Approvals

Medtronic Earns FDA Approval for Remote Patient Monitoring Pacemakers

Medtronic received FDA approval for its Azure pacemaker portfolio, which includes the Azure XT MRI and Azure S MRI.

The pacemakers allow for automatic, wireless remote monitoring, using Medtronic’s BlueSync technology, for a care provider’s evaluation of the patient’s time sheets.

BlueSync includes security controls such as access restrictions to ensure device integrity and end-to-end encryption to protect patients’ health data.

Implanted Lens for Post-Surgery Adjustment Snags FDA Approval

RxSight received the FDA’s approval for the first medical device system that allows for artificial lens adjustments post-cataract surgery with UV light-reacting material.

The system consists of the firm’s light adjustable lens and light delivery device. It was designed to eliminate the need for glasses, contact lenses or an additional surgery to address blurred vision after cataract surgery performed to replace an astigmatic patient’s natural lenses with an artificial lens. The system allows the physician to make small adjustments to the implanted lens during in-office procedures after the initial surgery.

Hologic Wins FDA Clearance for Breast Density Software

The FDA cleared Hologic’s Quantra 2.2 breast density assessment software for marketing.

The Quantra software uses an algorithm that can provide four categories of density assessments to clinicians performing routine breast cancer screenings. The device helps clinicians detect breast cancer in women with very dense breasts — who are up to five times more likely to develop the disease.

FDA Clears Medicrea’s 3D-Printed Titanium Interbody Devices

Medicrea won FDA clearance for its 3D-printed titanium interbody devices for spine surgery.

The firm’s IB3D suite allows surgeons to design patient-specific interbody devices. The custom implants are then created by the firm using 3-D printing additive manufacturing capabilities.

Biocartis Colorectal Cancer Assays Score CE Marks

Biocartis’ two liquid biopsy tests for the detection of tumor DNA mutations in patients with metastatic colorectal cancer have received CE-IVD marking.

The Idylla ctNRAS-BRAF mutation test can detect 18 NRAS and five BRAF mutations, with results in 110 minutes. The Idylla ctKRAS can detect 21 KRAS mutations with results in 130 minutes. The RAS tests, developed in collaboration with Merck KGaA, require less than a minute of hands-on time.

Butterfly Medical Earns CE Mark for Prostate Device

Tel Aviv, Isreal-based device manufacturer Butterfly Medical received a CE Mark for its novel device for non-surgical, office-based treatment of Benign Prostate Hyperplasia.

The device offers an alternative to first-line drug treatment or surgery, and the treatment can be performed in less than 10 minutes.