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3D-printed implants and scaffold technology – how bioengineering innovation could treat and prevent osteoarthritis
The need for new and effective ways to treat and preventosteoarthritis has never been more urgent. Demand for total joint replacements is rising every year, and expected to double by 2030, placing a huge strain on the NHS. Meanwhile, those living with the pain of early stage osteoarthritis or at risk of developing it due to injury face limited treatment options.That’s why Arthritis Research UK is investing in innovative research dedicated to developing medical technologies which could provide an answer. By 'medical technologies' we mean cutting-edge medical devices, orthotics, implants and imaging techniques, harness...
Source: Arthritis Research UK - November 23, 2017 Category: Rheumatology Source Type: news

Gambia:NA Health Committee Resumes Visit
[Foroyaa] The National Assembly Health Committee as part of its ongoing tour of health facilities, visited Farafenni General Hospital. The CEO of the hospital, Wandifa Samateh, highlighted the inadequate human resources, bio medical equipment, drugs and medical supplies, health specialists and subventions inter alia, as his facility's major constraint. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - November 23, 2017 Category: African Health Source Type: news

Everstone buys Malaysian medical devices company Chemopharm
The deal will be carried out via Everlife, the Singapore-headquartered fund said in a statement today without offering the deal value. (Source: The Economic Times)
Source: The Economic Times - November 23, 2017 Category: Consumer Health News Source Type: news

RxSight wins FDA nod for light-adjustable IOL
The FDA has cleared RxSight‘s implantable light adjustable intraocular lens and light delivery device. The company’s RxSight IOL is designed from a UV light reactive material meant to be treated by a specific Light Delivery Device, intended for use 17 to 21 days post-procedure. The lens is designed to be treated by 3-4 light treatments over 1 to 2 weeks in 40 to 150 second treatment periods, during which the patient must wear UV-protective glasses. “Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery. This syste...
Source: Mass Device - November 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance rxsight Source Type: news

UN agency gravely concerned by lack of medical services in Syria ’ s eastern Ghouta
Despite escalating violence and increasing humanitarian needs, life-saving medicines, medical equipment, and surgical supplies are being prevented from entering eastern Ghouta in Syria and the plan to transfer critically ill patients to hospitals elsewhere has not been approved, the United Nations health agency has warned. (Source: UN News Centre - Health, Poverty, Food Security)
Source: UN News Centre - Health, Poverty, Food Security - November 22, 2017 Category: International Medicine & Public Health Source Type: news

Did Stryker Steal Trade Secrets from Globus?
Globus Medical Inc. said in a lawsuit filed late last week that a former project engineer took trade secrets with her when she recently left Globus for a new job at Stryker. According to the lawsuit, filed in New Jersey federal court, Madeline Davis agreed that if she ever left her job at Globus, she would not work for a competitor for at least a year and a half.  So when she resigned from Audobon, PA-based Globus and took a position at Kalamazoo, MI-based Stryker, Davis broke her non-compete and non-disclosure (NCND) pacts with Globus, according to the complaint. Globus hired Davis as an associate project engine...
Source: MDDI - November 22, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

Will GOP Tax Bills Bring a Gift for Medtech Startups?
A bill that would create an incentive for investment in high-tech startups stands a chance of passing if it’s attached to one of the tax bills moving through Congress. That’s the opinion of Justin Klein, MD, a partner at New Enterprise Associates, a large venture capital firm that’s a major investor in medtech. AdvaMed recently announced its support for H.R. 4175 — the Invest in Innovative Small Businesses Act — which would create a tax credit for investments in high-tech businesses, including pre-revenue medtech and diagnostics startups. The company must have fewer than 250 employees, be hea...
Source: MDDI - November 22, 2017 Category: Medical Devices Tags: Medical Device Business Source Type: news

UE LifeSciences signs 'pivotal partnership' with GE
The partnership will bring the Philadelphia medical device companies handheld iBreastExam device to women in more than 25 developing countries across Asia and Africa. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - November 22, 2017 Category: Pharmaceuticals Authors: John George Source Type: news

