Search results
FDA brings lab tests under federal oversight in bid to improve accuracy and safety
WSB-TV 2 Atlanta· 5 days agoWASHINGTON — (AP) — Makers of medical tests that have long escaped government oversight will have...
FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In...
JD Supra· 2 days agoOn April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests ...
Can the 4 Medical Device Stocks Hit Targets This Earnings Season?
Zacks via Yahoo Finance· 4 days agoMedical Device companies' quarterly results are likely to reflect strength in customer demand. Let's...
Medtronic bags FDA approval for Inceptiv spinal cord stimulator
Medical Device Network via Yahoo Finance· 5 days agoElsewhere in the field of spinal cord stimulation, the US-based XStim has similarly received...
FDA Dataset Helps Firms Scrutinize Third-Party Chemistry Labs | JD Supra
JD Supra· 5 days agoMedical devices that contact the human body undergo biocompatibility safety assessments prior to market release, including tests for physiochemical properties ...
MMI pioneers Symani Surgical System in first US cases
Clinical Trials Arena via Yahoo Finance· 1 day agoThe first two US...conducted at Penn Medicine, Penn PresbyterianMedical Center. Surgeons performed a...
Inspira Technologies begins production of ART100 device By Investing.com
Investing.com· 2 days agoThe first batch of INSPIRA ART100 devices is currently under production and will be deployed to...
Tens of thousands of medical tests to now fall under federal oversight
The Hill via AOL· 5 days agoThe Food and Drug Administration (FDA) is revising long-standing rules to place laboratory tests...
FDA Once Again Stands Athwart Biomedical Innovation, Yelling 'Stop!'
Reason.com via Yahoo News· 5 days agoInterestingly, most of the thousands of current LDTs must be OK since the new FDA rules grandfather...
FDA brings lab tests under federal oversight in bid to improve accuracy and safety
San Francisco Chronicle· 5 days agoMakers of medical tests that have long escaped government oversight will have about four years to...