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April 10, 2017

Firehawk Obtains Regulatory Approval in Colombia

Keystone Heart and Shanghai MicroPort Medical announced that it recently obtained regulatory approval from Colombia's health authority INVIMA for its in-house developed Firehawk Rapamycin Target Eluting Coronary Stent System (Firehawk). Previously, Firehawk has received approval in several other Latin American countries, such as Brazil, Mexico and Argentina.


See more on FireHawk on Meddevicetracker.


Uniformed Services University of Health Sciences Awarded Grant to Study Hemodilution Utilizing Daxor’s BVA-100

Daxor announced that the Uniformed Services University of Health Sciences has been awarded a grant to study hemodilution utilizing Daxor’s BVA-100 device in collaboration with Duke University which is anticipated to start in May 2017.


The grant notes that Daxor’s method is recognized as the gold standard of accuracy and calls for an exploration of fluid hemodilution metrics using the company’s technology as a benchmark.


See more on BVA-100 on Meddevicetracker.



April 11, 2017

Z-Medica Products Approved For Use In Brazil

Z-Medica announced that the portfolio of QuikClot products has been approved by the National Health Surveillance Agency (ANVISA), the Brazilian regulatory agency responsible for medical devices. The ANVISA approval covers all of Z-Medica’s QuikClot products, which will be marketed to Brazilian military, hospitals and emergency medical services.


See more on QuikClot on Meddevicetracker.




April 12, 2017

ConforMIS Announces Positive Results from Customized iTotal PS Total Knee Replacement Comparative Study

ConforMIS announced that results from the first study of its iTotal PS total knee replacement were presented at the 2017 British Association for Surgery of the Knee (BASK) Annual Meeting.


In this single-center study, financially supported by ConforMIS, researchers assessed the kinematics of 31 patients (13 patients with a ConforMIS iTotal PS implant and 18 patients with an off-the-shelf implant) at least six months after surgery using advanced real-time mobile x-ray imaging and 2D-3D registration. Patients who received a ConforMIS iTotal PS demonstrated greater average range of motion during a deep knee bend (112° vs. 94°; p≤0.05). Additionally, iTotal PS patients saw greater lateral femoral rollback (11.73mm vs. 4.69mm; p≤0.05), medial translation (2.8mm vs. 1.0mm; p≤0.05) and greater axial rotation (10.85° vs. 7.58°) during deep knee bend, which is consistent with normal knee motion.


See more on the iTotal Knee Replacement System on Meddevicetracker.


Biotricity Files for its Second and Final FDA 510(k) to Bring Bioflux Solution to Market

Biotricity announced it has filed for a second and final 510(k) for the hardware portion of its Bioflux solution with the U.S. Food and Drug Administration (FDA). Biotricity has already received FDA approval for the software portion of its remote cardiac monitoring wearable.


Biotricity’s flagship product, the Bioflux solution, combines a proprietary mobile ECG monitoring device and an ECG viewer software package. Together with an accredited 24 hour, 7 day per week, ECG monitoring facility, Bioflux enables physicians to remotely monitor and diagnose patients with cardiovascular disease and coronary heart disease by detecting arrhythmias.


See more on bioflux on Meddevicetracker.



April 13, 2017

Acelity Announces Enhancements to V.A.C.ULTA Therapy System

Acelity announced that two significant enhancements to the V.A.C.ULTA Therapy System are now available in the U.S.


iOn RESULTS Remote Therapy Monitoring (RTM) connects hospitals to Acelity’s unique service and support offering to promote compliance and drive proper patient utilization of therapy. The V.A.C.ULTA 4 Therapy System simplifies functionality, reports summative therapy, and allows for on-screen selection of four different therapies on a single advanced device which can be tailored to a patient’s specific need and clinician’s preference.


iOn RESULTS Remote Therapy Monitoring works in conjunction with the V.A.C.ULTA Therapy System to monitor the therapy units’ performance in the hospital setting. The system enables timely feedback and therapy application optimization to enhance product performance metrics to identify hospital staff training or support needs.


