national health service, persistent systemic challenges may make change difficult to realize. While the deployment of AI, medical technologies and diagnostic tools are crucial to this transformation, barriers to adoption must be addressed for the plan to be successful.
Med-tech firms raising money in public or private financings, including: Calmwave, Hapbee Technologies, Icon Group, Siemens Healthineers, Varian Medical Systems.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Baylor Genetics, Casex, Circa Scientific, Dariohealth, Greenkey, Gentell, Icon, Prophase, Radiology Oncology Systems, Sensus, Siemens Healthineers.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acclaro Medical, Acera Surgical, Glaukos, Sysmex .
In recognition of the fact that diversity, equity and inclusion are necessary prerequisites for precision medicine, the European Academy of Neurology announced the launch of a DEI Hub at its 11th Congress, which is being held in Helsinki through June 24.
Ophthalmology company Polyactiva Pty Ltd closed a AU$40 million (US$25 million) series C round to advance late-stage clinical trials in the U.S. of its lead candidate, PA-5108.
Abbott Laboratories grabbed attention in early June with its announcement of a partnership with Tandem Diabetes Care Inc. to develop a multianalyte sensor for people with diabetes that would measure ketones as well as glucose.
RSS
