Approvals

Siemens Receives CE Mark for PCR Assay

Siemens’ Fast Track Diagnostics earned a CE Mark for a real-time PCR assay that can detect 14 human papillomavirus subtypes that put patients at high risk of abnormal growths.

The assay detects HPV 16, HPV 18 and 12 other high-risk HPV strains.

More than 90 percent of HPV infections are resolved within two years, but a small fraction of the 14 high-risk subtypes can cause neoplastic lesions.

LivaNova Aortic Valves Approved for Expanded Use Labeling

LivaNova earned a CE Mark and approval for expanded use of its Bicarbon aortic valves with lower dose blood thinners in low-risk patients.

The expansion means that a lower international normalized ratio — the standard for measuring blood coagulability — can be targeted following implantation of the valve in low-risk patients going through mechanical aortic valve replacement.

After implanting the aortic heart valves in patients with low risk of thromboembolic events, physicians can work with a lower-range level of anticoagulant therapy, potentially reducing the risk of bleeding without increasing the risk of blood clots.

Dexcom’s Glucose Monitoring System Receives FDA Approval

The FDA gave Dexcom’s continuous glucose monitoring system Dexcom G6 marketing approval and classified the product as a Class II device.

The Dexcom G6 can integrate with other medical devices and electronic interfaces like insulin pumps, blood glucose meters and automated insulin dosing systems.

The device is a small patch that users apply to their abdomen. A sensor within the device continuously measures glucose in the user’s body fluid and transmits readings every five minutes to its smartphone app.

FDA Clears inPrint 3D Software

Materialise’s Mimics inPrint software, designed to print 3D anatomical models for diagnostic use, received 510(k) clearance from the FDA.

The device converts DICOM medical image data to anatomical 3D models.

It is designed for pre-operative planning and printing physical models used for patient management, treatment and communication among surgeons.

7SBio’s Blood Collection Device Receives CE Mark

Seventh Sense Biosystems’ TAP, a one-step blood collection device, received a CE Mark in Europe.

The single-use device is painless and around the size of a stethoscope bell. It can hold up to 100 microliters of blood and secures the needles inside the device.

The device also is designed for attachment to future accessories, such as for connectivity and sample separation.

Emosis’ HIT Diagnostic Test Approved for Marketing by EC

The European Commission granted Emosis’ heparin-induced thrombocytopenia (HIT) diagnostic test a CE Mark.

The flow cytometry-based HIT Confirm test provides results in a half hour by reading selected platelet biomarkers.

The test can contribute to the diagnosis of potentially lethal HIT in patients treated by the anticoagulant.

Senseonics’ Eversense Recommended for Approval by FDA

Senseonics received a unanimous recommendation for approval from an FDA advisory panel for its implantable continuous glucose monitor for use in adults with diabetes.

The device is a fluorescence-based system that is implanted in the upper arm in a 5-to-10 minute office-based procedure. The implanted sensor lasts ninety days after which it is removed with another short procedure and replaced.

An external transmitter is taped on the skin above the implant to allow the glucose monitor to work with its accompanying smartphone or tablet mobile app, which displays and stores the glucose readings.

DxNow Cleared for ZyMot Sperm Separation Devices

The FDA granted 510(k) clearance for DxNow’s ZyMot ICSI and ZyMot Multi, devices intended for preparing motile sperm from semen to be used in infertile couples.

The devices facilitate the separation and preparation of highly-motile sperm with normal morphology to be used in assisted reproductive technology procedures.

The ZyMot devices can be used to prepare sperm for intracytoplasmic sperm injection, intrauterine insemination and in vitro fertilization procedures.