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FEATURE ARTICLE

Thomas Ring

Designing Compliant Wireless Medical Devices

By Thomas Ring

Medical Electronic Products of the future will be largely free from wires and cables, aside from a power source. “Wireless medical devices” offer numerous advantages. However, they are also subject to extensive legal regulations governing aspects such as the radio technology used in them. In addition, they may have to be assessed by a Notified Body such as TÜV SÜD.  

MTI Regulatory Summit

MTI Regulatory Intelligence and Networking Summit – REGISTER NOW!
The MTI Regulatory Intelligence & Networking Summit is an intimate and interactive forum designed to help regulatory leaders and their organizations recognize and understand key trends, challenges, and solutions impacting the strategy, execution, and monitoring of MedTech regulatory process and compliance. If you you wish to share your experience and knowledge, please submit an abstract for a session.

FEATURES

March 18, 2024
Marie Hattar

Designing Wearable Healthcare Devices We Can Trust

By Marie Hattar

As the proliferation of wearable healthcare devices expands in terms of application and availability, they’re also becoming smaller and more powerful. In turn, testing and validation in the design phase is becoming increasingly complex.

March 13, 2024
Shawn Luke

Bringing MedTech Innovation to Life

By Shawn Luke

While the MedTech industry continues to face significant challenges related to regulatory requirements, cybersecurity issues, recalls and lawsuits, leaders in the industry are navigating and overcoming these areas to push innovation forward like never before.

March 11, 2024
Karim Aly

Breath-based Analysis: Revolutionizing Disease Screening for a Healthier Tomorrow

By Karim Aly

Traditional screening tests suffer from a range of challenges. From logistical barriers to concerns regarding accuracy and reliability, achieving accurate diagnosis is frequently arduous. Imagine a revolutionary approach where early disease screening becomes as simple as collecting a breath sample. Thanks to cutting-edge sensor technology and advanced artificial intelligence, this vision is now on the brink of realization.

March 6, 2024
Post-market surveillance

Enhancing Post-Market Surveillance: Strengthening Medical Device Regulation in the UK

By Celegence

Post-market surveillance plays a critical role in the UK’s medical device regulatory framework. Manufacturers must prioritize establishing a comprehensive PMS system, developing clear and organized PMS plans, and promptly reporting incidents and corrective actions.

March 6, 2024
Hologic Genius Digital Diagnostics System

Hologic AI-Based Genius Diagnostics System Enters U.S. Market

By MedTech Intelligence Staff

In February, Hologic received FDA clearance for its Genius Digital Diagnostics System, which combines advanced imaging with AI-assisted review for cervical cancer screening. We spoke with Mike Quick, who led the development of the technology, and Dr. Hans Ikenberg, director of one of the first labs to work with the system.

March 6, 2024
Sanobar Syed

Overcoming Forecasting Challenges in Cell and Gene Therapies

By Sanobar Syed

Predicting the potential of cell and gene therapy pipelines presents unique challenges. Following are considerations for forecasters working with novel technologies.

February 28, 2024
Thomas Ring

Designing Compliant Wireless Medical Devices

By Thomas Ring

Medical Electronic Products of the future will be largely free from wires and cables, aside from a power source. “Wireless medical devices” offer numerous advantages. However, they are also subject to extensive legal regulations governing aspects such as the radio technology used in them. In addition, they may have to be assessed by a Notified Body such as TÜV SÜD.

February 28, 2024
Ashwini Sharan

Closed-Loop Technologies Reduce the Burden of Chronic Pain

By MedTech Intelligence Staff

Ashwini Sharan, M.D., Chief Medical Officer of the Neuromodulation Division at Medtronic, discusses the development of the company’s recently CE Marked Inceptiv closed-loop spinal cord stimulator system for chronic pain and how the company plans to further incorporate closed loop technologies in its neuromodulation pipeline.

February 21, 2024
James Darlucio

Navigating Sterilization Options for Silicone Medical Implants

By James Darlucio

How to choose the right sterilization method for silicone-based medical devices and a look at novel silicone technologies.

February 13, 2024
Randy Horton

FDA-Cleared SaMD by the Numbers

By Randy Horton

Orthogonal worked with Brian Binkowski, to gain a clearer picture of the state of SaMD approvals in the U.S. Following is what they learned about the rate of FDA approvals and clearances and which companies are having the most success getting their products cleared for the U.S. market.

