EMA committee backs label change for GSK’s Relvar Ellipta asthma therapy

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  • Medical device startups: Here’s how you handle requirements

    Developing the product requirements is one of the most complex activities associated with product development, yet one of the most important.  Bill Betten, Betten Systems Solutions This is the third in a series of articles that discusses the design of innovative products in the highly regulated medical environment. The previous two articles focused on the […]

  • How does autonomous robotic surgery affect product liability?

    As more medical device manufacturers offer autonomous robotic surgery to their surgeon customers, traditional lines of legal defense most often taken by companies may change, according to experts from Nutter. David L. Ferrera and Melanie V. Woodward, Nutter Robots in surgery are not new. Indeed robots have been assisting surgeons for years, giving surgeons more […]

  • Medtech stories we missed this week: Jan. 26, 2018

    From Attune Medical receiving FDA 510(k) clearance to Synapse Medical having CE Mark approval, here are some medtech stories we missed this week but thought were still worth mentioning. 1. Attune Medical gets FDA 510(k) clearance Attune Medical announced in a Jan. 8 press releasethat it has received FDA 510(k) clearance for its EnsoETM model […]

  • The 5 biggest issues in patenting combo products

    Complexity and ownership issues make combination products a patenting labyrinth. Here are five key points to help you navigate the maze. David J. Dykeman and Roman Fayerberg, Greenberg Traurig The rise of personalized medicine has spurred another trend: the growth of combination products that blend biologics, drugs and medical devices to improve patient treatment. However, […]

  • FDA, FTC warn companies over deceptive opioid cessation products

    The FDA and the Federal Trade Commission have posted joint warning letters to companies that make and distribute opioid cessation products. The two watchdogs warned that the companies are illegally marketing their unapproved products as treatments or even cures for people with opioid addiction and withdrawal. Selling unapproved products as therapies for opioid addiction is […]

  • Why customer-centric marketing isn’t enough for medtech

    Customer-centric marketing has been a key pillar of marketing strategies across industries in recent years. But in medtech, the marketing ecosystem is a little more complicated. Rachel Mele, Vennli Customer-centricity has been a key pillar of marketing strategies across industries in recent years. In 2016, nine in 10 CMOs said their organizations were trying to become […]

  • How FDA’s digital health plan is shaking up its review process

    FDA is asking questions about how to overhaul digital health product regulation and relying on expertise within the industry to do so, according to Bakul Patel, FDA’s associate center director for digital health, who recently spoke with MDO. In late 2017, FDA launched the Digital Health Innovation Action Plan. Within that plan is a recipe […]

  • 3 secrets of medtech success from a true industry pioneer

    From stents to TAVR, Stanton Rowe has built a medtech legacy out of accomplishing the seemingly impossible. Here are three lessons from his career. Stanton Rowe has played a major role in two of the top medtech innovation success stories of recent decades: stents and transcatheter valve replacements. Listening to him speak at DeviceTalks West […]

  • Report: CMS nixes plans for pathway for expedited medical device coverage

    The Centers for Medicare & Medicaid Services has cancelled plans to create a new regulatory pathway that aimed to accelerate medicare coverage for medical devices, according to a ModernHealthcare report. The federal agency reportedly withdrew the proposition, known as Excite, from review at the White House’s Office of Management and Budget this month, nine months after […]

  • What should really trigger a CAPA?

    When should a problem with a medical device trigger a CAPA (Corrective Action and Preventative Action)? Jon Speer at Greenlight Guru has some thoughts.  Jon Speer, Greenlight Guru After years of working with medical device companies, we’ve found that there is a particular area that is often rife with issues for companies: CAPA (Corrective Action and Preventative Action). […]

  • 3M submits 510(k) for steam sterilization system

    3M has submitted an application to receive FDA 510(k) clearance for its Attest Super Rapid System for steam sterilization. The steam sterilization system can provide biological indicator results in 24 minutes. A faster readout time for steam will help improve patient safety while increasing workflow for sterilization professionals. “The focus of our sterilization science at […]

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