Top News

Blog Post | July 3, 2019
Widespread concern has been raised about political misinformation, which can result in greater polarization between the parties or less trust in government. In many cases, however, the subject of misinformation is medical care, including the safety of FDA-approved or cleared medical devices and drugs. The result of this deception can be much more serious – including risk to health and even loss of life.
Press Release | June 20, 2019
The Advanced Medical Technology Association (AdvaMed) today announced that Jessica Lenard has joined the association as its Vice President for Government Affairs.
Press Release | June 7, 2019
Calls for Extending Negotiations, Exempting Medical Devices as Alternative Solutions


July 30, 2019 |
July 30, 2019 | 1:00 - 2:00 PM EST The ability to deliver products quickly with full confidence in quality can already feel like a balancing act between manufacturing and quality priorities. Add the... Read More
October 7, 2019 to October 8, 2019
| Washington, DC
Click here for the agenda FDA and industry experts are coming together to review the basics of 510(k) submissions. This unique opportunity will help you better understand the FDA perspective on 510(k... Read More
October 9, 2019 | Washington, DC
Click here to view the agenda During this interactive workshop, FDA and industry experts will lead you through the regulatory and practical guidelines governing when an investigational device... Read More
October 10, 2019 to October 11, 2019
| Washington, DC
Click here to view the agenda Completing the set of interactive submissions workshops, industry and FDA experts will lead you through the strategic considerations and practical steps of filing a... Read More
October 22, 2019 to October 23, 2019
| Arlington, VA
View and download the full agenda here Whether you have recently taken on compliance responsibilities, are about to set up a new compliance structure, are in the midst of revamping your existing... Read More

Industry News

LOS ANGELES--(BUSINESS WIRE)--MedTech Innovator, the premier nonprofit accelerator in the medical technology industry, today announced the 50 companies selected to participate in the organization’s flagship four-month program, featuring leading-edge device, diagnostic, and digital health technologies from around the world. These best-in-class startups will receive unparalleled visibility and access to leading manufacturers, providers, investors, and other industry stakeholders. “We take great...
Aimed at reducing medication errors and related healthcare costs, Ivenix prepares to bring its infusion system to the $4.7 billion North American infusion market BOSTON, June 11, 2019 – The U.S. Food and Drug Administration (FDA) has issued 510(k) clearance for the Ivenix Infusion System, ushering in a new era of infusion systems designed to make infusions safer, while lowering the total cost of ownership. Ivenix looks to disrupt the $4.7 billion North American infusion market, which has been...
FDA clearance marks key regulatory milestone and advances commercial strategy for launch in U.S. hospital market in 2019 FORT LAUDERDALE, Fla.--(BUSINESS WIRE)-- Motus GI Holdings, Inc., (NASDAQ: MOTS) ("Motus GI" or the "Company"), a medical technology company dedicated to improving clinical outcomes and enhancing the cost-efficiency of colonoscopy, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the second-generation Pure-Vu® System (“...
Toronto, CA -- Perimeter Medical Imaging, Inc. (“Perimeter Medical”) announced today that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the second generation of their platform imaging tool used in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization. Enhancements to the newly cleared OTIS™ 2.0 system over the previous generation include:  A novel specimen positioning...
CAMPBELL, Calif. -- Tioga Medical, a newly formed Shifamed portfolio company, announced today the closing of its Series A preferred stock financing, raising a total of $15M. Tioga Medical was founded to provide physicians and patients with an elegant transcatheter valve replacement experience that is procedurally simpler and less invasive than current mitral or tricuspid approaches, many of which require transapical access, intricate device sizing regimens, and/or excessive bulk in the...

Twitter Feed

July 16, 2019 - 11:01am
“Rarely do the House and Senate agree on anything, but in the case of the medical device tax repeal they do.” It’s…
July 15, 2019 - 12:02pm
The medical device tax runs contrary to Congress’ expressed goal of fueling small business expansion and economic g…