Driving Medical IoT Concepts with Force-Sensitive Resistor Technology
The Internet of Things (IoT) represents a growing wave of change that brings several new challenges to design engineers across all industries and markets. While it is a somewhat nebulous concept, IoT is broadly defined as a network of smart devices that communicate with one another wirelessly, with little-to-no direct human interaction. In general, physicians and patients are becoming more accepting of medical treatment methods that offer the best opportunity for patients to live a normal life. Human contact will always be an important part in all medical treatment, but the development of smart medical devices, systems, an...
Source: MDDI - July 18, 2018 Category: Medical Devices Authors: Rob Podoloff and  Andy Dambeck Tags: Digital Health Source Type: news

AngioDynamics to pay $12.5 million over false claims allegations: U.S. Justice Department
AngioDynamics Inc has agreed to pay the U.S. government $12.5 million to resolve allegations it caused healthcare providers to submit false claims to federal healthcare programs over the use of two medical devices, the Justice Department said on Wednesday. (Source: Reuters: Health)
Source: Reuters: Health - July 18, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Is Abbott Losing Share in Key Medtech Markets?
By and large, Abbott Laboratories had a phenomenal second quarter this year – and investors took notice. The company's stock hit its highest point since 1995 on Wednesday after beating Wall Street's quarterly expectations and raising its own outlook for 2018. Abbott, MD+DI's 2017 Medtech Company of the Year, clearly has a lot to celebrate as it continues to show the world what its made of. But at least one medtech analyst noticed that the company appears to have lost market share in cardiac rhythm management (CRM) and neuromodulation. Abbott reported CRM sales of $543 million in the second quarter, representing ...
Source: MDDI - July 18, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Cardiovascular Source Type: news

Syneron Candela wins FDA nod for Vbeam Prisma cosmetic laser
Syneron Candela said today it won FDA clearance for a next-gen version of its Vbeam, the Vbeam Prima cosmetic laser designed to treat skin conditions. The newly cleared device is intended for use in treating skin conditions including rosacea, port wine stains, acne, facial, leg and spider veins, scars, benign pigmented lesions and wrinkles, warts, stretch marks and photo aging, the Wayland, Mass.-based company said. “In a clinical study using Vbeam Prima, facial redness and rosacea symptoms were dramatically reduced after 4 treatments. I’ve worked with the Vbeam platform for years, and I am extremely excited ab...
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Food & Drug Administration (FDA) Regulatory/Compliance Syneron Medical Ltd. Source Type: news

Cognitive-focused dev Neuronetrix raises $2m
Cognitive disorder evaluation-focused developer Neuronetrix has raised $2 million in a new round of equity financing, according to a recently posted SEC filing. Money in the round came from eight anonymous investors, with the first sale noted on February 3. The Louisville, Ky.-based company is looking for an additional $3 million before closing the round, according to the filing. The company produces the FDA-cleared Cognision objective biomarker system designed to aid neurologists and physicians in differentiating between dementia and depression during diagnosis. The system also allows physicians to track disease progressi...
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neurological neuronetrix Source Type: news

Sterigenics expands in the UK
Sterigenics today announced plans to build a new facility in the Chesterfield/Derbyshire, U.K.’s Markham Vale North area as the company looks to expand its footprint in Europe. The 60,000 square-foot facility is expected to be completed by the fourth quarter of 2018, with plans to install a Nordion JS10000 gamma irradiator with a research loop, the Cleveland-based company said. The addition will add gamma sterilization capabilities to the company’s U.K.-based operations, in addition to its existing ethylene oxide facility in Somercotes/Derbyshire. Read the whole story on our sister site, Medical Design & Ou...
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Sterilization / Calibration Sterigenics International Inc. Source Type: news

FDA issues warning for Claris manufacturing site bought by Baxter
The FDA made public this week a warning letter that it sent to a Claris Injectables pharmaceutical manufacturing site earlier this month. Baxter (NYSE:BAX) acquired the Ahmedabad, India-based facility in its $625 million purchase of Claris Lifesciences‘ (BOM:533288) injectable drug business. The FDA noted that the site has twice invalidated out-of-specification results without thoroughly investigating the matter. Get the full story at our sister site, Drug Delivery Business News. The post FDA issues warning for Claris manufacturing site bought by Baxter appeared first on MassDevice....
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Baxter Claris Lifesciences Source Type: news

