Approvals

Baxter’s Altapore Bioactive Bone Graft Receives Extended 510(k) Clearance

Baxter received an extended 510(k) clearance for its Altapore bioactive bone graft, a bioactive and osteoconductive bone graft substitute.

The additional clearance allows the bone graft to be used as an autograft extender in posterolateral spinal fusion.

The bone graft received previous 510(k) clearance for use in orthopedic surgery in the pelvis and the extremities.

Stryker Receives 510(k) Clearance for Implantable Fracture Reduction Device

The FDA granted Stryker’s SpineJack implantable fracture reduction system 510(k) clearance for use in reducing osteoporotic vertebral compression fractures.

The SpineJack system had better results versus balloon kyphoplasty during the Sakos clinical study.

After the titanium implant is inserted and expanded, the restored vertebral body is stabilized by adding bone cement at low pressure. It is available in three sizes to adapt to different vertebral body sizes.

Abbott Earns CE Mark for Blood Test to Predict Cardiac Events

Abbott’s Troponin-I blood test has received CE Mark approval for predicting a patient’s chance of heart attack or other cardiac event.

The blood test can predict, potentially within months to years in advance, if patients who otherwise seem healthy may experience heart attacks or cardiac events.

Because the test can detect levels of troponin — even if they are very low — it can be used to determine cardiac risks in patients who exhibit no symptoms.

Sensile Medical Micropump Gains CE Mark

Sensile Medical’s wearable micropump received a CE Mark for treatment of Parkinson’s disease.

The device includes an automatic filling feature designed for use with liquid medicines, as well as a color display, charging unit and leather bag to attach the device to the user’s belt.

The micropump also has a programmable feature that can deliver a bolus with the press of a button.

TransEnterix’s Ultrasonic Instrument Cleared in EU

TransEnterix’s received the CE Mark for its Senhance Ultrasonic Instrument System, a device used in minimally invasive surgeries.

The ultrasonic device delivers controlled energy to seal and cut tissue while minimizing thermal injury to the body and it can be used to manage complex surgeries.

The device is particularly useful to laparoscopic surgeons because it can be used for a wide range of procedures.

Abbott’s Sensor-Based Glucose Monitor Gains CE Mark

Abbott’s Freestyle Libre 2, a sensor-based continuous glucose monitoring device, has received the CE Mark.

The device allows patients to self-monitor their blood glucose levels without the use of finger sticks.

The glucose monitor uses Bluetooth technology with its new alarm feature to alert patients when they have low or high glucose levels.

Kheiron’s Breast Cancer Screening Software Receives CE Mark

Kheiron Medical Technologies has been granted the CE Mark for its deep learning-based breast cancer screening software, making it the first UK company to receive the mark for deep learning radiology software.

The CE approval means that European healthcare providers can use the software as secondary analyzers of mammographic images in breast cancer screenings.

In a clinical study, the software performed better than the average national standards for breast cancer screening. It uses artificial neural networks and high performance computing to evaluate the medical images.

The company is currently seeking FDA approval for the software.

Xtreem Pulse’s Rapid Pulse Compressor Gains CE Mark

Xtreem Pulse’s PureFlow device received the CE Mark for its rapid pulse compression device, for use by athletes and individuals looking to improve their cardiovascular health.

The device promotes optimal performance and recovery, increasing oxygenation, circulation and detoxification by optimizing blood flow.

The increased blood flow caused by the device’s pumping action helps to send oxygen and nutrients into cells.

Applied BioCode Cleared to Market New Diagnostic Device

The FDA granted 510(k) clearance to Applied BioCode’s MDx3000 high-volume molecular diagnostic device that can detect 17 types of gastrointestinal pathogens, bacteria, parasites and viruses.

The system is based on Applied BioCode’s barcoded magnetic beads technology which offers up to 4,096 different barcoded patterns. Up to 100 different barcodes per assay can be run on the device.

Up to 94 patient samples can be completed on the system in less than five hours.

Acessa Health Cleared for Uterine Fibroid Ablation Device

The FDA granted 510(k) clearance to Acessa Health’s ProVu System, a device used to treat women with symptomatic uterine fibroids who don’t want to undergo a hysterectomy.

The system combines radiofrequency ablation, guidance mapping and ultrasound visualization to target and ablate the fibroid. The ablated fibroid is then absorbed harmlessly by the body over time.