As a first step toward implementation of its recently established Safety and Performance Based Pathway for medical devices, FDA is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices:

In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of important steps to update its Medical Device Reporting (MDR) Program, says Dr. Jeffrey E. Shuren, MD, JD,...

A new house bill is set to end the medical device tax once and for all. H.R. 2207 was introduced in April — it’s goal to permanently repeal the medical device excise tax that was imposed as a provision of the Affordable Care Act in 2010.

When digital devices and technologies became the rule rather than the exception, FDA had to rethink its regulatory framework and evaluation process for getting these devices to market. In January, FDA issued its new Software Precertification (Pre-Cert)...

Making changes to a regulatory process is usually difficult, slow, and often painful — after all, it involves lots of bureaucracy and many “cooks in the kitchen.” But I’m encouraged by FDA’s recent announcement that it plans to modernize the 510(k) pathway. In...

The IoMT has ushered in a new era for connected medical technology. But battery life is often mentioned as one of the impediments to the advancement of IoMT. Batteries in medical devices need a long lifespan so that users aren’t having to...

With a 2020 deadline looming for the European Union’s Medical Device Regulation (MDR), medical device makers “lack understanding of the new rules that govern the ability to sell products in one of the world’s largest markets,” according to a survey...

In September, FDA granted de novo classification to two apps offered in the new Apple Watch Series 4, which the tech giant says have been “redesigned and re-engineered to help users stay connected, be more active, and manage their health in powerful new...

Earlier this year, FDA sent a challenge to the medical device industry: develop devices and diagnostics to help combat, prevent, and treat the opioid crisis.

New research has confirmed what device companies have been saying since the medical device excise tax was imposed on medical devices as part of the Affordable Care Act: the tax forced them to cut funding for research and development.

The medical device industry’s active M&A market and uncrowded investment space make it attractive for investors looking to get into healthcare. A recent report from Silicon Valley Bank (SVB) says that as a result, traditional...

I am truly excited about this month’s inaugural MedInnovation conference. It’s goal is to present a roadmap for getting innovative — and by that, I mean game changing — emerging technologies to market. This intimate forum will be a platform for the exchange of ideas...

A virtual reality system for training surgeons is gaining traction with major medical device companies looking to mitigate misuse and liability concerns.

A new interactive conference will address key strategies for the commercialization of emerging medical technologies, and its unique format will have you on the edge of your seat.

In December, we asked Medical Design Briefs readers to cast their ballot to choose from our 12 Products of the Month the technology they felt was the most significant new introduction to the design engineering community in 2017. This year, our two winners address two critical needs in medical device...

FDA is monitoring the emerging field of 3D printing and additive manufacturing, an area FDA once considered a “futuristic technology on the distant horizon.”

The integration of robotics into medical devices has seen explosive growth in recent years with new applications in areas such as prosthetics and rehabilitation, surgical, and even drug-delivery devices. A new report predicts that the medical robotics market will...

FDA has qualified the first tool under its new Medical Device Development Tool (MDDT) program. According to AAMI, after some 20 years of use, manufacturers of devices designed to address heart failure will no longer have to justify using the Kansas City Cardio­myopathy...

In this world of increasingly smart technology, the one place that interconnectivity is critical is in healthcare. Patients and their care givers should be confident that the devices that are “talking” to one another are doing so safely and without error.

The Future of Medical Manufacturing implementing automation. It is embracing 3D printing, Industry 4.0, the Internet of Things, artificial intelligence (AI), and even augmented reality — the layering of the physical and digital worlds.