- Unveiling the Future of Neuropathy Treatment: NEUBIE Device Shows Remarkable Results
- Fore Genomics Partners with Inocras to Launch Pediatric Genetic Health Screening and Newborn Sequencing
- Surmodics Announces Successful Early Clinical Use of Pounce™ XL Thrombectomy System, Suitable for Non-Surgical Removal of Thrombi and Emboli from Iliac and Femoral Arteries
- Rob Wojciechowski Named Chief Operations Officer of ELIQUENT Life Sciences
- RapidAI Secures FDA 510(k) Clearance for Groundbreaking AI 3D Head and Neck CTA Imaging: Lumina 3D™
- Study Highlights How C2N’s PrecivityAD2™ Blood Biomarker Test Use Improves Clinical Decision-Making in the Evaluation for Alzheimer’s Disease
- How AI is Transforming Vision Care | By Matthias Hofmann, Co-founder & CEO of Eyebot
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
RAIsonance, Inc. Announces BARDA Contract to Continue Development of the AudibleHealth Dx Diagnostic SaMD for COVID-19 and Influenza Through AI-Powered Cough Analysis
The contract consists of just over $749,000 allocated to the continued development of RAIsonance’s AudibleHealth Dx Diagnostic SaMD. The device is designed to analyze a user’s Forced Cough Vocalization (FCV) in the diagnosis of illness, with the current focus on both COVID-19 and Influenza.
Tivic Expands Bioelectronic Portfolio; Files Patent Application for New Approach to Non-Invasive Vagus Nerve Stimulation
Jennifer Ernst, CEO of Tivic. “This patent could advance the field of bioelectronic medicine with a more precise approach to the treatment of cardiovascular, neurological/psychiatric, and systemic inflammatory chronic health conditions without surgery, implants, or pharmaceuticals.”
SK Biopharmaceuticals Wins Red Dot Design Award for Wearable Devices
The Red Dot Design Award is one of the world’s top design competitions that recognizes products for their design, aesthetics, functionality, impact, and innovation.
Cook Medical Receives Vizient Contract for Endoscopy Devices
This new Vizient agreement becomes effective April 1, 2023. The agreement will include Cook’s full line of endoscopy medical devices, including Hemospray® Endoscopic Hemostat.
Clinical Trials
Over 1,000 Patients Enrolled in Landmark SELUTION DeNovo Study
SELUTION DeNovo compares the treatment strategy using a novel sirolimus drug-eluting balloon [DEB SELUTION], versus a limus drug-eluting stent [DES].
AI Accurately Identifies Normal and Abnormal Chest X-rays
An AI tool that can accurately differentiate between normal and abnormal chest X-rays would greatly alleviate the heavy workload experienced by radiologists globally.
New Study Shows High Patient Satisfaction and Outcomes After Outpatient Joint Arthroplasty at Academic Medical Centers
The study, “Patient Satisfaction and Outcomes following Outpatient Joint Arthroplasty in Academic Medical Centers,” presented at the 2023 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, also showed that patients had short discharge times and low readmission rates after outpatient total joint arthroplasty.
Biotechnology News
Our Experts – Byline Articles
Read Their Views & Share With a Colleague or Two!
The Burden of Venous Leg Ulcers and Limited Health Literacy
Successful medical recovery often relies on a patient’s ability to independently manage and actively improve their own health condition. Being able to do this effectively requires an adequate level of health literacy (HL) – the ability to understand and act on healthcare advice to help oneself recover effectively. Read Bernard Ross, CEO and founder, Sky Medical Technology views.
A Conflict in the Interpretation of the Medical Device Amendments: Developing a Preemption Test for Hybrid Medical Devices
In 1976, Congress passed the Medical Device Amendments (MDA) to charge the FDA with reviewing the safety and effectiveness of medical devices. The MDA heavily regulates high-risk medical devices that are capable of supporting human life through a premarket approval process. Read what a litigation associate in BakerHostetler’s Houston office advises.
Growing Trends and Solutions for Improving Liver Health Management
Author Jon Gingrich, CEO, Echosens North America writes, “Nonalcoholic fatty liver disease (NAFLD) is an asymptomatic and underdiagnosed disease that affects 37% of U.S. adults and 70% of individuals with Type 2 diabetes. Nonalcoholic steatohepatitis (NASH), the more severe form of NAFLD marked by inflammation and ballooning, can lead to hepatic fibrosis, cirrhosis, and hepatocellular cancer (HCC) if left untreated.” Read more.
Executives on the Move
FDA Medical Device Updates
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
Market Reports