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The 4 Essential Elements of Device Design Today
(Source: MDDI)
Source: MDDI - April 28, 2017 Category: Medical Equipment Authors: mthibault Tags: Design Services Source Type: news

Report: NAFTA renegotiations could spell trouble for US medtech industry
The North American Free Trade Agreement may not be facing the gallows after the Trump administration this week said it does not plan to terminate it – but changes to the deal could have a huge impact on the medical device industry, according to a New York Times report. This week, Trump spoke with Mexican Pres. Enrique Peña Nieto and Canadian Prime Minister Justin Trudeau and said he would start the process or renegotiating the deal, despite previous promises to eliminate it, according to the report. Medical device manufacturers were identified as a particularly vulnerable sector to renegotiation in the report, as t...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News integer-holdings Medtronic North American Free Trade Agreement (NAFTA) Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 28, 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. Boston Scientific looks to lead the drug-eluting PAD market Angioplasty is not a new procedure – doctors have been widening obstructed arteries with balloons since the 1960s. But for years the medtech industry has been plague...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Straumann inks distro deal, ups stake in Rodo Medical
Dental device developer Rodo Medical said today that it entered into a new distribution agreement with Straumann Holding, which has increased its stake in Rodo Medical from 12% to 30% for an undisclosed sum. The agreement will provide Straumann with exclusive distribution rights outside of North America and South Korea with an option to increase Straumann’s participation to 51% in 2021, San Jose, Calif.-based Rodo Medical said today. “Rodo’s ability to develop a revolutionary concept, turn it into a medical device and bring it to market is impressive. Their entrepreneurial and scientific approach to innov...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Dental Distribution Rodo Medical Straumann Holdings AG Source Type: news

12 interesting wearables you should know
Wearable technology is probably one of those things you probably didn’t need but still wanted because people were always talking about the devices. Fitbit, Apple and Garmin are some of the main providers of health and wellness wearables. Each of them touts being able to track your fitness activity or measures your heart rate. However, consumer wearables are not regulated by the FDA and therefore are not intended to be used as a medical device. Wearables, though, are now coming into their own in medtech, with a bunch of devices going through the regulatory and approval process at FDA. Academic researchers, meanwhile, con...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Biotech Cardiovascular Diabetes mHealth (Mobile Health) Patient Monitoring Research & Development Respiratory Cardiac Insight Devices Hill Rom Klick Labs MedTech Nemaura Medical wearables wireless devices Zoll Medical Corp. Source Type: news

Titan Medical spikes talks with Chinese distributor
Titan Medical (CVE:TMD) said today that it’s spiking talks with Chinese distributor Longtai Medical over its Sport robot-assisted surgery platform so it can focus on winning regulatory approvals in the U.S. and Europe. Back in October 2015, Toronto-based Titan inked a private placement deal with Longtai, a subsidiary of Chinese medical device distributor Ningbo Long Hengtai International Trade Co., that could have ended up being worth more than $24 million. Longtai put up a $2 million deposit toward the distribution deal, but now that talks have ended that money must be returned, Titan said. “We are focused...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Distribution Robot-Assisted Surgery Wall Street Beat Titan Medical Inc. Source Type: news

Use of Symbols in Labeling https://go.usa.gov/x5N3e   #fda #medicaldevice
Use of Symbols in Labeling https://go.usa.gov/x5N3e  #fda #medicaldevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 28, 2017 Category: Medical Equipment Authors: ( at FDADeviceInfo) Source Type: news

Navigating the World of Consumer-Med Devices
(Source: MDDI)
Source: MDDI - April 28, 2017 Category: Medical Equipment Authors: mthibault Tags: Mobile Health Source Type: news

