Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abionyx, Clearpoint,Cortechs, Irras, Neurogen Sebia, Paradromics, Philips, Picard, Syncardia, Tasso.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Spryte Medical.
The U.K. Medicines and Healthcare products Regulatory Agency is calling for unified standards to harmonize microbiome research, after revealing major inconsistencies in the results when labs around the world analyzed identical reference samples of gut bacteria.
A new oral HER2-directed breast cancer therapy from Bayer AG, and its companion diagnostic from Thermo Fisher Scientific Inc., have been approved by the U.S. FDA. Hyrnuo (sevabertinib), a reversible tyrosine kinase inhibitor, was greenlit by the agency for adults with locally advanced or metastatic non-squamous advanced HER2-mutant non-small-cell lung cancer.
Abbott Laboratories made plans to enter the cancer screening market with its reported acquisition of Exact Sciences Corp. The deal will pay Exact Sciences shareholders $105 per share in cash, a nearly 50% premium to Exact’s unaffected share price on Nov. 19. That represents a total equity value of approximately $21 billion and an estimated enterprise value of $23 billion.
Solventum Corp. continued its restructuring with a second significant acquisition this year, the proposed purchase of privately held Acera Surgical Inc. for $725 million in cash plus up to $125 in contingent cash payments based on achievement of specified milestones. St. Louis.-based Acera projected that its synthetic wound care products will bring in $90 million in sales this year.
Archeon Medical SAS reported data from a study showing its real-time ventilation feedback device Eolife increased the survival rates of patients suffering out‑of‑hospital cardiac arrests. Furthermore, all the survivors in the Eolife group achieved full neurological recovery, three times the rate observed with conventional ventilation.
The resolution of the budget impasse between Democrats and Republicans on Capitol Hill sidestepped a number of problems, including some cuts to Medicare payment rates for clinical laboratory testing services. However, that pause is only in effect through the end of January 2026, leaving operators of these labs with a fiscal sword of Damocles to manage.
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