Coronavirus SARS-CoV-2 colorized scanning electron micrograph of a cell (pink) heavily infected with SARS-CoV-2 virus particles (teal and purple), isolated from a patient sample. Image courtesy of NIAID. MIS-C Multisystem inflammatory syndrome in children. #COVID19
December 22, 2020
NIH Begins Study of COVID Infection and Multisystem Inflammatory Syndrome in Children (MIS-C)
December 22, 2020 — An observational study has launched to evaluate the short- and long-term health outcomes of SARS-…
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With the FDA clearance of the Vital Data Sensor, Biotronik's Biomonitor IIIm features two-in-one detection, providing physicians the ability to monitor for early signs of potential life-threatening cardiac arrhythmias and body temperature increases potentially associated with fever.
December 22, 2020
FDA Clears Fever-Detecting Cardiac Monitor From Biotronik
December 22, 2020 — The U.S. Food and Drug Administration (FDA) cleared Biotronik's Vital Data Sensor, which identifies…
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The stent struts of the Biotronik Orsiro stent.
December 21, 2020
New Stent Kink Resistance Testing Proposed in ASTM International Standard
December 21, 2020 – A proposed ASTM International standard will answer the need for a standardized test method that…
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HeartMate 3 heart pump is now approved for use for pediatric patients battling advanced heart failure offering a new treatment option for this underserved population
December 21, 2020
FDA Approves Abbott's HeartMate 3 VAD for Pediatric Patients
December 21, 2020 — U.S. Food and Drug Administration (FDA) approved updated labeling December 17 for Abbott's…
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AI Medic Inc. has obtained official product certification from the NIDS for its own medical video analysis software, AutoSEG
December 16, 2020
AI Fully Automates Cardiac CT Image 3-D Analysis
December 16, 2020 — AI Medic Inc. announced that it has obtained official product certification from the NIDS (National…
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A peripheral artery disease (PAD) patient CT scan showing blockages in the femoral arteries in the legs with collateral flow in the leg on the right.
December 16, 2020
First-In-Human Use Reported for Bioresorbable Efemoral Vascular Scaffold System
December 16, 2020 — Efemoral Medical announced the first-in-human (FIH) use of the its Efemoral bioresorbable vascular…
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Corpath GRX interventional cardiology robotic system is comprised of two different components: 1. The control console. 2. The bedside unit.
December 16, 2020
Corindus Launches technIQ 1 Smart Procedural Automation Series for CorPath GRX Cath lab Robotic System
December 16, 2020 — Corindus, A Siemens Healthineers company and a leading developer of vascular robotics, began its…
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The Digisonics' cardiovascular information system (CVIS) system.
December 16, 2020
Intelerad Acquires Digisonics to Expand its Enterprise Imaging Workflow 
December 16, 2020 - Intelerad Medical Systems, a provider of enterprise imaging workflow solutions, has acquired…
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The Medis Quantitative Flow Ratio (QFR) is a novel, non-invasive, angiography-based physiologic FFR-like assessment of the presence and extent of coronary artery disease.
December 16, 2020
Acist Medical Partners With Medis to Distribute Angiography Image Derived FFR Quantification System
December 16, 2020 – Acist Medical Systems Inc. announced a formal distribution partnership with Medis Medical Imaging…
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COVID-19 has posed challenges for physicians whose cardiac patients are at-risk and reluctant to schedule an office visit. Floyd Russak, M.D., of Russak Personalized Medicine, an internal medicine physician practicing in Greenwood Village, Colo., manages many cardiac patients who do not have ready access to a cardiologist
December 15, 2020
Cardiac Monitoring in the Time of COVID-19: Next Generation Wearable ECG Technology Comes into Its Own
COVID-19 has posed challenges for physicians whose cardiac patients are at-risk and reluctant to schedule an office…
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Foldax Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) so the company to initiate a U.S. clinical study of its Tria biopolymer mitral surgical heart valve.