Johnson & Johnson lands $260m Defense Dept. contract for orthopedic devices
The U.S. Defense Dept. yesterday awarded a Johnson & Johnson (NYSE:JNJ) unit a contract for orthopedic products worth nearly $260.5 million. The 1-year contract with Piscataway, N.J.-based Johnson & Johnson Healthcare System includes 4 1-year options; the total maximum value of the agreement covers the life of the contract including the option years, if exercised, according to the Pentagon. The deal calls for J&J to supply orthopedic products to the Army, Navy, Air Force, Marine Corps and federal civilian agencies. The contract is slated to expire April 27, 2022, the DoD said. The Pentagon also said it gran...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Orthopedics Resuscitation Johnson & Johnson Physio-Control U.S. Defense Dept. Source Type: news

Medtronic, Abbott could still seek exit from India ’ s high-end stent market
Medtronic (NYSE:MDT) and Abbott (NYSE:ABT) could take another run at taking their high-end stents off the Indian market, after the Indian National Pharmaceutical Pricing Authority this week rejected their applications to withdraw. Earlier this month, Medtronic and Abbott said they would look to withdraw select high-value coronary stents from the Indian market in light of cost caps imposed by the NPPA. Medtronic filed to remove its Resolute Onyx stent from the market, while Abbott filed to remove both its Absorb and Alpine stents. But the NPPA rejected the applications, requesting that the companies consider other op...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Stents Wall Street Beat India Indian National Pharmaceutical Pricing Authority (NPPA) Source Type: news

Leading Hospice Pharmacy Innovator, Delta Care Rx, Launches New DME...
Nurses can now order hospice durable medical equipment and pharmacy at the patient’s bedside from any smart phone, laptop, or tablet. The single point of access integrates with existing EMR solutions.(PRWeb April 28, 2017)Read the full story at http://www.prweb.com/releases/2017/04/prweb14288270.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - April 28, 2017 Category: Pharmaceuticals Source Type: news

Merit Medical sees shares rise in after hours trading on Street-topping Q1
Shares in Merit Medical (NSDQ:MMSI) have risen in after hours trading today after the medical device maker beat expectations on The Street with its 1st quarter earnings. The South Jordan, Utah-based company posted profits of $14.8 million, or 32¢ per share, on sales of $171.1 million for the 3 months ended March 31, for bottom-line growth of 240.2% while sales grew 23.9% compared with the same period last year. Adjusted to exclude 1-time items, earnings per share were 28¢, well above the 23¢ consensus on The Street, where analysts were looking for sales of $163.9 million. “Our management team is pleased with our p...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Merit Medical Systems Inc. Source Type: news

ResMed Shares dip on Q3 release despite meeting EPS expectations
ResMed (NYSE:RMD) saw shares fall today in after hours trading after the medical device maker posted 3rd quarter earnings that met earnings per share expectations, but fell short on revenue. The San Diego-based company posted profits of $87.8 million, or 62¢ per share, on sales of $514.2 million for the 3 months ended March 31, for negative bottom-line growth of 3.3% while sales grew 13.3% compared with the same period in the previous year. Adjusted to exclude 1-time items, earnings per share were 71¢, just in line with expectations on The Street, where analysts were expecting to see sales of $519.9 million. “We h...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup ResMed Inc. Source Type: news

Tandem misses on Q1 earnings, beats rev estimates
Shares in Tandem Diabetes (NSDQ:TNDM) fell today after the medical device maker missed earnings expectations on Wall Street with its 1st quarter results, but beat revenue estimates. The San Diego-based company posted losses of -$23.8 million, or -75¢ per share, on sales of $18.9 million for the 3 months ended March 31, for bottom-line loss of -13.9% on sales loss of -6% compared with the same period last year. Get the full story at our sister site, Drug Delivery Business News. The post Tandem misses on Q1 earnings, beats rev estimates appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations MassDevice Earnings Roundup Pharmaceuticals Wall Street Beat Tandem Diabetes Care Source Type: news

NovoCure shares rise on Q1 EPS beat
Shares in NovoCure (NSDQ:NVCR) rose today after the medical device maker beat losses per share expectations on Wall Street with its 1st quarter earnings results. The St. Helier, Jersey-based company posted losses of $18 million, or 21¢ per share, on sales of $34.9 million for the 3 months ended March 31, seeing bottom-line losses shrink 49.1% while sales grew a massive 167.2% compared with the same period in 2016. Losses per share were ahead of the 24¢ consensus on The Street, while sales fell just short of expectations of $37 million. “Our growth continued in the 1st quarter 2017. It was the ninth consecutive qua...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup NovoCure Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 27, 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. Avedro raises $42m, opens new Mass-based manufacturing facility Avedro said today it raised $42 million in equity and debt financing and opened a new manufacturing facility in Burlington, Mass. The equity financing was led by H...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

#TBThursday: Medieval torture device or life-saving paramedic equipment? Learn more here: https://www.flickr.com/photos/fdaphotos/33495865113/in/album-72157624615595535/   … pic.twitter.com/pvYaLMi4AA
#TBThursday: Medieval torture device or life-saving paramedic equipment? Learn more here: https://www.flickr.com/photos/fdaphotos/33495865113/in/album-72157624615595535/ … pic.twitter.com/pvYaLMi4AA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 27, 2017 Category: Medical Equipment Authors: ( at US_FDA) Source Type: news

UPDATE: Integra Lifesciences shares down on Q1 release
Updated to correct the company who filed the report – previously identified Integer Holdings. Shares in Integra LifeSciences (NSDQ:IART) fell today slightly after the medical device maker posted 1st quarter earnings that met expectations on Wall Street. The Plainsboro, N.J.-based company posted profits of $6.4 million, or 8¢ per share, on sales of $258.6 million for the 3 months ended March 31, for a bottom-line slide of 52.4% while sales grew 9.2% compared with the same period last year. After adjusting to exclude 1-time items, earnings per share were 39¢, meeting the 39¢ consensus on The Street, where analysts...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Integra LifeSciences Corp. Source Type: news

Working to Raise Awareness and Reduce Health Disparities. A new post celebrating #NMHM17 & the work by @FDAOMH https://go.usa.gov/x599v   pic.twitter.com/6gOxRkMjuT
Working to Raise Awareness and Reduce Health Disparities. A new post celebrating #NMHM17 & the work by @FDAOMH https://go.usa.gov/x599v  pic.twitter.com/6gOxRkMjuT (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 27, 2017 Category: Medical Equipment Authors: ( at US_FDA) Source Type: news

Surgical robots: Hospital CTO talks differentiators in new crop of competitors
For the last 10 years, if anyone mentioned robotic surgery or surgical robots, 95 percent of the time they meant the da Vinci robot from Intuitive Surgical. “That product has been so dominantly successful that almost everybody who talks about it is talking with that as their reference point,” said Roger Smith, chief technology officer for Florida Hospital Nicholson Center. Smith’s primary work involves researching the effectiveness of surgical robots. Smith said that in the last several years, a few surgical robot companies have come onto the scene and are vying for market share. In the realm of abdominal or thoraci...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Heather Thompson Tags: Blog Devices Intuitive Surgical laparoscopy Medical Device Business Medical Equipment medical robotics minimally invasive Robotic Systems surgical robotics TransEnterix Source Type: news

Critic questions FDA ’s handling of Essure product complaints
FDA continues to update how it is informing the public about the controversial Essure permanent birth control device from Bayer. But at least one prominent critic sees holes in FDA’s efforts. “Many women are still being implanted with the device without adequate warnings of the risks associated with the device,” attorney Holly Ennis wrote in an April 20 blog post. Essure is a small metal coil that is implanted in the fallopian tubes via catheter. In 2015, FDA reported that in the 13 years since Essure’s approval, the agency had received 5,093 complaints, including for pain or menstrual irregularities after usi...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Heather Thompson Tags: Blog Bayer Essure FDA Implantables Medical Device Business permanent birth control postmarket Regulatory Source Type: news

BREAKING: Senate panel approves FDA nominee Gottlieb
A U.S. Senate panel voted today to approve Dr. Scott Gottlieb to lead the FDA, sending his nomination to the full Upper Chamber for a confirmation vote. The Senate Health, Education, Labor & Pensions Committee approved Gottlieb on a 14-9 vote. The full Senate is also expected to approve the nomination. Gottlieb, 44, is a former FDA deputy commissioner who has advocated a loosening of requirements needed for approval of new medical products. He is also a resident fellow at the conservative American Enterprise Institute think tank, a partner at venture capital firm New Enterprise Assoc., and sits on the boards of mult...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Wall Street Beat Capitol Hill Source Type: news

A Report From EMS 3.0 Summit 2017
Across the Potomac River from our nation’s capital, EMS leaders and visionaries gathered April 24, 2017 in Arlington, VA to discuss the future of EMS within the United States. Organized by the National Association of Emergency Medical Technicians (NAEMT) and in part sponsored by JEMS, the 2017 EMS Transformation Summit explored likely changes and key components of tomorrow’s EMS, also known as “EMS 3.0.” Matt Zavadsky, chief strategic integration officer, MedStar Mobile Health (Fort Worth, TX) and JEMS MIH Editor, served as moderator of the Summit’s agenda.  In his opening remarks, Zavadsky captured the sco...
Source: JEMS Administration and Leadership - April 27, 2017 Category: Emergency Medicine Authors: William K. Atkinson, PhD, MPH, MPA, EMT-P Tags: News Administration and Leadership Source Type: news

A Report From EMS 3.0 Summit 2017
Across the Potomac River from our nation’s capital, EMS leaders and visionaries gathered April 24, 2017 in Arlington, VA to discuss the future of EMS within the United States. Organized by the National Association of Emergency Medical Technicians (NAEMT) and in part sponsored by JEMS, the 2017 EMS Transformation Summit explored likely changes and key components of tomorrow’s EMS, also known as “EMS 3.0.” Matt Zavadsky, chief strategic integration officer, MedStar Mobile Health (Fort Worth, TX) and JEMS MIH Editor, served as moderator of the Summit’s agenda.  In his opening remarks, Zavadsky captured the sco...
Source: JEMS: Journal of Emergency Medical Services News - April 27, 2017 Category: Emergency Medicine Authors: William K. Atkinson, PhD, MPH, MPA, EMT-P Tags: News Administration and Leadership Source Type: news

SurModics misses on Q2 earnings, narrows outlook
Shares in SurModics (NSDQ:SRDX) fell today after the medical device maker missed earnings expectations on Wall Street with its 2nd quarter results and narrowed its full-year outlook. The Eden Prairie, Minn.-based company posted profits of $506,000, or 4¢ per share, on sales of $17.5 million for the 3 months ended March 31, for bottom-line loss of -38% on sales growth of 5% compared with the same period last year. Get the full story at our sister site, Drug Delivery Business News. The post SurModics misses on Q2 earnings, narrows outlook appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations MassDevice Earnings Roundup Wall Street Beat SurModics Inc. Source Type: news

How The Oceans Became Choked With Plastic
Imagine an area 34 times the size of Manhattan. Now imagine it covered ankle-deep in plastic waste — piles of soda bottles and plastic bags, takeout containers by the mile, drinking straws as far as the eye can see. That’s a total of about 19 billion pounds of garbage. And according to one of the best estimates available, that’s how much plastic waste ends up in our oceans every year. “We’re being overwhelmed by our waste,” said Jenna Jambeck, an environmental engineer who led the 2015 study that determined this staggering number. According to Jambeck’s research, this figure is on...
Source: Science - The Huffington Post - April 27, 2017 Category: Science Source Type: news

