Operating Rooms Get a Dose of Augmented Reality
Operating rooms are set to get a dose of augmented reality because of a new clearance from FDA. The agency recently signed off on an augmented surgical navigation system from Mariner Endosurgery. The Ontario-based company’s LaparoGuard is an augmented surgical navigation system that enables surgeons to annotate areas of 3D safety zones during minimally invasive procedures, to aid surgeons in guiding their tools and informing their surgical approach. Similar to the heads-up display of a fighter jet, LaparoGuard allows surgeons to annotate areas of risk, and then see 3D renderings of surgeon-defined safety ...
Source: MDDI - December 15, 2018 Category: Medical Devices Authors: Omar Ford Tags: Regulatory and Compliance Imaging Source Type: news

Early stage ortho company Edge Surgical raises $4m
Early stage medical device company Edge Surgical said on Wednesday that it raised $4 million in a Series A round of financing, with funds slated to support increased manufacturing, marketing and sales of its EDG Ortho 65mm device. The Chicago-based company said that the Series A round also included $3 million raised plus a convertible note, which brings the total funding obtained so far to $5.7 million, all from angel investors. The EDG Ortho 65mm, the company’s first device, is a single-use electronic depth gauge designed to accurately measure length for orthopedic surgical screws and to mitigate bioburden contamina...
Source: Mass Device - December 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Orthopedics edgesurgical Source Type: news

Fertility Tracker Guarantees Pregnancy Within One Year
Until recently, detecting the time during a woman’s cycle when she is most likely to conceive has been imprecise. Methods included measuring basal temperature spikes, which only detect ovulation after the fact, or urine tests that indicate a surge in luteinizing hormone, which predict ovulation is imminent within 12-36 hours. Both require meticulous recording of data by the user. Ava Science offers a fertility tracker that requires much less effort on the part of the user. Ava, a device that is worn on the wrist like a bracelet while the woman is sleeping, measures key physiological parameters to detect s...
Source: MDDI - December 14, 2018 Category: Medical Devices Authors: Susan Shepard Tags: Digital Health Source Type: news

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE383   #MedicalDevice #FDApic.twitter.com/X4IprwU8R2
GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/X4IprwU8R2 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 14, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here: https://go.usa.gov/xE3ke   #FDA #MedicalDevice
#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here: https://go.usa.gov/xE3ke  #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 14, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI: Jeff Shuren, Director of the Center for Devices & Radiological Health, released a statement on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data. Read the statement here: https://go.usa.gov/xE3kf   #MedicalDevice
#ICYMI: Jeff Shuren, Director of the Center for Devices & Radiological Health, released a statement on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data. Read the statement here: https://go.usa.gov/xE3kf  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 14, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI: @SGottliebFDA issued a statement on the #FDA ’ s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products. Read the statement here: https://go.usa.gov/xE3kk   #MedicalDevice
#ICYMI: @SGottliebFDA issued a statement on the #FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products. Read the statement here: https://go.usa.gov/xE3kk  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 14, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Moody ’ s: Outlook strong for medical devices in 2019
The medical device industry should see a stand-out year in 2019, according to a Moody’s report on the industry, Medtech Dive reports. The financial services company predicts a positive outlook for medtech, with forecasted earnings before interest, tax, depreciation and amortization of between 4.5% and 5.5% for companies on an organic basis, according to the report. The positive outlook for medtech stands out from the rest of the healthcare field, with pharmaceuticals and U.S. for-profit hospitals only receiving a stable outlook, Medtech Dive reports. Revenue growth for device companies will be driven through inn...
Source: Mass Device - December 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Moody's Investor Service Source Type: news

RNAIII (RIP) & Deriv. as potential tools for the treatment of S. aureus biofilm infections
(Bentham Science Publishers) S. aureus under the biofilm mode of growth is often related to several nosocomial infections, more frequently associated with indwelling medical devices (catheters, prostheses, portacaths or heart valves).The present paper will provide an overview on the activity and potential applications of RIP as biofilm inhibiting compound, useful in the management of S. aureus biofilm infections. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 14, 2018 Category: International Medicine & Public Health Source Type: news

Colorectal Cancer Screening Pill to Be in US Pilot Study
Check-Cap is getting one step closer to having its capsule-based screening method for colorectal cancer on the U.S. market. The Isfiya, Israel-based company has received FDA conditional approval for an IDE to initiate a pilot study of the C-Scan capsule. FDA’s conditional approval of the IDE requires Check-Cap to provide additional information to the agency and the company may begin enrolling patients immediately upon approval by the study site's Institutional Review Board (IRB). The trial will consist of up to 45 patients and it will be a single-arm study. Patients who are enrolled will be those conside...
Source: MDDI - December 13, 2018 Category: Medical Devices Authors: Omar Ford Tags: Regulatory and Compliance Implants Source Type: news

Apple & #039;s Medical Hires: Big Deal or Much Ado About Nothing?
Apple has been careful to keep its future healthcare plans under wraps, but whatever it is, expect that it will be big. “Apple has a huge opportunity in health … and I don’t want to talk about the future because I don’t want to give away what we’re doing, but this is an area of major interest to us,” CEO Tim Cook said during Apple’s earnings call in November, according to Seeking Alpha transcripts. The ECG app recently became available to Apple Watch Series 4 customers in the United States, and U....
Source: MDDI - December 13, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Business Source Type: news

Edwards to add 370 employees in Costa Rica
Edwards Lifesciences (NYSE:EW) is slated to add 370 to its workforce in Costa Rica as part of an expansion plan in the region, according to a post from the Costa Rican Investment Promotion Agency (CINDE). The Irvine, Calif.-based company originally established its facilities in Costa Rica in 2016, and currently employs 480 employees in the region. “Edwards Lifesciences continues expanding with Costa Rica, generating new jobs in Cartago and adding value to the medical devices exports. In our country, the company has a high-tech plant for manufacturing cardiovascular valves which are exported worldwide. It is...
Source: Mass Device - December 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Edwards Lifesciences Source Type: news

Facing headwinds, medtech sector won't be left to its own devices
Here ’s a look at three key issues facing the medical device sector — and the Massachusetts health care economy at large — in 2019. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - December 13, 2018 Category: American Health Authors: Allison DeAngelis Source Type: news

Supplier Stories for the Week of December 9
(Source: MDDI)
Source: MDDI - December 13, 2018 Category: Medical Devices Authors: Daphne Allen Tags: 3-D Printing Source Type: news

Study Links Air Pollution with Rescue Inhaler Use
This study is unique in that it looked at how air pollution impacts someone’s day-to-day life, in terms of their symptoms,” said Meredith Barrett, vice president of research at Propeller Health, in an interview with MD+DI. She said past studies have had to rely on mortality or hospitalization data to understand how air pollution affects asthma, which represents more rare and severe exacerbation events. “By using this medication-use data, we’re able to look at the daily burden of disease,” she said. Data was gat...
Source: MDDI - December 13, 2018 Category: Medical Devices Authors: Susan Shepard Tags: Digital Health Source Type: news

ATS Panel: U.S. Home Oxygen Delivery System Broken
(MedPage Today) -- CMS competitive bidding for durable medical equipment to blame, experts say (Source: MedPage Today Pulmonary)
Source: MedPage Today Pulmonary - December 13, 2018 Category: Respiratory Medicine Source Type: news

New Field Test Discerns Between Ebola and Lookalike Fevers
At the close of the 2014-2016 West Africa Ebola crisis, the Paul G. Allen Foundation identified diagnostic gaps as one of the major deficiencies that had contributed to the outbreak’s spread. “The standard diagnostic tests that exist are very good, but they’re hard to do out in the field in the middle of an outbreak like we saw in West Africa,” said John Connor, a virologist at the Boston University National Emerging Infectious Diseases Laboratory (NEIDL). Instead, samples need to be sent to a facility capable of running the tests, which means it could...
Source: MDDI - December 13, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: IVD Source Type: news

How One Engineer & #039;s Blood Disorder Enabled the Development of an Anemia Detection App
Every month from the time he was six months old, Rob Mannino has had to go into a clinic to receive a blood transfusion. Mannino has an inherited blood disorder known as beta-thalassemia, which is caused by a mutation in the beta-globin gene. “My doctors would test my hemoglobin levels more if they could, but it’s a hassle for me to get to the hospital in between transfusions to receive this blood test. Instead, my doctors currently have to just estimate when I’m going to need a transfusion, based on my hemoglobin level trends," Mannino said. For his biomedical eng...
Source: MDDI - December 12, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Source Type: news

UK preparing for ‘worst-case’ medical supply Brexit plan
The UK government is preparing for a “worst-case” Brexit scenario in which no deal is reached between the country and the European Union by March 29, the date the country is slated to leave the EU, according to a recent release from UK health minister Matt Hancock. Preparations include increasing the stock holding capacity in the country and beginning to stockpile medical supplies to address possible border delays that may result from a ‘no deal’ exit. Efforts are also underway to develop measures to “allow continued movement of products into the UK from the EU at short notice,” accordin...
Source: Mass Device - December 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Regulatory/Compliance Brexit Source Type: news

Can One App Help Stem the Tide of Opioid Abuse?
Digital health solutions could be the most viable means of curbing the opioid abuse epidemic. FDA contributed to the support of this belief earlier this week, when it gave a nod to Pear Therapeutics’ mobile medical app. The solution, called reSET-O, is used to help those with opioid use disorder stay in recovery programs. The Boston, MA-based company said the reSET-O app is a prescription cognitive behavioral therapy intended to be used in addition to outpatient treatment under the care of a health care professional, in conjunction with treatment that includes buprenorphine and contingency management. &a...
Source: MDDI - December 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news

Could Devices Help Pharma Improve Outcomes?
Many of today’s pharmaceuticals are delivered by a specialized device. To explore all the considerations that go into bringing such complex products to market as well as the potential benefits for patients, MD+DI checked in with Chrissy Bell, Global Business Leader – Inhalation and Connected Health, 3M Drug Delivery Systems, and asked her a few questions.  How are drug delivery manufacturers and pharmaceutical companies working together these days to develop devices? Bell: Generics are having a major impact on how pharmaceutical and drug-delivery entities work tog...
Source: MDDI - December 12, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news

December 4, 2018: Medical Device Maker ev3 Agrees to Plead Guilty and Pay $17.9 Million for Distributing Adulterated Device
(Source: Office of Criminal Investigations (OCI) Press Releases)
Source: Office of Criminal Investigations (OCI) Press Releases - December 12, 2018 Category: Medical Law Source Type: news

Sanuwave confirms acting CEO Richardson as company head | Personnel Moves – December 12, 2018
Sanuwave said late last month that it lifted acting CEO and board chair Kevin Richardson to a permanent position in the corner office. Richardson joined the Suwanee, Ga.-based company in 2009 as board chair, and has served as acting CEO since 2014. He also served as managing partner of investment management firm Prides Capital from 2004 to September 2018. Sanuwave said that Richardson took over as the permanent CEO as of November 30, and that he will continue to serve as board chair alongside his new position heading the company, according to an SEC filing.  Common Sensing lifts Schmid to CEO, White to board chair Com...
Source: Mass Device - December 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Bose Corp. Bristol-Myers Squibb Co. Common Sensing glympsebio INSIGHTEC Insulet IsoRay Merck novadipbiosciences owensminor rmsmedical Sanuwave Visioneering Technologies Zimmer Biomet Source Type: news

Appeals court OKs $248m Stryker win over Zimmer Biomet
The U.S. Court of Appeals for the Federal Circuit this week affirmed Stryker‘s (NYSE:SYK) enhanced $248 million win in a surgical tool patent case against Zimmer Biomet (NYSE:ZBH). The Federal Circuit court affirmed the judgement in a per curiam ruling dated on Monday, according to recently released court documents. The damages in the case were previously enhanced due to a US Supreme Court ruling which made it easier to award enhanced damages. In July, Western District of Michigan Judge Robert Jonker reaffirmed an earlier decision to award enhanced damages “in light of the Supreme Court’s clarificati...
Source: Mass Device - December 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Featured Legal News Patent Infringement Stryker Zimmer Biomet Source Type: news

Olympus Unit Pleads Guilty to Resolve U.S. Duodenoscope Probe Olympus Unit Pleads Guilty to Resolve U.S. Duodenoscope Probe
An Olympus Corp subsidiary pleaded guilty on Monday and agreed to pay $85 million to resolve charges that it failed to file reports with U.S. regulators regarding infections connected to its duodenoscopes while continuing to sell the medical devices used to view the gastrointestinal tract.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 12, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news

Reprocessed Duodenoscopes Are Still Too Dirty
Preliminary findings from sampling studies of duodenoscopes currently in clinical use indicate higher-than-expected contamination rates after reprocessing, FDA reported in a safety notice this week. The news coincided with Olympus agreeing to pay $85 million to settle a federal investigation that began in 2015 related to its duodenoscope. Back in 2015, FDA ordered all three U.S. duodenoscope manufacturers—Olympus, Fujifilm, and Pentax—to conduct two postmarket surveillance studies to determine whether healthcare facilities were able to properly clean and disinfect...
Source: MDDI - December 12, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

Can Olympus Finally Put Its Scope Problems in the Past?
Olympus has been plagued with lawsuits and criminal investigations stemming from problems with its duodenoscopes for more than three years, but a plea agreement with the U.S. Department of Justice could help Olympus learn from its mistakes and move on. Check out these MD&M West conference sessions featuring the latest regulatory and quality information. MD&M West will be Feb. 5-7, 2019 in Anaheim, CA. The Tokyo, Japan-based company admitted that it failed to file adverse event reports involving infections that occurred in Europe in 2012 and 2013 that were associated with its TJF-Q180V duodenoscope. After pleading&A...
Source: MDDI - December 11, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Regulatory and Compliance Source Type: news

Report: India still lacks solid medical device regulation
It has been 13 years since Indian health authorities were directed to create a framework for medical device regulation, but only 23 of 5,000 product categories are currently regulated, according to a report from the Hindu BusinessLine. In 2005, a Chief Justice at the Bombay High Court overhearing a case involving drug-eluting stents was shocked to find out that there was no framework to regulate medical devices, and directed the Central and State regulatory bodies to create a an entity to regulate the devices, according to the report. On January 1 this year, the Indian gov’t implemented Medical Device Rules, but the ...
Source: Mass Device - December 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Source Type: news

In2Bones intros ‘ see-through ’ implant for flat feet
(Image courtesy of In2Bones) Orthopedic surgical device developer In2Bones announced the global launch of its “see-through” PitStop implant for children and adults with flat feet. One of the most common foot deformities, flat-foot often starts during adolescence and continues into adulthood. In2Bones (Memphis, Tenn.) developed the PitStop subtalar implant to restore the stability of a patient’s arch during the walking process. Several traditional metallic sublatar implants can be limiting because of material’s stiffness compared to the adjacent bones, causing pain and biomechanical adaptat...
Source: Mass Device - December 11, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Implants Orthopedics In2Bones Source Type: news

Enhancing post-market safety
Ashton Steinhagen, lead clinical research associate for IMARC Research, Inc. The FDA released a follow-up statement to their “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” release that was unveiled in April 2018.  The focus was expanding on post-market surveillance for medical devices. In this plan, the main objectives were to promote and improve public safety and detect safety risks earlier while keeping all those involved, including physicians, informed.  The plan specifically focuses on these five points. Establish a robust medical device patient safety net in th...
Source: Mass Device - December 11, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news

Olympus fined $85 million in duodenoscope case; former exec faces prison
(Photo by rawpixel on Unsplash) Olympus (TYO:7733) and a former senior executive in Japan have pleaded guilty in Newark, N.J., to failing to file required adverse event reports involving infections connected to duodenoscopes, and to continuing to sell the devices in the United States despite those failures, the Justice Department announced.   Tokyo-based Olympus and Hisao Yabe, 62, both entered guilty pleas before U.S. District Court Judge Stanley Chesler in Newark Federal Court: Olympus to three counts, and Yabe to one count, of distributing misbranded medical devices in interstate commerce in violatio...
Source: Mass Device - December 11, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Food & Drug Administration (FDA) Legal News Olympus Source Type: news

House tax bill would delay medical device tax by another 5 years
A bill to extend this year’s tax cuts would also put a five-year moratorium on the medical device tax enacted as part of the Affordable Care Act. Although the 2.3% levy on prescribed medical devices was enacted as part of the Affordable Care Act in 2010, it didn’t go into effect until 2012 and was mothballed two years later; that moratorium, extended earlier this year, was slated to end in 2020. The U.S. House Ways & Means Committee yesterday released the tax extenders legislation including the new moratorium, which would pause the tax until 2025. The House has voted several times for an outright ...
Source: Mass Device - December 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Business/Financial News medicaldevicetax Source Type: news

The Cloud of Uncertainty Thickens Over MiMedx As Auditor Quits
The hits just keep coming for MiMedx Group this year. Ernst & Young (EY), the firm hired to audit the company's financial statements for the past two years, has resigned after advising the company that the internal controls necessary for MiMedx to develop reliable financial statements do not exist. EY told MiMedx that the firm is unable to rely on representations from the current interim CEO and interim CFO because they, in turn, would have needed to rely on representations from certain legacy management personnel still in positions that could affect what is reflected in the company's books and records. In ...
Source: MDDI - December 11, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

LumiThera Announces a Distribution Agreement for the Valeda Light Delivery System with Miloftalmica in Italy
SEATTLE, Dec. 11, 2018 -- (Healthcare Sales & Marketing Network) -- LumiThera Inc., a commercial-stage medical device company focused on developing photobiomodulation (PBM) therapies for ocular disorders and disease, announced a distribution agreement wit... Devices, Ophthalmology, Distribution LumiThera , Miloftalmica, photobiomodulation, Valeda Light Delivery (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 11, 2018 Category: Pharmaceuticals Source Type: news

Adaptiiv adds updates to 3D Bolus software
3D-printed medical device manufacturer Adaptiiv has released the latest version...Read more on AuntMinnie.comRelated Reading: Adaptiiv inks deal with the University of Hong Kong CIVCO Radiotherapy teams up with 3D printing firm (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - December 11, 2018 Category: Radiology Source Type: news

Olympus unit pleads guilty to resolve U.S. duodenoscope probe
An Olympus Corp subsidiary pleaded guilty on Monday and agreed to pay $85 million to resolve charges that it failed to file reports with U.S. regulators regarding infections connected to its duodenoscopes while continuing to sell the medical devices used to view the gastrointestinal tract. (Source: Reuters: Health)
Source: Reuters: Health - December 10, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

.@US_FDA is emphasizing the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes. Read more: https://go.usa.gov/xPShF   #MedicalDevice #FDApic.twitter.com/HiJbgPnsPt
. @US_FDA is emphasizing the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes. Read more: https://go.usa.gov/xPShF  #MedicalDevice #FDA pic.twitter.com/HiJbgPnsPt (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 10, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Millar wins expanded CE Mark for Mikro-Cath pressure catheter
Millar has received a CE Mark approval expansion for its Mikro-Cath Pressure Catheter. The expansion now includes airway and intra-compartmental pressure measurements. The new expansion will give physicians the opportunity to make improvements in respiratory care while delivering a continuous monitoring technique for measuring compartment pressure and diagnosing acute compartment syndrome at onset. Mikro-Cath can be easily integrated into more critical care programs for trauma patients that need ventilation treatment. The pressure catheter offers an increased level of continuous data accuracy for respiratory and compa...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Catheters Millar Source Type: news

Olympus Medical pleads guilty to failing to file events notice: Justice Department
Olympus Medical Systems Corp. and a former senior executive in Japan pleaded guilty on Monday to failing to file required adverse event notices about infection outbreaks linked to one of its medical devices, the U.S. Justice Department said. (Source: Reuters: Health)
Source: Reuters: Health - December 10, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Bay Labs, Edwards collaborate on AI for heart imaging
Artificial intelligence (AI) software developer Bay Labs and medical device...Read more on AuntMinnie.comRelated Reading: Bay Labs: AI software less variable than doctors for EF Bay Labs wins FDA nod for AI echocardiography software AI firm Bay Labs nets $5.5M in financing Edwards debuts non-coronary stents (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - December 10, 2018 Category: Radiology Source Type: news

FDA grants breakthrough status to joint Merck-Bayer AI program
Merck and Bayer have been granted FDA Breakthrough Device Designation for the collaborative Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Artificial Intelligence Pattern Recognition software. CTEPH can be difficult to diagnose because its symptoms are similar to asthma and chronic obstructive pulmonary disease symptoms. CTEPH affects five people per million annually worldwide. Computed tomography pulmonary angiography and a ventilation/perfusion scan can be used to determine if thromboembolic occlusion is causing pulmonary hypertension in patients. Get the full story on our sister site, Medical Design & Outsour...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Food & Drug Administration (FDA) Bayer Merck Source Type: news

Hologic wins FDA nod, launches next-gen Omni hysteroscope
Hologic (NSDQ:HOLX) said today that it launched its next-gen Omni hysteroscope in the U.S. after having received FDA 510(k) clearance earlier in the month. The newly cleared Omni hysteroscope features a three-in-one modular scope and is intended for both diagnostic and therapeutic procedures, the Marlborough, Mass.-based company said. “Experts agree that direct visualization of the uterine cavity in women with abnormal uterine bleeding is the gold standard that allows physicians to accurately identify and collect quality samples and remove pathology – in a safer and more effective manner than blind biopsy ...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Women's Health Hologic Source Type: news

Edwards Lifesciences, Bay Labs ink cardio-focused collab AI-dev deal
Edwards Lifesciences’ (NYSE:EW) and  cardiovascular artificial intelligence medtech firm Bay Labs, have inked a multi-faceted collaborative cardiovascular-focused development deal, Bay Labs said today. San Francisco-based Bay Labs said that the partnership involves multiple initiatives including the development of new AI-powered algorithms in Bay Labs’ EchoMD software suite and the integration of EchoMD algorithms into Edwards’ CardioCare quality care navigation platform, as well as support for ongoing clinical studies. “Our vision is to improve patient care throughout the continuum from d...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Research & Development baylabs Edwards Lifesciences Source Type: news

Nexxt Spine launches Saxxony posterior cervical spine system
Nexxt Spine has received FDA 510(k) clearance and has commercially launched its Saxxony Posterior Cervical Thoracic System. The system is designed to stabilize cervical (C1 to C7) and thoracic (T1 to T3) spinal segments through posterior screw fixation. “The Saxxony System adds a robust posterior complement to our well received anterior cervical fixation offering as we continue to innovate and grow our fusion portfolio,” Andy Elsbury, president of Nexxt Spine, said in a press release. Get the full story on our sister site, Medical Design & Outsourcing. The post Nexxt Spine launches Saxxony posterior ce...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Implants Orthopedics Nexxt Spine Source Type: news

