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

FDA approval of Optune Lua follows the Phase 3 LUNAR trial, showing significant improvement in median overall survival for metastatic NSCLC patients.

As chief medical officer, Foley is expected to guide the clinical direction of True Digital Surgery and the advancement of its Digital Surgical Exoscope Platform.

The app will work alongside prescription drug treatment Flexilev.

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

Multiple studies show that an adaptive deep brain stimulation system reduced symptoms associated with Parkinson disease by 50%.

The acquisition of Ypsomed’s pen needles and blood glucose monitoring system is expected to increase MTD’s production capacity to over 2.5 billion units.

Partnership with Abbott for Simplera CGM will expand access to the advanced automated insulin delivery.

Velys recently received 510(k) clearance from the FDA for planning and instrumenting spinal fusion procedures across the cervical, thoracolumbar, and sacroiliac spine.

Ouva’s AI-powered technology will be added to AvaSure’s digital platform.

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

Empara’s virtual assistant is the latest attempt to use AI to simplify the user experience in the healthcare industry.

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.

The company announced updates to its software to focus on this issue.

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

According to the manufacturer, the LFR-260 features advanced technology that allows patients to compare multiple prescriptions simultaneously, eliminating the need for traditional refraction methods.

Becton, Dickinson, and Company will acquire Edwards Lifesciences’ Critical Care Product Group for $4.2 billion in cash to expand its own smart connected care solutions.

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

The catheters approved by the FDA include the Plato 17, a DMSO-compatible microcatheter, and the Socrates 38, an aspiration catheter specifically designed for treating ischemic strokes.

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

Technology designed to effectively address blood clots by combining capabilities of larger devices with smaller catheters.

Capital also expected to assist the advancement of Evergreen's radiopharmaceutical discovery pipeline into clinical trials.

Decree comes amid the FDA’s 2021 inspection of Philips’ Murrysville facility and the subsequent voluntary recall of its sleep and respiratory care devices.

The concussion test, which shows results after 15 minutes, can help evaluate patients up to 24 hours after injury, company says.

Evolut FX+ transcatheter aortic valve replacement system design includes a larger coronary access window through a modified frame.

Spinoff seeks to aid pharmaceutical companies in accelerating early clinical development programs.

AI-powered radiology solutions can be used with both chest x-rays and breast cancer detection.

The CGM system is for adults over the age of 18 years who do not use insulin, such as individuals with T2D who use oral medications, a US population of 25 million.

The agency teamed up with the software company to develop platforms and networks to collect de-identified data.