The FDA announced the TEMPO pilot, an approach to encourage the use of digital technologies that meet people where they are.

The delivery of healthcare is currently undergoing unprecedented transformation. The speed and intensity with which this transformation is happening is the combination of underlying long-term trends, ...

To navigate increasingly complex global regulations and rising market expectations, organizations are embracing the Intelligent MedTech Lifecycle: a unified, data-driven approach that breaks down ...

When it comes to testing, the most significant difference between CSV and CSA is that CSV focuses on a “test everything” approach, while CSA encourages us to use critical thinking to test more ...

Titanium has become a vital material in modern medicine due to its strength, light weight, corrosion resistance, and exceptional biocompatibility with high long-term success rates and minimal risk of ...

Infographics can propel MedTech research and campaigns and enhance the user experience. Here Fabricio Pamplona, co-founder of online infographic maker for scientists Mind the Graph, explores the power ...

The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry’s ability to make technology a ...

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 ...

Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s ...

The use of Radio-Frequency Identification (RFID) technology in healthcare, particularly within closed-loop systems, presents complexities, including potential limitations on interoperability that can ...

As medical device costs continue to be a growing area of hospital expenditures, many hospitals control the savings through device reprocessing programs. The shift toward planned obsolescence is ...

A recent project conducted by Northeastern graduate students looked at device recalls over the past five years and some of the common threads. In 2018, the top causes of recalls were software, ...