Top News

Press Release | May 5, 2021
WASHINGTON, D.C. – A growing number of patient groups are expressing their support to the Centers for Medicare & Medicaid Services (CMS) of the Medicare Coverage of Innovative Technology (MCIT) rule that would allow Medicare to cover breakthrough medical technologies that treat chronic and debilitating conditions once the FDA approves or clears those treatments as safe and effective.
Press Release | May 4, 2021
WASHINGTON, D.C. – The MedTech Conference, powered by AdvaMed, will host its trademark award-winning programming and networking opportunities in a new hybrid structure, combining the benefits of both in-person and virtual events, on September 27th – 30th. Attendees can participate in The MedTech Conference in a fully virtual environment, and they can also take advantage of limited-capacity in-person gatherings in Washington, D.C. and in Minneapolis, Minnesota.
Blog Post | April 27, 2021
Breakthrough technologies have the potential to turn our healthcare hopes into medical miracles: A next-generation gene sequencing test to detect advanced cancer, a wearable artificial kidney, and an eye scanner that can diagnose Alzheimer’s disease are all real innovations in the regulatory pipeline. Unfortunately, that’s no guarantee that they’ll reach patients. The current coverage and reimbursement landscape is standing in their way.

Events

May
10
May 10, 2021 to May 12, 2021 | Online
Please join us virtually from May 10-12, 2021 for the 13th Annual FDA/AdvaMed Medical Device Statistics Issues Conference. This annual conference brings together leading authorities from FDA,... Read More
May
19
May 19, 2021 | Online
Throughout the COVID-19 pandemic, a unique type of leadership has been critical towards effectively navigating and responding to this extraordinary  challenge. Leading during an uncertain, ever-... Read More
May
25
May 25, 2021 |
What are the key digital health trends in China? How does risk class classification for the NMPA (former CFDA) work? Are there any fast-track regulatory pathways? What are the latest updates... Read More
May
27
May 27, 2021 | Online
Innovation continues to accelerate in pediatric medtech and digital health, solving unmet needs and improving outcomes, despite a challenging environment for developing new products for pediatric... Read More
May
27
May 27, 2021 | Online
Innovation and product development is costly. But when organizations get it right, it does more than just generate returns on investment. A strong I&PD strategy can help medtech companies drive... Read More

Industry News

MY01 provides the necessary immediate and timely information (1) to aid physicians in monitoring patients at-risk of developing Compartment Syndrome.(2)   MONTREAL, May 6, 2021 /PRNewswire/ - MY01 Inc. is on a mission to empower healthcare professionals with the ability to pre-empt severe medical conditions, improving patient outcomes. MY01 inc. today announced U.S. Food and Drug Administration 510(k) clearance for the MY01 Continuous Compartment Pressure Monitor with full Bluetooth...
San Diego— March 8, 2021 — iAssay, Inc., and DDTD (Drugs & Diagnostics for Tropical Diseases), a 501(c)(3) nonprofit, have signed a Memorandum of Understanding (MOU). DDTD is a mission-driven organization to develop accurate, affordable, mass-market treatments and diagnostics for low-resourced and under-served organizations. This step enables organizations to provide DDTD’s high performance COVID-19 serology tests along with automatic digitized reads that are transmitted simultaneously and...
SALT LAKE CITY--(BUSINESS WIRE)--O2TODAY ("O2TODAY"), a mask company that develops, manufactures and commercializes face masks for medical and non-medical uses, and SINTX Technologies, Inc. (NASDAQ: SINT) (“SINTX” or the “Company”) (www.sintx.com), an original equipment manufacturer (OEM) of silicon nitride ceramics, announced today they have entered into a worldwide exclusive licensing agreement. O2TODAY expects to release their first consumer mask integrated with SINTX’s silicon nitride...
BOSTON, Jan. 20, 2021 -- Haemonetics Corporation (NYSE: HAE) ("Haemonetics"), a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, today announced that it has entered into a definitive agreement to acquire privately-held Cardiva Medical, Inc., ("Cardiva") an industry-leading manufacturer of vascular closure systems based in Santa Clara, California. Under the terms of the agreement, Haemonetics will acquire Cardiva for an...
Washington, Jan. 14, 2021 (GLOBE NEWSWIRE) -- Today, the U.S. Small Business Administration announced 38 companies, seven organizations and 14 individuals as the winners of the prestigious Tibbetts Award for their accomplishments in creating cutting-edge technologies. The Tibbetts Awards, named after Roland Tibbetts, the founder of the SBIR Program, honors these awardees for the exceptional successes they achieved through SBA’s Small Business Innovation Research (SBIR) and Small Business...

Twitter Feed

May 7, 2021 - 4:56pm
There are breakthrough solutions that can help treat traumatic brain injury, emphysema, heart disease, and… https://t.co/tesxho0isB
May 7, 2021 - 1:58pm
leverages existing FDA legal authority through the Breakthrough Devices Program to identify promising… https://t.co/djgW40c61B