December 14, 2020
Foldax to Initiate FDA Clinical Study of Biopolymer Mitral Heart Valve
December 14, 2020 - Foldax Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an…
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The U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) Dec, 12 for the COVID-19 vaccine submitted by Pfizer Inc. in partnership with BioNTech Manufacturing GmbH. It is the first mRNA vaccine to gain an FDA clearance and the first COVID vaccine to gain FDA clearance.  #COVID #COVID19 #SARSCoV2 #vaccine #COVIDVaccine
Dave Fornell, Editor
December 14, 2020
FDA Clears First COVID-19 Vaccine Under an Emergency Use Authorization
December 14, 2020 — The U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for…
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SoniVie, an Israeli company developing the Therapeutic Intra-Vascular Ultrasound (TIVUS) System to treat a variety of hypertensive disorders, announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The  TIVUS System for renal artery denervation treats resistant hypertension, which is defined as blood pressure that remains above 140/90 mmHg despite use of three antihypertensive medications of different classes at the best tolerated doses.
December 09, 2020
FDA Grants Breakthrough Device Designation for the TIVUS Renal Artery Denervation System
December 9, 2020 — SoniVie, an Israeli company developing the Therapeutic Intra-Vascular Ultrasound (TIVUS) System to…
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The Spectrum Dynamics Veriton-CT64 Digital SPECT/CT nuclear imaging system has its SPECT detectors housed in extendable arms to get as close to the patent's chest as possible to improve cardiac perfusion image quality. #RSNA2020 #RSNA20 #RSNA
December 04, 2020
Spectrum Dynamics Receives Approval From Health Canada for Veriton-CT64 Digital SPECT/CT
December 4, 2020 — Spectrum Dynamics Medical, Inc., has received Canadian Medical Device License from Health Canada for…
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December 03, 2020
The DAIC November-December 2020 Digital Edition
View the November-December 2020 digital edition of Diagnostic and Interventional Cardiology (DAIC) magazine, include…
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Attune Medical’s ensoETM is a single use thermal regulating device that is placed in the esophagus similar to a standard gastric tube and connected to an external heat exchange unit, creating a closed-loop system for heat transfer to increase or decrease patient temperature. Its placement in the esophagus, with proximity to blood flow from the heart and great vessels, allows highly efficient heat transfer. EPs are now looking at the device as a way to prevent RF damage to the esophagus during ablations.
December 03, 2020
Esophageal Cooling May Help Prevent Injury From Cardiac Ablations
December 3, 2020 – Attune Medical reports the first major peer-reviewed clinical publication using its ensoETM device…
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An example of a body composition analysis of an abdominal CT slice with the subcutaneous fat in green, skeletal muscle red and visceral fat in yellow. This was automatically identified and analyzed via a deep learning algorithm to assess the risk for heart attack and stroke in more than 12,000 patients. #RSNA2020 #RSNA20 #RSNA
December 02, 2020
AI Measured Abdominal Fat Accurately Predicts Heart Attack and Stroke Risk
December 2, 2020 – Automated deep learning analysis of abdominal computed tomography (CT) images produces a more…
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cyanosis, cyantosis COVID-positive infant.
December 02, 2020
COVID-19 Can Impact Hearts in Young Children
December 2, 2020 — A 2-month-old infant diagnosed with COVID-19 (SARS-CoV-2) experienced reversible myocardial injury…
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CMS coverage changes effective as of Dec. 2, 2020 will open up the use of LVADs to more Medicare patients, including use of the HeartWare and HeartMate ventricular assist devices.
December 02, 2020
CMS Updates Coverage Policies for Artificial Hearts and Ventricular Assist Devices
December 2, 2020 — The Centers for Medicare and Medicaid Services (CMS) finalized updates to Medicare coverage policies…
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GE Healthcare is introducing a new, smaller and lighter weight robotic driven angiography system for image guided therapy, the Allia IGS 7 angiography system. #RSNA20 #RSNA2020
December 01, 2020
GE Introduces Robotic Angiography Gantry That Addresses Ergonomic Issues
December 3, 2020 — GE Healthcare is introducing a new version of its robotic driven angiography system for image guided…
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