Surmodics Inc. reported plans to be acquired by private equity firm Golder, Thoma, Cressey, Rauner Inc. for $43 a share for a total equity valuation of approximately $627 million. The per-share acquisition price represents a 41.1% premium to Surmodics’ 30-trading day volume-weighted average closing price through May 28, 2024. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Echonous, Fastwave Medical, Moleculight, Preludedx, Sherlock, Skylinedx. Read More
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. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Comar. Read More