V.A.C.ULTA 4 Therapy System provides simplified functionality through a software upgrade that provides enhanced pathways to the device’s four negative pressure therapies: V.A.C. Therapy, V.A.C. VERAFLO Therapy, PREVENA Therapy and ABTHERA Therapy. The new system provides a device that allows usage of the four different therapies that can be tailored depending on a patient’s need and the clinician’s varying levels of experience. Therapy setup pathways for each therapy have shown significant reduction in numbers of screens and button pushes, saving clinicians’ time. For example, V.A.C. VERAFLO Therapy can now be initiated with 38 percent fewer steps.


See more on the V.A.C.ULTA Therapy System on Meddevicetracker.




April 14, 2017

Apple Testing a Noninvasive Blood Glucose Monitor

Apple is developing a continuous noninvasive blood sugar monitoring technology.


Work is reportedly fairly advanced. Apple is said to be running the effort from an offsite location in Palo Alto, California. From there, a team of engineers, thought to number 30 as of last year, is working on optical sensors to measure blood glucose noninvasively through the skin.


The nature of glucose and other factors means it is tough to accurately record levels using light, but Apple has reportedly advanced to the point that it is running feasibility trials and assessing its regulatory options. With Apple already using an optical sensor in its Watch to measure heart
rate, the interest in using light to track glucose suggests that technology developed in the diabetes project has a natural home in its wrist-worn device. However, Apple CEO Tim Cook told The Telegraph in 2015 the timelines for U.S. Food and Drug Administration (FDA) clearance would deter the company from making a regulated Watch.


See more on the Apple Continuous Glucose Monitor on Meddevicetracker.




April 15, 2017

PlexBio Presents Pi Code Technology

PlexBio announced that it presented a new multiplex diagnostic assay technology called Pi Code Technology at the Fifth International Molecular Diagnostics Europe conference in Lisbon, Portugal.


The Pi Code Technology platform is able to rapidly determine the status of a wide range of somatic gene mutations or gene rearrangements typically seen in various cancers. In combination with SelectAmp, a mutation-enriching PCR amplification technique that dramatically increases mutation detection sensitivities, the new analytic approach presented by PlexBio holds strong promise for use with ‘liquid biopsy’ samples. The company’s scientific presentation focused mainly on the mutation analysis results obtained for the EGFR gene (a gene very often associated with lung cancer), but preliminary work on a range of liquid biopsy-compatible ‘cancer panels’ was also presented.


The use of liquid biopsy samples in place of preserved solid tumors sections has been the focus of significant clinical study in recent years. The liquid biopsy approach, which uses blood and other bodily fluids that are more easily obtained, has the benefit of being non-invasive and less expensive than the traditional biopsy approach where samples are removed from the patient surgically or by needle aspiration. The objective of the new technique is to enable clinicians to determine a patient’s cancer status with a simple blood or fluids draw and to then quickly implement a treatment plan. The approach is poised to move rapidly into routine clinical practice.


See more on Pi Code Technology on Meddevicetracker.


April 17, 2017

Cardiovascular Systems Initiates Voluntary Recall of Saline Infusion Pump

Cardiovascular Systems (CSI) announced it has initiated a voluntary recall of its 7-10014 Saline Infusion Pump, an accessory to the Diamondback 360 Orbital Atherectomy Systems. CSI initiated a customer communication of the recall by letter and informed customers that they may continue to use the affected Saline Infusion Pumps until they receive a replacement.


The Saline Infusion Pumps provide saline and lubricant infusion during orbital atherectomy procedures and electrical power to the orbital atherectomy device. CSI has determined that electromagnetic interference present in the hospital environment may cause the Pumps to switch to standby mode during use, requiring the Pump to be reset prior to continuing treatment. Restoring Pump operation can result in a temporary delay in the orbital atherectomy procedure. In coronary artery procedures, this delay of therapy could present an additional risk of a temporary, medically reversible injury. However, there have been no reports of patient injury to date.


