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April 3, 2017

Singulex Issued CE Mark for Hypersensitive Diagnostic System

Singulex announced that the Company has been issued CE mark approval for its Sgx Clarity System, a fully-automated, in vitro diagnostic (IVD) platform powered by Single Molecule Counting technology – a technology capable of measuring biomarkers at the lowest levels. This hypersensitive mechanism highlights a few important implications of this device; however, most noteworthy is the device will lead to more accurate diagnoses, and subsequently better tailored treatments to combat diseases. For now, only clinicians and patients within the European Union will be able to reap the benefits of this new technology; nevertheless, with plans to file a 510(k) application to the United States Food and Drug Administration (FDA) by the end of 2017, clinicians and patients in the United States can expect access to the technology as early as 2018. As Singulex continues to enroll patients in several studies across Europe to examine the product’s utility in heart disease patients, this immediate availability in Europe signifies the starting point for the Company to demonstrate the touted advantages of Sgx Clarity in a wider array of patients and settings.


See more on the Sgx Clarity System on Meddevicetracker.


Great Basin Obtains FDA Clearance for Whooping Cough Test

Great Basin Scientific announced the Company has been issued 510(k) clearance from the United States Food and Drug Administration (FDA) for its Bordetella Direct Test, a sample-to-result polymerase chain reaction (PCR) test that detects Bordetella pertussis (i.e., whooping cough) directly from patient specimens. Estimations suggest that there are about 16 million cases of whooping cough per year, of which approximately 195,000 result in death. And although this ratio of case-to-death of whooping cough might seem insignificant when compared to other infectious diseases such as influenza or tuberculosis, there nevertheless is a significant need to find quicker and more accurate ways of diagnosing the disease. Simply, quicker and more accurate diagnoses lead to better treatments and lower mortality rates. The approval of Great Basin’s test is therefore significant, because it provides healthcare professionals with a quicker and more reliable means of detecting whooping cough in patients. Whereas conventional methods of detection require 7-10 days of test-to-result time, the Great Basin system is able to provide results in less than a minute. With the availability of this test in the United States, and availability pending in Europe via an anticipated CE mark approval by the end of Q2 2017, Great Basin is bullish in decreasing mortality in pertussis victims.


See more on the Bordetella Direct  Test on Meddevicetracker.

REVA Gains Approval in Europe, Continues Wait in United States

After filing for CE mark in August 2016, REVA announced that its Fantom Bioresorbable Scaffold has been issued clearance in the Europe Union, following several releases of positive data from its FANTOM II safety and efficacy clinical study. The device, which is designed to provide the same acute benefits as more conventional permanent drug-eluting metal stents, is able to resorb from the body over a period of time, and restore the natural movement and function of the repaired artery. Studies across Europe and Brazil have demonstrated the device’s effectiveness in comparison to more traditional methods; however, the Company still awaits the initiation of its United States trial, which plans to begin by the end of 2017 and enroll 2,000 or more patients. To that end, though this CE mark approval is a significant step forward for REVA, it is no secret that the CE mark pathway is not as strenuous as the approval pathway through the United States Food and Drug Administration (FDA). Therefore, though REVA can now breathe a sigh of relief in light of its approval in Europe, the Company will now turn its attention to achieving its next milestone, Investigation Device Exemption (IDE) approval in the United States, which it hopes to solidify by the end of 2017.


See more on the Fantom Bioresorbable Scaffold on Meddevicetracker.



April 4, 2017


Chembio Announces Point-of-Care Collaboration with FIND

Chembio Diagnostics announced it will be collaborating with FIND, an international non-profit organization, to develop a point-of-care test that identify multiple life threatening acute febrile illnesses common in the Asia Pacific. The Companies noted that this project will be carried out over the next twelve months to create a test that will be based on Chembio’s DPP technology platform, which is already being developed to run tests for indications such as Malaria, Dengue Fever, Zika Virus, Marburg Hemorrhagic Fever, and Ebola. With the success of this new collaboration, Chembio is optimistic that it will be able to release a product capable of detecting several infectious diseases at once, further solidifying its position as a major player in the global point-of-care diagnostics marketplace.


