FDA Clears DL Precise One-Click Segmentation & Measurement Tool Delivers Consistent Precision in All Medical Imaging Modalities

The FDA has granted 510(k) clearance for DeepLook, Inc.’s DL Precise, a one-click software tool to automate segmentation and measurement of suspicious objects across all medical imaging modalities, delivering critical improvements in workflow and reporting precision.

 

While imaging technology has advanced profoundly, radiologists still routinely use mouse-driven calipers to estimate the size of suspicious objects – and variability continues to undermine the results.  Moreover, manual measurement is tedious and time-consuming, requiring multiple mouse clicks and drags, hundreds of times each day.  Consistent, accurate measurement is essential to assess growth or reduction of suspicious objects over time, a recurring need in both clinical and research settings.

DL Precise’s entry into the emerging marketplace for a consistent measurement tool with its deterministic algorithm helps ensure reliable performance for today’s workflow demands.  The company’s future decision-support and diagnostic products will leverage this core technology to offer key radiomic metrics and enhance AI/machine learning applications.  At the same time, DeepLook’s vivid color enhancement helps radiologists visually assess the software’s quantification.

While other measurement products are trained on particular imaging modalities, organs or types of nodules, DeepLook’s patented technology applies to any medical image – a universal utility for mammography, ultrasound, CT and MRI.  DL Precise’s automated data can feed directly into structured reports, allowing for easy comparisons even across acquisition modalities – for instance, comparing mammograms to supplemental ultrasound images.

DL Precise is an affordable plug-in utility that works on any DICOM image and in all 510(k)-cleared viewers.  Integration with PACS partners is simple, adapted to each viewer interface.  End users can master the mechanics in minutes.  DL Precise has successfully completed its first integration with the mammography workstation of Three Palm Software, a respected industry innovator.

For a brief video illustrating DL Precise’s ease-of-use, visit https://www.deeplookmedical.com/dl-precise.

Hot this week

Recor Medical Supports European Society of Cardiology’s Hypertension Guidelines

Record Medical notes the new guidelines, "2024 ESC Guidelines for the management of elevated blood pressure and hypertension," have been published online and recommend the consideration of renal denervation (RDN) as a safe and effective treatment option for patients who have uncontrolled resistant hypertension or those that have uncontrolled hypertension with a higher risk of cardiovascular disease, who express a preference to undergo RDN.

ConTIPI Medical Selects EVERSANA to Support U.S. Commercialization of Non-Surgical Medical Device ProVate for Women with Pelvic Organ Prolapse

EVERSANA is a leading provider of global commercial services to the life sciences industry, to support commercialization for the ProVate device in the United States to help women experiencing pelvic organ prolapse.

Boston Scientific Obtains CE Mark for ACURATE Prime Aortic Valve System

The ACURATE Prime aortic valve system is designed with several features to build upon the clinical performance of the ACURATE neo2™ platform including an additional valve size, which expands the treatment range to patients with a larger anatomy.

Noctrix Health Announces New CMS Reimbursement Codes and Payment for Nidra Tonic Motor Activation Therapy for Restless Legs Syndrome

Nidra TOMAC Tonic Motor Activation Therapy, which was authorized for marketing in the United States last year following its designation as a "Breakthrough Device" by the US Food & Drug Administration (FDA), remains the only clinically validated, non-pharmaceutical treatment available for patients with RLS.

Haemonetics Announces Full Market Release for VASCADE MVP® XL Vascular Closure System

Haemonetics notes the VASCADE MVP XL system is now available to U.S. hospitals as the newest addition to Haemonetics' VASCADE® portfolio of vascular closure systems featuring an innovative collapsible disc technology and a proprietary resorbable collagen patch designed to promote rapid hemostasis.