Stereotaxis Inc. recently received CE mark recertification for all its devices currently available in Europe under the new Medical Device Regulation (MDR) regulatory framework. The MDR has replaced the European Medical Device Directive and includes more stringent standards but meeting the new requirements comes with frustrations and costs for many companies.
Despite U.S. NIH policy and its peer-review grant process, providing for inclusive enrollment in phase III NIH-funded clinical trials seems to be a check-the-box exercise for many researchers. In a review of a sample of phase III NIH-funded trials conducted between 2016 and 2020, the Health and Human Services Office of Inspector General found that two-thirds had the required inclusive enrollment plans, but 57% of the trial plans provided no explanation or rationale for the enrollment targets.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Comar.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akili, B-Secur, Evotec, Exero, Fire1, Head Diagnostics, Innovheart, NH Theraguix, Virtual Therapeutics.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Echonous, Fastwave Medical, Moleculight, Preludedx, Sherlock, Skylinedx.
Dornier Medtech launched a first-of-its-kind artificial intelligence tool called Urogpt to support patients with kidney stones. Developed in collaboration with leading urologists, Urogpt marks a milestone in the company's commitment to leveraging digital innovation to empower kidney stone sufferers through patient-first solutions. The app provides urology patients with access to on-demand advice and actionable insights that inform and reassure users when navigating the complexities of their condition.
Urteste S.A. has developed a urine-based diagnostic test for the early detection of brain tumors. The prototype, which can detect the activity of brain-specific enzymes in urine, is a breakthrough test and the first solution of this type in the world, Grzegorz Stefański, CEO and co-founder of Urteste S.A., told BioWorld.
The European Council formally approved another delay for the In Vitro Diagnostic Regulation
implementation, which now gives developers of existing high-risk in vitro diagnostics until December 2027 to obtain a renewed CE mark.
The problem of counterfeit devices has perplexed the U.S. FDA for some time, given that the agency had previously been forced to send the illicit products back to the originator, only to see the same devices reenter the U.S.
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