Page 40 - Breakthrough Device News Today

(Photo by Sebastian Kaulitzki/Getty Images) Those keeping an eye on the digital therapeutics industry over the last several years likely remember the name Dthera Sciences. The startup and its CEO Ed Cox became one of the developing spaces many standard bearers around 2018. During that timeframe it landed a Breakthrough Device designation from the FDA for its Alzheimers symptoms treatment, with Cox chairing a handful of industry networking events through the following months. But despite t...

Medtronic Announces First Procedures in Pivotal Trial to Evaluate Novel Ablation Technology in Treating Atrial Fibrillation Study Will Determine the Safety and Effectiveness of Pulsed Electrical Fields to Interrupt Irregular Heart Rhythms Medtronic plc the global leader in medical technology, today announced the first procedures in the investigational device exemption pivotal trial to evaluate the PulseSelect ™ Pulsed Field Ablation System, a novel, breakthrough technology that uses pulsed el...

Novel cartilage regenerative product, Chondro3 is a biomimetic graft for osteochondral lesions The Company's second FDA Breakthrough Device designation granted in 2021 Locate Bio, an orthobiologics

/PRNewswire/ -- Medcura, Inc., a commercial-stage medical device company, announced today that it has been awarded a $2M follow-on grant to expand its...

Vice President, Head of Investor Relations Good morning and welcome to Medtronics Fiscal Year 2021 Third Quarter Earnings Video Webcast. Im Ryan Weispfenning, Vice President and Head of Medtronic Investor Relations. Before we start the prepared remarks, Im going to share with you a few details to keep in mind about todays webcast. Joining me today are Geoff Martha, Medtronic Chairman and Chief Executive Officer; and Karen Parkhill, Medtronic Chief Financial Officer. Geoff and Karen will provide...

Share this article Share this article PORTLAND, Ore., Feb. 23, 2021 /PRNewswire/ -- Inovise Medical today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its AUDICOR ® heart failure management system. The system uses clinically tested algorithms to detect the risk of decompensation at home in patients who have been previously hospitalized for heart failure. Inovise Medical, Inc. Michael Mirro, MD, Director of the Parkview Mirro Center for ...

FDA Clears Coronary Intravascular Lithotripsy to Breakup Calcified Lesions With Sound Waves  Shockwave Medicals transformative technology now available for calcified coronary plaque A comparison showing angiography and optical coherence tomography (OCT) views of an undilated mid right coronary artery calcified lesion, post dilation with the Shockwave intravascular lithotripsy system, and the final result after stenting. The technology allows calcified lesions to be broken up without the need f...

Shockwave Intravascular Lithotripsy FDA Approved to Treat Advanced Heart Disease Transformative Technology Now Available for Calcified Coronary Plaque February 16, 2021 07:00 ET | Source: Shockwave Medical, Inc. Shockwave Medical, Inc. Santa Clara, California, UNITED STATES SANTA CLARA, Calif., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to trea...

The Shockwave intravascular lithotripsy system produces a flash of light as it releases a sonic shockwave, as seen here as it is about to shatter a gypsum bead during a TCT 2019 demonstration at the vendors booth. You can see the cracks forming as the bead breaks apart in the right bead. The technology combines a miniaturized lithotripsy system with a low-pressure balloon catheter to expand peripheral or coronary arteries without causing vessel trauma. Photo by Dave Fornell

To embed, copy and paste the code into your website or blog: On January 14, 2021, CMS finalized a regulatory definition for determining whether an item or service is "reasonable and necessary" for Medicare coverage purposes. Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary," 86 Fed. Reg. 2987 (Final Rule, January 14, 2021). In response to President Trumps October 3, 2019 Executive Order 13890 directing the Secretary of HHS to clarif...