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Latest From Omnyx LLC
From 'Back' To 'Front': FDA, Industry Experts Advise Device Manufacturers On Best Inspection 'War Room' Practices – And Don't Forget The Swedish Fish
Ever since the first FDA inspection took place decades ago, manufacturers have relied on so-called "inspectional war rooms" – spaces where subject matter experts and others work to fulfill investigator needs – but such back rooms can cause headaches for device firms and stretch out inspections if they select unsuitable workers to staff and manage them. Larry Kopyta, a quality/regulatory VP for Omnyx, says it's vital for employees to be adequately trained on FDA inspection activities, but he notes that it's even more important to not clog up a rear room with an excessive number of workers, warning that things "can easily become out of control. You need to find a good ringmaster." Yet a back room isn't the only place manufacturers should be careful about using the right people. Present in the front room – where investigators traditionally work when onsite at a firm – should be helpful, reliable facilitators that aid investigators with requests and answer an array of questions.
Noteworthy news from medtech start-ups. This month we profile Ibris, which is developing prognostics to identify breast cancer patients in need of chemotherapy, and Delphinus Medical Technologies, whose platform enables 3-D full breast ultrasound.
Patients with aggressive estrogen receptor-positive breast cancer need chemotherapy in addition to treatment with anti-estrogen therapies. The question for physicians: how to determine how aggressive a cancer is going to be? Ibris Inc. is working to provide that information with a rapid, predictive, prognostic test that can identify ER-positive breast cancer patients requiring chemotherapy.
GE Acquires Clarient To Anchor Its Molecular IVD Business
GE is buying Clarient, which provides molecular cancer tests. It intends to make Clarient the cornerstone around which it builds out a molecular in vitro diagnostics business, combining Clarient with its own diagnostic imaging expertise to give it a full suite of triage and cancer diagnostic capabilities. In some ways, it could solve GE's long-standing issue of how to innovate in healthcare and move into high-value businesses without taking on the risks and timelines of pharma-style R&D.
Diagnostic Imaging Equipment & Supplies
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