As one of the most impactful regulatory updates to the EU medical device market in recent years, the European Union’s Medical Device Regulation 2017/745 (MDR) has been a hot topic of conversation since it entered into force in May 2017.
How a 1969 Battery Ad Inspired a Medical Device Invention
The year was 1969 and Robert Fischell was lying on the couch in his living room, reading IEEE Spectrum, a magazine published by the Institute of Electrical and Electronics Engineers, when he saw an advertisement that would lead to one of the world’s greatest medical device inventions.
Medtronic Cuts Guidance After Disappointing Q223
Medtronic today announced its second quarter fiscal 2023 financial results, reporting it delivered better than expected earnings but saw disappointing revenue numbers……
3M Cuts Outlook Despite Strong 3Q22 Earnings
Overseas sales and divestitures are the culprits behind 3M cuttings its outlook for 2022, despite posting better-than-expected earnings for 3Q22. The overseas sales drop is a result of a stronger dollar……
The moon landing was a giant leap in more ways than Neil Armstrong could probably have imagined when he took that historical first step on July 20, 1969. The medtech industry, for example, owes at least five major technological advancements to the Apollo 11 mission.
What’s Trending in the World of Medtech Materials
Klein spoke ahead of the show about what participants can expect from the panel. (Editor’s note: Responses are from Klein’s personal perspective as a medical materials engineer, and not as an official representative of AtriCure or SPE.)
What are the advantages of silicone 3D printing?
Prototyping is the first application that comes to one’s mind when referring to 3D printing. A use which makes sense regarding today’s sustainable development issues.
Maximizing the Value of AI in Cancer Care
Cancer treatment has come a long way in recent years and is now evolving more rapidly through the integration of artificial intelligence (AI) tools, such as machine learning (ML).
Designing for Human Factors Standards
Medical device usability and how to efficiently integrate new regulatory standards into the product development process seems to be on a lot of people’s minds at the moment.
Smart Toilet Seat Wins FDA Nod to Monitor Heart Rate
Casana has developed a unique way of measuring a person’s heart rate and oxygen saturation. The Rochester, NY-based company is measuring a patient’s vitals with its smart toilet, the Heart Seat.
How can antimicrobials prevent healthcare-associated infections?
In the past century, modern medicine has broken countless barriers towards a safer, more effective healthcare protocol.
These ear tubes with liquid infused materials may improve ear infection treatment outcomes
A research collaboration in Boston may have uncovered a design overhaul to improve outcomes for ear tubes known as tympanostomy tubes.
Sensors: The Heart of Minimally Invasive Equipment Technology
Through the years, minimally invasive equipment technology has grown exponentially, offering new ways for doctors to diagnose and treat their patients.
Stratasys and CollPlant Partner to Bioprint Breast Implants
When it comes to 3D printing in healthcare, a long-term goal has been to print human tissue that can potentially be grown into new organs. While 3D printing a new heart for a patient isn’t currently a reality, a growing number of companies are developing their own methods of printing tissue that can be used in implants, and, they hope, eventually organs.
Practical Strategies for Digitization and Integration in Medtech Manufacturing
Data science continues to evolve to support increasing demands for predictive insights and dynamic systems. The innovation in this field is welcomed and is changing all industry sectors, including medtech manufacturing.
Flexible Films for Medical Devices and Packaging—A Medtech Makers Q&A
Packaging for medical devices must accomplish a number of tasks. First, it must protect the device within from damage during transportation to the end user.
Don’t Fear the Audit: Benefits of Good Quality Practices
Quality is a loaded word. For the general public, it connotes excellence, value, worth—all of which we strive for in our business. But for some in the medical device industry, it’s about bureaucracy, liability, and conflict. Maintaining a quality management system (QMS) per the expectations of regulatory bodies can be time-consuming, confusing, expensive, and tedious.
Study Suggests Increased Number of PMA Supplements Increase Recall Risk
a study published in JAMA Network Open reported that high-risk medical devices whose manufacturers file supplements to the FDA so modifications can be made to PMA-approved products are 30% more likely to be the subject of any recall and high-risk Class I recall.
FDA Pilot Program Supports Streamlined Regulatory Submission Processes for Medical Device Manufacturers
The current U.S. regulatory framework for medical devices under the Center for Devices and Radiological Health (CDRH) includes extensive review of test protocols and results for each submission, a process that can be burdensome for both manufacturers and regulatory bodies.
Timeline Mystery for Updated EtO Rules
Thirty-six months (give or take a few) filled with controversy, legal battles, protests, anxiety, anger, and bewilderment—with likely more to come.
ResMed Completes Medifox Dan Acquisition for €958.6 Million
ResMed has completed its acquisition of Medifox Dan, a German provider for software solutions for out-of-hospital care personnel, for €958.6 million……
Medtech Could Be Bracing Itself for Another Huge Acquisition
Temasek Holdings could be looking to sell its Advanced MedTech unit, according to a report from Reuters……
Join in MedTech World, and communicate with more than 2000 global advanced suppliers.