Approvals

Edwards Lifesciences Granted De Novo Request for Acumen HPI Software

The FDA granted Edwards Lifesciences its De Novo request for the company’s Acumen hypotension prediction index (HPI) software, technology that uses predictive analytics to indicate the presence of potential low blood pressure before it occurs in surgical patients.

The Acumen HPI uses software algorithms to assess cardiovascular vital signs and predict future cardiovascular status. The HPI feature is part of the Edwards Accumen intelligent decision-support software suite and is used with the minimally invasive FloTrac IQ sensor.

Harmonus’ ProBx Software Granted 510(k) Clearance

The FDA gave Harmonus’ ProBx software 510(k) clearance for use in MRI-guided prostate interventions.

The software targets and confirms suspicious lesions and creates a detailed record of sampling locations, allowing the doctor to monitor the lesions and treat them.

It is attached to an MRI console and receives digital images that can be displayed in 2D and 3D.

Iridex Probe Earns CE Mark

Iridex’s G-Probe Illuminate was cleared for marketing in Europe, offering both transillumination and laser fiber for targeted transscleral cyclophotocoagulation (CPC).

It is the company’s third probe powered by the CYCLO G6 glaucoma laser system, and features built-in transillumination that optimizes the probe’s placement. The device helps physicians deliver more targeted laser treatment.

Advantis’ Cloud-Based Neuroimaging Software Receives CE Mark

Advantis received a CE Mark for its Brainance MD cloud-based neuroimaging software used for advanced processing of brain magnetic resonance images.

The software analyzes various types of images including diffusion tensor imaging, dynamic susceptibility contrast perfusion and functional MRI, in an integrated user environment.

Brainance is accessible from a web browser and supports collaborative analysis. It is compatible with picture archiving and communication (PAC) systems and the digital imaging and communications in medicine (DICOM) standard.

FDA Gives Life Spine Clearance for Plateau-Lo

Life Spine received 510(k) clearance for its Plateau-Lo insert and rotate spacer system, used for micro-invasive lumbar interbody fusions.

The product combines with the company’s AVATAR percutaneous screw system and its CENTRIC-T pedicle-based retractor system for use in micro-invasive procedures.

Plateau-Lo features an aggressive tooth pattern that prevents graft migration, a bullet tip for simple insertion, and large, open graft windows to contain bone grafts and maximize visibility.

Balt USA’s Optima Coil System Granted 510(k) Clearance

The FDA granted Balt USA 510(k) clearance for its Optima coil system, a product used in the treatment of aneurysms.

The system consists of a coil, pusher and instantaneous thermal detachment system, and has moved to full market release in Europe and a limited market release in the U.S.

The Optima provides physicians a soft coiling and rapid detachment system to help treat complex aneurysms.

Additional Clearance Awarded to Cook Medical Endomicroscopy System

The FDA granted further 510(k) clearance to Cook Medical’s Cellvizio confocal laser endomicroscopy (CLE).

The probe-based CLE system uses laser scanning technology to create real-time images of internal tissue microstructure.

The new indication allows the product to be used for in vivo imaging of the internal microstructure of tissues, helping urologists identify cells, vessels and their architectures during endoscopic procedures.

Agendia’s MammaPrint BluePrint Kit Obtains CE Mark

Irvine, California-based Agendia received a CE Mark for its next-generation sequencing-based MammaPrint BluePrint breast cancer recurrence and molecular subtyping kit.

MammaPrint analyzes 70 genes most connected with breast cancer recurrence to determine a low or high risk of cancer recurrence result, while BluePrint analyzes 80 genes which classify a patient’s breast cancer into functional molecular subtypes.

The device can aid physicians in personalizing treatment management for patients by identifying early-stage breast cancer in women that is at a genomic low or high risk for distant metastasis within five years.

Longhorn Vaccines and Diagnostics’ PrimeStore Cleared by FDA

The FDA granted 510(k) clearance for Longhorn Vaccine’s PrimeStore molecular transport medium, designed to inactivate pathogens and stabilize RNA and DNA for downstream molecular testing and characterization.

PrimeStore is used for stabilization, transportation and inactivation of infectious unprocessed nasal washes thought to contain influenza A virus RNA. It is also intended to do the same for infectious unprocessed sputum samples thought to contain Mycobacterium tuberculosis DNA from human samples.

The molecular transport device can accelerate efforts to identify and control seasonal, pandemic and endemic diseases like influenza and M. tuberculosis.

Orthofix Wins 510(k) Clearance for G-Beam Fusion Beaming System

The FDA gave Orthofix’s G-Beam fusion beaming system clearance for the treatment of the debilitating condition Charcot foot where bones in the foot weaken and collapse.

The G-Beam devices can be implanted in the affected foot’s medial and lateral columns to give alignment, stabilization and fixation.