Approvals

FDA Clears Smart Watch for Epilepsy Management

Massachusetts-based devicemaker Empatica obtained FDA 510(k) clearance for its Embrace smart watch intended to aid patients with epilepsy management.

The wearable device uses machine learning technology to monitor patients to detect dangerous, convulsive seizures and alert caregivers. It also monitors sleep, rest, and physical activity.

Masimo Gets CE Mark for Heart Disease Screening App

Masimo, a Switzerland-based global developer of health monitoring technologies, received a CE Mark for its critical congenital heart disease newborn screening application called Eve.

The new mark allows for Eve to be used in the EU with the company’s Rad-97 Pulse CO-Oximeter device.

The application features an automated synchronization algorithm designed to reduce calculation errors and it provides visual instructions, animations, and an easy-to interpret display of screening results.

Orthofix Snags FDA Nod for Expandable Spine Fusion System

The FDA cleared Orthofix International’s Forza XP expandable spacer spinal fusion system.

The system is indicated for posterior or transforaminal lumbar interbody fusion procedures for patients with degenerative disc disease. It enables surgeons to place bone graft material inside the device after implantation.

FDA Approves RadioGenix System for Key Medical Isotope in Diagnostic Imaging

NorthStar Medical Radioisotopes received FDA approval for its RadioGenix System indicated for producing technetium-99m, the most widely used radioisotope in medical imaging.

The Tc-99m diagnostic agent is intended to aid clinicians in diagnosing ailments, such as coronary artery disease and cancer, by producing images of internal organs and evaluating their function.

The new technology was “the result of a broad collaboration across the federal government and industry, and has the potential to benefit many patients as well as restore the U.S. ability to domestically supply a critical medical diagnostic tool for the first time in 30 years,” said FDA Commissioner Scott Gottlieb.

“Because the imaging agent has a limited shelf life, a stable supply chain is critical,” he said.

Canon Medical Imaging System Snags Expanded Clearance

Canon Medical Systems received expanded 510(k) clearance for new neuro and cardiac MR imaging capabilities on its Vantage Galan 3T XGO Edition.

The system’s expanded capabilities were designed to provide higher resolution brain diffusion weighted imaging with “up to 30 percent improved signal-to-noise ratio,” the devicemaker said.

It is also features the company’s MultiBanD SPEEDER technology for faster image sampling.

Naviswiss Miniature Hip Navigation Unit Snags CE Mark

Switzerland-based medical technology company Naviswiss received a CE Mark for its Total Hip Replacement THR miniaturized handheld navigation unit.

The navigation system is designed to aid orthopedic surgeons in implanting artificial joints with greater accuracy to reduce time and costs of surgical procedures.

According to Naviswiss, the system provides surgeons “cup alignment, leg length and offset.”

FDA Approves Expanded IDE Program for Skin Regeneration Device

Regenerative Medicine Company AVITA Medical received FDA approval to increase the number of patients by 20 who can receive treatment with its skin regeneration medical device under the agency’s Compassionate Use Investigational Device Exemption program.

This is the fifth expansion the FDA has approved for this program, bringing the total number of patients who may be treated with the RECELL Autologous Cell Harvesting Device to 88.

FDA Approves Becton Dickinson HPV Assay

The FDA granted premarket approval to Becton Dickinson for its BD Onclarity HPV assay.

The assay is performed on the company’s molecular platform for automated sample processing for the detection of high-risk HPV using samples from cervical cancer screening using the BD SurePath liquid-based cytology vial.

Viz.AI Scores FDA Nod for Stroke Care App

San Francisco-based healthcare company Viz.AI received FDA marketing authorization for its stroke care ContactCT application.

The software device provides clinical decision support using deep learning algorithms to automatically analyze CT neuro images for the detection of indicators associated with stroke.

It also notifies clinicians when a potential stroke is identified in their patients, enabling direct-to-intervention care. The company obtained a CE Mark for ContactCT just last month.