NIH director Collins touts AF detection capabilities of iRhythm ’ s Zio ECG patch
iRhythm Technologies‘ Zio ECG patch won praises from NIH Director Dr. Francis Collins this week for its ability to aid in the detection of atrial fibrillation. In an NIH Director blog post, Dr. Collins warned that while the dangers of atrial fibrillation are known, many individuals do not know they have atrial fibrillation and therefore cannot receive appropriate care. While doctors mainly screen for AFib by checking pulse, Dr. Collins recommended new mobile health technologies for detecting AF, including iRhythm’s Zio patch. Results from the mSToPS trial of the patch, which Dr. Collins referenced, indicated th...
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular iRhythm Technologies Inc. Source Type: news

National Guideline Clearinghouse to live on despite feds bowing out
The nonprofit that has run the recently shuttered National Guideline Clearinghouse (NGC) for 20 years plans to replace the website and run it privately. Funding to support the federal Agency for Healthcare Research and Quality’s (AHRQ) clinical practice guideline website ended on July 16. ECRI Institute, which developed and maintained NGC since its inception in 1998, announced it plans to launch an interim, subscription-based website in September, with “many additional features planned for the near future.” The initial site will enable users to search and retrieve ECRI’s summarizations of clini...
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog News Well ECRI Institute National Guidelines Clearinghouse NGC Source Type: news

OD-OS claims European ophthalmic-laser patent win over Iridex
Navigated retinal laser system developer OD-OS said this week it won a European patent spat with Iridex (NSDQ:IRIX) related to ophthalmological laser systems. The German company said that the European Patent office revoked Iridex’s MicroPulse patent, which will allow OD-OS to manufacture and market its Navilas laser system in the region. The Navilas system features a computer-assisted laser delivery system and digital documentation, the company said. OD-OS touted image-guided, pre-planned laser delivery allows for the application of confluent laser patterns without overheating, and that digital documentation all...
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Legal News Optical/Ophthalmic Patent Infringement Iridex Corp. od-os Source Type: news

HSCC announced today a new workstream, conducted under the Task Group, that will discuss and seek input on a software bill of materials (SBOM) for medical devices. SBOMs can ensure that users have better understanding of what software elements are in a medical device.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 18, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

THREAD: We ’ re proud to work with the public-private Healthcare Sector Coordinating Council ’ s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity: https://healthsectorcouncil.org/health-sector-mobilizes-against-cyber-threats/   …
THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity: https://healthsectorcouncil.org/health-sector-mobilizes-against-cyber-threats/ … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 18, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Cook Medical touts launch, first use of Advance CS, Compass CT systems
Cook Medical today announced the launch and first use of its Advance CS coronary sinus infusion catheter and Compass CT disposable pressure transducer designed for treating heart failure patients. The CS catheter is a percutaneous balloon infusion catheter designed for use in retrograde coronary sinus infusion procedures to infuse therapeutic agents into the heart via the coronary venous system, while the Compass CT pressure transducer monitors infusion pressure and pressure in the heart during the procedure, the Bloomington, Ind.-based company said. Read the whole story on our sister site, Drug Delivery Business News...
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Drug Pumps Cook Medical Source Type: news

Vallum wins FDA nod for nano-textured PEEKplus spinal implant
Vallum Corp said today it won FDA 510(k) clearance for its PEEKplus nanotextured spinal interbody fusion device, touting it as the first nanotextured PEEK interbody device to win an FDA nod. The Nashua, N.H.-based company’s PEEKplus nanotextured surface features nano-scale concavities of between 20 and 50 nanometers created by the impact of argon atoms across the existing PEEK microsurface. Vallum said that such nanotexturing below 100 nanometers has been shown to benefit osteoblast functions necessary to grow bone and promote fusion. “Receiving the first FDA clearance for a PEEK interbody fusion device incorpo...
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal vallum Source Type: news

Novartis posts Q2 beat, promises to hold off on drug price hikes
Shares in Novartis (NYSE:NVS) were up today after the company beat expectations on Wall Street with its second-quarter financial results. The Switzerland-based company posted profits of $7.77 billion, or $3.34 per share, on sales of $13.16 billion for the three months ended June 30. Novartis saw its quarterly sales climb 7% compared with the same period last year. Get the full story at our sister site, Drug Delivery Business News. The post Novartis posts Q2 beat, promises to hold off on drug price hikes appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: MassDevice Earnings Roundup Pharmaceuticals Wall Street Beat Novartis Source Type: news

