Approvals

Roche Gains CE Mark for Insulin Micropump Device

Roche received a CE Mark for its Accu-Chek Solo insulin micropump system, offering tube-free delivery and personalization.

The system is made up of two parts — a semi-disposable, lightweight insulin micropump and a remote control that includes blood glucose monitoring and dosage advice.

Users can administer dosages directly from the pump or with the handheld remote and the pump can be taken off and attached without wasting insulin.

MedicalGorithmics’ Mobile Cardiac Rehabilitation System Cleared

The FDA granted 510(k) clearance for MedicalGorithmics and U.S. subsidiary Medi-Lynx Cardiac Monitoring’s PocketECG cardiac rehabilitation system.

The device is used during rehabilitation training for automated arrhythmia detection and electrocardiography (ECG) monitoring.

The device, about the size of a smartphone, monitors the heart rate and heart rhythm of patients during rehabilitation exercises to automatically detect abnormalities and arrhythmias, helping them stay aware of workout safety and intensity.

Israeli Devicemaker Cleared for Urinalysis Test

The FDA granted Healthy.io 510(k) clearance for its home-based urinalysis test Dip.io device that enables a smartphone to read urine tests.

Dip.io comes with testing cups, disposable test strips and instructions for home testing. In addition, a panel of colors and patterns allows the smartphone to read the test strip regardless of lighting.

The test kit gives immediate results for clinical-grade urine tests and does not require mailing.

Co-Diagnostics’ IVD for Tuberculosis Gets CE Mark

Co-Diagnostics received a CE Mark for its Logix Smart MTB test, an in vitro diagnostic for diagnosing tuberculosis.

Tuberculosis was listed by the World Health Organization as one of the top ten causes of death globally. The disease often shows no early symptoms, leading to late diagnosis that can prove fatal.

The company is not currently seeking FDA approval for the IVD, as the U.S. has a low domestic rate of tuberculosis incidents.

PerkinElmer Receives Clearance for Two Assays

The FDA granted 510(k) clearance for two new PerkinElmer assays developed by its Euroimmun subsidiary.

The assays screen and diagnose anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis, disorders that can be hard to diagnose.

The two assays provide reliable ANCA screening results and eliminate the need to run several analyses for each sample.

Reva’s Bioresorbable Scaffold Earns CE Mark

Reva announced that its Motiv bioresorbable scaffold received a CE Mark for treating below-the-knee peripheral artery disease.

The device is made from a proprietary polymer designed specifically for use in vascular scaffolds.

The scaffold is used for patients experiencing critical limb ischemia, a severe artery blockage of the lower extremities, and is visible under x-ray for accurate placement in the

Adherium Gains Clearance for OTC Sales of Hailie Sensor

The FDA granted additional 510(k) clearance for the Adherium digital health platform, clearing over-the-counter sales of its Hailie sensor, a device designed for use with asthma inhalers.

The sensor, previously known as Smartinhaler, attaches to a patient’s asthma or COPD inhaler to monitor and encourage consistent use, allowing patients to self-manage their asthma treatment.