Approvals

PeraHealth Receives Clearance for Clinical Surveillance Technology

The FDA granted PeraHealth 510(k) clearance for PeraTrend, its clinical surveillance technology.

The real-time, predictive technology utilizes the Rothman Index to leverage data within a hospital’s electronic records to quantify and visualize patient risks, improvements and deterioration.

The index it utilizes uses a range of physiological measures, such as labs, vital signs and nursing assessments, to continuously measure a patient’s condition.

Nextremity Solutions Cleared for Lapidus Procedure System

The FDA granted clearance for Nextremity Solutions to market its InCore Lapidus system.

The device is used to stabilize and correct multi-planar deformities while giving visibility for the surgeon’s preferred joint preparation during Lapidus procedures.

It is indicated as a three-part construct meant for internal fixation for First Metatarsocuneiform Arthrodesis (Lapidus or Tarsometatarsal Fusion), and has an application pending for a CE Mark.

BrainsWay Granted Clearance for Deep TMS Stimulator

The FDA awarded BrainsWay 510(k) clearance for its new stimulator, which will be integrated into the BrainsWay deep transcranial magnetic stimulation system for treating major depressive disorder.

The device is designed for use with the company’s proprietary H-Coil helmet in treating MDD. It includes new features that increase physician ease of use and improve energy efficiency.

The stimulator also provides a patient management system with a depression treatment protocol and a tool for motor threshold detection.

Stryker Wins Expanded CE Mark for Stent Retriever

Stryker won an expanded CE Mark for its Trevo stent retriever, a thrombectomy device used as a front-line treatment for acute ischemic stroke.

The expanded indication increases the previously cleared treatment window by 18 hours to 24 hours, following a similar action by the FDA in February.

Clinical trial data showed that patients treated with the Trevo Retriever in the six- to 24-hour window were almost four times as likely to be functionally independent at 90 days post stroke.

CardioFocus Gains Approval for Excalibur Balloon

The FDA granted CardioFocus’ HeartLight Excalibur balloon approval for treating paroxysmal atrial fibrillation.

The device optimizes the magnitude and speed of target tissue contact during pulmonary vein isolation procedures. It also allows users to make real-time adjustments to the balloon’s size.

FDA Clears OrthoPediatrics’ Pediatric Nailing Platform

OrthoPediatrics’ received 510(k) clearance for its pediatric nailing platform, its 25th surgical system cleared by the FDA.

OrthoPediatrics markets systems for pediatric trauma and deformity, scoliosis and sports medicine, among other orthopedic procedures.

The new platform will allow surgeons to treat a wider range of pathologies, the company said.

BacterioScan Cleared for UTI Infection Detection System

The FDA granted 510(k) clearance for BacterioScan’s rapid infection detection system, an automated diagnostic system approved for detecting urinary tract infections.

Current UTI testing is a manual culturing process that can require 2 days or more for results. BacterioScan’s system can detect UTIs in a matter of hours with a laser sensor that reduces lab turnaround time.

CurveBeam Wins 510(k) Clearance for Weight Bearing CT System

CurveBeam received FDA 510(k) marketing clearance for its LineUP multi-extremity weight bearing CT system.

The system allows radiologists and orthopedic specialists to visualize three-dimensional bone detail of the lower extremities while the patient is standing so they can assess the anatomy in the weight-bearing position. The LineUP can perform bilateral scans of legs from below the heel to above the knee and accessories enable scanning of hands, wrists and elbows.

Caliber Imaging & Diagnostics Gets 510(k) Clearance for Improved VIVASCOPE

Caliber Imaging & Diagnostics won 510(k) clearance from the FDA for modifications to its VIVASCOPE imaging system, a microscopy tool that allows dermatologists to non-invasively visualize cellular structures in the skin.

The system uses a low-powered laser to provide high-resolution images of the epidermis in thin, optical slices.