Medtronic, GE Healthcare, Change Healthcare to share $33m in Israeli grants
Medtronic (NYSE:MDT), GE Healthcare (NYSE:GE) and Change Healthcare have received approximately $33.1 million (NIS 120 million) from the Israeli government to support expanding the companies R&D centers in the country, according to a CTech report. The grants are part of a six year, $264 million (NIS 922 million) program headed by the Israeli Ministry of Economy and the Israel Innovation Authority intended to promote digital health and accelerate the biomed industry in the country, according to the report. Healthcare software, analytics and network solutions dev Change Healthcare received a $5.5 million (NIS 2...
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Research & Development changehealthcare GE Healthcare Medtronic Source Type: news

FDA Hits Baxter with Warning Letter in Connection with Claris Acquisition
A full year after acquiring Claris Injectables, FDA has hit Baxter with a warning letter in connection with the agency’s inspection of the acquired facilities in Ahmedabad, India. Baxter added Claris to the pharmaceuticals side of its business last year and the $625 million deal is expected to provide a foundational growth platform for the company. FDA began an inspection of the Claris facilities the same day the deal closed, July 27, 2017, which resulted in a Form-483 noting several observations. The company responded to the 483 on Aug. 25 and said in a recent regulatory filing with the Securities and Exchange Commi...
Source: MDDI - July 18, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Business Source Type: news

Abbott Labs tops profit estimates, raises full-year earnings forecast
Abbott Laboratories raised its full-year earnings forecast and reported a quarterly profit that beat analysts' estimates, powered by higher sales across its businesses, including its top-earning medical device unit. (Source: Reuters: Health)
Source: Reuters: Health - July 18, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Abbott ’ s Q2 results top estimates, medical device sales up 11%
Abbott (NYSE:ABT) today reported second-quarter results that came in ahead of the consensus expectation, with its medical device division posting sales growth of more than 11%, and raised its earnings outlook for the rest of the year. The Chicago-area healthcare giant posted profits of $733 million, or 41¢ per share, on sales of $7.77 billion for the three months ended June 30, for profit growth of 159.0% on sales growth of 17.0% compared with Q2 2017. Adjusted to exclude one-time items, earnings per share were 73¢, two pennies ahead of Wall Street, where analysts were looking for sales of $7.71 billion. Abbott&r...
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat Abbott Source Type: news

Proposed medical device regulatory changes to Order No. 650 in China
By Teemo Chang and Stewart Eisenhart, Emergo Group The Chinese government has issued draft changes to the country’s medical device regulatory framework that would allow easier market access for foreign manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. The post Proposed medical device regulatory changes to Order No. 650 in China appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

Medical devices woes weigh on British conglomerate Smiths Group
Shares in FTSE 100 engineering company drop 7% (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - July 18, 2018 Category: Pharmaceuticals Source Type: news

Smiths Group medical unit hurt by EU medical devices regulation
Smiths Group Plc expects a 2 percent drop in full-year revenue at its medical unit, hurt by some products losing certifications under a new regulation and the loss of two contracts in the United States, it said on Wednesday. (Source: Reuters: Health)
Source: Reuters: Health - July 18, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Health Tip: Use Tampons Safely
-- Tampons -- cylindrical devices used to stem a woman's menstrual flow -- are regulated by the U.S. Food and Drug Administration as medical devices. The FDA offers these tips for safe tampon use: Follow all directions on the product's label. Wash... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - July 18, 2018 Category: General Medicine Source Type: news

Avenger receives FDA approval for Pantheris altherectomy device
Avinger (Redwood City, Calif.) recently received FDA approval for its Pantheris image-guided altherectomy device that is designed to treat peripheral artery disease (PAD). Pantheris is the first medical device to be approved for diagnostics and treatment of PAD. The device lets doctors see inside arteries to treat blockages. It features a built-in camera and can shave plaque without causing damage to blood vessels. The device can also be used by physicians to use the real-time intravascular imaging tool to identify features of blood vessels, include necrotic cores, fibroatheromas, calcium and stent struts. Get the full sto...
Source: Mass Device - July 17, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Avinger Source Type: news

Avinger receives FDA approval for Pantheris altherectomy device
Avinger (Redwood City, Calif.) recently received FDA approval for its Pantheris image-guided altherectomy device that is designed to treat peripheral artery disease (PAD). Pantheris is the first medical device to be approved for diagnostics and treatment of PAD. The device lets doctors see inside arteries to treat blockages. It features a built-in camera and can shave plaque without causing damage to blood vessels. The device can also be used by physicians to use the real-time intravascular imaging tool to identify features of blood vessels, include necrotic cores, fibroatheromas, calcium and stent struts. Get the full sto...
Source: Mass Device - July 17, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Avinger Source Type: news