The Oceans Are Drowning In Plastic -- And No One's Paying Attention
Imagine an area 34 times the size of Manhattan. Now imagine it covered ankle-deep in plastic waste — piles of soda bottles and plastic bags, takeout containers by the mile, drinking straws as far as the eye can see. That’s a total of about 19 billion pounds of garbage. And according to one of the best estimates available, that’s how much plastic waste ends up in our oceans every year. “We’re being overwhelmed by our waste,” said Jenna Jambeck, an environmental engineer who led the 2015 study that determined this staggering number. According to Jambeck’s research, this figure is on...
Source: Science - The Huffington Post - April 27, 2017 Category: Science Source Type: news

Let ’s Design for People as Consumers, Not Patients
(Source: MDDI)
Source: MDDI - April 27, 2017 Category: Medical Equipment Authors: MDDI Staff Tags: Design Services Source Type: news

Jury verdict to cost Cardiovascular Systems $25 million
A California jury has awarded a former Cardiovascular Systems Inc. employee $25.1 million in damages after finding the company wrongfully terminated him. Steven Babyak, a former CSI regional sales manager, sued the medical-device maker in 2015. He claimed the company fired him after he voiced concerns that CSI was paying kickbacks to doctors and violating other laws. The jury awarded Babyak $2.7 million in general damages and $22.4 million in puni tive damages. In a regulatory filing, New Brighton-based… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - April 26, 2017 Category: American Health Authors: Katharine Grayson Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 26, 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. Baxter sees shares lift on Street-beating Q1 earnings release Baxter shares have risen today after the medical device company topped expectations on Wall Street with its 1st quarter earnings results. The Deerfield, Ill.-based c...
Source: Mass Device - April 26, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

NuVasive shares tumble despite beating Q1 EPS forecast
Shares in NuVasive Inc. (NSDQ:NUVA) fell today more than 4% after the medical device maker posted 1st quarter earnings that topped EPS estimates but fell short on sales. The San Diego, Calif.-based company posted profits of $12.8 million, or 22¢ per share, on sales of $249.9 million for the 3 months ended March 31. The company saw sales grow 16.2% compared to last year while its profits shot up from the red, having reported losses of $3.4 million during the 1st quarter of 2016. After adjusting to exclude 1-time items, earnings per share were 38¢, just in line with the 38¢ consensus on The Street. Revenue fell just shor...
Source: Mass Device - April 26, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Nuvasive Source Type: news

Underwriters Laboratories acquires Emergo Group
Global safety science company Underwriters Laboratories (UL) has acquired Emergo, a privately held firm that provides regulatory services and market access services to medical device manufacturers. The financial details of the acquisition were not disclosed. The acquisition, announced yesterday, combines UL’s range of services to support global regulatory approvals for the health sciences industry with Emergo’s medical device registration expertise. Get the full story on our sister site, Medical Design & Outsourcing.  The post Underwriters Laboratories acquires Emergo Group appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 26, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Business/Financial News Mergers & Acquisitions Emergo Group UL Underwriter's Laboratories Source Type: news

MITA backs proposed device regulation consistency
The Medical Imaging and Technology Alliance (MITA) is applauding bipartisan...Read more on AuntMinnie.comRelated Reading: MITA praises Aetna for covering CT colonography Industry groups laud new medical imaging bill MITA testifies at medical device user fee hearing MITA: MedPAC offers no new proof of imaging overuse MITA applauds bill to repeal medical device tax (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - April 26, 2017 Category: Radiology Source Type: news

Baxter sees shares lift on Street-beating Q1 earnings release
Baxter (NYSE:BAX) shares have risen today after the medical device company topped expectations on Wall Street with its 1st quarter earnings results. The Deerfield, Ill.-based company posted profits of $272 million, or 50¢ per share, on sales of $2.48 billion for the 3 months ended March 31. The company saw its bottom line shrink 92% while sales grew 4.2% compared with the same period in 2016. After adjusting to exclude 1-time items, earnings per share were 58¢, just ahead of the 53¢ consensus on The Street, where analysts were looking for sales of $2.43 billion for the quarter. “Encouraged by a solid start to 201...
Source: Mass Device - April 26, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Baxter Source Type: news

