FDA’s Breakthrough Designation Now Includes Health Equity Provision
Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions
Author Information
Ron Shinkman
Ron Shinkman is a veteran journalist and editor, with more than 20 years of experience in the healthcare business realm. He served as Los Angeles bureau chief of Modern Healthcare, and also wrote for the Los Angeles and Orange County Business Journals.
Posts by the Author
Dx Deals: Collaboration Takes Psoriasis Testing to New Level
Partnership between Mindera and PBM aims to optimize treatment matches for the disorder, as some drugs cost nearly six figures annually
FDA Watch: A New Blood Test for Accurate Alzheimer’s Detection
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan
Diagnostics Pipeline: FDA Tweaks Quality System Regs to Align with Global Standards
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
FDA Watch: New Test for Esophageal Conditions is Coming to the US
UK-developed assay that uses a sponge appears to reduce the need for more invasive endoscopies.
Dx Deals: Quest and Labcorp Move beyond Laboratory Testing
Both companies have made recent moves to diversify further.
Diagnostics Pipeline: More AI-Reliant Platforms Being Approved by the FDA
Such assays rely more on imaging and computer power than tissue samples to make diagnoses.
FDA Watch: New BD Collection System Uses Just Tiny Amounts of Blood
Whether the MiniDraw™ device dredges up memories of Theranos’ failed tech remains to be seen.
Dx Deals Roundup: Pact Aims to Improve Prostate Cancer Detection Among Hispanic Males
More aggressive use of artificial intelligence may mitigate issues that lead to the uneven impact of the disease on this group.
Recent FDA Approvals Show Growing Sophistication of At-Home Tests
Once confined to areas such as pregnancy testing, these assays can now be used to detect STIs and other health issues.