Medtronic Weathered Disasters by Bending, Not Breaking
Medtronic's revenue and earnings per share beat analyst expectations in the fiscal 2018 second quarter, despite getting hit with multiple natural disasters. The company delivered 3% comparable constant currency revenue growth during the quarter, CEO Omar Ishrak said during the company's earnings call. "These financial results are very encouraging when considered in the context of a quarter in which we faced three hurricanes and the California wildfires," he said. Ishrak said Hurricane Maria, in particular, took a significant toll on the company's manufacturing operations in Puerto Rico, and thousands of Medt...
Source: MDDI - November 22, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

NxStage shares dip on Q3 EPS miss
Shares in NxStage Medical (NSDQ:NXTM) have fallen slightly today after the medical device maker missed expectations on Wall Street with its third quarter earnings results. The Lawrence, Mass.-based company posted losses of $8.9 million, or 14¢ per share, on sales of $97.3 million for the 3 months ended September 30, seeing losses grow nearly 900% while sales grew a smaller 5.8% compared with the same period during the previous fiscal year, according to an SEC filing. Losses per share were well ahead of Wall Street analysts’ consensus, who expected to see the company break even. The company did not issue a r...
Source: Mass Device - November 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup NxStage Medical Inc. Source Type: news

FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients
FDA approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens ’ power after cataract surgery so that the patient will have better vision when not using glasses. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 22, 2017 Category: American Health Source Type: news

WHO gravely concerned by deteriorating situation in eastern Ghouta, Syrian Arab Republic
22 November 2017, Damascus, Syrian Arab Republic – Seven people have been killed and 42 people injured in Damascus city and surrounding areas in recent days. In eastern Ghouta, Rural Damascus, local health authorities report that during a 4-day period alone from 14 to 17 November, 84 people were killed, including 17 children and 6 women; and 659 people were injured, including 127 children and 87 women. During the same period, more than 200 surgical operations were conducted in eastern Ghouta’s overwhelmed and under-resourced hospitals. Despite escalating violence and increasing humanitarian needs, life-savin...
Source: WHO EMRO News - November 22, 2017 Category: Middle East Health Source Type: news

Stroke Rehab Technology Aims To Speed Healing
Watching someone who has suffered a stroke try to perform everyday actions such as walking down the sidewalk or even bringing a cup to their lips can serve as a sobering reminder of how fragile full and robust health is, and also serves as an inspiration for those dedicated to improving the lives of those patients. Steven Plymale, recently named CEO of Toronto-based MyndTec, said his reaction to watching videos of patients using the company's MyndMove functional electrical stimulation (FES) rehabilitation system was one of the reasons he joined MyndTec. "They are very compelling," Plymale said of the demonstratio...
Source: MDDI - November 22, 2017 Category: Medical Devices Authors: Greg Goth Tags: Electronics Source Type: news

Europe ’ s medtech alliance seeks prompt action on new med device rules
European medtech industry group MedTech Europe today said it is seeking “swift action” from national and European Union authorities after the implementation of new regulations, saying that additional resources need to be invested to make sure the regulations are successful. The medtech group published three separate position papers on the matter, calling attention to new in vitro medical device regulation and medical device regulations and what steps it believes need to be taken to make the regulations successful. In its first paper, the group suggests that additional resources will be needed to help implement ...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance MedTech Europe Source Type: news

Regenerative vessel stent dev Cardiovate raises $1m
Early stage medical device developer Cardiovate has closed a $1 million seed round to help support research and development for a scaffold the company claims can help regenerate vascular tissue, according to an Xconomy report. The Texas-based company, formed in 2012 by a student and two University of Texas in San Antonio, is developing the NeoVessel, designed to replace portion of clogged blood vessels and encourage new tissue regeneration, according to the report. Cardiovate hopes its product will replace other treatments, including synthetic stents and grafts, and claims that its graft also dissolves after encouraging ti...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Stent Grafts cardiovate Source Type: news

