- R3 Vascular Secures WCG IRB Approval and CMS Category B Medicare Coverage for the ELITE-BTK Pivotal Trial of its MAGNITUDEÒ Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease
- Vergent Bioscience Receives FDA Fast Track Designation for Abenacianine for Injection (VGT-309) to Help Surgeons Visualize Tumors in the Lung During Surgery
- Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy
- PharmaEssentia Reaffirms its Commitment to Robust and Reliable Access to Interferon Therapies Amid Global Supply Challenges
- 50% of Older Adults to Rely on Wearables for Life-Saving Alerts by 2034, ScienceSoft Predicts
- YolTech Therapeutics Granted FDA Orphan Drug and Rare Pediatric Disease Designations for YOLT-203 to Treat Primary Hyperoxaluria Type 1
- AI Hype vs. Reality: Medical Billing’s Need for Human Expertise | By John T Bright, CEO & Founder at Med Claims Compliance Corporation (MCC)
Medical Device News Magazine delivers the latest updates from the medical device and biotechnology sectors.
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Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook
Medtronic Receives CE Mark for Extravascular Defibrillator System That Treats Abnormal Heart Rhythms
The Medtronic Aurora EV-ICD system provides the life-saving benefits of traditional ICDs while avoiding certain risks because its lead (thin wire) is placed outside the heart and veins. The Aurora EV-ICD system is investigational in the United States.

Elysium Health Announces Addition of Nine Systems to Leading Biological Age Test INDEX™ Alongside Launch of Aging Research Center by Elysium Health™
“Epigenetic clocks have been a major advance for the aging field, as they enable the precise study of biological aging without requiring a protracted timeline,” said Elysium Health chief scientist and MIT professor Leonard Guarente, Ph.D.

Syqe Medical Announces Agreement with Israeli Ministry of Defence to Provide the SyqeAir Technology to Veterans
Hagit Kamin, CEO of SyqeAir Medical, said: It is our privilege to help veterans who mainly suffer from chronic pain and PTSD to establish a functioning daily routine for themselves, and we are honored for the opportunity to make a positive impact on their lives.
Stimulating the Brain: Here’s How You Can Cope With Depression
tDCS devices aren’t a replacement for mental health professionals or pharmaceuticals. Still, they’re medically-approved devices (in most instances) that can alleviate symptoms of depression and allow many to cope on a day-to-day basis.
Clinical Trials
Volta Medical Announces Completion of Patient Enrollment in TAILORED-AF Clinical Trial for Treatment of Atrial Fibrillation
Volta Medical notes: The TAILORED-AF clinical trial is an international, multicenter, randomized controlled study designed to confirm the clinical significance of VX1 and lay the groundwork for establishing VX1 as a new standard of care for persistent AF ablation.
Study Unravels Interplay Between Sleep, Chronic Pain and Spinal Cord Stimulation
The study, published in the journal Stereotactic and Functional Neurosurgery, successfully established minimally clinical important difference ranges for the insomnia severity index outcome measure to help gauge improvement in insomnia after spinal cord stimulation.
Clinical Study Shows Vista.ai Significantly Reduces Cardiac MRI Scan Time
The findings show that Vista.ai’s AI-guided image acquisition software improves cardiac MRI (CMR) scan times and achieves high adoption rates by hospital imaging staff. Dr. Kwong will discuss the learnings and implications of the study at an interactive breakfast symposium at 7:20 a.m. PST on Jan. 27, 2023, at the SCMR Scientific Sessions in San Diego.
Biotechnology News
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How Bionic Clothing is Focused on Revolutionizing Access for Individuals of All Abilities – By Jeremiah Robison, Founder and CEO of Cionic
In 1974, we were introduced to Colonel Steve Austin, an astronaut who became the world’s first “bionic” man after a test flight crash. He was

How Magnetoencephalography is Optimising Neurosurgery
Magnetoencephalography is often overlooked by physicians during the referral stage. Read Professor Stefano Seri MD, FRCP views.

The Importance of Patient-centred Care in Diagnostic Radiography
To mark World Radiography Day (November 8, 2021), Dr Emma Hyde, Associate Professor in Diagnostic Imaging at the University of Derby and National Teaching Fellow, discusses the importance of patient-centred care in diagnostic radiography, and shares their research findings and a new educational resource. Read on.
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