Regulation

Tarver takes over the lead role at CDRH after serving as interim director since July.

The TensWave is designed to provide user-friendly pain relief, complementing Zynex’s NexWave electrotherapy device.

Clearance of the NeuroLF Brain PET system marks Positrigo’s first device of its kind to be approved in the United States.

Approval of the Mynx Control Venous vascular closure device was based on results from the ReliaSeal trial, which demonstrated 100% procedural and device success in cardiac ablation procedures.

Cordella is the first pulmonary artery pressure-guided platform indicated for home-based comprehensive heart failure patient management.

Both systems are over-the-counter products that provide continuous glucose monitoring.

Roche’s human papillomavirus solution is reportedly one of the first of its kind to be available in the United States.

Treatment marks the first dissolving stent approved in the United States for treating chronic limb-threatening ischemia in arteries below the knee.

Osteoboost is the first non-pharmacological therapy approved to treat low bone density in postmenopausal women.

Biologics license application filed for 89Zr-DFO-girentuximab (TLX250-CDx; Zircaix), a PET imaging agent for clear cell renal cell carcinoma.

The Elecsys NfL test is designed to aid in detecting disease activity and to offer insights in disease management for patients with multiple sclerosis.

The agency differentiates between software that has a notable impact on the effectiveness and safety of drug use.

The device provides surgeons with GPS-like guidance.

The MARS platform combines magnets and machinery.

The device, developed by magAssist, is an interventional ventricular assistance device.

Session at DIA discusses the International Medical Device Regulators Forum (IMDRF), its importance and how harmonization could be improved by harmonization.

Product liability issues can be costly to companies that aren’t prepared for them.

Medical devices regulation in the EU call for products to be monitored for their safety and not rely on complaints.

Medical IP’s software analyzes bone, muscle, fat, organs, and the central nervous system.

The two C-Path executives discuss how the organization works to translate new research into marketable treatments.

Culjat discusses how the FDA is considering regulations for certain types of mobile apps and software.

Representatives from regulatory authorities of the countries of Malaysia, Australia and South Korea discussed their respective challenges in the “International Drug-Device Combinations Session” at DIA Europe 2023.

New interactive tool, other resources help use regulatory strategy to drive successful business strategy for digital medical product development

Fiscal year 2024 budget includes improvements to medical device supply and shortage issues that negatively impact patients

COPD digital app can now be prescribed by medical providers in Germany and will be covered by statutory health insurance.

Trial will compare patients that undergo cardiac radioablation with Varian's CRA system vs. standard-of-care catheter ablation.

The joint pilot will test the use of a single eSTAR, an interactive form that guides applicants through the process of preparing FDA medical device submissions.

The hope is to build a formal framework for using digital health technology in clinical trials in Europe and beyond.