Stryker shares steady on Street-topping Q1 earnings
Shares in Stryker (NYSE:SYK) have stayed steady today after the medical device maker slimly topped expectations on Wall Street with its 1st quarter earnings results. The Kalamazoo, Mich.-based company posted profits of $444 million, or $1.17 per share, on sales of $2.96 billion for the 3 months ended March 31. That equates to bottom-line growth of 10.4% while sales grew 18.4% compared with the same period last year. After adjusting to exclude 1-time items, earnings per share were $1.48, just ahead of the $1.43 consensus on The Street, where analysts were looking for sales of $2.9 billion. “Our positive momentum conti...
Source: Mass Device - April 26, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Stryker Source Type: news

Edwards shares rise on Beat-and-Raise Q1
Shares in Edwards Lifesciences (NYSE:EW) rose today after the medical device maker topped expectations on Wall Street with its 1st quarter results. The Irvine, Calif.-based company posted profits of $230.2 million, or $1.06 per share, on sales of $883.5 million for the 3 months ended March 31, for bottom-line growth of 61% while sales grew 26.7% compared to the same period in 2016. Edwards earnings per share handily topped the 82¢ consensus on The Street, and revenue came in well above the $777.8 million expectations from analysts. “Our 1st quarter continued a trend of exceptional growth for Edwards at both the to...
Source: Mass Device - April 26, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Edwards Lifesciences Source Type: news

A Look at Current Technology to Prevent and Detect Sepsis
(Source: MDDI)
Source: MDDI - April 26, 2017 Category: Medical Equipment Authors: MDDI Staff Tags: IVD Source Type: news

Proxy Biomedical rebrands as Aran Biomedical
Proxy Biomedical said today it will now operate under the new group company and brand Aran Biomedical. The Galway, Ireland-based company said the new identity is part of a rebranding and restructuring strategy “to position the company in line with the broader range of capabilities now servicing key growth markets of cardiovascular, general surgery and orhtopaedics.” Aran said that the rebranding comes after a significant expansion of its facilities and upgrades to production equipment. “The company has grown and diversified significantly from its origins, servicing the General Surgery market. Establishing...
Source: Mass Device - April 25, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News aran biomedical Source Type: news

Why You Must Know the Difference Between ' Intended Use ' and ' Indications for Use '
(Source: MDDI)
Source: MDDI - April 25, 2017 Category: Medical Equipment Authors: Jamie Hartford Tags: Regulatory and Compliance Source Type: news

Biotech company's R & D, execs migrating to Twin Cities
British biotech company Collagen Solutions is consolidating its research and development operations in the Twin Cities about a year after hiring a Minnesota-based CEO. The business, which makes collagen products and biomaterials for use in medical devices and research, has identified prospective sites for a R&D facility in the southwest metro area, said CEO Jamal Rushdy in an e-mail. Rushdy, a former Tornier executive, works out of Collagen Solutions’ office in Eden Prairie along with three other… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - April 25, 2017 Category: Health Management Authors: Katharine Grayson Source Type: news

Biotech company's R & D, execs migrating to Twin Cities
British biotech company Collagen Solutions is consolidating its research and development operations in the Twin Cities about a year after hiring a Minnesota-based CEO. The business, which makes collagen products and biomaterials for use in medical devices and research, has identified prospective sites for a R&D facility in the southwest metro area, said CEO Jamal Rushdy in an e-mail. Rushdy, a former Tornier executive, works out of Collagen Solutions’ office in Eden Prairie along with three other… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 25, 2017 Category: Biotechnology Authors: Katharine Grayson Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 25, 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. ALung submits FDA IDE app for HemoLung device ALung Technologies said today it submitted an investigational device exemption application to the FDA as it seeks to begin a clinical study of its Hemolung Respiratory Assist System...
Source: Mass Device - April 25, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

