Welcome to Medpoint, LLC, a leading domestic and international consulting firm for Quality Assurance, Regulatory and Clinical Affairs. We have over 50 of the most highly qualified consultants working all levels of projects in Medical Device, Biotech, and Pharmaceutical in over 90 countries.
Our clients span the spectrum from start-up to Fortune 20 and look to us for short-term or long-term expertise in the following areas:
Boston Scientific Corp. (NYSE:BSX) will pay Johnson & Johnson (NYSE:JNJ) $1.725 billion to settle a quartet of patent infringement lawsuits concerning the companies’ lines of cardiovascular stents.
The Natick, Mass.-based medical devices monolith agreed to the settlement, which calls for it to pay J&J $1 billion today and the rest in about a year, said it [...]
In a significant development for congenital heart disease patients, Medtronic, Inc. (NYSE: MDT), announced today that its Melody® Transcatheter Pulmonary Valve has received U.S. Food and Drug Administration (FDA) approval under a Humanitarian Device Exemption (HDE). This innovative medical device is the first transcatheter heart valve to receive FDA approval.
Delivered through a catheter requiring only [...]
The Food & Drug Administration is asking Congress to foot its $4.03 billion bill to overhaul its own operations and increase its scrutiny of the medical device, pharmaceutical, food and tobacco industries.
As it lays out its ambitious plans for fiscal 2011 and beyond, the federal watchdog agency wants a 23 percent boost to its annual [...]
Diagnostic Hybrids, a leading developer of in vitro diagnostic fluorescent staining kits and cell culture products, announces the U.S. Food and Drug Administration (FDA) (510k) clearance of its D3 FastPointTM L-DFATM RSV/MPV Identification Kit, which allows for the identification of respiratory syncytial virus and human metapneumovirus from a patient’s specimen in under 25 minutes. The [...]
Continue reading »MediSens Wireless, a startup company in UCLA’s on-campus technology incubator at the California NanoSystems Institute, has obtained approval under federal Food and Drug Administration guidelines to begin clinical trials on its novel wireless body-monitoring system, which assesses muscle and neuromotor functions in the upper extremities.
The Clinical Movement Assessment System (CMAS) is designed for a wide [...]
