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Medigus prices $7.5m round
Medigus (TLV:MDGS) today priced an upcoming offering, looking to raise approximately $7.5 million. The Israeli company plans to float approximately 979,714 Class A units in the offering at $3.50 per unit, and 1.2 million Class B units at $3.50 per unit. Each Class A unit in the round consists of 1 American Depositary Share and 1 Series A warrant to purchase an additional share, while each Class B unit includes 1 pre-funded ADS purchase warrant and 1 Series A warrant to purchase an additional share. The warrants are exercisable immediatley or at 6 months following the issuance date with a term of 5 years. H.C. Wainwright ...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Medigus Ltd. Source Type: news

7 medtech stories we missed this week: March 24, 2017
[Image from unsplash.com]From companies receiving CE marking to other companies adjusting their distribution deals, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Viveve Medical closes public offering Viveve Medical announced that it closed its underwritten public offering of 8,625,00 shares of its common stock, according to a March 22 news release. The public offering price was $4 per share, and the company estimates that the net proceeds from the offering will be nearly $31.7 million after deducting underwriting discounts and commissions. 2. Masimo receives CE Mark for Rad-97 P...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Business/Financial News Clinical Trials Orthopedics Astute Medical Bonesupport Cerebral Therapeutics DiamiR Flowonix Glaukos Masimo Ortho Clinical Diagnostics Viveve Medical Source Type: news

Short of votes, Trumpcare bill is withdrawn
Republican leaders in the US House of Representatives today withdrew the GOP-backed Trumpcare bill, which aimed to begin dismantling and replacing Obamacare, due to a shortage of votes. A vote on the measure was planned after Trump cut off negotiations with Republicans who had balked at the plan and issued an ultimatum to vote on Friday, win or lose. The legislation saw opposition from both moderate and conservative Republicans, and neither House leaders nor the White House were able to create a plan which satisfied both parties. Speaker Paul Ryan (R-Wi) reportedly spoke to Trump at 3 p.m. and was instructed to pull the ...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Healthcare Reform Capitol Hill Source Type: news

Researchers tout preclinical results for one-shot vaccination method
Researchers from Boston Children’s Hospital said today that they achieved strong vaccine responses in preclinical models by adding adjuvants to boost the immune response. The team’s work was published the Journal of Clinical Investigation-Insight and the Journal of Allergy and Clinical Immunology.  Vaccines have the potential to drastically reduce infant mortality, the researchers said, but newborns often don’t respond optimally because their immune systems produce weak antibody responses. The team wrote that their work could potentially help amplify newborns’ immune response to vaccinations. Get the full story...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Pharmaceuticals Research & Development Boston Children's Hospital Source Type: news

The top medtech stories of early 2017
[Image courtesy of the White House]The new Trump administration and Republican Congress – and all the accompanying change and uncertainty – is the major story for the medical device industry (and the world in general) during the first three months of the year. But there are many other medtech stories worth noting from the first quarter of 2017. There was an FDA warning over Abbott’s Absorb bioresorbable stent, a continued spate of M&A deals, a slew of cardiology research breakthroughs including a customizable robotic heart out of Harvard, and much more. Here are the top medical device stories of early 2017. Nex...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Chris Newmarker Tags: Business/Financial News Food & Drug Administration (FDA) Healthcare Reform Medicare Mergers & Acquisitions Affordable Care Act Donald Trump Obamacare top stories Source Type: news

FDA: Philips HeartStart MRx recall is Class I
The FDA today classified a Royal Philips (NYSE:PHG) recall of its HeartStart MRx monitor/defibrillator over electrical issues as Class I. A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency. The HeartStart MRx monitor/defibrillator is designed to deliver lifesaving electrical shocks to people with sudden cardiac arrest or to pace individuals with a slow heart beat, according to the FDA. Electrodes on the unit are attached to the patient and then connected to the device to h...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Recalls Royal Philips Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 24, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Mirabilis Medica wins CE Mark, FDA IDE for Mirabilis system Uterine fibroid-treating device developer Mirabilis Medica said today it won CE Mark approval in the European Union and FDA investigational device exemption for its Mi...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

