Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Airiver Medical, Association of Medical Device Reprocessors, Bioporto, Catheter Precision, Johnson & Johnson, Positron, Roche.
Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab).
New research has filled in missing links between gene variants that have been implicated in disease through genome-wide association studies and how the variants drive disease pathology. The research involved using induced pluripotent stem cells derived from healthy donors and transforming them into macrophages. These were then exposed to 24 different stimuli mimicking infection and inflammation, and the gene expression profiles assessed six and 24 hours later, to see which genes were turned on or off in response.
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.
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.
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.
The U.S. FDA’s draft guidance for package labeling recommendations for hernia mesh products did not draw a large volume of comments, but the Medical Device Manufacturers Association advised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.
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.
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