Approvals

Medtronic Clinician Programmer for Implantable Pump Wins FDA Approval

The FDA approved Medtronic’s clinician programmer for use with its SynchroMed II intrathecal drug delivery implantable pump.

The pump is intended for treating chronic pain and severe muscle spasticity by delivering medications directly to the fluid surrounding a patient’s spinal cord.

The clinician programmer application provides visual tools, such as flex dosing graphics, and guided workflows, with the goal of simplifying treatment management. It can be used on a tablet.

FDA Clears Masimo Pulse Oximeter Device

The FDA cleared Masimo’s Rad-97 Pulse CO-Oximeter device for home use.

The Rad-97 combines advanced connectivity and communication capabilities with an interface that can be customized for used at home.

The device captures patient data in real-time from third-party Bluetooth-enabled devices, such as thermometers and weight scales. It can also include an optional integrated camera for clinicians to remotely interact with patients via live video and audio.

Hologic Breast Biopsy Systems Gets CE Mark

Hologic received a CE Mark for its Brevera breast biopsy system.

The system was designed for improving biopsy accuracy by providing real-time imaging. It features automated tissue sample collection to minimize manual handling.

Cepheid Achieves FDA Clearance and CLIA Waiver for Flu Assay

California-based molecular diagnostic company Cepheid achieved FDA clearance and a Clinical Laboratory Improvement Amendments waiver for its Xpert Xpress Flu test.

The test is indicated for use in detection of Flu A and B RNA. It can be performed using patients’ nasal swabs in under 20 minutes.

FDA Clears Medtronic Aspiration System

Medtronic’s neurovascular business unit received FDA clearance for its Riptide Aspiration System.

The system features the company’s Arc Catheter, Riptide Aspiration Tubing, Riptide Aspiration Pump and Riptide Collection Canister.

It is intended to aid clinicians in removing blood clots using the Arc Catheter to restore blood flow in ischemic stroke patients.

Boston Scientific Gets FDA Nod for Spinal Cord Stimulator System

The FDA approved Boston Scientific’s Spectra WaveWriter spinal cord stimulator system.

It is the first system approved by the FDA to simultaneously provide paresthesia-based spinal cord stimulation and a sub-perception therapy, the company said.

The system is designed to customize therapy to the patient’s individual needs for pain relief as it allows for both therapy types to be combined and target a specific area, or they can used separately for managing multiple pain areas.

Becton Dickinson and Check-Points Snag CE Mark for Resistant Bacteria Assay

Becton Dickinson and Netherlands-based Check-points Health received a CE Mark for a molecular screening assay to detect carbapenemase-producing organisms.

The organisms have acquired the ability to produce carbapenemase, an enzyme that renders carbapenem antibiotics ineffective.

The BD MAX Check-Points assay can detect five common carbapenemase genes. It can be completed in less than 2.5 hours, which is up to 10 times faster than traditional tests, enabling earlier infection control measures.

Check-Cap Gets CE Mark for Ingestible Cancer Screening Capsule

Israel-based medical diagnostic company snagged a CE Mark for its ingestible colorectal cancer screening capsule for use on its C-Scan system.

The system does not require any preparation, unlike traditional methods for which patients must receive laxative preparations and endoscopies.

It combines the ingestible, Z-ray capsule with wireless tracking to generate 2D and 3D maps of the patient’s colon.