False Claims Collections Top $1B In First Half Of Year

The US government continued its focus on False Claims Act enforcement and collected funds totaling more than $1bn in the first of this year alone – $155m of which was medtech-related. 

The government collected more than $1bn in False Claims Act settlements and penalties in the first six months of 2024, a new report from law firm Gibson Dunn found.

More from Regulation

EU Commissioner: Medtech Regulations Assessment To Wrap Up by End 2025

 

Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.

Rapid Action Required For Medtech Compliance With EU Batteries Regulation

 

As deadlines approach, the regulatory landscape for medtech batteries is set to change, with an emphasis on sustainability and ethical practices.

US FDA Should Regulate ‘Dangerous’ Prescription Software Platform As A Medical Device, Says Patient Advocacy Group

The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.

Urgent Call for Leadership In EU Medtech To Steer Through Regulatory Challenges

 

EU medtech trade associations present detailed arguments for the European Commission’s 'targeted evaluation' of medtech regulations, highlighting the need for immediate course correction.

More from Policy & Regulation

European Medicine Agency’s CHMP Qualifies First AI Tool For Use In Clinical Trials

 

With the support of AIM-MASH AI Assist only one pathologist is needed to reliably make a histology assessment of inflammatory liver disease to decide whether patients should be included in MASH clinical trials.

One Death Linked To Calyxo Urological System

 

The US FDA has issued an early alert about the CVAC system from Calyxo, which urologists use in removing urinary stones.

Urgent Call for Leadership In EU Medtech To Steer Through Regulatory Challenges

 

EU medtech trade associations present detailed arguments for the European Commission’s 'targeted evaluation' of medtech regulations, highlighting the need for immediate course correction.