J & J ’s Cerenovus launches global thrombectomy registry
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said today that it launched a new registry aiming to collect and analyze stroke-inducing blood clots removed with the company’s Embotrap II revascularization device. The Irvine, Calif.-based company touted the Excellent registry as the single largest global registry of its kind to date, looking to enroll up to 1,000 ischemic stroke patients across 50 locations in the U.S. and Europe. Investigators in the trial will collect and analyze clots removed to explore how different characteristics, including size, composition and density may affect outcomes, the com...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Featured Neurological cerenovus johnsonandjohnson Source Type: news

Del. supremes uphold Fresenius bailout on Akorn buy
Delaware’s Supreme Court ruled last week to uphold a decision by the state’s Chancery Court that Fresenius (ETR:FRE) could walk away from its $4 billion merger with Akorn (NSDQ:AKRX). The initial deal was designed to help Fresenius move into new therapeutic areas and dosage forms, including eye drugs, ear drops, nasal sprays and respiratory drugs. But Fresenius abandoned the purchase in April, pointing at an investigation that found material breaches of FDA data integrity requirements related to Akorn’s operations. Get the full story at our sister site, Drug Delivery Business...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Featured Legal News Mergers & Acquisitions Pharmaceuticals Wall Street Beat Akorn Fresenius Source Type: news

Viveve prices $20m offering
Viveve (NSDQ:VIVE) last week priced a follow-on offering worth $20 million. Englewood, Colo.-based Viveve’s eponymous device uses cryogen-cooled monopolar radiofrequency tech designed to treat gynecological conditions. The company said Dec. 6 that it floated 13.3 million shares at $1.50 apiece, for gross proceeds of $20.0 million. The offering includes a 30-day underwriters option on another 2.0 million shares that would reap $3.0 million if fully exercised. The offering is slated to close Dec. 11. Viveve said it plans to use the proceeds to continue commercializing its device, winning further regulatory clearan...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Wall Street Beat Women's Health Viveve Source Type: news

MiMedx accounting firm quits
The troubles at MiMedx (NSDQ:MDXG) continued last week with the resignation of the accounting firm tapped to audit its books in the wake of a financial scandal. Marietta, Ga.-based MiMedx last July ousted ex-CEO Parker Petit and president & COO William Taylor amid a board-directed independent investigation that had already prompted the departure of CFO Michael Senken and treasurer John Cranston in June. At the time, MiMedx said it would restate all of its earnings reports going back to 2012 and was cooperating with U.S. Securities & Exchange Commission and Justice Dept. investigations into ...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Regenerative Medicine Wall Street Beat MiMedx Group Inc. Source Type: news

Judge guts plaintiff ’ s case in 2nd Cook Medical IVC bellwether
An Indiana judge last week gutted the plaintiff’s case in the second bellwether trial in the multi-district litigation brought over Cook Medical‘s inferior vena cava filters. Tonya Brand sued Cook in 2014, alleging that the Celect IVC filter implanted prior to a spine procedure fragmented, sending the broken pieces into her thigh and near her spine. Her lawsuit included claims for  strict liability and negligent failure to warn, strict liability and negligent design defect, negligent manufacturing, negligence per se, breach of warranty, loss of consortium, and punitive damages. Cook filed for sum...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Legal News Product Liability Vascular Cook Medical Source Type: news

Latest CyberKnife Treatment Planning System Improves Treatment Delivery Throughput
The CyberKnife® Treatment Planning System comes with VOLO™ Optimizer that helps in improving efficiency by reducing time for creating high quality treatment plans. The VOLO™ optimizer builds treatment planning methods with new tools for assisting in offering optimum clinical experience. It reduces SRS/SBRT treatment times and enables clinicians to generate and evaluate more plans each day. The system allows the clinicians to create plans for multiple cases in the same day.This story is related to the following:Clinical Medical Equipment (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - December 10, 2018 Category: Medical Devices Source Type: news