Five months after raising $45 million, Lunaphore Technologies SA reported its consent to be acquired by Bio-Techne Corp., a reagents and instruments manufacturer for the diagnostic market. This acquisition by the Nasdaq-listed bio-tech giant, “will enable us to begin a worldwide commercial rollout of our products and automated spatial biology technology,” Ata Tuna Ciftlik, co-founder and CEO of Lunaphore Technologies, told BioWorld. The amount of the transaction was not disclosed. This acquisition is expected to close in the third quarter of 2023. Read More
Parasym Ltd.’s neuromodulation technology significantly decreased postural tachycardia syndrome (POTS) and has the potential to be a safe and effective treatment for individuals living with the condition, according to a recent study. The result from the trial represents a substantial breakthrough for people with POTS, as there are no U.S. FDA approved treatments for the condition, Nathan Dundovic, co-founder at Parasym, told BioWorld. Read More
Device makers are often cited in U.S. FDA warning letters for making claims not seen in the approved labeling, but the authors of a recent review of artificial intelligence (AI) products cleared by the FDA suggest that FDA documents and marketing materials should disclose the presence of AI in these products. The authors of an article in the Journal of the American Medical Association said that only about 80.6% of the products were represented with accurate statements about the presence of AI, although FDA regulation does not require that marketing materials make such disclosures. Read More
South African Rugby and the U.S. National Football League (NFL) are actively studying ways to more quickly and reliably diagnose concussions and find more effective treatment for their sequelae. Researchers at the University of Birmingham and Marker Diagnostics Ltd. have identified a biomarker that signals a concussion has occurred, while a team at Electrocore Inc. is working with the NFL to address post-concussion headaches. Read More
Theralase Technologies Inc. has pioneered technology said to selectively infiltrate and kill non-muscle invasive bladder cancer (NMIBC) at the cellular level. Bladder cancer generally is the 10th most common cancer in the world (6th in men and 17th in women), and gradually showing up in greater numbers in other patient groups. Read More
The U.S. FDA’s draft guidance for patient-matched guides for orthopedic surgical implants is presumably a much-needed document for makers of these guides, and bench testing may suffice for many such applications. However, the draft states that clinical testing may be required when a manufacturer intends to claim that their guides could reduce surgical times. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Broncus, Coloplast, Kerecis, Koru Medical, Owlet, Pentax Medical, Sequana Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Changzhou Biowin, Getinge, Motive Health, Shineco. Read More
