Approvals

FDA Clears ControlRad’s C-Arm Radiation Reducer Solution

The FDA granted ControlRad 510(k) clearance for its ControlRad Trace technology that is integrated into mobile C-arms to reduce radiation during fluoroscopic imaging procedures.

Trace is designed to reduce the ionizing radiation patients and radiologists are exposed to during procedures, which can increase their lifetime risk of cancer. Radiation produced during C-arm procedures can also increase a patient’s risk of cataracts, atherosclerosis and strokes.

The company says ControlRad Trace reduces radiation up to 89 percent without compromising image quality or workflow.

Kurin’s Blood Culture Contaminant Diverter Gets CE Mark

Kurin has earned the CE Mark for its Kurin Lock, allowing the devicemaker’s FDA-cleared blood culture collection sets to be marketed in the European Economic Area with the novel contaminant diverter.

The Kurin Lock specimen diversion device works with Kurin’s blood culture set to automatically divert the initial portion of blood in each draw, which can contain potential contaminants.

Patients may be exposed to unnecessary antibiotics as a result of contaminated blood cultures, the company said, which can also lead to extended hospital stays.

Stryker Grabs PMA for Aneurysm Adjunctive Stent

The FDA has granted Stryker premarket approval for its Neuroform Atlas aneurysm adjunctive stent for treating wide-neck, intracranial aneurysms.

The self-expanding nitinol stent is approved for use alongside metal coils to pack weakened blood vessels in the brain. It received prior approval under a humanitarian device exemption, confining its use to approved hospitals.

The stent features improved conformability and a “low-profile” delivery system that assists in the treatment of difficult aneurysms.

FDA Clears MagStim’s Horizon Performance Platform

MagStim has earned the FDA’s go-ahead for its Horizon Performance platform, a device used to treat patients with depression through magnetic pulse therapy.

By using transcranial magnetic stimulation, the device allows patients to avoid the side effects of drugs and invasive treatments.

The platform has been used in situations where antidepressant treatments are ineffective and before therapies such as electroconvulsive therapy are considered.

Qiagen’s Syndromic Testing System Cleared by FDA

The FDA granted Qiagen 510(k) clearance for its QIAstat-Dx syndromic testing system and respiratory assay panel for detection of multiple respiratory viral and bacterial pathogens. The panel provides simultaneous testing for more than 20 pathogens.

Syndromic testing with molecular diagnostics can identify illnesses that manifest as a set of symptoms with uncertain causes, such as influenza or pneumonia.

Qiagen said it expects to release numerous diagnostics for infectious diseases, oncology and other areas. The company plans to launch a gastrointestinal panel later this year.

The QIAstat-Dx system earned a CE-IVD Mark in January 2018.

DiaSorin Molecular’s Herpes Assay Grabs CE Mark

DiaSorin Molecular earned the CE Mark for its Simplexa HSV 1/2 and VZV Universal Direct MDx assay, a diagnostic for the herpes simplex and varicella-zoster viruses.

The assay is designed for use on the devicemaker’s Liaison MDx instrument. It can detect and differentiate between DNA associated with herpes 1 and 2 and the varicella-zoster virus, which causes shingles and chickenpox.

The real-time PCR assay does not require upfront extraction, produces results in about an hour and involves minimal hands-on interaction.

Flat Medical’s Epidural Protector Cleared by FDA

The FDA granted Flat Medical with 510(k) clearance for its EpiFaith syringe, a device used for delivering safe epidural injections.

The indicating syringe is a physician-oriented safeguard for epidural analgesia during labor, chronic pain management and surgical anesthesia.

The device alerts anesthesiologists to the moment it has arrived at the epidural space, avoiding the risk of paralysis, prolonged admission times and associated costs.