Medical Device Regulations & Compliance
5 Steps To Eliminate Weak Links In Your Data Governance
Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.
September 2022 will be remembered as a seminal turning point in digital health in the U.S. With the FDA’s final guidance on Clinical Decision Support (CDS) software, the FDA disregards a Congressional directive when it enacted the 21st Century Cures Act in 2016.
Latin America is a compelling region to conduct medtech early feasibility studies due to its ethnically diverse population, its high rate of urbanization, and more. Here, the author spotlights Colombia, Brazil, and Mexico as the hotspots for medtech feasibility studies in Latin America.
To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?
Q-Submissions are a mechanism available to request feedback from the FDA. It is the pathway for a medical device sponsor to reach out to request a meeting or written responses related to a product’s regulatory strategy or testing plan. The time and money for a Q-Submission pales in comparison with what is needed to correct testing and regulatory strategies later on.
WHITE PAPERS & CASE STUDIES
The Dynamic Regulatory Environment Of Drug-Device Combination Products
Examine the dynamic regulatory environment of drug-device combination products and provides concrete steps to take to navigate regulatory complexities and decrease time to market.
Explore the urgent need for businesses to adopt strong data integrity practices and identifies measures for how to achieve and sustain compliance.
Learn how Meta Biomed implemented a solution to accelerate digital transformation, improve collaboration in a reliable, secure, and scalable cloud environment, and more.
Learn how to significantly lighten the software validation load for your cloud environment system with these eight key practices.
Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.
Edwards' Self-Expanding Transcatheter Heart Valve Receives CE Mark2/15/2018
Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, recently announced it has received CE Mark for its self-expanding CENTERA valve for severe, symptomatic aortic stenosis patients at high risk of open-heart surgery.
Arterys’ Oncology Imaging Suite With Deep Learning Cleared By FDA2/15/2018
Arterys Inc., the leader in intelligent, cloud-based medical imaging software solutions, recently announced its fifth 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Embrace Becomes First FDA-Cleared Seizure-Monitoring Smart Watch2/5/2018
Empatica Inc has received clearance from the FDA for Embrace, its award-winning smart watch. Embrace uses AI (advanced machine learning) to monitor for the most dangerous kinds of seizures, known as "grand mal" or "generalized tonic-clonic" seizures, and send an alert to summon caregivers' help.
FDA Clears Zimmer Biomet’s Total Shoulder Arthroplasty System1/3/2018
Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the Sidus® Stem-Free Shoulder system as a total shoulder arthroplasty solution for patients with good bone stock that have either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or who had previous surgeries of the shoulder that do not compromise the fixation.
K2M’s 3D-Printed Expandable Corpectomy Cage With Cervical Spine Indications Gains CE Mark12/20/2017
K2M Group Holdings, Inc.(NASDAQ:KTWO) (the "Company" or "K2M"), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it received a CE Mark for its CAPRI® Cervical 3D Expandable Corpectomy Cage System* featuring Lamellar 3D Titanium Technology™, and the successful completion of its first surgical case.
First Wire-Free Radar Breast Tumor Localization System For Long-Term Implant Cleared By FDA11/13/2017
Cianna Medical, Inc. has received FDA clearance of the SAVI SCOUT® reflector for long term implant. The SAVI SCOUT reflector is an integral part of the SCOUT system for wire-free breast tumor localization.
CardioFocus’ HeartLight Excalibur Balloon For AF Treatment Earns CE Mark10/27/2017
CardioFocus, Inc. today announced the European CE Mark approval of the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of atrial fibrillation (AF).
Acutus Medical’s Real-Time Cardiac Mapping Systems Cleared By FDA10/24/2017
Acutus Medical® today announced that the U.S. Food and Drug Administration has cleared the AcQMap® High Resolution Imaging and Mapping System and the AcQMap® 3D Imaging and Mapping Catheter for use in patients for whom electrophysiology procedures have been prescribed.
FDA Clears Game Ready’s Multi-Modality Recovery Device10/6/2017
The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary orthopedic rehabilitation device, the Med4 Elite™.
FDA Approves Implantable To Treat Central Sleep Apnea10/6/2017
The U.S. Food and Drug Administration today approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea.