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UPDATE: Silk Road Medical prices $120m IPO
Updated to include comment from CEO Erica Rogers Silk Road Medical late yesterday priced its initial public offering, looking to raise approximately $120 million. The Sunnyvale, Calif.-based company said it plans to float 6 million shares of its common stock at a price of $20 per share. The offering also includes a 30-day underwriters option to purchase an additional 900,000 shares of common stock. Silk Road Medical produces the Enroute transcarotid neuroprotection and stent system, which is intended for use during the transcarotid artery revascularization procedure, or TCAR. “The Enroute system is part of the devic...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Vascular Wall Street Beat Silk Road Medical Inc. Source Type: news

Using wearable devices in clinical trials
Brandy Chittester, chief of clinical operations, IMARC Globally, more than 325 million people own wearable, connected devices, and more than 2.5 billion own smartphones. Using wearable devices in clinical trials can bring huge benefits, however, there are also concerns. Here’s a look at how researchers are using wearable devices — and what you should consider before using them in your own research. How wearable devices are advancing medicine Right now, ClinicalTrials.gov, a global database of clinical trials, lists nearly 200 trials with “wearable devices” or “wearable technology” in the description. This in...
Source: Mass Device - March 12, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news

Terumo ’ s MicroVention wins FDA approval for Web brain aneurysm device
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today that it won pre-market approval from the FDA for the Web brain aneurysm device it acquired when it bought Sequent Medical back in 2016. Aliso Viejo, Calif.-based MicroVention said the PMA for the Web embolic coil covers the treatment of intracranial wide neck bifurcation aneurysms. “We are proud to offer our latest innovation to the neuroendovascular market in the United States with the introduction of the Web system, achieving the most rigorous standard of FDA approval through the PMA process,” MicroVention president & CEO Richard Cappetta sai...
Source: Mass Device - January 7, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Food & Drug Administration (FDA) Neurological Regulatory/Compliance MicroVention-Terumo Inc. Sequent Medical Source Type: news

Medtronic to pay $51m to settle Covidien, ev3 DoJ investigations
Medtronic (NYSE:MDT) said yesterday that it agreed to pay $50.9 million to settle a number of U.S. Dept. of Justice probes into marketing activities from companies it acquired, Covidien and ev3. Medtronic said that its subsidiary ev3, acquired when the Fridley, Minn.-based medtech giant picked up Covidien in 2015, agreed to plead guilty to a misdemeanor charge related to its marketing of the Onyx Liquid Embolic System, pay $17.9 million and adopt new compliance and reporting terms for three years. The charges relate to ev3’s marketing of the device for “unproven and potentially dangerous uses,” federal prose...
Source: Mass Device - December 5, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Legal News Medtronic Source Type: news

Neovasc touts Tiara TMVR success rate in study
A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation. Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study had had a previous aortic valve replacement. Such patients have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the TMVR anch...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiac Implants Cardiovascular Featured Replacement Heart Valves Research & Development Mayo Clinic neovasc Neovasc Inc. Source Type: news

Philips, AHA, UPMC launch $30m heart-focused venture fund
Royal Philips (NYSE:PHG) said late last week it is joining with the American Heart Association and UPMC to launch a $30 million heart-focused collaborative venture capital fund. The newly formed Cardeation Capital fund will support innovation in products for treating heart disease and stroke care. The fund will be managed by Aphelion Capital, with each major player contributing $10 million, Amsterdam-based Philips said. Cardeation Capital will look to invest in companies trying to treat cardiovascular diseases and stroke and their risk factors, including diabetes, according to Philips. “At Philips our goal is to imp...
Source: Mass Device - May 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Wall Street Beat American Heart Assn. royalphilips UPMC Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 15, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. FDA cuts could threaten medtech innovation: Here’s why The Trump administration’s proposed federal budget could hurt the speed and quality of FDA review times, says a top expert at Musculoskeletal Clinical Regulatory Advise...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news