February 7, 2024
Steve Cumper

Top 5 Safety Hazards in Medical Device Manufacturing (and How to Reduce the Risk)

Manufacturing jobs can be dangerous, but knowledge is the first step to minimizing the risks associated with these positions. This article discusses five of the most common safety hazards in medical device manufacturing, with tips on how to reduce the risk of employee injuries while maintaining productivity.

January 31, 2024
Dhaval Shah

Care Beyond Walls: Six Digital Trends Shaping Health Care in 2024

By Dhaval Shah

Emerging technologies, integrated vendor ecosystems and enhanced regulatory compliance will redefine care delivery and shape the needs of healthcare stakeholders. Following are six healthcare technology trends that will shape care delivery and the MedTech market in 2024.

January 30, 2024
Clinical Evaluation

Role of Clinical Evaluation Report Consultants

By Anushree Singh

Ensuring the safety and efficacy of healthcare products is of utmost importance. The clinical evaluation process of medical devices is vital for demonstrating the device’s safety and performance in accordance with the regulatory requirements. How are device makers navigating this complex process effectively.

January 24, 2024
Neeraj Mainkar

Advancements in AI: Shaping the Future of Spine Surgery

By Neeraj Mainkar

While AI is already making significant contributions to pre-operative planning and post-operative analysis, its utilization intra-operatively remains a key area for further development. Collecting and utilizing comprehensive intra-operative surgical data, as facilitated by innovative applications of existing technologies such as light field, will pave the way for advanced AI applications in spine surgery.

January 17, 2024
PreciseDX

How AI Can Advance Breast Cancer Detection and Treatment

By Ted M. Diehl, Wayne Brinster

The integration of artificial intelligence (AI) into breast cancer detection and treatment is already making a profound impact. AI-powered algorithms enhance early detection by analyzing vast amounts of data and identifying subtle abnormalities often invisible to the human eye. These technologies empower healthcare professionals to make informed decisions, improving the accuracy of diagnoses and tailoring treatment plans to the specific genetic makeup and health conditions of individual patients. This integration represents a paradigm shift in the cancer care continuum.


MTI ON-DEMAND LEARNING

MTI On-Demand

ASK THE EXPERT

Caroline Irungu

Ask the Expert: Digital Continuity – Strategies for Product Recall Resilience

December 7, 2023 3:20 pm | By Inga Hansen

Class 1 recalls are at a 15-year high. To reduce the number of recalls and nonconformances, medtech manufacturers need quality management and traceability processes that go beyond documenting and tracking changes to effectively connect people, processes and data.  

Stefano Vicenzetto

Ask the Expert:  Improving Sustainability in Medical Device Manufacturing

November 28, 2023 2:32 pm | By Inga Hansen

Stefano Vicenzetto, Design Systems Engineer at Flex, shares his insights on how Circular Economy principles can be applied within the MedTech industry to reduce environmental impact by shifting away from the linear take, make and waste approach.

Dhirti Roy

Ask the Expert: Benefits and Challenges of the eStar Submission Process

November 20, 2023 11:00 am | By Inga Hansen

Companies must now electronically submit all FDA 510(k) submissions using the eSTAR platform. Dr. Dhriti Roy, vice president of Regulatory Affairs Transformation at Essenvia and faculty at Oxford University’s MedTech innovation platform, highlights the benefits and challenges of eSTAR, as well as processes and tools companies need to adopt as they transition to this new submission process.

Doug Donahue

Ask the Expert: Four Key Reasons Medical Device Manufacturers Should Be Looking at Mexico

October 25, 2023 12:16 pm | By Inga Hansen

The growth of the medical device industry brings increased competition and a need to find ways to become more efficient and cost-competitive, without compromising quality. In this column, Doug Donahue, Director of Foreign Direct Investment and Manufacturing for Guanajuato's Medical Device Cluster and co-managing partner of Entrada Group, discusses the benefits, challenges and opportunities available for companies investigating Mexico as a manufacturing site.

NEWS

March 17, 2024 1:09 pm
Artificial Intelligence Graphic

FDA Outlines its Approach to Artificial Intelligence Regulation

By MedTech Intelligence Staff

“Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development.