The Pumps included in the recall were distributed between April 7, 2015 and April 4, 2017. The company plans to recall and replace approximately 900 units currently in customer inventory. CSI expects to record approximately $1.5 million of expenses in its third quarter of fiscal 2017 related to the recall and replacement of all affected Saline Infusion Pumps. The recall and related charge do not have an adverse effect on third quarter revenue and net loss guidance provided by the company on January 25, 2017. The company will provide additional financial updates during its regularly scheduled third quarter earnings conference call on May 3, 2017.


See more on the Diamondback 360 Coronary OAS Micro Crown, Coronary OAS, and Peripheral OAS on Meddevicetracker.


April 18, 2017

Biocept Awarded Additional Patent in Japan for Target Selector Liquid Biopsy Platform

Biocept announced that it has been awarded Japanese Patent No. 6081434 entitled, DEVICES AND METHODS OF CELL CAPTURE AND ANALYSIS. The issued patent covers the use of antibodies for the capture of any target of interest from any sample type on a device surface. This includes CTCs, as well as other targets of interest such as sub-cellular vesicles and exosomes that are shed by solid tumors into the blood stream.


This patent is broader than previously issued patents owned by the Company, and is the nineteenth patent issued to Biocept related to its core liquid biopsy technology. This is the third patent issued in Japan for Biocept.


See more on the Target Selector Platform on Meddevicetracker.


Cellnovo Acquires Commercial License for Artificial Pancreas Technology from TypeZero Technologies

Cellnovo Group and digital health company TypeZero Technologies announced the completion of a worldwide commercial license agreement for the integration and the commercialization of TypeZero’s Artificial Pancreas (AP) technology into Cellnovo’s mobile diabetes management systems. The non-exclusive worldwide agreement allows Cellnovo to commercialize a Cellnovo-TypeZero product in the future. Integration efforts are currently underway with a product launch expected in 2018. No financial terms have been disclosed.


TypeZero’s AP software, known as inControl AP, will be incorporated directly into Cellnovo’s Bluetooth enabled micropump. inControl AP continuously monitors blood glucose levels via a smartphone application and automatically delivers corrections to regulate blood sugar levels through an integrated insulin pump.


In February 2016, Cellnovo announced a partnership with TypeZero to utilize Cellnovo’s e-connected insulin patch pump alongside TypeZero's inControl AP software in an artificial pancreas (AP) program.


See more on the Cellnovo System on Meddevicetracker.



April 19, 2017

ResApp Extends SMARTCOUGH-C Study

ResApp Health announced that it will extend the SMARTCOUGH-C study through to the end of May 2017 and increase maximum recruitment to 1,500 patients. Enrollment in the study has progressed well across eleven recruitment locations maintained by the three participating hospitals, however the incidence of pneumonia and croup among study patients has been unseasonably low. Increasing the recruitment target is a prudent step that will ensure the study generates statistically strong results and maximize the range of diseases included in ResApp’s de novo submission to the U.S. Food and Drug Administration (FDA).


The company advises that it remains on-track to complete enrollment, release top-line results and submit its de novo submission to the FDA in the first half of CY2017.


See more on ResAppDx on Meddevicetracker.


NuVasive Launches New Spinal Trauma Portfolio

NuVasive announced the launch of the new RELINE Trauma portfolio.
The RELINE Trauma Portfolio is a trauma system that was designed to provide surgeons the flexibility to customize their approach intra-operatively, including traditional open, MAS (Maximum Access Surgery) or hybrid procedures, depending on the pathology and patient needs, as well as customize implant types, depending on surgeon preference. The system is further touted to offer an enhancing effect on the surgeon’s ability to dial-in fracture correction through a dual rack system achieving independent lordosis restoration and parallel compression/distraction for ligamentotaxis. This enables procedures to be completed by one surgeon rather than two, helping reduce the total cost of the procedure.


