The use of organoids in preclinical research has reached a tipping point, with U.S. FDA approval of the first drug to enter clinical trials on the basis of efficacy data derived only from these advanced cell models.
The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities include security in a health care facility’s network.
The U.S. Department of Justice (DOJ) has filed a complaint in civil court against Fresenius Vascular Care Inc., of Berwyn, Pa., alleging the company had performed unnecessary procedures in nine clinics in the New York area. When paired with a recent Supreme Court case that went against Davita Inc., of Denver, this action may signal a source of pressure on dialysis services in the U.S., a set of developments that have already cost both these companies significantly on the stock market.
Venus Medtech (Hangzhou) Inc. received the green light in China for its transcatheter pulmonic valve replacement (TPVR) system Venusp-Valve. It is a self-expanding TPVR product for the treatment of severe pulmonary regurgitation (≥3+) in patients after a congenital heart defects procedure with native right ventricular outflow tract.
Reflexion Medical Inc. entered into a nonexclusive worldwide licensing agreement with Mirada Medical Ltd., allowing Mirada’s Redengine image registration algorithms to be integrated into Reflexion’s X1 treatment planning software. The algorithms align a patient’s anatomy between distinct imaging modalities or between radiotherapy treatments.
Xilis Inc. added $19 million to its series A financing round, bringing the total amount raised to over $89 million. FPV Ventures led the extension, with participation from Alexandria Venture Investments and EQT Life Sciences, Mubadala Capital Management, Pear Ventures, GV, the Duke Angel Network, Catalio Capital Management, Two Sigma Ventures, Felicis Ventures and Alix Ventures.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Centinel Spine, Onkos Surgical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Basecare Medical, Empirical Spine, Haier Biomedical, Northwest Pathology, Reliance Medical Systems.
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