March 14, 2024 3:39 pm
EPA Logo

EPA Issues Final Rule on Ethylene Oxide Emissions

By MedTech Intelligence Staff

“We’ve arrived at a historically strong rule that will protect the most exposed communities from toxic air pollution while also ensuring that there will be a process that safeguards our nation’s critical supply of sterilized medical equipment.”

March 13, 2024 3:44 pm
MTI Newswire

Mayo researchers invented a new class of AI to improve cancer research and treatments

Mayo Clinic News Network/ -- In a review published in Cancers, the researchers note that this emerging class of AI offers an innovative way to use massive datasets to help discover the complex causes of diseases such as cancer and improve treatment strategies.

March 12, 2024 6:52 pm
FDA Logo

FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations

By MedTech Intelligence Staff

The new draft guidance proposes select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” and focuses on information FDA considers necessary to support obligations under section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.”

March 11, 2024 10:08 am
MTI Newswire

Early Diagnosis & Remote Monitoring Fuel Wearable Device Growth to US$84.8 Billion by 2034

NEWARK, Del./PRNewswire -- The wearable medical device market is poised for significant growth, with a projected CAGR of 8.20% from 2024 to 2034. This translates to an expected market value increase from US$ 38,580.9 million in 2024 to a staggering US$ 84,848.6 million by 2034.

March 5, 2024 9:11 pm
MedAccred Logo

MedAccred Program Makes Qualified Manufacturers List Publicly Available

By MedTech Intelligence Staff

Medtech stakeholders can now search for MedAccred accredited suppliers. Accredited companies included in the QML have achieved MedAccred Accreditation after meeting stringent critical process audit requirements set by MedAccred OEM Subscribers, which include Baxter, BD, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Roche Diagnostics, and Stryker.

March 5, 2024 4:47 pm
Cardio Diagnostics Holdings logo

USPTO Issues Patent for Risk Detection of Cardiovascular Disease   

By MedTech Intelligence Staff

Cardio Diagnostics announced issuance of new U.S. Patent for “Compositions and Methods for Detecting Predisposition to Cardiovascular Disease.”

March 5, 2024 4:43 pm
Award

Application Period Open for Excellence in Pursuit of Health Equity Award

By MedTech Intelligence Staff

The Joint Commission and Kaiser Permanente are accepting applications now through April 30 for the 2024 Bernard J. Tyson National Award for Excellence in Pursuit of Healthcare Equity. The award recognizes major achievements in improving healthcare disparities.

March 4, 2024 8:46 pm
Addressing engineering challenges in point-of-care diagnostic devices

Addressing engineering challenges in point-of-care diagnostic devices

By Flex

Discover what to consider when designing and manufacturing point-of-care diagnostic devices, including ensuring measurement accuracy and reliability, user-friendly operation, and scalable production with validated manufacturing processes.

February 27, 2024 5:43 pm
NIST logo

NIST Releases Updated Cybersecurity Framework

By MedTech Intelligence Staff

The National Institute of Standards and Technology (NIST) has updated its Cybersecurity Framework (CSF) guidance document for reducing cybersecurity risk. The new 2.0 edition is designed for all audiences, industry sectors and organization types. This is the framework’s first major update since its creation in 2014.


Upcoming Events & Webinars

April 9, 2024 – 2:00 pm – 3:00 pm
Japan Medical Device Registration & Reimbursement
June 3, 2024 – 8:00 am – June 5, 2024 – 4:00 pm
MTI Regulatory Intelligence and Networking Summit


On Demand Events & Webinars

December 5, 2023
Post-EU MDR Compliance: Key Insights and Activities to Maintain Compliance after Device Certification
November 30, 2023
Real-World Evidence: Not Just for PMCF
September 28, 2023
EU MDR & IVDR Lessons for Regulatory Strategy
September 26, 2023
Optimizing CER and PMS Document Writing with Technology and AI
September 21, 2023
Crossing the eSTAR Chasm: Transitioning to FDA’s Mandatory 510k eSTAR Submission Process by October 2023
September 12, 2023
Bridging the GAP Agile/Compliance
July 12, 2023
Accelerating Corrective Actions for Rapid Introduction of New Products: Strategies for Success
June 8, 2023
Not All Medical Products Are Created Equal. Harnessing the Power PLM!
June 6, 2023
Mastering EU MDR: Essential Strategies for Effective Risk and Document Management
April 20, 2023
Regulatory Strategy as Competitive Advantage









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