FDA Watch: EU’s New IVD Regulations Could Drive More Firms to Seek FDA Approval
Although the timelines have been extended several times, IVDR complexity has created a concerning bottleneck in the approval process
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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.
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Dx Deals: New Premerger Regulations Could Slow Down Pace of Transactions
The new rules, which were approved by the FTC in October and will go into effect in mid-January, aim to put a damper on consolidation
Diagnostics Pipeline: Testing for Intestinal Parasites Takes Step Forward
The EasyScreen assay received 510(k) clearance from the Food and Drug Administration earlier this year–but with a catch
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
Esophageal Pre-Cancer Testing Gaining Greater Traction
How three companies are addressing screening challenges with tests that help improve chances of early detection
Dx Deals: Labcorp Acquires Stake in European Testing Giant
$152.1 million SYNLAB deal is expected to create a new channel for Labcorp to market its sophisticated specialty assays
Dx Deals: More than $62 Million Invested in Startup Labs in Recent Weeks
The rounds of funding to Clarapath, PreciseDx, and Precision Epigenomics come at a time when other M&A activity is seasonally slow
FDA Watch: FDA Moves Slowly on AI-Driven Lab Devices
The agency has approved fewer than 10 tests in the past three years, but a new pipeline of AI-powered products is expected to emerge soon
Diagnostics Pipeline: Recent FDA Approvals Aim to Make HPV Testing for Women More Accessible
Expansion of use for two assays gives patients the option to self-collect specimens at home and in the clinic, which may help address gaps in screening
FDA Watch: Could Guardant Health’s Colon Cancer Assay Be a Blockbuster?
The company is hiring at least 100 sales representatives this year to spread awareness and uptake of its recently FDA-approved Shield test