Medical device, network security company CyberMDX bags $10M Series A
CyberMDX, a connected medical device and clinical network security firm, announced today that it has closed $10 million in Series A funding. The financing round was led by Pitango Venture Capital, with additional backing from OurCrowd Qure. The company ’s MDefend software product is deployed to a provider’s network, CyberMDX CEO Amir Magner told MobiHealthNews. The tool is non-intrusive, and doesn’t apply any software within the protected devices themselves. (Source: mobihealthnews)
Source: mobihealthnews - July 17, 2018 Category: Information Technology Source Type: news

NuVasive Launches Next-Gen Reline Spine Fixation System
NuVasive has launched its Reline MAS Midline (RMM), the next evolution of its Reline system designed to provide procedural versatility in a compact midline construct. The San Diego, CA-based company said the RMM incorporates extremely low-profile modular implants and advanced system instrumentation to address alignment and potentially reduce adjacent segment transition syndrome. The system, when combined with NuVasive access and interbody technologies, is designed to provide a minimally invasive approach to bilateral decompression under complete visualization, interbody fusion, and stabilization with pedicle scre...
Source: MDDI - July 17, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Orthopedics Source Type: news

Natus Medical lifts Kennedy to the corner office | Personnel Moves – July 17, 2018
Natus Medical (Nasdaq: BABY) said last week that its current CEO Jim Hawkins is retiring from their position, with current chief financial officer Jonathan Kennedy slated to take over as prez & chief exec. Kennedy has operated as CFO since April 2013, while the retiring Hawkins spent 14 years as the chief exec, the Pleasanton, Calif.-based company said. “It has been a privilege to serve as Natus’ CEO over the past 14 years and I thank Natus’ talented employees for their hard work and partnership on this journey. I am proud of all that we have accomplished in building Natus into the mark...
Source: Mass Device - July 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Analogic berkshiresterilemanufacturing evidentmedical hancockjaffelabs Helius Medical Technologies MedCrypt Myomo Inc Natus Medical Inc. Source Type: news

The #FDA invites you to join us and discuss how we can increase medical device options for children at the Pediatric Medical Device Development public meeting. Click the link to register. #Pediatrics https://go.usa.gov/xUXHq   #MedicalDevicepic.twitter.com/hL7vawmOgR
The #FDA invites you to join us and discuss how we can increase medical device options for children at the Pediatric Medical Device Development public meeting. Click the link to register. #Pediatrics https://go.usa.gov/xUXHq  #MedicalDevice pic.twitter.com/hL7vawmOgR (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 17, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

MassDevice co-founder Johnson to lead MassMEDIC
MassDevice co-founder Brian Johnson is set to depart from the publication he founded nearly 10 years ago and take over as president of the Massachusetts Medical Device Industry Council. Johnson will succeed Tom Sommer as president of the regional medical technology association. Sommer has served as MassMEDIC’s president since the group was founded in 1996. The association is the largest regional medtech organization, representing more than 300 members. Since Johnson launched MassDevice.com in 2009 with executive editor Brad Perriello, the site has evolved into the leading online journal of the medtech ...
Source: Mass Device - July 17, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News MassMEDIC Source Type: news

CyberMDX closes $10m Series A
Healthcare cybersecurity group CyberMDX said today it closed a $10 million Series A round of financing. The Series A round was led by Pitango Venture capital and joined by OurCrowd Qure, the New York-based company said. CyberMDX provides non-intrusive solutions related to risk management and threat prevention and detection functionality for medical devices and other internet of medical things devices. “The expedited growth of connected medical devices poses exceptional challenges for hospital network security. Connected devices have become an integral part of hospitals’ IT networks, yet they are not monitored a...
Source: Mass Device - July 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Funding Roundup Software / IT cybermdx Cybersecurity Source Type: news

Ghana:MP Donates Medical Equipment to Bole District
[Ghanaian Times] / (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - July 17, 2018 Category: African Health Source Type: news

Trade group MassMedic picks MassDevice.com founder as next president
Journalist and MassDevice.com co-founder Brian Johnson has been tapped to become MassMedic's second-ever president in September, the trade group announced Tuesday. Johnson will replace founding president Tom Sommer, who announced his departure earlier this year. Sommer started MassMedic — short for the Massachusetts Medical Device Industry Council — in 1996, and has overseen its growth into the largest regional medtech association in the country. Many of the largest medical device companies… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - July 17, 2018 Category: American Health Authors: Allison DeAngelis Source Type: news