Despite stormy quarter, Medtronic earnings beat Wall Street estimates
Medical-device giant Medtronic reported profits that beat Wall Street expectations Tuesday despite battling hurricanes and wildfires during its most recent quarter. The company’s adjusted second-quarter earnings totaled $1.46 billion, or $1.07 per share. That’s down from $1.56 billion, or $1.12 per share, but better than analysts’ estimated 98 cents per share. The company’s stock rose about 5 percent to $83.07 per share in afternoon trading Tuesday. Hurricane Maria ultimately cost Medtronic… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - November 21, 2017 Category: Pharmaceuticals Authors: Katharine Grayson Source Type: news

Despite stormy quarter, Medtronic earnings beat Wall Street estimates
Medical-device giant Medtronic reported profits that beat Wall Street expectations Tuesday despite battling hurricanes and wildfires during its most recent quarter. The company’s adjusted second-quarter earnings totaled $1.46 billion, or $1.07 per share. That’s down from $1.56 billion, or $1.12 per share, but better than analysts’ estimated 98 cents per share. The company’s stock rose about 5 percent to $83.07 per share in afternoon trading Tuesday. Hurricane Maria ultimately cost Medtronic… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - November 21, 2017 Category: Biotechnology Authors: Katharine Grayson Source Type: news

Globus sues Stryker, ex-engineer for trade secret theft
Globus Medical (NYSE:GMED) yesterday sued Stryker (NYSE:SYK) and a former Globus engineer, alleging that she took proprietary trade secrets with her when she took a new job at Stryker earlier this month. The lawsuit, filed in the U.S. District Court for New Jersey, alleges that Madeline Davis broke her non-compete and non-disclosure pacts with Globus when she took the job Nov. 1 at Stryker. Hire in 2015 as an associate project engineer and promoted to project engineer in January, Davis worked on the Forge corticocancellous spacer for cervical fusion, according to the complaint. The NCND agreements bar Davis ...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Orthopedics Globus Medical Stryker Source Type: news

Sunshine Act: Are Docs Still Getting Free Lunches From Reps? Sunshine Act: Are Docs Still Getting Free Lunches From Reps?
Pharmaceutical and medical device companies are tracking their interactions with physicians; CMS is reporting that information on its website. Has the Sunshine Act achieved its desired impact?Medscape Business of Medicine (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 21, 2017 Category: Consumer Health News Tags: Family Medicine/Primary Care Article Source Type: news

Medtronic ’ s fiscal Q2 tops The Street
Medtronic (NYSE:MDT) posted fiscal second-quarter numbers that beat both sales and earnings forecasts on Wall Street, after a better-than-expected recovery from Hurricane Maria. The Fridley, Minn.-based medical device giant reported profits of $2.02 billion, or $1.48 per share, on sales of $7.05 billion for the three months ended Oct. 27, for a bottom-line gain of 80.9% on a -4.0% sales decline compared with the same period last year. Adjusted to exclude one-time items, earnings per share were $1.06, 8¢ ahead of The Street, where analysts were looking for sales of $6.93 billion. “Our second-quarter financial res...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat Medtronic Source Type: news

UPDATE: Medtronic ’ s fiscal Q2 tops The Street
UPDATED November 21, 2017, with segment results, share prices Medtronic (NYSE:MDT) posted fiscal second-quarter numbers that beat both sales and earnings forecasts on Wall Street, after a better-than-expected recovery from Hurricane Maria. The Fridley, Minn.-based medical device giant reported profits of $2.02 billion, or $1.48 per share, on sales of $7.05 billion for the three months ended Oct. 27, for a bottom-line gain of 80.9% on a -4.0% sales decline compared with the same period last year. Adjusted to exclude one-time items, earnings per share were $1.06, 8¢ ahead of The Street, where analysts were looking for s...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat Medtronic Source Type: news

The FAQs on encryption, FIPS 140 and medical devices
By Stewart Eisenhart, Emergo Group As cybersecurity vulnerabilities become a more urgent concern for the medical device industry, encryption requirements are emerging as a key tool to address medical device cybersecurity concerns. In the US, compliance with the FIPS 140-2 standard can help manufacturers of network-connected devices and software demonstrate encryption capabilities able to protect patient and user data. 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...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

