Approvals

Avatera Nabs CE Mark for Robotic Laparoscopy Device

Avatera has received the CE Mark for its Avatera system, a robotic device used to perform minimally invasive laparoscopy procedures.

The device consists of two components: a surgical robot with four arms used to control an endoscope and Avatera instruments, and a control unit containing manual input devices, foot switches and an eyepiece.

The system employs a single-use concept for instruments and sterile accessories, removing the risk of cross-contamination.

Axonics Earns FDA Premarket Approval for Sacral Neuromodulation Device

Axonics has obtained the FDA’s premarket approval for its sacral neuromodulation system for treating overactive bladder and urinary retention.

The implantable, rechargeable device is the first of its kind to be approved by the FDA, and the only sacral neuromodulation device greenlit for full-body MRI scans without removal.

With the agency’s decision, patients receiving an MRI scan anywhere below the head can avoid additional surgery, as they no longer need to have their neurostimulator removed before they undergo the scan.

FDA Clears Ultromics’ AI-Powered EchoGo

Ultromics has received 510(k) clearance from the FDA for its AI-powered technology, EchoGo, which assists in the measurement of heart functions, including automated cardiac strain.

The technology automatically analyzes ultrasound-based heart scans to calculate cardiac strain. It is the first AI application cleared for that use. EchoGo also measures left ventricular ejection fraction and left ventricular volumes.

Hologic’s Breast Cancer Imaging Technology Cleared

Hologic’s 3DQuorum Imaging Technology received 510(k) clearance from the FDA. The technology lowers the number of 3D images needed in reviews of breast cancer.

The technology, powered by Hologic’s artificial intelligence analytics system, reconstructs high resolution 3D data to make six millimeter “SmartSlice” images, helping physicians to more quickly identify areas of interest in breast cancer patients.

Using Hologic’s 3DQuorum, radiologists require only one third of the 3D images they normally require during review, the company said.

Sky Medical’s Geco Device Cleared for Marketing

UK-based Sky Medical Technology received 510(k) clearance from the FDA for its geko device for stimulation of the calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism (VTE).

The device was previously cleared for immediate post-surgical stimulation of calf muscles to prevent VTE, increasing blood circulation and edema reduction.

The geko is a battery powered, wearable device the size of a wristwatch and worn at the knee. It stimulates the common peroneal nerve activating the calf and foot muscle pumps, resulting in increased blood flow in the deep veins of the calf.

Paige Earns CE Mark for Prostate Cancer Detection Solution

Paige has earned the CE Mark for the Paige Prostate, a first-in-class prostate cancer detection solution, along with the Paige Insight, its AI-based digital pathology viewer.

The vendor neutral products allow pathologists to view and collaborate on digitized slides from different sites and scanners. The Paige Prostate provides clinical grade accuracy, with equivalent performance in images taken with multiple scanners and on slides prepared at hundreds of institutions.

Pathology practices around the world have begun to embrace digital pathology to “realize the potential of the technology with real-time quality assurance, gains in productivity, and improved collaboration across sites,” said Paige CEO Leo Grady.

Biocept’s Sample Collection Kit Earns CE Mark

Biocept has received the CE Mark for its CEE-Sure blood collection tube and sample collection shipping kit.

The collection tube is designed to keep blood samples from coagulating and to protect cells, allowing samples to be transported without refrigeration or special shipping conditions.

The product offers the ability to preserve and ship specimens containing circulating tumor cells, circulating tumor DNA, and circulating tumor RNA for use in oncology and prenatal diagnostics, as well as other molecular testing.