CMS updates on criteria for Dexcom G5 coverage
Shares in DexCom Inc. (NSDQ:DXCM) jumped 9% today after the Centers for Medicare & Medicaid Services updated the criteria for coverage of the company’s G5 Mobile continuous glucose monitor. The device is the only therapeutic CGM classified as durable medical equipment under Medicare Part B. Patients covered by Medicare who have Type I or II diabetes and intensively manage their insulin will be able to obtain reimbursement, according to the updated criteria. Get the full story at our sister site, Drug Delivery Business News. The post CMS updates on criteria for Dexcom G5 coverage appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Regulatory/Clearance Wall Street Beat Centers for Medicare and Medicaid Services (CMS) DexCom Inc. Source Type: news

Report: Theranos trades extra shares for vows not to sue
Theranos is looking to avoid lawsuits from investors by offering them additional shares if they promise not to sue the company, according to a Wall Street Journal report. Shares to be offered will come from CEO Elizabeth Holmes personal stake in the company, which may cause the founder to lose a majority ownership in the blood-testing company, sources close to the company told the WSJ. The arrangement will cover investors who joined in Theranos’ most recent $600 million round of financing, but will not cover investors from earlier rounds. Investors approved in the deal would receive 2 times the shares they originally bo...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Business/Financial News Theranos Source Type: news

Study: Laser-activated gold microstructures deliver cargo directly into cells
Researchers from the Harvard University’s John A. Paulson School of Engineering and Applied Sciences have developed a method to deliver molecules into cells using gold microstructures. The team published their work in ACS Nano. Previous work has been done to deliver drugs or DNA into cells by tricking or forcing open the cell membrane, but the Harvard team says those methods are limited in the type of cargo they can carry. Get the full story at our sister site, Drug Delivery Business News. The post Study: Laser-activated gold microstructures deliver cargo directly into cells appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Oncology Research & Development Harvard University Source Type: news

Creo Medical wins expanded CE mark for Speedboat RS2 electrosurgical device
Creo Medical said today it won expanded CE mark approval for its Speedboat RS2 electrosurgical device, now cleared for the use of microwave energy as well as radiofrequency. The U.K.-based company said that in a 30-patient clinical study, the Speedboat RS2 successfully demonstrated safety and efficacy in applying microwave energy to coagulate bleeds in the colon. Creo Medical touted the device as the 1st to use microwave energy combined with radiofrequency. “Our vision is to enable physicians to move the point of treatment from the operating theatre under general anaesthetic to a procedure under sedation in the endo...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Regulatory/Compliance Surgical Vascular Creo Medical Source Type: news

Align Technology inks sales deal  with Zfx
Align Technology (NSDQ:ALGN) said today it inked a sales agreement with Zfx GmbH to expand the sales of its iTero Element intraoral scanners in European, Asian and African countries. Through the non-exclusive deal, Zfx will act as a sales agent for the company’s iTero Element intraoral scanners amongst its network of customers, including laboratories, milling centers and dental professionals. “The addition of iTero intraoral scanners with the Zfx digital restorative platform exemplifies our shared commitment to provide digital restorative solutions and efficiency to dental professionals. Through this relations...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Dental Align Technology Source Type: news

Mirabilis Medica wins CE Mark, FDA IDE for Mirabilis system
Mirabilis Medica said today it won CE Mark approval in the European Union and FDA investigational device exemption for its Mirabilis System designed to treat uterine fibroids. The Bothell, Wash.-based company’s Mirabilis system is designed to use ultrasound to both provide imaging and ablation during procedures to remove uterine fibroids, the company said. The device uses low-intensity ultrasound waves to locate fibroids within the body, and a high-intensity ultrasound to heat and kill the fibroid tissue to provide relief from symptoms due to the growths. “The Mirabilis System has been in development for nearly 10...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Women's Health Mirabilis Medica Source Type: news

Cordis recalls select S.M.A.R.T. flex vascular stent systems
Cardinal Health (NYSE:CAH) subsidiary Cordis this week released an urgent field safety notice recalling its S.M.A.R.T. Flex vascular stent systems in sizes 5x200mm and 6x200mm over deployment issues. The company is recalling the devices over reports of deployment difficulty with the devices in the 2 particular sizes. The most commonly reported deployment issue is the inability to deploy the stent, which can result in intra-procedural delays while a replacement device is prepped, Cordis said. Cordis warned that partial stent deployment could cause ischemia which would require further intervention. A total of 3 patient in...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Recalls Stents Cardinal Health Cordis Corp. Source Type: news

