Approvals

C4 Imaging Wins Additional FDA 510(k) Clearance for Sirius MRI Marker

C4 Imaging won an additional 510(k) marketing clearance for its Sirius MRI marker used during the treatment of prostate cancer with brachytherapy.

The additional clearance is for sterilization with ethylene oxide. Previously only gamma sterilization was available.

The company said it is assessing plans to supply Sirius for prostate cancer patients outside the U.S.

Douglas Medical Products Receives 510(k) Clearance for IV Administration Set

Douglas Medical Products won 510(k) clearance for its Tubetech IV administration sets for use in peristaltic IV infusion pumps.

The device controls the flow in the IV tubes. It is available for use in hospitals, alternative site settings and long-term care facilities.

Douglas Medical, a contract manufacturer of IV administration sets, said it will begin commercialization of the product immediately.

FDA Clears Agilent’s GenetiSure Dx Postnatal Assay

Agilent Technologies received 510(k) marketing clearance for the GenetiSure Dx Postnatal Assay, the company’s first comparative genomic hybridization assay for diagnostic use.

The device enables clinical geneticists to detect genetic aberrations associated with developmental delay, intellectual disabilities, congenital irregularities, and unexplained dysmorphic features.

The device is intended for use on the Agilent SureScan Dx microarray scanner system, a Class II exempt medical device.

FDA Approves Two Ortho Hepatitis B Assays

Ortho Clinical Diagnostics received FDA approval for its Vitros HBeAg and Anti-HBe assays for use with the company’s Vitros 5600 and 3600 systems.

Both assays are currently available on the Vitros ECi/ECiQ immunodiagnostic systems.

The assays are used to diagnose individuals with acute or chronic hepatitis B or in recovery from hepatitis B infection.

FDA Approves GlaxoSmithKilne’s Triple Trelega Ellipta Inhaler

The FDA has approved the triple inhaler developed by GlaxoSmithKline and Innoviva to treat chronic obstructive pulmonary disease.

The Trelega Ellipta dry powder inhaler uses fluticasone furoate, umeclidinium and vilanterol to help adults with COPD manage the condition. The device is the first once-daily product approved in the U.S. that combines three active molecules in a single inhaler for COPD patients.

An EMA panel recently recommended approval for the Trelegy Ellipta triple-combination inhaler.

Medtronic Receives FDA Approval of Spinal Cord Stimulator

Medtronic received FDA approval of the Intellis platform for the management of certain types of chronic pain.

The device is placed under a patient’s skin to deliver mild electrical impulses through a lead implanted in the epidural space to block pain signals from going to the brain.

The device tracks and records patient activity 24/7 and is managed on the Samsung Galaxy Tab S2 tablet interface, enabling physicians to monitor progress and make modifications to suit their patients’ therapy needs.

App for Substance Abuse Treatment Wins FDA Marketing Clearance

The FDA approved marketing of a prescription smartphone app to help patients with substance abuse issues. The app, reSET, from Pear Therapeutics, is the first approved mobile medical application for treatment of substance use disorder.

The app is designed for use in outpatient therapy for abuse of alcohol, cocaine, marijuana and stimulants. It is not intended for treatment of opioid dependence.

The app delivers cognitive behavior therapy that teaches skills for increasing abstinence. In clinical trials of a desktop-based version, it achieved better results than those experienced by patients who engaged in conventional face-to-face therapy alone.

SurModics Wins 510k Clearance and CE Mark for Balloon Dilation Catheter

SurModics won both a 510(k) clearance from the FDA and a CE Mark in the European Union for its 0.014″ low-profile percutaneous transluminal angioplasty balloon dilation catheter.

The device includes the company’s Serene hydrophilic coating for low friction and particulates.

SurModics said it plans to launch the device in the coming months.

Mazor Robotics Snags CE Mark for Surgical Platform

Mazor Robotics, a Caesarea, Israel-based manufacturer of surgical robotic systems, announced it has received CE Mark approval for its Mazor X Surgical Assurance Platform.

The platform, which received 510(k) clearance as a Class II device in 2015, is a guidance system for spine surgery with 3-D planning tools, precision mechanics pre-op analytics software, and intraoperative surgical arm verification.

Mazor X will be marketed and sold in Europe by the company’s commercial partner Medtronic.

FDA Blesses Heart Pump for Right Heart Failure

The FDA approved Abiomed’s PMA for its new Impella RP heart pump.

The device is designed to deliver flow and pressure without the need for surgical insertion. It stabilizes a patient’s hemodynamics by providing more than four liters of blood per minute.

It is the only percutaneous temporary ventricular support device for treating acute right heart failure that has received the agency’s approval, according to Abiomed.

Arkis Wins FDA Clearance for CerebroFlo Catheter

Arkis Biosciences’ new catheter intended for external ventricular drainage of cerebrospinal fluid has received FDA marketing clearance.

CerebroFlo is the first neuro catheter to incorporate Endexo, a catheter technology for reducing protein adhesions and activation with demonstrated success in in vitro studies.

Arkis was awarded an exclusive license of the Endexo technology from Interface Biologics for neurological cerebrospinal fluid applications.

Stryker Wins FDA Clearance for 3D-Printed Fusion Cage

Stryker has obtained 510(k) clearance for its Tritanium C 3D-printed interbody fusion cage.

The new implant, intended for treating cervical spine cell attachment and proliferation in patients with degenerative disc diseases, is designed to reduce stiffness, minimize subsidence and contain bone graft.