WASHINGTON, D.C. – Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement on the Department of Health and Human Services’ (HHS’s) progress on the agency’s “Regulatory Sprint To Coordinated Care,” as reflected in today’s proposed rule regarding the confidentiality of substance use disorder patient records:
Press Release | August 22, 2019
Press Release | August 2, 2019
WASHINGTON, D.C. – Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement on CMS’s FY 2020 Inpatient Prospective Payment System (IPPS) final rule:
Press Release | July 30, 2019
WASHINGTON, D.C. – Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement on CMS’s release Monday evening of proposed CY 2020 Medicare payment rules – including the CY 2020 Medicare Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center proposed rule and the CY 2020 End Stage Renal Disease (ESRD) Prospective Payment System (PPS) proposed rule – that would support patient access to medical technology innovation.
September 23, 2019 to September 25, 2019| Boston, MA
The MedTech Conference will bring together more than 3,000 attendees to network, conduct business, gain access to capital, and share insights in Boston, MA, from Sept. 23–25. Learn more about 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
Medical technology innovators are pioneering new devices and technologies for one reason alone—to improve and save the lives of patients. To that end, patient safety is at the heart of what we do. Learn more at safety.advamed.org.
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...
Ivenix Infusion System Receives FDA 510(k) Clearance; Poised to Revolutionize the Infusion Pump Industry
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...
August 23, 2019 - 4:01pm
August 23, 2019 - 3:01pm
“As former head of FDA’s Office of Device Evaluation, I know the hundreds of scientists, engineers and clinicians t… https://t.co/zHHPL5fvml