Ensuring medical devices are shielded from cybersecurity threats is, in the words of the U.S. Food and Drug Administration, a "shared responsibility" among all stakeholders. Medical technology companies, hospitals, physicians, IT professionals, providers, regulators and patients all need to work together so that the safety and integrity of interconnected medical devices – everything from pacemakers and ICDs to monitors and infusion pumps – is not compromised due to cyber threats.
Blog Post | April 20, 2018
AdvaMed Applauds Summit of the Americas' Focus On Importance of Business Ethics and Good Regulatory Practices
Press Release | April 20, 2018
Lima, Peru – The Advanced Medical Technology Association (AdvaMed) issued the following press release following the recent conclusion of the VIII Summit of the Americas in Lima, Peru on April 14.
Press Release | April 17, 2018
Washington, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker on FDA’s Medical Device Safety Action Plan:
May 8, 2018 | Washington, DC
The 2018 ASA AdvaMed Statistical Conference will bring together leading scientists to present and lead discussions on important statistical challenges in precision medicine. We invite interested... Read More
May 9, 2018 to May 10, 2018| Washington, DC
Join us for the 11th year of the Annual FDA-AdvaMed Medical Devices and Diagnostics Statistics Conference. This annual conference brings together leading authorities from FDA... Read More
May 10, 2018 |
A key question at the end of a company’s pivotal trial is, “Did we make our endpoints?” While demonstrating safety and effectiveness important, sponsors may be missing an even more important question... Read More
June 12, 2018 to June 13, 2018| Washington, DC
During this workshop you'll establish a clear understanding how the regulatory affairs function is pivotal to every recall and every team decision. After partaking in ... Read More
June 19, 2018 | Minneapolis, MN
Join us June 19 for a day-long conference in Minneapolis hosted by the AdvaMed Women’s Executive Network. The conference will feature two tracks: A Morning Industry Track will highlight the... Read More
Ricky Payne, a father of three, experienced a heart attack during his son's football game. Doctors were able to take stress off his heart and help with long-term recovery using life-changing medical technology.
Helius Medical Technologies, Inc. Announces Uplisting to Nasdaq and Pricing of Public Offering of Class A Common Stock and Warrants
Helius Medical Technologies, Inc.
NEWTOWN, PA., April 11, 2018 - Helius Medical Technologies, Inc. (“Helius” or the “Company”) today announced the pricing of an underwritten public offering of 2,141,900 shares of its Class A common stock and warrants to purchase 2,141,900 shares of its Class A common stock at a public offering price of US$7.47 per share and accompanying warrant, before underwriting discounts and commissions. The net proceeds to the Company from this offering, after deducting the underwriting discounts,...
California-based Myoscience, Inc. announced today that it received 510k clearance from the US FDA for Smart Tip with Nerve Stim, the latest innovative tip for Myoscience’s iovera° platform technology. With the FDA clearance for Smart Tip with Nerve Stim, physicians will be able to stimulate a nerve in advance of delivering iovera° cold therapy to the treatment area, reducing patient treatment times. Additionally, the use of Smart Tip with Nerve Stim enables physicians using iovera° to access...
It sometimes strikes without warning. People of any age, race, ethnicity and gender are at risk. In fact, it is the leading killer of both men and women in America. It is heart disease, and each year it claims the lives of over 600,000 Americans, accounting for one-quarter of all deaths in the United States.
Boston Scientific commends the efforts of key champions in the U.S. House and Senate for their successful efforts to suspend the medical device tax, allowing the device industry to reinvest in work to benefit patients.
LINCOLNSHIRE, ILL. – Nov. 8, 2017 – Sysmex America announced today that its Sysmex XW-100 received clearance from the U.S. Food and Drug Administration (FDA)—making it the first Clinical Laboratory Improvement Amendments (CLIA)-waived, complete blood count (CBC) system. Once prepared for each day’s use, the XW-100 will allow health care professionals to provide patients with blood test results in as few as three minutes.
April 26, 2018 - 3:40pm
April 26, 2018 - 11:45am
Every day, more than 200 million Americans live active, healthy lifestyles because of medical technology. America’s… https://t.co/0uvTPrDzGn