News

MedTech Dive6h
A judge blocked the FDA’s plan to regulate LDTs. What now?
Attorneys say the FDA is unlikely to challenge the court’s decision, though Congress could still look to modernize lab test ...
JD Supra1h
Addressing Data Integrity Challenges in Medical Device Submissions
The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...
As FDA slashes workforce, number of new medical devices reaching the public has fallen
U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low ...
STAT2d
FDA plans to phase out animal testing in drugs in what it calls a ‘paradigm shift’
The move comes after lawmakers sought to force the agency to update regulations that would allow alternatives to animal ...
When AI In Medical Devices Evolves Faster Than Regulations: How Do We Keep Up?
The question is not whether AI will transform healthcare; it’s whether regulators can keep pace with that transformation.
MassDevice1d
EBR wins FDA nod for leadless pacing system
EBR designed its WiSE system to significantly expand the population of patients who could benefit from CRT. The leadless ...
FDA reverses course on telework after layoffs and resignations threaten basic operations
The Food and Drug Administration is reversing course on its requirement for all staffers to report to the office.
National Law Review5d
District Court Strikes Down FDA’s LDT Rule, Opens the Door for Challenges to FDA’s Regulation of Other “Services” as Medical Devices
On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s ...
National Law Review1d
Post‑Chevron Spotlight: Federal Court Nixes FDA Rule Reclassifying Laboratory Services as Medical Devices
In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court ...
Judge foils FDA plan to regulate lab-developed tests
The FDA finalized a rule to oversee lab-developed tests as if they were medical devices, prompting lawsuits. Opponents said ...
Medical Xpress7d
As FDA slashes workforce, number of new medical devices reaching the public has fallen
U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as sources say recent layoffs have had ...