Despite FDA's efforts to centralize CLIA waiver reviews and bring more consistency to the process, one reform group tied to the diagnostics industry says the agency is not addressing the real problem: the fundamental standard for a waiver determination that FDA established in a 2008 guidance.
US FDA's process for reviewing test-waiver applications under the Clinical Laboratory Improvement Amendments (CLIA) is set to undergo enhancements based on a draft user-fee reauthorization agreement.
In the deal that was inked last month, the agency says it will establish a centralized management group for CLIA...
Ahead of the ADA conference, Abbott announced Tandem as the fourth partner to integrate Abbott’s dual glucose-ketone sensor with automated insulin delivery. Expanded Medicare CGM coverage, FDA label expansions and new ADA guidelines position Abbott to grow its CGM footprint in a competitive market.
The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
Cecilia Lindgren, Aneira Health’s co-founder and chief science officer, said that the company has “redesigned the diagnostic model.” The subscription-based platform offers clinical-grade and AI diagnostics alongside clinical consultation.
The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.
With a test platform designed to mirror the biological diversity of cancer, Harbinger Health is moving beyond traditional performance measures to introduce cancer-specific sensitivity and “intrinsic accuracy” as cornerstones of its clinical narrative.
Eko hopes its new partnership with Boehringer Ingelheim to develop algorithms for accurately detecting heart murmurs in dogs will pave the way for more collaborations with medical and pharmaceutical companies to advance early detection in humans as well as animals.
