Herrmann Ultrasonics is going to introduce two features to ensure more safety when changing welding tools within the production process at MD&M West this year. An RFID reader has been integrated into the tooling that guarantees that the right tool is installed for the production. Not only is it built into the sonotrode, but also […]
FDA Advisory Committees: Independent, Informed, Essential, and Evolving
By: Robert M. Califf, M.D. One of the most common concerns raised when I meet with medical leaders is the need to improve the function of FDA’s Advisory Committees (ACs). ACs play a key role in FDA’s decision-making process by providing independent expert advice on extraordinarily complex issues. Just as importantly, they offer a forum […]
Augmented reality will change the way you view surgery
Royal Philips, a leader in integrated image-guided therapy solutions, recently developed an augmented reality approach to spinal surgery, helping surgeons perform image-guided open and minimally-invasive surgery. When placing pedicle screws, the augmented reality (AR) technology had an overall accuracy of 85%, compared to the 64% accuracy of non-AR assisted surgical navigation. Ronald Tabaksblat, Senior VP and Business Leader Image Guided […]
Trump’s HHS pick defends ACA repeal and replacement
President-elect Donald Trump’s nominee for Health and Human Services Department secretary—Rep. Tom Price (R-Ga.)—maintained during a Senate committee hearing on Wednesday that the incoming administration wants to make sure everyone still has access to health insurance after an ACA repeal. But Price also presented a radically different version from the Obama administration when it comes to […]
Introducing IMEDS, a public-private resource for evidence generation
By: Robert M. Califf, M.D. FDA has been working to establish a national resource for FDA-approved medical products that can be used by public and private-sector entities, including regulated industry, to conduct large scale evaluations of safety issues in an environment that is secure and protects patient privacy. These evaluations include epidemiologic studies of medical […]
Donald Trump: 5 questions medtech needs to ask
From tax breaks to Obamacare repeal, medtech companies are likely due to experience major changes under President Donald Trump. The situation, though, remains unpredictable. “I don’t think that there has been a scenario, not since I’ve been a professional and in politics, where we really know so little about exactly what the key priorities are […]
Final guidance issued by FDA for IDE benefits and risks
By Stewart Eisenhart, Emergo Group Final guidance from the US Food and Drug Administration lays out key factors the agency uses to assess benefits and risks of Investigational Device Exemption (IDE) applications for medical device clinical trials. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
South Korean medical device regulatory changes updates
By Stewart Eisenhart, Emergo Group Enforcement dates for various new and updated medical device regulations in South Korea have now gone into effect, according to Emergo consultants in Seoul. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those […]
Medtronic, J&J and Stryker best places for medtech sales rep jobs
Medtronic, Johnson & Johnson and Stryker remain at the top of the list of best places to work in medical device sales, according to a MedReps.com survey of medical sales representatives. The survey polled more than 1,200 MedRep community members, with more than one-third of the voters favoring their current employers. The other two-thirds voted from […]
EarlySense wants to get its mobile health sensor into your home
Health monitor company EarlySense is expanding into the consumer space. The Waltham, Mass.–based company announced Tuesday that is has created a contact-free consumer health monitor that can share information on heart, breathing cycles, stress and sleep indicators with users and their families and caregivers. The Live by EarlySense is a two-part system that is similar […]