Lilly details plans for $850m investment in U.S. operations
Eli Lilly (NYSE:LLY) said today that it plans to invest $850 million in its U.S. operations in 2017. The company presented details of its plans at the Lilly Technology Center in Indianapolis, joined by federal, state and local government officials. Lilly said it will invest in an $85 million expansion of its Trulicity device assembly operations as a part of its 5-year plan to expand manufacturing operations in the U.S. The company also officially dedicated a $140 million insulin cartridge production facility today. The move to invest in manufacturing in the U.S. comes after President Donald Trump repeatedly urged drug- and...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Wall Street Beat Eli Lilly & Co. Source Type: news

Heart Societies update guidelines to support cardiac monitors for syncope patients
Medtronic (NYSE:MDT) said today that new guidelines from the American College of Cardiology, the American Heart Association and the Heart Rhythm Society now recommend the use of cardiac monitors for patients with syncope. The updated guidelines for patients with syncope, or unexplained fainting, was published online in the Journal of the American College of Cardiology, Circulation and HeartRhythm. Medtronic said that the new guidelines support the use of its Seeq MCT system, a wireless continuous external heart monitor that can be worn up to 30 days, and its Reveal Linq ICM with TruRhythm detection, an implantable monito...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Patient Monitoring Medtronic Source Type: news

European advisory committee backs label update for Nordisk ’ s Tresiba
Shares in Novo Nordisk (NYSE:NVO) were up 2% this morning after the European Medicines Agency’s Committee for Medicinal Products for Human Use backed the company’s application for a label update to its Tresiba insulin injection. The company submitted an application in November to add data from 2 studies to the medication’s label. The final ruling is expected to come from the committee in 60 days. Get the full story at our sister site, Drug Delivery Business News. The post European advisory committee backs label update for Nordisk’s Tresiba appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Regulatory/Clearance Wall Street Beat Novo Nordisk Source Type: news

Abbott divests 60% of its stake in Mylan
Abbott (NYSE:ABT) divested 60% of its remaining stake in Mylan (NSDQ:MYL) this week, according to regulatory filings, disposing of 44 million shares at $41.60 apiece. The trade was valued at $1.7 billion. In 2014, Mylan bought Abbott’s generics business outside the U.S. in a deal that rang in at nearly $5.3 billion. The deal allowed Canonsburg, Penn.-based Mylan to cut its tax bill by moving its tax address outside the U.S., and Abbott received an ownership stake of 21% with 105 million shares of the company. Get the full story at our sister site, Drug Delivery Business News. The post Abbott divests 60% of its stake ...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Pharmaceuticals Regulatory/Clearance Wall Street Beat Abbott Labs Mylan Source Type: news

Little or no audit preparation common device QMS problem
By Stewart Eisenhart, Emergo Group In the second in a series of blog posts examining common problems medical device firms deal with related to quality management system audits, Emergo discusses how lack of proper internal audit preparation leads to last-minute scrambles and business headaches. 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 Little or no audit preparation common device QMS problem appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog Source Type: news

House delays vote on Trumpcare bill
The US House of Representatives today indefinitely delayed its vote on the Trumpcare legislation, which looks to begin dismantling Obamacare and replacing it with a GOP-supported framework. The Trump administration and the GOP had hoped the day would signal a significant turn for conservatives, with Trump and House Republican leaders planning the vote on the 7th anniversary of former President Barack Obama signing his name to the Affordable Care Act, which became known as Obamacare. Sen. Majority leader Mitch McConnel (R-Ky.) informed senators that a vote on the bill may not be held in the House before Monday, according to...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Healthcare Reform Legal News Capitol Hill Source Type: news

NuVasive shareholders win class action cert in alleged kickback case
A federal court this week certified a class of NuVasive Inc. (NSDQ:NUVA) investors in a suit alleging that the company lost share value after it hid a kickback scheme. A judge in the US District Court for the Southern District of California this week granted a motion for class certification, appointing Brad Mass and Daniel Popov as class representatives, according to court documents. The class action suit is on behalf of investors who purchased shares in the company between Oct. 22, 2008 and July 30, 2013. Plaintiffs in the suit allege that NuVasive submitted false claims to Medicare and Medicaid in violation of stat...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Legal News Nuvasive Source Type: news

