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.
The American Clinical Laboratory Association has followed through on its promise to file suit against the U.S. FDA over the agency’s final rule for lab-developed tests. The lawsuit will be heard in the U.S. District Court for the Eastern District of Texas, which is also the venue for litigation against another federal government agency, the Federal Trade Commission, suggesting that litigants expect a favorable review of their case in this court.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beckman Coulter, Vuze Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Canary Medical, Cancer Check Labs, Mannkind, Pulmatrix, Surmodics.
A little over two months after the granting of its very first patent which described computer-based systems for diagnosing psoriasis, Belletorus Corp. welcomed the publication of two continuation-in-part child filings on similar such systems for the diagnosis of eczema and determining the severity of skin diseases such as psoriasis, eczema and skin cancer.
The European Association for Medical Devices of Notified Bodies has issued its survey of member NBs for 2023, which includes data that suggest a diminishing appetite for inspections under the Medical Device Single Audit Program. However, the more concerning metric is that the gap between applications for new or renewed medical devices and the number of completed applications continues to widen, a gap that stood at nearly 10,000 such applications at the end of calendar year 2023.