How Medtronic & #039;s Pacemakers Are Now Harder to Hack
FDA approved Medtronic's Azure pacemakers, which feature the company's new BlueSync technology to protect patients from having their device hacked. The BlueSync technology is also now available with the Medtronic Percepta portfolio of quadripolar, MR-conditional cardiac resynchronization therapy pacemakers (CRT-Ps), the company said. BlueSync is intended to enable more secure wireless remote monitoring via Medtronic's CareLink Network, by limiting access to the device functionality and also by protecting patient data. Connected medical devices like pacemakers add value to patient care by enabling remote patient monito...
Source: MDDI - November 21, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Cardiovascular Source Type: news

GE Healthcare inks licensing deal with Israel-based DiA Imaging Analysis
GE Healthcare (NYSE:GE) has inked a multi-year, non-exclusive licensing and professional services deal with medical imaging analysis company DiA Imaging Analysis, according to a press release from the company. Through the deal, Israel-based DiA said it intends to develop its automated imaging analysis tech to work with GE’s ultrasound devices. “We are pleased to partner with DiA Imaging Analysis. GE Healthcare has a long history of bringing innovative solutions to our customers around the world. These tools would bring new capabilities to ultrasound at the point of care,” GE healthcare primary & ...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging diaimaginganalysis GE Healthcare Source Type: news

NeuX, GoX Studio ink development deal for smart chronic pain stim
West Palm Beach, Fla.-based medtech firm NeuX Technologies said it inked a strategic alliance deal with GoX Studio looking to combine their technology platforms to improve treatments for chronic pain and musculoskeletal injuries. Through the deal, NeuX said it plans to combine its Interactive Neuromuscular Stimulation tech platform with GoX’s SmarWork platform to deliver improved diagnosing, treatment, measurement, monitoring and prevention for chronic pain and injuries, according to a press release. “Solutions for treating chronic pain and injuries often fail because they treat the symptoms. NeuX’s Inter...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Pain Management goxstudio neuxtechnologies Source Type: news

Myomo readies $17m offering
Myomo said late last week it is looking to raise approximately $17.4 million in a new offering of shares and warrants to support its myoelectric braces and orthotics designed for individuals with neuromuscular disorders. In the offering the company plans to float approximately 1.5 million shares of common stock and warrants to purchase an additional 750,000 shares at an assumed combined offering price of $6.25 per share and 0.5 warrants. Read the whole story on our sister site, The Robot Report The post Myomo readies $17m offering appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Myomo Inc Source Type: news

Why LivaNova Is Unloading Its CRM Business
LivaNova, formerly known as Sorin Group, has decided to get out of the cardiac rhythm management (CRM) business and shift more focus to its areas of strength.  The London-based company plans to sell its CRM business to Shanghai-based MicroPort for $190 million in cash. The business, which makes high-voltage defibrillators, cardiac resynchronization therapy devices and low-voltage pacemakers, generated about $249 million in net sales in the fiscal year 2016. The business has roughly 900 employees with operations chiefly in Clamart, France; Saluggia, Italy; and Santo Domingo, Dominican Republic. The company said in Sept...
Source: MDDI - November 20, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Medical Device Business Source Type: news

Advanced Bionics wins FDA nod for HiFocus Slimj cochlear implant electrode
Advanced Bionics said late last week it won FDA approval for its HiFocus SlimJ electrode designed for use with the company’s HiRes Ultra cochlear implant. The Valencia, Calif.-based company touts the new electrode as featuring a thin, straight design for easier insertion during procedures and a slim profile to protect the delicate structures of the cochlea during insertion. “The HiFocus SlimJ electrode addresses the surgeon need for an alternate type of electrode whilst still offering full spectrum coverage and maintaining the performance potential of the individual. And surgeons have commented that it is easy ...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Otolaryngology Ear, Nose & Throat Regulatory/Compliance Advanced Bionics LLC Source Type: news

