FDA Approves Johnson & Johnson’s VARIPULSE Pulsed Field Ablation Platform for AFib
The approval is based on results from the admIRE study, which showed 100% of atrial fibrillation patients achieved acute procedural success.
Dermasensor, a handheld AI device, can help physicians screen for skin cancer
Dermatologist Rebecca Hartman, MD, MPH, explains how DermaSensor is designed to scan and assess skin lesions to aid cancer screening efforts.
Michelle Tarver named new FDA device chief
Tarver takes over the lead role at CDRH after serving as interim director since July.
FDA approves Novocure’s Optune Lua, a wearable device to disrupt lung cancer cells
FDA approval of Optune Lua follows the Phase 3 LUNAR trial, showing significant improvement in median overall survival for metastatic NSCLC patients.
True Digital Surgery Appoints Kevin T. Foley as Chief Medical Officer
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.
Alex Therapeutics and Navamedic Partner For Companion App for Parkinson’s Treatment
The app will work alongside prescription drug treatment Flexilev.
FDA Clears Zynex’s TensWave for Transcutaneous Electrical Nerve Stimulation Therapy
The TensWave is designed to provide user-friendly pain relief, complementing Zynex’s NexWave electrotherapy device.
Research Highlights Key Advancements in Implementing Adaptive Deep Brain Stimulation for Parkinson Disease
Multiple studies show that an adaptive deep brain stimulation system reduced symptoms associated with Parkinson disease by 50%.
MTD Group Acquires Ypsomed's Pen Needles, Blood Glucose Monitoring Systems
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.
FDA Approves Medtronic’s Simplera Continuous Glucose Monitor, Announces Partnership with Abbott
Partnership with Abbott for Simplera CGM will expand access to the advanced automated insulin delivery.
Johnson & Johnson MedTech Launches Velys Active Robotic-Assisted System for Planning, Instrumenting Spinal Fusion Procedures
Velys recently received 510(k) clearance from the FDA for planning and instrumenting spinal fusion procedures across the cervical, thoracolumbar, and sacroiliac spine.
AvaSure Acquires Ouva and Adds Smart Room Solutions to its Platform
Ouva’s AI-powered technology will be added to AvaSure’s digital platform.
FDA Clears Positrigo’s NeuroLF Brain PET System for the Diagnosis of Multiple Brain Disorders
Clearance of the NeuroLF Brain PET system marks Positrigo’s first device of its kind to be approved in the United States.
AI-Controlled Virtual Assistant Announced for Digital Health Network for Self-Funded Healthcare Plans
Empara’s virtual assistant is the latest attempt to use AI to simplify the user experience in the healthcare industry.
FDA Approves Cordis’ Vascular Closure Device for Cardiac Ablation Procedures
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.
FDA Grants Premarket Approval to Endotronix’s Cordella Pulmonary Artery Sensor System to Support Patients with Heart Failure
Cordella is the first pulmonary artery pressure-guided platform indicated for home-based comprehensive heart failure patient management.
Aidoc AI Software Used to Reduce Missed Follow Up Appointments
The company announced updates to its software to focus on this issue.
FDA Clears Two Abbott Glucose Monitoring Systems
Both systems are over-the-counter products that provide continuous glucose monitoring.
Evolution Optiks Receives FDA 510(k) Clearance for LFR-260 as the First Light Field Powered Subjective Tele-Fractor
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.
BD Acquires Edwards Lifesciences Critical Care Product Group to Bolster Monitoring Technology
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.
FDA Approves Roche’s HPV Self-Collection Solution, Allowing Patients to Gather Their Own Samples in a Healthcare Setting
Roche’s human papillomavirus solution is reportedly one of the first of its kind to be available in the United States.
FDA Approves Two of Scientia Vascular’s Neurovascular Catheters
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.
FDA Approves Abbott’s Dissolving Stent System for Chronic Limb-Threatening Ischemia in Arteries Below the Knee
Treatment marks the first dissolving stent approved in the United States for treating chronic limb-threatening ischemia in arteries below the knee.
Expanse Ice Receives FDA 510(k) Clearance for ICE Aspiration System for Peripheral Arterial, Venous Systems
Technology designed to effectively address blood clots by combining capabilities of larger devices with smaller catheters.
Evergreen Theragnostics Raises $26M in Capital to Aid Commercialization Efforts for the Ga-68 DOTATOC Diagnostic Kit
Capital also expected to assist the advancement of Evergreen's radiopharmaceutical discovery pipeline into clinical trials.
Philips Respironics Finalizes Consent Decree Regarding Business Operations in the US with Department of Justice, FDA
Decree comes amid the FDA’s 2021 inspection of Philips’ Murrysville facility and the subsequent voluntary recall of its sleep and respiratory care devices.
FDA Approves Abbott’s i-STAT TBI Whole Blood Rapid Test to Assess Patients for Concussions at Bedside
The concussion test, which shows results after 15 minutes, can help evaluate patients up to 24 hours after injury, company says.
FDA Approves Evolut TAVR System, Medtronic’s Treatment for Symptomatic Severe Aortic Stenosis
Evolut FX+ transcatheter aortic valve replacement system design includes a larger coronary access window through a modified frame.
TNO Launches Peregrion, Aiming to Increase Market Presence of Accelerated Biomedical Mass Spectrometry Technology
Spinoff seeks to aid pharmaceutical companies in accelerating early clinical development programs.
Use of AI Screening Tool for Cancer Expands Globally
AI-powered radiology solutions can be used with both chest x-rays and breast cancer detection.
