Top News

Blog Post | April 20, 2018
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.
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:

Events

April
24
April 24, 2018 to April 25, 2018
| San Francisco, CA
Leading experts and innovators will come together on April 24-25, 2018 with key decision-makers to discuss the critical technology and business issues facing the future digital medtech landscape. ... Read More
May
08
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
09
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
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
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

Industry News

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,...
PR Newswire
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...
Media Planet
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
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.
Sysmex America
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.

Twitter Feed

April 23, 2018 - 3:05pm
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April 23, 2018 - 2:15pm
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