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This article was originally published in The Gray Sheet

Executive Summary

Israeli firm will provide interactive sensor technology for incorporation into Guidant's Ancure abdominal aortic aneurysm (AAA) endograft under a Feb. 12 development and supply agreement. The sensors will allow physicians to monitor the performance of the endograft and its potential for rupture throughout the life of the patient, according to Guidant...

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Financings In Brief

Remon Medical Technologies: Waltham, Mass. concern announces close of oversubscribed $26 mil. Series C financing, which will help expand U.S. presence of its wireless, intra-body communication technology for use in therapeutic products. First-time investors in the financing round include Guidant, Triathlon Medical Ventures and Medica Venture Partners. Guidant previously incorporated Remon's interactive sensor technology into its Ancure abdominal aortic aneurysm endograft (1"The Gray Sheet" Feb. 18, 2002, In Brief). Other major Remon financiers include Polaris Venture Partners, Concord Ventures, Lilly Ventures, KBL Healthcare Ventures and Ofer Hi-Tech. The privately held firm intends to commercialize its communication technology through a mixture of internal efforts and external strategic collaborations. Remon is now conducting clinical trials of its Impressure device, which offers an on-demand, non-invasive way to monitor intra-aneurysm pressures after endograft procedures. The firm's HeartLook device for measuring pulmonary artery pressure is also under investigation...

QUOTED. 22 January 2020. Steve Niedelman.

Steve Niedelman of the law firm King & Spalding gave manufacturers a few words of advice when prepping their so-called front rooms, where US FDA investigators do the majority of their work during facility inspections. See what he said here.

FDA’s Follow-Up Sunscreen Trial Shows More Of The Same: Absorption Of All Tested UV Filters

The FDA emphasizes that findings from its second, more extensive clinical study on the absorption potential of sunscreen active ingredients are not in themselves signals that the UV filters are unsafe. However, they portend heavy work ahead for industry if the ingredients are to remain GRASE and available for use in OTC sunscreen drug products stateside.  



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