Could the Next Big Thing in Medtech Stem from Your Idea?
So, you have a great idea for a new medical device that could improve outcomes, save lives, and make your company lots of money. You just need to get your idea in front of the right person to help make it a reality—which, of course, is easier said than done. Selling ideas to upper management was the topic of discussion during a plenary session at the recent MD&M Minneapolis Conference. Experts on the panel shared these tips to give your pitch its best chance of success. Don't miss your chance to network with your medtech colleagues in Silicon Valley at the BIOMEDevice San Jose Conference and Expo, December 6&ndas...
Source: MDDI - November 20, 2017 Category: Medical Devices Authors: Jamie Hartford Tags: MD & M Minneapolis Medical Device Business Source Type: news

TransEnterix opens the doors to a competitive US surgical robotics market
The surgical robotics market in the US has finally become competitive. In October, the FDA granted clearance to only the second robotic surgical system to date – TransEnterix‘s (NYSE:TRXC) Senhance laparoscopic platform. The clearance was a huge milestone for the Morrisville, N.C.-based company and was quickly followed by yet another – almost exactly a month after receiving a nod from the federal watchdog, TransEnterix logged its 1st sale of the platform to the Orlando-based Florida hospital. Read the whole story on our sister site, The Robot Report The post TransEnterix opens the doors to a competit...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics TransEnterix Source Type: news

Milestone Scientific plans launch for Botox injection device
Milestone Scientific (NYSE:MLSS) said today that it plans to launch a cosmetic injection instrument designed to deliver botulinum toxin. The company’s new drug delivery instrument is slated to include an integrated electronic record-keeping feature, as well as improved needle placement compared to its dental injection device. Get the full story at our sister site, Drug Delivery Business News. The post Milestone Scientific plans launch for Botox injection device appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Wall Street Beat milestonescientific Source Type: news

Cambridge Consultants prototypes miniaturized robot for cataract surgery
Cambridge Consultants showed off its prototype of a miniaturized robot designed for cataract surgery last week at its annual Innovation Day event. The system, Axsis, is one of the smallest known robots for surgical use, according to the firm, featuring instruments of just 1.8mm in diameter. Get the full story at our sister site, The Robot Report. The post Cambridge Consultants prototypes miniaturized robot for cataract surgery appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Optical/Ophthalmic Robotics Surgical Cambridge Consultants Source Type: news

#FDA approves first telehealth option to program cochlear implants remotely https://go.usa.gov/xnBe2  
#FDA approves first telehealth option to program cochlear implants remotely https://go.usa.gov/xnBe2  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 20, 2017 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Covers for Hospital Bed Mattresses: Learn How to Keep Them Safe #FDA https://go.usa.gov/xnBea  
Covers for Hospital Bed Mattresses: Learn How to Keep Them Safe #FDA https://go.usa.gov/xnBea  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 20, 2017 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

MicroPort < sup > ® < /sup > Enters into Binding Letter of Intent to Buy Cardiac Rhythm Management Business Franchise from LivaNova for $190 Million
(Source: Microport News Release)
Source: Microport News Release - November 20, 2017 Category: Medical Devices Source Type: news

Report: India eyes penalties for Johnson & Johnson over metal-on-metal hips
Johnson & Johnson (NYSE:JNJ) could reportedly be on the hook again for the metal-on-metal hip implants it pulled from the market in 2010, this time in India and for much less than it’s cost the company elsewhere. The world’s second-largest medical device maker has fielded numerous lawsuits about its ASR metal-on-metal hip replacement since it pulled the ASR XL Acetabular and ASR Hip Resurfacing systems from the market in August 2010, “due to the number of patients who required a second hip replacement procedure, called a revision surgery.” Three years later Johnson ...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Metal-on-Metal johnsonandjohnson Source Type: news

LivaNova to deal CRM biz to MicroPort for $190m
LivaNova (NSDQ:LIVN) said today that it inked a deal to sell its cardiac rhythm management business to China’s MicroPort Scientific (HK:00853) for $190 million in cash. The companies, which are already partners in a CRM join venture in the People’s Republic, said the sale for LivaNova’s 900-worker CRM business is slated to close during the second quarter next year. LivaNova, formed by the $2.7 billion merger of Italy’s Sorin and Cyberonics in October 2015, said in September that it was putting the CRM business on the auction block. The business pulled in sales of $249 m...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Wall Street Beat Cardiac Rhythm Management LivaNova MicroPort Scientific Source Type: news

