Eudamed development on schedule

By Ronald Boumans, Emergo Group European regulators appear on track to launch the Eudamed database for medical devices in March 2020, but stakeholder accessibility may take longer than that. 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

Charting the FDA’s course for 2018-2020

By: Jeff Shuren, M.D., J.D. Since 2012, we at the Center for Devices and Radiological Health have set as our North Star the vision of patients in the U.S. having access to high-quality, safe, and effective medical devices of public health importance first in the world. “First in the world” is not about a competition

Webinar: The top medtech stories of 2017

This webinar was presented live on Tuesday, January 30, 2018. Click below to watch on demand.     The medtech industry saw its transformation accelerate in 2017: Whether it’s the roster of largest companies, business models or the regulatory environment, times are a-changing. Competition is also heating up in areas including diabetes care and robotic

FDA delays contentious medical device intended use rule

By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration has indefinitely delayed implementation of part of a final rule covering intended use determinations by the agency following industry questions and concerns. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are

Crystal IS UVC LEDs compliant with ISO 10993-5 Cytotoxicity

Crystal IS recently announced that its Klaran HC UVC LEDs are the first high performance UVC LEDs to be ISO 10993-5 Cytotoxicity compliant. The company’s Klaran HC products have previously been tested and proved to be biocompatible to be used in Class I and Class II medical devices that need an FDA 510(k) submittal. Crystal

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

FDA announces deadline for UDI compliance for low-risk medical devices

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has formally pushed back some Unique Device Identification (UDI) compliance deadlines by two years for qualifying low-risk medical devices. 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

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 […]