Biosensors International launches US pivotal for BioFreedom DCS
Biosensors International said today it enrolled the 1st patient in a pivotal US study of its BioFreedom drug-coated stent. The Singapore-based company’s Leaders Free II study is an ongoing trial examining the use of the BioFreedom DCS in patients at high bleeding risk who receive an ultra-short dual anti-platelet drug regimen of 1 per month. “We are excited to participate in the BioFreedom DCS US Pivotal IDE study and begin building the HBR patient database in America, which is a significant and relatively unstudied US population,” Dr. Michael Butler of Alabama’s Huntsville Hospital, who performe...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Stents Biosensors International Group Ltd. Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 23, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. InVivo wins Health Canada nod for cervical neuro-spinal scaffold trial InVivo Therapeutics said today it won Health Canada approval to initiate a clinical study of its neuro-spinal scaffold in patients with acute, complete AIS ...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

How to hire a compliance-minded CRO
Clinical research sponsors continue to outsource the management of their clinical trials, spending millions of dollars for a pivotal phase and significant risk medical device trial.  Choosing a clinical research organization with compliance expertise will protect your investment and ensure your product is ultimately approved. The right CRO should understand their important role as a partner in compliance who shares your commitment to protect human subjects and ensure data integrity.  They should collaborate with your team and offer strategic recommendations that mitigate risk and streamline your process, rather than slo...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news

Zoll Medical wins Health Canada nod for next-gen AEDs
Zoll Medical said this week it won approval from Health Canada for its Zoll AED 3 and Zoll AED 3 BLS automated external defibrillators and launched them in the region. Both newly-cleared AEDs provide real-time feedback to communicate appropriate timing for effective CPR through audible and visual prompts, which the Chelmsford, Mass.-based company said can be critical to a patient’s survival. “We are extremely excited to add the Zoll AED 3 and the Zoll AED 3 BLS to our portfolio of automated external defibrillators. With the addition of these new devices, we are able to offer our public access and BLS customer...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Regulatory/Compliance Resuscitation Zoll Medical Corp. Source Type: news

Gamida Cell wins additional EMA orphan drug designation for NiCord
Gamida Cell said today that the European Medicines Agency granted its NiCord cell graft an additional orphan drug designation as a treatment for hematopoietic stem cell transplantation, or bone marrow transplantation. The treatment is a graft derived from umbilical cord blood which has been expanded and enriched with stem and progenitor cells, according to the company. The EMA previously granted orphan drug designation to NiCord for acute myeloid leukemia. Get the full story at our sister site, Drug Delivery Business News. The post Gamida Cell wins additional EMA orphan drug designation for NiCord appeared first on MassD...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Oncology Regulatory/Clearance Stem Cells Wall Street Beat Gamida Cell Source Type: news

BioStable Science & Eng wins FDA nod for Haart 300 aortic annuloplasty device
Cardiovascular device developer BioStable Science & Engineering said yesterday it won FDA 510(k) clearance for its Haart 300 aortic annuloplasty device. The Austin, Texas-based company touted the Haart 300 as the 1st commercially available internal annuloplasty device designed for aortic valve repair, expected to be available to select US heart centers this summer. “We are very grateful for the cooperation between the BioStable management team and FDA that allowed the company to obtain this market clearance earlier than anticipated, and we look forward to the Haart 300 Aortic Annuloplasty Device being availab...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves BioStable Science & Engineering Source Type: news

Ethicon closes Torax Medical buy
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it closed its acquisition of Torax Medical, and its Linx acid reflux treatment portfolio, for an undisclosed amount. The Linx system from Shoreview, Minn.-based Torax is an implant composed of interlinked titanium beads with magnetic cores that augments the esophageal sphincter’s barrier function to prevent reflux in patients with gastro-esophageal reflux disease. Torax is also developing a similar device, Fenix, designed to treat fecal incontinence. “Torax and Ethicon share a vision for the transformational role that our products can have in advancin...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Mergers & Acquisitions Otolaryngology Ear, Nose & Throat Ethicon Johnson & Johnson Torax Medical Inc. Source Type: news

Intact Vascular finishes patient enrollment for angioplasty clinical trial
Intact Vascular said today that it finished enrollment for the Toba II clinical trial evaluating its Tack Endovascular System in combination with standard or drug coated balloon angioplasty in arteries above the knee. The company’s trial enrolled 210 patients and will focus on the superficial femoral artery and the proximal segment of the popliteal artery, according to Intact. Get the full story at our sister site, Drug Delivery Business News. The post Intact Vascular finishes patient enrollment for angioplasty clinical trial appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Vascular Wall Street Beat Intact Vascular Source Type: news