How medtech companies can benefit from agile marketing
[Image from unsplash.com]Getting a medical device to market can be tough. It has to go through several hoops at the FDA, including the 5-step premarket requirements that include: classifying the device; choosing the correct premarket submission; preparing appropriate information for premarket FDA submission; sending a premarket submission to the FDA and communicating with FDA staff during review; and completing the device establishment listing and registration. Once approval or clearance is reached, medical device companies can begin to market their products to their target audience. Angela Hill, CEO of Incitrio Marketing...
Source: Mass Device - April 25, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Pre-Market Approval (PMA) agile marketing incitriomarketing medical device marketing MedTech Source Type: news

Beware of products for people & pets claiming to cure cancer on websites or social media. #fdahealthfraud http://go.usa.gov/x5kpv   pic.twitter.com/YjvocY6JOw
Beware of products for people & pets claiming to cure cancer on websites or social media. #fdahealthfraud http://go.usa.gov/x5kpv  pic.twitter.com/YjvocY6JOw (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 25, 2017 Category: Medical Equipment Authors: ( at US_FDA) Source Type: news

San Antonio biotech company expanding its presence in combat medicine
Prytime Medical Devices Inc. has taken another big step in the commercialization of its flagship product — the ER-REBOA Catheter. The San Antonio-based company made an agreement with Combat Medical Systems to market its products to a larger market. The new deal will give Combat Medical the exclusive right to sell Prytime Medical’s ER-REBOA and other technologies it may produce to the U.S. military and to the federal government. Prytime Medical President and CEO David Spencer said the deal is… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - April 25, 2017 Category: American Health Authors: W. Scott Bailey Source Type: news

Here ’s how much NuVasive’s 5 highest-paid executives earned
The five highest-paid executives at NuVasive Inc. each pulled in nearly $2 million in compensation last year, with an average of $3 million each. San Diego-based NuVasive (Nasdaq: NUVA) is a medical device manufacturer in the middle of setting up a $45 million manufacturing facility in West Carrollton. That facility will be where all of its medical implants and other devices around the world are produced. By the end of this year it plans to have 300 employees working there. Here are NuVasive’s… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 25, 2017 Category: Biotechnology Source Type: news

Medical Device Alert: BD Plastipak 100ml catheter tip syringe with Luer slip adaptor
The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a medical device alert for specific lots of BD Plastipak 100ml catheter tip syringe with Luer slip adaptor manufactured by Bec (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - April 25, 2017 Category: Drugs & Pharmacology Source Type: news

m.Doc Connects Mobile Ultrasound to its mHealth Platform
Holistic medical services at the "point of care" - anytime and anywhere! That is what the Cologne-based start-up m.Doc is promising to deliver, via software that enables the transfer of data from medical devices, wearables and classic apps to the m.Doc digital health platform. As of now, that also includes data from the Vscan Extend mobile ultrasound device made by GE Healthcare under a partnership arrangement. (Source: eHealth News EU)
Source: eHealth News EU - April 25, 2017 Category: Information Technology Tags: Featured Industry Business and Industry Source Type: news

Neural Interface Research Moves Forward, Inside and Outside Silicon Valley
(Source: MDDI)
Source: MDDI - April 25, 2017 Category: Medical Equipment Authors: MDDI Staff Tags: Research and Development Source Type: news

SSCOR Is Very Pleased and Excited to Announce That as of January 2017, Ross I. Baum Is Our New Director of Marketing
April 24, 2017   Ross has an extensive history marketing medical devices and supplies.  He served as Director of Marketing for Promed and Bound Tree Medical before founding Carson Marketing Group to serve the marketing needs of many healthcare companies.   We are excited to have Ross’ commitment to quality, desire to learn and grow, and work ethic at SSCOR as we continue to make Clearing the Airway our #1 Priority! (Source: JEMS Operations)
Source: JEMS Operations - April 24, 2017 Category: Emergency Medicine Authors: SSCOR Tags: Industry News Operations Source Type: news