Is There Hope for an Endologix Comeback?
A year ago, Endologix CEO John McDermott walked into the VEITHsymposium at the New York Hilton-Midtown, saw the look on the face of his head of regulatory and clinical affairs as he approached the Endologix booth, and knew something was wrong. Sure enough, FDA had just asked Endologix to provide two-year patient follow-up data from its EVAS-FORWARD study of the Nellix endovascular aneurysm sealing (EVAS) system. "So that night we worked through the night to get out our press release first thing the next morning to inform the world that there was going to be pushback in the timeline and the clinical requirements,&...
Source: MDDI - November 19, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

JMX Plastic Push-Pull Connector Series are offered in nine layouts.
JMX Plastic Push-Pull Connector Series are available in 0.5, 0.7, 0.9 and 1.3 mm diameters. Units are offered in solder and crimp versions and can sustain voltages up to 10 A/1200 V. Products are suitable for medical, instrumentation and measurement applications. Featuring permanent one-piece assemblies, connectors offer 2,000 mating cycles. JMX provides waterproof and extreme high temperature resistance and is IP 68 rated.This story is related to the following:Health, Medical,& Dental Supplies and EquipmentSearch for suppliers of:Medical Connectors (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - November 18, 2017 Category: Medical Devices Source Type: news

Dentsply Sirona reintroduces the CEREC ® MC Milling Unit to the U.S. market
The entry-level milling solution is available again as part of the U.S. CEREC product portfolio, offering an attractive and affordable path to digital dentistry and single-visit restorations CHARLOTTE, N.C., Nov. 14, 2017- Dentsply Sirona announced today the reintroduction of the CEREC MC Milling Unit to the U.S. dental market.CEREC MC is ideal for practitioners who are interested in single- visit chairside inlays, onlays, and single-unit veneers and crowns. With the ability to wet grind and dry mill, dentists can use a vast array of chairside materials to produce single-unit restorations in one office visit.Used in c...
Source: Dental Technology Blog - November 17, 2017 Category: Dentistry Source Type: news

FDA releases framework guidelines for regenerative med development
The FDA this week laid out guidelines for a new framework it’s implementing for the development and oversight of regenerative medicine products including novel cellular therapies. The framework is laid out through four guidance documents which build on the FDA’s existing regulatory approach and describe more clearly which products are regulated as drugs, devices and biological products, according to a new FDA release. The documents include new science-based processes for ensuring the safety and effectiveness of such products and a risk-based framework for how it plans to enforce actions against potentially harm...
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regenerative Medicine Regulatory/Compliance Source Type: news

Is the First Bioprinted Heart Just Around the Corner?
A Chicago bioprinting startup that seeks to 3-D print human hearts for transplantation has added to its scientific advisory board of heavy hitters. But its CEO won’t say how close the company is to producing its first viable heart. Biolife4D just announced it has added regenerative biomaterials expert Adam  Feinberg, PhD to lead its scientific advisory team. Feinberg is associate professor of materials science & engineering and biomedical engineering at Carnegie Mellon University and principal investigator of the regenerative biomaterials and therapeutics group. Feinberg uses materials-based engine...
Source: MDDI - November 17, 2017 Category: Medical Devices Authors: Nancy Crotti Tags: Cardiovascular Implants Source Type: news

Belluscura plans IPO to commercialize licensed Stryker IP
Medical device group Belluscura is planning a U.K.-based IPO that could be worth up to $13.2 million after it picked up the rights to make and sell certain Stryker (NYSE:SYK) devices, according to a filing from the company. The company was created by Tekcapital in 2015 to pick up and commercialize rights to medical devices. So far, the company has acquired licenses to manufacture and sell four medical device product lines from Stryker, including the Snap II, Passport, Slyde and Wire Caddy devices, according to the filing. Earlier this week, Belluscura said it picked up the rights to manufacture and sell Styrker’...
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Initial Public Offering (IPO) belluscura Source Type: news

