Companion diagnostics (CDx) play a pivotal role in personalized medicine—one of the fastest growing areas of medicine. Regulation of CDx is fairly well established in western countries, but the east is not far behind. Here we look at current and on the horizon regulatory guidances and directives for CDx manufacturers seeking to enter the Asian markets.
Megan Coder, Vice President for Product and Policy at the Digital Medicine Society (DiMe), discusses the society’s new project aimed at researching global regulations for digital health to create a foundation for approval and patient access that can cut across regions.
Understanding the latest trends, tools and challenges in access management empowers cybersecurity professionals to make better choices in safeguarding their systems. Following we look at emerging trends, regulatory requirements and how shifts in the workplace are impacting the risk of cyber attacks.
For life sciences companies seeking to develop, deploy and successfully commercialize digital health products and solutions, the pathway to success can have many twists, turns and roadblocks. This article examines some of the major challenges to bringing digital health products to market and explores potential opportunities to ease the journey.
While the road ahead might be unpredictable, the core dynamics of the life sciences sector and the coming expiry of patents worth over $100 billion are poised to drive a renaissance in biotech mergers and acquisitions.
Previous EU regulatory acts did not cover products without an intended medical purpose—typically devices with aesthetic indications. This now changes with Annex XVI of the EU Medical Device Regulation (MDR). Notified Bodies can assess these products for their conformity with the regulation. However, responsibility for proactively pursuing the EU certificate of conformity for the products rests with the manufacturers.
As VP of Product Marketing for a MedTech startup, my role is to champion pioneering medical technology, strategically spark interest and drive it out of the design lab and into the field where it will ultimately change, or even save lives. Over the last two decades, I’ve seen the industry evolve in interesting ways, and I’ve learned some enduring lessons about market introduction and launch of market-making technologies post-FDA clearance.
The recent Supreme Court ruling in Amgen v. Sanofi reminds patent practitioners that the scope of disclosure defines what has been enabled and that purely functional claiming can be problematic.
A recent study from Ethicon and the Cleveland Clinic outlined opportunities and barriers to better sustainability practices in operating rooms. We spoke with Vishnu Kalra, President, U.S. Ethicon, to learn more about the study’s findings, Ethicon’s efforts to develop more sustainable products and practices, and how other companies can get started.
Device manufacturers may see the EU MDR extension as an opportunity to take their collective feet off the gas. But slowing down or pausing a device’s testing program could jeopardize a successful transition and exacerbate the problem the deadline extension was designed to fix.