Johnson & Johnson tightens outlook as Q2 results top forecast
Second-quarter sales and earnings topped the consensus forecast today for Johnson & Johnson (NYSE:JNJ), prompting the healthcare giant to tighten its outlook on the rest of the year. New Brunswick, N.J.-based J&J posted overall profit growth of 3.1% to $3.95 billion, or $1.45 per share, on sales growth of 10.6% to $20.83 billion for the three months ended June 30, compared with Q2 2017. Johnson & Johnson’s largest division, pharmaceuticals, drove the lion’s share, growing revenues 19.9% to $10.35 billion. Adjusted to exclude one-time items, earnings per share were $2.10, 3¢ ahead of the co...
Source: Mass Device - July 17, 2018 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat johnsonandjohnson Source Type: news

If you are misusing an #opioid just to keep from getting sick from #withdrawal symptoms, it ’ s time to break the cycle of dependence. Read our “ Finding Quality Treatment for Substance Use Disorders ” for hotline and provider information. http://bit.ly/2EIJb9l   #MondayMotivation
If you are misusing an #opioid just to keep from getting sick from #withdrawal symptoms, it’s time to break the cycle of dependence. Read our “Finding Quality Treatment for Substance Use Disorders” for hotline and provider information. http://bit.ly/2EIJb9l  #MondayMotivation (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 16, 2018 Category: Medical Devices Authors: ( at DrMcCance_Katz) Source Type: news

Google executive Heidi Dohse on becoming a heart patient
For more than 30 years, Google (NSDQ:GOOG) executive Heidi Dohse has been fully dependent on pacemakers to help power her heart. But that hasn’t stopped her from becoming a competitive cyclist, competing in events around the world. At DeviceTalks Minnesota, Dohse spoke with Randall Shiestl, VP of R&D at Boston Scientific‘s (NYSE:BSX) global technology unit, about her journey through the healthcare system and into the world of medical technology after she was diagnosed with a rare arrhythmia in 1983. Now on her seventh pacemaker, Dohse shared her story of learning to trust the medical devices that keep ...
Source: Mass Device - July 16, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiac Implants Boston Scientific Google Inc. Source Type: news

Judge Refuses to Dismiss Negligence Suit Against Abbott/St. Jude
There's never really a good place to have a medical emergency, but sitting on an airplane is certainly far from ideal, as Kristen Bull knows all too well.  Bull was on an airplane on the tarmac at a South Carolina airport in October 2015 when her implanted cardioverter defibrillator (ICD) malfunctioned and fired six times. She was taken to the Grand Strand Regional Medical Center, however, the hospital was not equipped to deactivate the device, which was manufactured by St. Jude Medical and used the company's Riata ST lead. A St. Jude representative came to the hospital the next morning to deactivate Bull's ICD, ...
Source: MDDI - July 16, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Cardiovascular Source Type: news

Colorado medical device company raises $22 million
A Westminster company specializing in bone-grafting technology said it's raised $22 million in financing. Cerapedics, an orthobiologics company, said the financing was led by family investment fund KCK Group. The money, company officials said, will accelerate the development of Cerapedics' i-Factor peptide enhanced bone graft. "This financing will allow Cerapedics to further invest to increase physi cian access to i-Factor and to build clinical evidence for new indications," said Valeska Schroeder,… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 16, 2018 Category: Biotechnology Authors: Ben Miller Source Type: news

ProPharma acquires European company
Overland Park-based ProPharma Group has acquired a Netherlands company that provides compliance, technical support and other services to the pharmaceutical industry. ProPharma, which announced the deal in a Monday release, did not disclose the price or other terms of the deal to acquire Xendo Holdings BV. ProPharma provides compliance consulting to pharmaceutical, biotech and medical device companies worldwide. It employs about 100 people in the metro area. T he acquisition will include Swedish… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 16, 2018 Category: Biotechnology Authors: Russell Gray Source Type: news

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information http://go.usa.gov/xQvE9   pic.twitter.com/kT7EqyTPxr
On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information http://go.usa.gov/xQvE9  pic.twitter.com/kT7EqyTPxr (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 16, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Federal health officials estimate that nearly 48 million people are sickened by food contaminated with harmful germs each year. Fresh produce can become contaminated in many ways. Follow these 7 tips for cleaning fruits and vegetables https://go.usa.gov/xU9VY   pic.twitter.com/ldh9OQWMWT
Federal health officials estimate that nearly 48 million people are sickened by food contaminated with harmful germs each year. Fresh produce can become contaminated in many ways. Follow these 7 tips for cleaning fruits and vegetables https://go.usa.gov/xU9VY  pic.twitter.com/ldh9OQWMWT (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 16, 2018 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