Valeritas prices $53m IPO
Valeritas today priced its upcoming initial public offering, looking to raise $52.5 million through the sale of 5.25 million shares at $10 per share. The offering includes a 30-day underwriters option for the purchase of an additional 787,500 shares, which would take the total funding possible in the round to approximately $60 million. Bridgewater, N.J.-based Valeritas makes the V-Go basal insulin delivery system for Type II diabetes, a fully disposable, continuous-delivery device that’s designed to function for 24 hours based on a preset rate, with on-demand dosing for meals. Shares are expected to begin trading on th...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Initial Public Offering (IPO) Valeritas Holdings Source Type: news

InVivo wins Health Canada nod for cervical neuro-spinal scaffold trial
InVivo Therapeutics (NSDQ:NVIV) said today it won Health Canada approval to initiate a clinical study of its neuro-spinal scaffold in patients with acute, complete AIS A cervical spinal cord injuries. The Cambridge, Mass.-based company said it is in late stage conversations with several site research ethics boards, and expects to announce the 1st Canadian site for the study “in the coming weeks.” The neuro-spinal scaffold is designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting, InVivo said. “This approval is an important step towards...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Spinal InVivo Therapeutics Source Type: news

Supreme Court declines review of Retractable Tech case against BD
Retractable Technologies (NYSE:RVP) said on Monday that the US Supreme Court denied its request to review an overturned $352 million anti-trust win over Becton Dickinson (NYSE:BDX). With the ruling, the case goes back to the Eastern District of Texas, where it was sent by the Fifth Circuit Court of Appeals, for a redetermination of the amount of damages to which BD must disgorge. A 1-day bench trail is set for May 11, the Little Elm, Texas-based company said. Last month, Retractable Tech filed a petition for a writ of certiorari with the Supreme Court to review the overturned case. The decision from the federal appeal...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Legal News Becton Dickinson & Co. Retractable Technologies Inc. Source Type: news

Tandem Diabetes Care prices $22.5m public offering
Tandem Diabetes Care (NSDQ:TNDM) today announced the pricing details of a $22.5 million underwritten public offering. The company priced 18 million shares of its common stock at $1.25 apiece. Tandem also gave underwriters a 30-day option to buy up to an additional 2.7 million shares of common stock at the public offering price. The offering is expected to close on March 28. Get the full story at our sister site, Drug Delivery Business News. The post Tandem Diabetes Care prices $22.5m public offering appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Funding Roundup Wall Street Beat Tandem Diabetes Care Source Type: news

The stem cell ‘skin gun’ that’s aiming to disrupt wound care
RenovaCare’s SkinGun uses a patient’s own stem cells to heal their wounds faster and more efficiently than a traditional skin graft. Pennsylvania state police officer Matthew Uram suffered severe second-degree burns to his face, right arm and leg after a friend’s bonfire got out of control. Uram was facing months of painful skin grafts, the standard treatment in wound care for burns. But instead, he was one of the first patients to be treated with RenovaCare’s stem-cell-spraying SkinGun. Get the full story at our sister site, Drug Delivery Business News. The post The stem cell ‘skin gun’ that’s aiming to dis...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Stem Cells Wound Care RenovaCare Source Type: news

The stem cell therapy that could reverse hearing loss
Frequency Therapeutics is betting that it can change the lives of millions of Americans with hearing loss, by triggering the body’s natural ability to heal itself. Researchers have used cells in regenerative medicine for decades – in 1931, the father of cell therapy, Paul Niehans, treated a patient with material from calf embryos. Although today’s healthcare practitioners have left bovine embryonic cells behind, procedures such as bone marrow transplants are routinely used to replenish a patient’s cells after they’ve been destroyed. When scientists first derived stem cells in 1981 – a decade after Niehans’s d...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Stem Cells Wall Street Beat Frequency Therapeutics Source Type: news

Mylan recalls 81,000 EpiPens over reports of device failure
Mylan (NSDQ:MYL) recalled 81,000 EpiPen emergency allergy auto-injectors this week after receiving 2 reports that the device failed to work in emergencies. The recall affects devices in Australia, New Zealand, Europe and Japan, the company reported. Canonsburg, Penn.-based Mylan said that in both cases, patients received treatment using an alternate EpiPen. The drugmaker also said that it is working with regulatory authorities in affected countries to inform them about the recall. Get the full story at our sister site, Drug Delivery Business News. The post Mylan recalls 81,000 EpiPens over reports of device failure appe...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Recalls Wall Street Beat Mylan Source Type: news

