The U.K. Medicines and Health Care Products Regulatory Agency posted a draft guidance on the use of real-world evidence to serve as a control arm for clinical trials.
The recent emphasis on eliminating animal studies for preclinical studies of U.S. FDA-regulated products amplifies a long-standing concern, but the U.S. Government Accountability Office raised the question of whether organ-on-a-chip methods are ready to fill the gap.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apreo Health, Ischemaview, Route 92 Medical, Vapotherm, Zoll Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akoya, Konica Minolta Healthcare, Medithinq, Newvue, Philips, Quanterix, Quipt, Sinopharm, Virtuoso.
Medtronic plc revealed plans to spin off its underperforming diabetes unit as a separate public company during its fourth quarter 2025 earnings call on May 21. The company expects to complete the separation within 18 months.
Shockwave Medical Inc., a unit of Johnson & Johnson Medtech, reported positive 30-day results from the EMPOWER CAD trial, which used its intravascular lithotripsy system in women with complex, calcified coronary artery disease. The results from the first prospective, real-world percutaneous coronary intervention study in female patients confirmed the benefit of coronary patients as seen in other retrospective analyses.
Galvanize Therapeutics Inc.’s Aliya pulsed electrical field system could enable surgeons to perform a biopsy and ablate lung tumors at the same time, a study in the Journal of Surgical Oncology indicates.
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