#FDA ’ s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I ’ m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments: https://go.usa.gov/xQ7Jb   pic.twitter.com/hQxiKdMZBK
#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments: https://go.usa.gov/xQ7Jb  pic.twitter.com/hQxiKdMZBK (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 16, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Abbott ’ s St. Jude Medical must face negligence suit over Riata leads
Abbott (NYSE:ABT) subsidiary St. Jude Medical must face a negligence lawsuit brought over its recalled Riata defibrillator leads after a federal judge ruled that the case is not rpeempted by fedral rules. Plaintiff Kristen Bull was implanted with a St. Jude implantable cardioverter defibrillator using Riata leads in November 2010, just a month before the company pulled the silicone-coated wires after finding that some of the internal conductors had worn through their insulation. In November 2011 the company warned that the Riata leads appeared to fail more frequently than previously reported, leadi...
Source: Mass Device - July 16, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Legal News Product Liability Abbott Cardiac Rhythm Management stjudemedical Source Type: news

Exclusive: DHSC taken to court for 'manifest errors' over £730m contract
The Department of Health and Social Care is being taken to court over allegations of improper behaviour during the awarding of a £730m contract to deliver medical equipment to the NHS, HSJ can reveal. (Source: HSJ)
Source: HSJ - July 16, 2018 Category: UK Health Source Type: news

Medical device startup acquires Irish diagnostics firm
Kypha, a St. Louis-based medical device company, has acquired Ireland-based Biosensia, a diagnostics platform and contract development company. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - July 16, 2018 Category: Pharmaceuticals Authors: Diana Barr Source Type: news

9 trends in medical device user interface design
By Valerie Ng and Jon Tilliss, Emergo Group As the influence of technology in our everyday lives continues to grow, the standard for aesthetically pleasing and contemporary user interface (UI) designs in the healthcare space continues to evolve. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. The post 9 trends in medical device user interface design appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - July 16, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

Out with the Old, in with the ... Newish?
  It takes a strong leader to admit when his time is up. Endologix CEO John McDermott is that type of leader, which he proved this week with the announcement that he will be stepping down as CEO of the struggling endovascular aneurysm repair (EVAR) company.     Endologix has had its fair share of hurdles over the past couple of years, but it seems like things might finally be looking up for the Irvine, CA-based company. In May, the company promoted John Onopchenko to the role of CEO. Prior to the promotion, Onopchenko was the company's chief operating officer, a p...
Source: MDDI - July 16, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

NEMA Adds New Tests in NU 2-2018 Performance Measurement Standards of PET
The National Electrical Manufacturers Association publishes NEMA NU 2-2018 Performance Measurements of Positron Emission Tomographs (PET). The revised standards include two new tests: Measurement of TOF resolution for TOF equipped PET scanners and Co-registration accuracy between computed tomography and PET components of PET/CT scanner. NEMA NU 2-2018 offers uniform and consistent method for measuring and reporting performance parameters.This story is related to the following:Health, Medical,& Dental Supplies and EquipmentSearch for suppliers of:Trade Associations (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - July 14, 2018 Category: Medical Devices Source Type: news

Siga wins FDA nod for oral smallpox treatment
Siga Technologies (NSDQ:SIGA) today won FDA approval for its oral formulation of tecovirimat as a treatment of smallpox in the case of a potential outbreak. The drug is designed to mitigate the impact of a potential bioterrorism attack, according to the New York-based company. Siga also touted that the FDA granted its request for a priority review voucher, giving them the option for accelerated FDA review of a future product. Get the full story at our sister site, Drug Delivery Business News. The post Siga wins FDA nod for oral smallpox treatment appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - July 13, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat sigatechnologies Source Type: news

AED startup HeartHero raises $2m in seed funding
Medtech startup HeartHero said this week it raised $1.5 million in a seed investment round to support the development of its next-gen automated external defibrillators. HeartHero is developing a portable, “easy-to-use” AED with intentions of making the device affordable to the general populace. The Denver-based company said the $1.5 million was over its initial funding goal, and that funds in the round came from a venture capital firm, angel investors and grant funding. “Now that we have closed our seed round of funding, we are one step closer to empowering millions to save their loved ones from a cardiac...
Source: Mass Device - July 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Cardiovascular hearthero Source Type: news