Digital health, artificial intelligence (AI), machine learning and more — these concepts continue to generate buzz in the medtech world. Last month, the FDA published guidance on clinical decision support (CDS) software. It helped to clear up what constitutes a medical device and what doesn’t. Early last year, the agency published a predetermined change control […]
Hogan Lovells
COVID-19 is here: Medtech may never be the same
The COVID-19 pandemic promises to change nearly every aspect of our lives — remote working, social distancing and Zoom-bombing likely will be part of our professional lexicon for years to come. But the pandemic also will bring big changes to the medtech industry, which got caught in the center of some political, geopolitical and yes […]
DeviceTalks Weekly: Ep. 3 – Deconstructing medtech’s alphabet soup – DPA, MDR, FDA are all in the news
In this week’s DeviceTalks Weekly, we’ll examine how governmental effort, both foreign and domestic, are hitting the medtech industry. Our guests include Tracy Eberly, CEO of Fang Consulting, a regulatory advisory group. Eberly will update listeners on what pushing back the MDR deadline could mean for medtech companies and why some companies may be less […]
FDA proposes enforcement discretion for medical device data systems
By Yarmela Pavlovic and Jennifer Henderson
Mako Surgical names new regulatory VP | Personnel Moves
Mako Surgical (NSDQ:MAKO) tapped Lawrence Gibbons to replace its regulatory affairs vice president, James Keller, who resigned effective Feb. 3.
Gibbons, 60, was most recently with Fisher & Paykel Healthcare (NZE:FPH), where he helped establish a manufacturing facility in Mexico and set up the quality system at the company’s New Zealand headquarters.