Trump proposes higher FDA fees for drug, medical device FDA registrants
By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fee increases in the Trump Administration’s proposed 2018 federal budget would disproportionately impact smaller medical device companies, as these firms make up the majority of the US medical device industry. 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 Trump proposes higher FDA fees for drug, medical device FDA registrants appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

TransEnterix adds hernia repair to Senhance robotic surgical platform
TransEnterix (NYSE:TRXC) said today it is looking to expand the use of its Senhance robotic surgical system to include hernia repair surgeries, touting that the system has been used in for the 1st time in such procedures in Germany. Research Triangle Park, N.C.-based Transenterix said that Dr. Dietmar Stephan and Dr. Frank Willeke performed up to 3 hernia surgeries with the robotic platform per day during the system’s 1st weeks of clinical use at the St. Marien-Krankenhaus Siegen hernia repair center in Germany. “We are pleased to offer robotic hernia repair utilizing the Senhance Robotic System, and all ou...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Robot-Assisted Surgery Robotics Surgical TransEnterix Source Type: news

Tryton Medical touts 1st commercial implant of Side Branch stent
Tryton Medical said today that its Side Branch Stent designed to treat coronary bifurcation lesions has been used in its 1st commercial procedure, performed by Dr. Martin Leon and Dr. Ajay Kirtane at the New York-Presbyterian Hospital . The side-branch stent is designed to be compatible with any conventional drug-eluting stent in the main vessel, and comes in sizes ranging from 2.5mm to 3.5mm, the Durham, N.C.-based company said. “Dr. Leon and the cath lab team at Columbia University Medical Center played an integral role investigating the Tryton Side Branch Stent through extensive clinical research leading to the ...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Stents Surgical Vascular Tryton Medical Inc. Source Type: news

6 visual impairment breakthroughs you need to know
[Image courtesy unsplash.com]About 285 million people have some form of visual impairment in the world, according to the World Health Organization. Of that number, 39 million are considered blind, and 246 million have low vision. Three-fifths of all vision impairment can be prevented or cured. Uncorrected refractive errors are one of the main causes of vision impairment in the world. There has been a host of recent breakthroughs, however, that offer hope for the visually impaired. There’s a smart watch that relays smartphone notifications using braille and retinal prosthetics that could restore sight. Here are 6 recent...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Biotech Clinical Trials Implants Optical/Ophthalmic Prosthetics Research & Development blindness eSight Corporation gene therapy Keratonconus MedTech Nanovision Biosciences retinitis pigmentosa University of California San Diego Source Type: news

FDA green-lights Aegis Medical trial for Sierra ligation device
This study will confirm the safety of the Sierra device for patient use, and will lay a solid foundation for future efforts to demonstrate that Sierra can prevent stroke in AF patients and eliminate the need to take blood thinners for stroke prevention,” principal investigator Dr. Sheldon Singh of Toronto’s Sunnybrook Health Sciences Centre said in a prepared release. “For many AF patients, anticoagulants are used to reduce the risk of stroke. One of the downsides of these drugs is that they can result in life-threatening bleeding. Aegis has developed a minimally invasive, non-vascular LAA closure device,...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Aegis Medical Innovation Source Type: news

QT Vascular raises $14m
QT Vascular said this week it inked a private placement deal with Gem Global Yield Fund for up to $14.3 million (SGD $20 million) over the next 30 months. In the funding agreement, Singapore-based QT Vascular will receive up to $7.2 million (SGD $10 million) over the next 30 months, with an option for an additional $7.2 million on identical terms to the original agreement. The option is available for a period of 6 months, the company said. Funds are slated to support repaying existing debt, improve cash flow and increase production to support its non-drug coated Chocolate PTA products. “This agreement with GEM Globa...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Catheters QT Vascular Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 22, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Japan clears Novocure’s 2nd gen Optune device Novocure said today it won approval from the Japanese Ministry of Health, Labour and Welfare for its 2nd-gen Optune device. The Optune is a mobile device that delivers low-intensi...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: MassDevice Tags: Blog News Well Plus 5 Source Type: news

