Approvals

Shape Memory’s Embolic Coil Grabs CE Mark

Shape Memory Medical has received the CE Mark for its TrelliX embolic coil system, a device that obstructs or occlude blood flow in vascular abnormalities.

The device’s indications include intracranial aneurysms and other neurovascular abnormalities, including arteriovenous malformations and embolizations in the peripheral vasculature.

The company claims the coil is “a game-changing product, particularly for medium to giant aneurysms, that may offer significant advantages in neurovascular and peripheral vasculature applications.”

Solasia Pharma’s Episil Pain Relief Device Approved in Korea

South Korea’s National Institute of Medical Device Safety Information has approved Solasia Pharma’s pain relief device, a product that delivers episil oral liquid for creating a protective film over oral wounds.

The pocket-sized medical device is indicated for managing and relieving oral cavity pain resulting from chemotherapy or radiotherapy. The device has already been cleared in the U.S., the EU, Japan and China.

According to clinical results, episil quickly provides oral pain relief and physical protection that lasts up to eight hours.

FDA Clears AI Reconstruction Tech for Canon Medical’s CT Scanner

The FDA granted Canon Medical’s ultra-high resolution CT system 510(k) clearance for its Advanced Intelligent Clear-IQ Engine (AiCE).

The company’s Aquilion Precision and Aquilion ONE / Genesis edition computed tomography systems use a deep learning algorithm to separate the signal from noise, suppress noise and enhance signal.

The Aquilion Precision uses deep learning neural networks “specifically trained to perform one task — reconstruct images that are sharp, clear, and distinct,” the company said.

Cortechs’ Brain Disorder Monitor Snags Brazilian Clearance

Cortechs Labs received regulatory clearance in Brazil for its NeuroQuant neurodegenerative brain disorder monitor.

The device software helps to diagnose and monitor neurodegenerative brain disorders using magnetic resonance imaging. In five to seven minutes, the results are available for review in picture archiving and communication systems.

NeuroQuant produces volumetric measurements of a patient’s brain structure and compares the measurements to a normative database that adjusts for gender, age and intracranial volume.

The software was previously cleared in the U.S., EU, Canada, Australia and South Korea.

Fidmi Earns FDA Clearance for Enteral Feeding Device

Fidmi Medical received 510(k) clearance for its low-profile enteral feeding device, a gastronomy tube designed to deliver nutrients to patients.

The device can be used for initial placement as well as replacement and features an inner tube that is easily replaceable by patients at home, eliminating the need to visit healthcare facilities for replacement procedures.

The company noted that complications from gastronomy tubes are common and tube replacements are often necessary due to clogging and dislodgements.

Philips Earns FDA Approval for Low-Dose Drug-Coated Balloons

The FDA approved Royal Philips’ two new Stellarex 0.035” low-dose drug-coated balloons for peripheral artery disease patients.

The 150mm and 200mm balloons have the agency’s go-ahead for treating de novo and restenotic narrowing in two upper leg arteries, the native superficial femoral or popliteal arteries.

The approval broadens the available options for physicians treating peripheral artery disease patients with a high risk of recurrent narrowing of an artery previously cleared with a stent or angioplasty.