RELINE Trauma is integrated with proprietary NuVasive Computer Assisted Technologies such as NVM5, NuvaLine, NuvaMap and NuvaMap O.R., all within the Integrated Global Alignment (iGA) platform. iGA allows surgeons to calculate, correct and confirm spinal alignment through preoperative planning, intraoperative assessment, and postoperative confirmation for their trauma cases. Additionally, constructs are further enhanced with the integration of the Bendini system which expedites manual rod manipulation via computer-assisted bend instructions.


See more on Reline on Meddevicetracker.



April 20, 2017

Polyganics Announces Enrollment of the First Patient in its PROTECT NEURO Study

Polyganics announced that it has enrolled the first patient in its international PROTECT NEURO study to treat and prevent symptomatic neuroma. The first patient was treated at Stanford Medicine.


The PROTECT NEURO (Prospective Cohort Evaluation Of NEUROCAP in the Treatment of Symptomatic Neuroma) study is aimed to collect additional evidence for the long-term effectiveness of NEUROCAP, in the reduction of symptomatic nerve pain in patients with a history of having painful neuroma. PROTECT is a prospective cohort evaluation of NEUROCAP’s performance in the surgical management of peripheral nerve-ends in both upper and lower extremities including amputation. 92 patients will be enrolled for the study which will run in 17 medical centers in both Europe and the United States.


Completion of the study enrollment is due to take place in the fourth quarter 2017 and final results including two-year patient follow-up are expected in 2019.
Polyganics’ NEUROCAP is a transparent tubular device with a sealed end, a first-in-kind transparent nerve capping device that combines synthetic and bioresorbable qualities.


See more on NEUROCAP on Meddevicetracker.


Alabama Medical Center First in Southeast to Offer CoreValve Evolut Pro TAVR Device

The Structural Heart Program at Princeton Baptist Medical Center recently became the first center in the Southeast to implant the U.S. Food and Drug Administration (FDA)-approved CoreValve Evolut Pro.


The transcatheter aortic valve replacement (TAVR) device is indicated for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open-heart surgery. Recently unveiled clinical data showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics for the self-expanding valve.


The Evolut Pro device features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. The biocompatible porcine pericardial tissue wrap, in addition to other design elements, is incorporated to address the occurrence of blood leaking through the sides of the valve. It is both recapturable and repositionable, so accuracy in placement and control during the procedure is increased.


The Evolut Pro System is delivered through the EnVeo R Delivery Catheter System and is indicated for vessels down to 5.5 mm. The EnVeo R system features an InLine Sheath that makes it the lowest delivery platform currently on the market, according to Medtronic. It also provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route.


See more on Evolut R on Meddevicetracker.


First European Patients Treated With DC Bead LUMI Radiopaque Drug-Eluting Beads

BTG announced the treatment of the first patients in the EU with DC Bead LUMI. Two patients were treated for hepatocellular carcinoma (HCC) and one patient was treated for malignant colorectal cancer metastasized to the liver (mCRC). DC Bead LUMI is the first commercially available radiopaque drug-eluting bead (DEB) in the EU which can be loaded with doxorubicin or irinotecan for the local treatment of tumours in patients with HCC and mCRC, respectively. DC Bead LUMI is a next-generation development of DC Bead, the drug-loadable embolic bead.


At the Istituto Oncologico Veneto, Padova, Italy, Dr Camillo Aliberti, Director of Radiology, and his team performed transarterial chemoembolization (TACE) procedures using DC Bead LUMI, enabling real-time, visible, lasting confirmation of bead location during and post-embolization of tumors in the liver.


See more on DC Bead on Meddevicetracker.




April 21, 2017

MicroPort Signs Strategic Partnership Agreement with China Medical Instrument

Shanghai MicroPort Medical recently signed a strategic partnership agreement with China Medical Instrument ("China Medical Instrument").
China Medical Instrument is a subsidiary of China National Pharmaceutical Group Corporation ("SINOPHARM") which covers various business segments including sales, logistics, group purchasing, government centralizing procurement, and international trade. It is involved in distributing, retailing, developing and manufacturing medical devices.


See more on MicroPort Scientific on Meddevicetracker.



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