onmedic news

Auditors: FDA needs to boost cybersecurity

Federal auditors say the FDA needs to ramp up its cybersecurity efforts in order to deter hackers.

Federal auditors have determined the FDA needs to ramp up its cybersecurity efforts in order to deter hackers.

Auditors for the U.S. Health & Human Services Dept.'s Inspector General's Office tested many of the FDA's IT systems in the wake of a security breach last October that exposed approximately 14,000 user accounts.

Dept. of Health & Human Services (HHS), Food & Drug Administration (FDA)

News Well, Cybersecurity/Hacking, Regulatory/Compliance

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ReFlow has new Wingman35 in U.S. market

ReFlow Medical announced FDA clearance for its Wingman35 crossing catheter.

On the heels of CE Mark approval in Europe, ReFlow Medical announced FDA clearance for its Wingman35 crossing catheter and said it has already been used in California vascular clinics.

Food & Drug Administration (FDA), ReFlow Medical

News Well, 510(k), Catheters, Regulatory/Compliance

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Stealth hypertension startup Sympara Medical raises nearly $6m

Sympara Medical quietly secures $5.5 million in funding from a handful of investors as it develops a device to treat hypertension.

Stealthy Sympara Medical quietly secured $5.5 million in funding from a handful of investors for the hypertension device it's developing.

San Francisco-based Sympara disclosed the funding in a regulatory filing, after recording $4.3 million with the SEC in 2013.

Sympara Medical

News Well, Hypertension, Funding Roundup

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://www.massdevice.com/news/stealth-hypertension-startup-sympara-medical-raises-nearly-6m

Gynesonics wins FDA nod for VizAblate pilot trial

Gynesonics wins investigational device exemption from the FDA for a pilot trial of its VizAblate uterine fibroid treatment.

Gynesonics said it won an FDA investigational device exemption for its VizAblate system with an outpatient option for treating symptomatic uterine fibroids.

Food & Drug Administration (FDA), Gynesonics

News Well, Clinical Trials, Investigational Device Exemption (IDE), Gynecological

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Survey: Stroke still a mystery to many

Despite stroke being the 2nd leading cause of death worldwide, many people still don't recognize risk factors and warning signs, according to a new poll sponsored by Covidien and the World Stroke Organization.

Covidien, World Stroke Organization

News Well, Stroke

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Boston Scientific, Bard CEOs cool on consolidation

The CEOs of medical device companies Boston Scientific and C.R. Bard are cool on the consolidation trend in medtech, saying they don't see the need for mega-deals to grow their businesses.

Boston Scientific, C.R. Bard

News Well, MassDevice.com Earnings Roundup, 2014, Q3, Wall Street Beat

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://www.massdevice.com/news/boston-scientific-bard-ceos-cool-consolidation

Five major factors will determine the future of the medical device industry | Medtech Wall Street news for the week of October 20, 2014

Here's a look at some of the top Wall Street stories for medical device companies this week: 5 factors affecting the future of medtech; Medtech VC deals post double-digit increases in Q3; Breast implant maker Sientra sets IPO range; GE CEO Immelt: Global experience got Flannery the top spot at GE Healthcare; GI Dynamics proposes 1-for-10 reverse stock split

5 factors affecting the future of medtech

October 20, 2014 by Brad Perriello

A.T. Kearney, National Venture Capital Assn. (NVCA), PricewaterhouseCoopers (PwC), Sientra, Thomson Reuters, GE Healthcare, GI Dynamics

News Well, Wall Street Beat

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/ZJe7NP

dijous, 23 d’octubre del 2014

October 20, 2014 by Brad Perriello