Arterys Receives 510(k) Clearance for Arterys Software
Arterys has received 510(k) clearance from the FDA for its software for cloud-based medical image visualization and quantification.
This clearance allows the Arterys product to be used in clinical settings for the quantification of cardiac flow, which includes 4D flow and 2D Phase Contrast workflows, and cardiac function measurements.
Arterys now plans on launching the product in the U.S. through a partnership with GE Healthcare as the ViosWorks 4D product.
Onkos Surgical Receives FDA 510(k) Clearance for Eleos Limb Salvage System
Onkos Surgical has received clearance from the FDA to market the Eleos Limb Salvage System to treat patients with significant bone loss due to cancer, trauma, or previous surgical procedures.
The Eleos system is a long-term reconstructive option for oncology patients.
Tyto Care Receives FDA Clearance
The FDA has granted 510(k) clearance for its digital stethoscope, a device that will be part of the company’s advanced set of digital examination tools.
TytoCare’s modular exam tools and telehealth platform enable a remote examination of the heart, lungs, heart rate, temperature, throat, skin and ears. Examinations can be done in real time as part of a live video telehealth visit, or in advance of a telehealth exam.
Tyto Care has presented two new products: TytoPro for clinicians to capture and share remote examination data, conduct a specialist consultation, or get a second opinion and TytoHome for consumers to use at home to connect with a clinician.
Neural Analytics Receives 510(k) Clearance for Transcranial Ultrasound System
Neural Analytics has received 510(k) clearance from the FDA for its next-generation ultrasound device, the Lucid M1 Transcranial Doppler Ultrasound System.
The device system is a battery-operated medical-grade tablet device designed to be moved easily throughout a medical facility in a range of settings that require the rapid assessment of blood flow in the brain to expedite treatment for conditions such as traumatic brain injury.
There are 2.5 million people affected by TBI each year in the U.S. and 14.8 million people affected globally.
FDA Approves IDE for Balloon Angioplasty Clinical Study
The FDA has granted staged approval for Intact Vascular’s investigational device exemption application to begin its Tack Optimized Balloon Angioplasty II BTK clinical study.
The study will examine the safety and efficacy of the tack endovascular system when used to repair dissections in the arteries below the knee following percutaneous transluminal angioplasty as a treatment for critical limb ischemia.