Approvals

FDA Approves Abbott’s Premie Heart Opening Treatment

The FDA approved Abbott’s Amplatzer Piccolo occlude, a device that can be implanted in babies weighing as little as two pounds to treat patent ductus arteriosus.

The minimally-invasive device, which is smaller than a pea, is able to treat the life-threatening opening between two blood vessels leading from the heart that can occur, most often in babies born prematurely.

The self-expanding, wire mesh device is inserted in the baby via a small insertion in the leg and directed through vessels to the heart, where it is placed to seal the opening.

Gramercy’s Nitinol Staple System Cleared by FDA

Gramercy Extremity Orthopedics received FDA clearance for its Nitinol staple system for treating bone-related conditions.

The staple system is cleared to fixate osteotomies and small bone fragments. It’s also cleared for joint fusion surgery.

The device provides an array of sterile symmetric and asymmetric, barbed and smooth nitinol staples that come in various widths and lengths.

IschemaView Gains Expanded Clearance for Neuroimager

The FDA handed medical imaging developer IschemaView expanded clearance for its Rapid neuroimaging platform.

The imaging platform is intended for use in selecting stroke patients that are expected to benefit from endovascular thrombectomy, which treats strokes by pulling blood clots out of arteries.

FDA Clears Immuno Concepts’ Rodent Tissue Slides

The FDA granted 510(k) clearance for Immuno Concepts’ Histofluor rodent liver, kidney and spleen tissue slides.

The rodent tissue slides are available in both mouse and rat substrates, and all components come ready-to-use.

The slides can be used manually or with Immuno Concepts’ Image Navigator device, an automated microscope that can capture multiple images and assemble them into a panoramic view.

FDA Approves Teva’s Digital Inhaler

Teva’s ProAir Digihale, a digital inhaler device that works in conjunction with a mobile app, has been approved by the FDA.

The device, which has sensors built in that detect device use and measure respiratory flow, connects to a mobile application and provides inhaler use information for patients with asthma and COPD.

The inhaler is indicated to treat or prevent bronchospasms in patients aged four years or older with obstructive airway disease, and to prevent exercise-induced bronchospasms in patients of the same age.

Edwards Lifesciences’ Heart Valve Approved

The FDA approved Edwards Lifesciences’ SAPIEN 3 Ultra, a heart valve used in transcatheter aortic valve replacements.

The system is intended for severe, symptomatic aortic stenosis patients found to be at intermediate or greater risk of needing open-heart surgery.

The valve includes technological enhancements and a new delivery system that builds on the previous SAPIEN 3 units.

Japan Clears Foundation Medicine’s Genomic Profiling Assay

Japan’s Ministry of Health, Labor and Welfare approved Foundation Medicine’s FoundationOne CDx genomic profiling assay.

The sequencing-based assay can detect substitutions, insertion and deletion alterations and copy number alterations in 324 genes, and is able to detect genomic signatures such as the tumor mutations in DNA.

The assay, which received FDA approval in 2017, can also select gene rearrangements that have been found to spur cancer growth.

Bedsore Scanner Receives Marketing Authorization From FDA

The FDA granted Bruin Biometrics marketing clearance for its SEM Scanner, a wireless device for assessing patients at higher risk of pressure ulcers.

The scanner can identify specific areas of the patient’s body that are at increased risk of pressure damage.