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Edwards Lifesciences Receives CE Mark Approval for Acumen HPI

Edwards Lifesciences announced that it received CE Mark for its Acumen Hypotension Probability Indicator (HPI). This technology alerts clinicians to potential hypotension, or abnormally low blood pressure, in their surgical and critical care patients before it occurs. HPI is comprised of a hypotension probability parameter, an alarm, and a secondary screen. The hypotension probability parameter indicates the possibility of a hypotensive event using machine learning techniques developed from more than 20,000 past patient events. The alarm alerts clinicians when hypotension probability exceeds an upper threshold. The secondary screen visually links blood pressure to hemodynamic flow parameters, such as cardiac output and contractility. HPI forms part of Edwards Acumen decision-support software suite and is enabled by the minimally invasive FloTrac IQ sensor.

See more information on the Acumen HPI on Meddevicetracker.


Profusa Receives CE Mark Approval for Lumee Oxygen Platform

Profusa announced that it received a CE Mark to market its Lumee Oxygen Platform for continuous, real-time monitor­ing of tissue oxygen. Lumee is comprised of hydrogel biosensors, a specially designed biosensor injector, an optical reader, and a touch-screen user interface. Adhered to the skin’s surface or held by hand, the optical reader is used to read the fluorescent signal from the embedded biosensor through the skin and then relays the data to a touch-screen tablet computer for an encrypted personal record and historical tracking. Potential applications include monitoring of compromised tissue, such as peripheral artery disease (PAD) that results in narrowing of blood vessels and reduced blood flow to the lower limbs; chronic wounds (diabetic ulcers, pressure sores) that do not heal properly; and reconstructive surgery. Results obtained from an initial study that was published by the Journal of Vascular Surgery showed that the Lumee successfully reported local tissue oxygen levels during surgical intervention, as well as post-operatively for 28 days in patients with peripheral artery disease.

See more information on the Lumee Oxygen Platform on Meddevicetracker.


St. Jude Medical Received FDA Approval for BurstDR

St. Jude Medical announced U.S. Food and Drug Administration (FDA) approval of BurstDR stimulation, a physician-designed form of spinal cord therapy that constitutes part of the Prodigy MRI spinal cord stimulation system. BurstDR stimulation works differently from other traditional spinal cord stimulation (SCS) designs, utilizing intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns. BurstDR stimulation was evaluated within the SUNBURST study, a prospective, randomized multicenter study which confirmed BurstDR stimulation offered superior pain relief over traditional SCS therapy. With this FDA approval, patients receiving new implants of the St. Jude Medical Proclaim Elite and Prodigy MRI spinal cord stimulation systems will have immediate access to the new therapy.

See more information on BurstDR on Meddevicetracker.

Trinity Biotech Withdraws 510(k) Premarket Submission for the Meritas Troponin-I Test and Meritas Point-of-Care Analyzer

Trinity Biotech announced that it is withdrawing its 510(k) premarket notification submission for the Meritas Troponin-I Test and Meritas Point-of-Care Analyzer. The Meritas Troponin-I (cTnl) test is a single use, rapid one-step fluorescence immunoassay for in vitro quantitative determination of cTnI in EDTA anticoagulated human whole blood and plasma specimens. The test is to be used with the Meritas POC Analyzer and can aid in the diagnosis of myocardial infarction (MI). At a meeting with the FDA on September 29th, the FDA asked Trinity to consider withdrawing their submission, due to concerns related to the device’s operating temperature range and its inconsistent clinical performance compared to the data presented by the most recently cleared laboratory Troponin device. Despite demonstrating excellence performance for the POC Analyzer, Trinity decided to withdraw the submission based on the uncertainty that their product will meet the performance standard of the recently cleared laboratory device. Trinity said it will embark upon an internal process, expected to take between 9 and 12 months, to determine the best future opportunity for this platform.

See more information on Meritas Troponin-I Test and the Meritas POC Analyzer on Meddevicetracker.

Siemens Received FDA Approval for Xprecia Stride Coagulation System and Xprecia System PT Controls

The U.S. Food and Drug Administration (FDA) issued 510(k) clearance for the Xprecia Stride Coagulation System Analyzer and the Xprecia System PT Controls. The Xprecia Stride Coagulation System is an in vitro diagnostic medical device that is used to provide an INR (International Normalized Ratio) based on a prothrombin time (PT) response in whole blood and is intended for point of care professional use for the monitoring of warfarin therapy. The system consists of a hand-held Xprecia Stride Coagulation Analyzer, used in combination with single-use PT/INR test strips, Xprecia System PT/INR Strips, and Xprecia System PT Controls (Liquid Quality Controls). The system was officially approved by the FDA on Friday, September 30.

See more information on Xprecia Stride Coagulation System on Meddevicetracker.

Owlstone Receives CE Mark Approval for ReCIVA (Pediatric)

Owlstone Medical announced that it has developed and received CE mark approval for a pediatric version of the company’s disease breathalyzer, ReCIVA (Respiration Collector for In Vitro Analysis), extending the scope of breath testing in early stage diagnostics and therapy response to include children and in particular, the difficult to manage group of child asthma patients. Owlstone uses ReCIVA in combination with the Field Asymmetric Ion Mobility Spectrometer (FAIMS) sensor platform, to accurately and selectively detect volatile organic compounds (VOCs) in exhaled breath, which have been shown to correlate to an inflammatory subtype in asthma. In addition, Owlstone recently initiated the Lung Cancer Indicator Detection (LuCID) trial in Europe to investigate the diagnostic accuracy of FAIMS using ReCIVA for diagnosis of lung cancer by analysis of VOCs.

See more information on the ReCIVA Breath Sampler on Meddevicetracker.

St. Jude Medical Receives PMA Approval for Infinity DBS System

St. Jude Medical announced approval from the U.S. Food and Drug Administration (FDA) and first implant of the Infinity Deep Brain Stimulation (DBS) system and its DBS directional leads, the first directional lead approved in the U.S. The DBS system, combined with a wireless iOS software platform available to DBS patients and physicians, provides a discreet, personalized experience for patients suffering from Parkinson’s disease or essential tremor. The implant delivers mild electrical pulses to specific targets in the brain to stimulate the structures involved in motor control. It comes in two sizes and offers a maintenance-free and long-lasting recharge-free system. In addition, the system is upgradeable, providing patients the potential to access new therapy advances without the need for repeat surgery.

See more on the Infinity DBS System on Meddevicetracker.

Viveve Medical Receives FDA Approval for Viveve System

Viveve Medical announced that its Viveve System has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA), now indicated for use in general surgical procedures for electrocoagulation and hemostasis. In September, Viveve announced the submission of an Investigational Device Exemption (IDE) to the FDA, under a De Novo 510(k), for authorization to begin the VIveve Treatment of the Vaginal Introitus to EValuate Efficacy (VIVEVE II) study involving use of the Viveve System for the treatment of vaginal tissue to improve sexual function in women. The system uses patented, radiofrequency (RF) technology to treat the condition of vaginal laxity, which results from overstretching the vaginal introital (opening) tissue during childbirth. Unlike surgical vaginal reconstruction procedures, the Viveve System can tighten vaginal tissue without incisions, tissue ablation, or anesthesia. Patients experience minimal post-treatment restrictions and recovery times due to the non-surgical nature of the treatment, which only requires a 30-minute procedure in a physician’s office.

See more on the Viveve System on Meddevicetracker.