House committee urges HHS to improve med device cybersecurity
The US House Energy and Commerce committee is looking to the Department of Health and Human Services to shore up medical device cybersecurity, according to a report from The Hill. Committee Chair Greg Walden (R-Ore.) sent a letter to the HHS asking it to require device makers to provide a listed bill of materials, including third-party software components, used in each of its products, according to the report. “Stakeholders do not know, and often have no way of knowing, exactly what software or hardware exist within the technologies on which they rely to provide vital medical care. This lack of visibility directly af...
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Software / IT Cybersecurity Dept. of Health & Human Services (HHS) Source Type: news

Staar Surgical plans pivotal of Visian EVO ICL presbyopia optic for Q1 2018
Staar Surgical (NSDQ:STAA) this week reported results from the feasibility clinical study of its Evo+ Visian ICL with aspheric optics designed to reduce presbyopia, and that based on the results it plans to launch a pivotal clinical study of the device during the 1st quarter next year. The Monrovia, Calif.-based company’s EVO+ Visian ICL is designed to be surgically implanted and operate with the patient’s eye to correct vision. The lens is designed to be positioned inside the eye between the iris and natural lens where it stays indefinitely. Staar Surgical said that it presented results from 24 patients i...
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Optical/Ophthalmic STAAR Surgical Co Source Type: news

Medical Device Design Is Critical to Bringing Healthcare into the Home
Medical technology is going consumer. Both patients and care givers hold an increasing expectation that the devices they use to manage care will operate with the same ease and usability as the digital products they use every day to manage their lives. As healthcare moves to a home setting, patients require design elements that make the technology easier to use, more intuitive, and more accessible. Medical device companies are responding by focusing during design and development on those needs that are harder to tease out. To succeed in this potential consumer market, the biggest asset to any device is good design and ...
Source: MDDI - November 17, 2017 Category: Medical Devices Authors: Scott Thielman Tags: Design Source Type: news

Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?
There are so many different technical terms, documents, and acronyms you need to know working in the medical device field. There are three types of files specifically that cause a great deal of confusion: the design history file, 510(k) submission, and the technical file. As with any kind of files in medical device development, these require a lot of effort. However, if you have good background knowledge, I think you will find there are similarities between each. Design History File The design history file is an FDA term described in 21 CFR Part 820.30, which talks about design controls and how they must be kept in a ...
Source: MDDI - November 17, 2017 Category: Medical Devices Authors: Jon Speer Tags: Regulatory and Compliance Source Type: news

G Medical Innovaions raises $10m to support Prizma medical smartphone case
Mobile health dev G Medical Innovations said today it raised $10.3 million (AUSD $13.5 million) to support commercialization of its Prizma medical smartphone accessory and case. The Australian company said the round was “substantially oversubscribed,” with funds raised through the sale of 31.4 million shares at 33¢ (AUSD 43¢) per share. G Medical’s Prizma medical smartphone case is designed to allow users to use their smartphone as a mobile medical monitor to measure a wide range of vital signs and record the data into a cloud-based storage solution. Data collected from the Prizma can then be sh...
Source: Mass Device - November 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diagnostics mHealth (Mobile Health) gmedicalinnovations Source Type: news

Voluntis gets FDA clearance to add last two basal insulins to app
Medical device software company Voluntis has received an updated FDA clearance (as well as an updated CE mark) for its Insulia app, a " digital companion " app for people with Type 2 diabetes. Insulia offers realtime basal insulin dose coaching, and the new clearance makes the app usable with two additional brands of insulin:  Basaglar and Tresiba. (Source: mobihealthnews)
Source: mobihealthnews - November 16, 2017 Category: Information Technology Source Type: news

Teleflex announces upcoming $500m senior note offering
Teleflex (NYSE:TFX) today announced a new public offering of senior notes due 2027, looking to raise approximately $500 million. The Wayne, Penn.-based company has not yet released prices of the notes, and said that the interest rates and other terms will be determined at pricing. Teleflex said that net proceeds from the round will be used to repay approxiamtely $491.2 million in debt borrowings under its revolving credit facility, according to a press release. J.P. Morgan, Bank of America Merrill Lynch and PNC Capital Markets will act as joint book-running managers in the offering, the company said. Earlier this mont...
Source: Mass Device - November 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Teleflex Source Type: news