Billiontoone Inc.’s Northstar Select comprehensive genomic profiling liquid biopsy assay identified more treatable variants than other tumor profiling platforms in a study published in The Journal of Liquid Biopsy. Notably, the test found clinically actionable alterations substantially below the limit of detection for other tests.Read More
Ciliatech SAS received CE certification under the Medical Device Regulation for its Intercil Uveal Spacer, a surgical implant developed to treat glaucoma. The cilio-scleral inter-positioning device lowers intraocular pressure without penetrating the anterior chamber, marking the arrival of a new treatment option for glaucoma patients. Read More
Iantrek Inc. reported the close of a $42 million series C financing round, which it said will facilitate the U.S. commercial launch of its Alloflo Uveo, a bio-interventional ophthalmic surgery solution targeting the lightly used uveoscleral pathway, as well as broader pipeline expansion. Read More
The U.S. FDA’s draft guidance for package labeling recommendations for hernia mesh products did not draw a large volume of comments, but the Medical Device Manufacturers Association advised the agency that the information disclosed on package labels should be limited as the package is often too small to provide adequate readable information. Read More
The U.S. FDA’s Aug. 11, 2025, warning letter to LeMaitre Vascular Inc. discloses that the agency was troubled by what it saw as problems with sterility-related processes used to manufacture the Artegraft device, findings that could complicate relations between the company and its customers. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arctx, Simbiosys Inc., Ricoh, Shemed, Tasso. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ciliatech, Neusoft. Read More