See more on Chembio’s DPP technology on Meddevicetracker.

Polymer Technology System Gains Expanded Clearance

Polymer Technology System (PTS Diagnostics) announced that it received 510(k) clearance from the United States Food and Drug Administration (FDA) for an expanded range of HDL cholesterol measurements via the Company’s PTS Panels lipid panel test strips. The strips, analyzed by the Company’s CardioChek Lipid Analyzer system, now has a measurement range from 20 to 120 mg/dL (0.52 to 3.1 mmol/L) for HDL. PTS notes that this change is important because it allows its analyzer to be used in approximately 98% of the adult population in the United States, whereas competing companies can only be used on what is estimated to be between 93-95% of the population.


See more on the CardioChek on Meddevicetracker.



April 5, 2017


Vectura Announces Launch of New Ventavis (iloprost) Nebulizer

Vectura announced that its partner, Bayer AG, has successfully launched Breelib in Poland. The Breelib device, which was designed through a collaboration between Vectura and Bayer, builds upon Vectura’s United States Food and Drug Administration (FDA) 510(k) cleared FOX Inhalation System. The new device was specially designed to deliver Ventavis, a synthetic prostacyclin analog that dilates systemic and pulmonary arterial vascular beds, at an optimal particle size to allow for a breath-actuated nebulization at a fixed volume and flow rate. The product, which was approved by the European Medicines Agency in October 2016, was subsequently granted marketability in Europe the following December. Insofar, this product launch in Poland is the first publically released launch of the device in Europe; however, it can be expected that more launches will follow. This prediction is given credence by Vectura’s recent intimation that use of Breelib reduced inhalation time from 11 minutes to just 3 minutes in a clinical study. These data, which we anticipate to be published in the near future, may further bolster performance expectations of Breelib in Europe.


See more on Breelib on Meddevicetracker.

TandemLife Reveals Success in High-Risk Patient

TandemLife announced that the first successful Canadian implant of its TandemHeart circulatory support device has been completed at the Peter Munk Cardiac Centre, University Health Network in Toronto. The minimally invasive device, comprised largely of a heart pump and controller system, and propelled by a motor that extracts oxygenated blood from the left atrium of the heart, returning the blood to the rest of the body’s vital organs, was implanted in a three-hour procedure in a 55-year old heart failure patient, whom was not a candidate for heart surgery. As one of the only products of its kind, this successful procedure could represent a major milestone for TandemLife to save the lives of people not able to able to undergo heart surgery, which, represents a higher percentage of people globally each year. To that end, through their TandemHeart support device, the Company holds promise to become a leader in non-invasive, high-risk angioplasty procedures.


See more on the TandemHeart System on Meddevicetracker.



April 6, 2017


Abbott Withdrawals ABSORB BVS from Commercial Use

Abbott announced that its Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS will only be available for use in clinical registry settings at select sites and institutions. This news precedes several releases of disappointing data, wherein the Company found significant increases in target lesion failure in multiple clinical studies, one of which was the pivotal ABSORB III trial. Since the release of these discouraging data, the United States Food and Drug Administration (FDA) has been investigating the stent over the overall safety and efficacy concerns raised through clinical findings. To make things worse, Abbott had to terminate its AIDA clinical study, over the same safety issues that were revealed by interim reports. As the first device of its kind cleared by the FDA, the Company looks to correct their current dilemma surrounding its BVS. Already, Abbott seems to be pushing the blame on what they have referred to as sub-optimal implant techniques and patient selection. If these problems, or other problems not associated to the device composition itself, do not solve the current problem, then it is likely this blunder may reflect more poorly on the FDA and any regulatory agency that approved the device for marketing in its respected territory. After all, Abbott was not the party who cleared its device for commercial use. For now, we will stay tuned for an update in the unfolding events surrounding the one of a kind product.


See more on the ABSORB BVS on Meddevicetracker.



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