Medical Innovation Exchange

diagnostics

Veranex Acquires Fusion Biotec

Veranex Acquires Fusion Biotec     Global, tech-enabled service provider to the MedTech industry Veranex has acquired Fusion Biotec, a design and engineering firm for complex electro-mechanical diagnostic instrumentation and medical devices located in Orange, California. Fusion boasts a 15,000-square-foot facility in Orange, California, and an in-house team of more than 45 engineering experts, who largely serve …

Veranex Acquires Fusion Biotec Read More »

Lace To Helm New RQM+ Reimbursement Division

Lace To Helm New RQM+ Reimbursement Division     RQM+, a global MedTech regulatory and quality service provider, has launched a reimbursement division to provide its clients with reimbursement services, in addition to regulatory, quality, clinical and laboratory services, throughout the medical device and diagnostics product lifecycle. Daniel Lace, MD, will lead the new division and …

Lace To Helm New RQM+ Reimbursement Division Read More »

WHO Convenes Panel to Identify Priority Pathogens for Research and Oversight 

WHO Convenes Panel to Identify Priority Pathogens for Research and Oversight      The World Health Organization (WHO) announced that it is launching a global scientific process to update the list of priority pathogens to guide global investment, research and development of vaccines, tests and treatments. The process began on November 18 with a meeting of …

WHO Convenes Panel to Identify Priority Pathogens for Research and Oversight  Read More »

The Real Impact of IVDR on Clinical Evidence Requirements

The Real Impact of IVDR on Clinical Evidence Requirements     For many manufacturers of IVD devices now on the European market, meeting the evidence required of the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will require tremendous work. With the shortage of notified bodies and resources, numerous outstanding guidance questions, as well as …

The Real Impact of IVDR on Clinical Evidence Requirements Read More »

American Health Care Has a Diagnostics Problem

American Health Care Has a Diagnostics Problem     As everyone knows, America has among the world’s highest healthcare costs, spending $4.1 trillion per year—about $12,500 per person, or three times the OECD average. But another aspect of our health system gets far less attention: our focus on reactive treatment instead of proactive diagnostic and preventive …

American Health Care Has a Diagnostics Problem Read More »