Varex Imaging inks 3-year supply deal with Toshiba Medical
Varex Imaging (NSDQ:VREX) said today it inked a renewed 3-year pricing agreement with Canon‘s (NYSE:CAJ) Toshiba Medical subsidiary. Through the deal, Salt Lake City, Utah.-based Varex Imaging will supply Toshiba Medical with its computed tomography tubes for integration into its CT imaging systems. The agreement is set to take effect April 1. “The continuation of our four-decades long relationship with Toshiba Medical Systems is a testament to its strength and Toshiba Medical’s confidence in our ongoing ability to develop new X-ray imaging component technology that improves performance, contributes to fas...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Imaging Toshiba Medical Systems Corp. Varex Imaging Source Type: news

FDA warns on lymphoma risk associated with breast implants
The FDA this month warned of an association between breast implants and the development anapestic large cell lymphoma. The federal watchdog warned that the rare T-cell lymphoma can develop following implants, based on data the agency, and other health and regulatory bodies worldwide, have been collecting since 2011. The exact number of cases “remains difficult to determine,” the FDA said, though data indicates that the occurrence of BIA-ALCL is more common following the implantation of breast implants with textured surfaces over those with smooth surfaces. The FDA said it has received a total of 359 medical dev...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cosmetic/Aesthetic Food & Drug Administration (FDA) Women's Health Source Type: news

How to make ultrasound zap tumors in a moving organ
[Image courtesy of Fraunhofer Institute for Medical Image Computing]Researchers led by the Fraunhofer Institute for Medical Image Computing think they’ve overcome the challenges standing in the way of using ultrasound to kill cancer tumors in organs that move with breathing. Until now, health practitioners have mostly limited ultrasound to treating prostate cancer, bone metastases and uterine myoma, according to the Fraunhofer Institute (Bremen, Germany). Organs that move when a patient breathes are trickier, with doctors telling patients to hold their breath or putting the patients under anesthesia. The Trans-Fusi...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Chris Newmarker Tags: Imaging Research & Development Ultrasound Cancer Fraunhofer Institute for Medical Image Computing MedTech Source Type: news

Medtronic wins FDA nod for CoreValve Evolut Pro
Medtronic (NYSE:MDT) said today it won FDA approval for its CoreValve Evolut Pro transcatheter arortic heart valve replacement designed for treating severe aortic stensosis. The newly cleared, next-gen CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said. “Medtronic remains committed to working with interventional cardiologists and cardiac surgeons to deliver solutions that address patient needs with the safety and performance profile they expect from Medtronic. We are excited ...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news

Hologic closes $1.7B Cynosure buy
Hologic (NSDQ:HOLX) said today that it closed its $1.65 billion acquisition of Cynosure Inc. (NSDQ:CYNO) and its portfolio of medical aesthetic products and devices. Marlborough, Mass.-based Hologic paid $66 per share for a total of 17 million shares of Class A stock, representing approximately 70.6% of the company’s outstanding shares. “We are pleased to complete our acquisition of Cynosure, and look forward to working with Michael Davin and the entire Cynosure team to achieve even greater success in the large, rapidly growing medical aesthetics market. Acquiring Cynosure, combined with divesting our blood...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cosmetic/Aesthetic Mergers & Acquisitions Cynosure Inc. Hologic Inc. Source Type: news

Do patient advocacy organizations have a conflict of interest?
[Image from Unsplash]At least 83% of U.S. patient advocacy organizations receive financial support from medical device, drug and biotechnology companies, according to new research out of the University of Pennsylvania’s Department of Medical Ethics and Health Policy. The Penn research team – which included Matthew McCoy, Harald Schmidt and Ezekiel Emanuel – examined websites and annual reports for 104 organizations with annual revenues over $7.5 million. Most of the organizations examined took money from the companies they also worked with on behalf of patients. But other than that, there were few details when...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Chris Newmarker Tags: Business/Financial News Clinical Trials Healthcare Reform News Well Research & Development MedTech patient advocacy patient advocacy organizations University of Pennsylvania Source Type: news

Medtronic plans $2B debt flotation
Medtronic (NYSE:MDT) today announced a series of upcoming offerings, looking to bring in approximately $2 billion. The Fridley, Minn.-based company announced 2 offerings to be held through its subsidiary Medtronic Global Holdings, or Medtronic Luxco, looking to bring in $1 billion in 1.7% senior notes due 2019 and $850 million in 3.35% senior notes due 2027. Medtronic released details on an additional offering of $150 million in 4.625% senior notes due 2045, to be held by itself and not its subsidiary Medtronic Luxco. The notes in this offering will form a single series with the $4 billion in outstanding 4.625% notes du...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Medtronic Source Type: news