Meddevicetracker Weekly News Write-Up, January 23, 2017
January 17, 2017
Chembio’s DPP HIV-Syphilis Assay Receives CE Mark
Chembio Diagnostics received CE Mark approval for its DPP HIV-Syphilis combination assay for the simultaneous Point-of-Care detection of HIV and Syphilis. The Chembio DPP HIV-Syphilis Assay is now cleared to be marketed and sold within the member states of the European Union and the Caribbean region, except for Puerto Rico. The Chembio DPP HIV-Syphilis Assay is a single-use, rapid screening test for the detection of antibodies to HIV types 1 and 2 and syphilis Treponema pallidum using finger stick whole blood, venous whole blood, serum, or plasma, and provides results in as little as 15 minutes.
See more information DDP HIV-Syphillis Assay on Meddevicetracker.
Cre8 EVO Receives CE Mark
Alvimedica announced the CE Mark of its new polymer-free Amphilimus eluting stent, Cre8 EVO. Manufactured by CID S.p.A., a member of Alvimedica group, the stent is polymer-free providing a controlled elution of the Amphilimus formulation through the Abluminal Reservoir Technology. The thin cobalt chromium body, sealed by the Bio Inducer Surface, provides high haemo- and bio-compatibility increasing the rate of strut coverage and thus potentially reducing thrombogenicity. Upon the availability of Cre8 EVO, Alvimedica is soon starting the Diab8 randomized trial. It is an all comer study done in patients with diabetes mellitus where Cre8 EVO is compared to Everolimus Eluting Stents.
See more information on the Cre8 Stent on Meddevicetracker.
OrthoSpace Announces Enrollment Milestone in the InSpace Pivotal Study
OrthoSpace announced that it has surpassed the midway point for patient enrollment in its U.S. Investigational Device Exemption (IDE) pivotal study of the InSpace biodegradable balloon system for the treatment of massive rotator cuff tears. Enrollment of 184 patients at 19 North American sites is on track to be completed by the end of 2017. InSpace is currently commercially available outside of the United States and has been implanted in over 10,000 patients in 15 countries.
The InSpace IDE Pivotal Study is a randomized, single-blinded, controlled study that compares the InSpace System to conventional repair or partial repair of full-thickness massive rotator cuff tears. The study’s primary efficacy outcome is the change in the Western Ontario Rotator Cuff Index (WORC), which assesses patient-reported quality-of-life metrics, at 12 months post-operatively when compared to baseline.
See more information on the InSpace System on Meddevicetracker.
CRF Health Receives FDA Clearance of Next-Gen Wireless Glucometer
CRF Health announced the launch and U.S. Food and Drug Administration (FDA) clearance of its Entra BLE Smart wireless glucose meter. This new glucometer utilizes next-generation, low-energy Bluetooth technology delivering extended battery life and enhanced connectivity compared to traditional Bluetooth devices.
See more information on the Entra BLE Smart Glucometer on Meddevicetracker.
January 18, 2017
Abbott Launches Proclaim DRG Neurostimulation System in Europe
Abbott announced the European launch of the Proclaim DRG Neurostimulation System, designed to deliver dorsal root ganglion (DRG) stimulation to patients suffering from chronic neuropathic pain. Through the Proclaim platform's Bluetooth wireless technology and iOS software, the Proclaim DRG Neurostimulation System offers patients a more intuitive therapy experience, compared to current systems with traditional controllers that can be difficult to operate. The Proclaim DRG has been CE Marked and is indicated for the management of chronic intractable pain.
See more information on the Proclaim DRG on Meddevicetracker.
MDxHealth Announces Horizon BCBS Coverage for ConfirmMDx
MDxHealth announced that the Horizon Blue Cross Blue Shield of New Jersey has issued a positive medical policy for the ConfirmMDx for Prostate Cancer Test. This is the fourth Blue Cross Blue Shield Association licensee to establish positive coverage policy and adds to the growing list of payers covering ConfirmMDx for Prostate Cancer.
See more information on the ConfimMDx on Meddevicetracker.
Ascensia Diabetes Care Receives Canada Approval for CONTOUR Next Link
Acensia Diabetes Care received a license from Health Canada for the CONTOUR NEXT LINK 2.4 blood glucose meter to be used with the new Medtronic MiniMed 630G insulin pump and continuous glucose monitoring (CGM) system with SmartGuard technology. The CONTOUR NEXT LINK 2.4 connects wirelessly with the Medtronic MiniMed 630G System with SmartGuard technology. The meter provides blood glucose test results, which are used for insulin dosing and calibration of the MiniMed 630G's CGM sensor.
See more information on the CONTOUR Next Link Meter and MiniMed 630G on Meddevicetracker.
January 19, 2017
Terumo Acquires Bolton Medical
Terumo announced that it has entered into a definitive agreement under which Terumo has agreed to acquire Bolton Medical from its parent company. The transaction is expected to close in a few months and it will be funded through cash on hand and debt. The closing is subject to antitrust clearance and other customary closing conditions. The impact of the acquisition on Terumo's financial is currently being scrutinized.
See more information on the Terumo Corporation on Meddevicetracker.
January 20, 2017
OssDsign receives FDA Clearance for Cranial PSI
OssDsign announced that it received FDA 510(k) clearance to market its flagship product, the OSSDSIGN Cranial PSI (patient specific implant). The OSSDSIGN Cranial is intended for the reconstruction of cranial defects, a surgical procedure known as cranioplasty, which is known to have a high complication rate. Each implant is made to the patient’s unique requirements based on the patient’s CT information and uses advanced computer-aided design and 3D-printing technology to produce a unique device. The implant is made from a proprietary calcium phosphate composite, which is reinforced by a strong titanium skeleton.
See more information on the OSSDSIGN Cranial on Meddevicetracker.