Baxter touts Theranova HDx dialysis tech study data

Baxter (NYSE:BAX) today released new data from studies exploring expanded hemodialysis with its Theranova dialyzer, touting the device’s ability to clear large middle molecules at a higher rate than standard hemodialysis and equal or faster removal rates compared to high-volume hemodiafiltration.

Results from a number of studies and poster presentations on the Theranova dialyzer were presented at the 55th Congress of the European Renal Association and European Dialysis and Transplant Association meeting this month, Baxter said.

The Deerfield, Ill.-based company’s Theranova dialyzer is designed to extend the range of molecules that it filters from the blood, which the company claims “more closely mimics the natural kidney.” The expanded hemodialysis therapy works on standard equipment and does not require the generation of replacement fluid, Baxter said.

Baxter touted that data from two studies presented at the meeting indicated that during treatment with the Theranova dialyzer, albumin levels remained stable during treatment.

In an independent study exploring the effects of its HDx therapy in comparison to high-flux HD in conventional settings, data indicated no loss of serum albumin or serum protein with use of the Theranova dialyzer in conventional HD compared to high-flux dialyzer hemodiafiltration. No relevant differences in adequacy, anemia or bone mineral metabolism parameters were noted, Baxter added.

A separate independent study, researchers found Baxter’s HDx to be superior to standard high-flux HD in removing middle and larger molecules, and found it non-inferior to hemodiafiltration in clearing small and larger middle molecules.

“HDx therapy enabled by Theranova was designed to filter a wider range of toxins from the blood than conventional HD filters, because we believe this is a critical step to transforming renal care and improving patient outcomes. We are committed to fully exploring and supporting robust scientific exchange about HDx therapy to understand its full potential for dialysis patients,” Baxter renal care biz GM Laura Angelini said in a press release.

Earlier this week, Baxter announced the launch of two updates for its Sharesource remote patient monitoring platform designed to monitor home peritoneal dialysis patients including the addition of a new modeling software tool and improvements to the clinical portal.

The post Baxter touts Theranova HDx dialysis tech study data appeared first on MassDevice.

from MassDevice https://ift.tt/2kFaq96

Tela Bio, Aroa Biosurgery win CE Mark for OviTex bioscaffolds

Tela Bio said today that its partner Aroa Biosurgery won CE Mark approval in the European Union for its OviTex Reinforced BioScaffold, which Tela Bio will commercially launch in the region.

Malvern, Penn.-based Tela Bio said that is has offered the OviTex RBS for ventral hernia repairs and abdominal wall reconstruction procedures in the US since July 2016.

The OviTex RBS devices are surgical implants with integrated biologic and synthetic materials to allow the movement of fluid and cells through the product, Tela Bio said. The company touted that more than 2,000 procedures have been performed with the OviTex RBSs to date.

“Securing EC Certification will provide the opportunity for patients with complex hernia in Europe to gain access to the advantages of OviTex RBSs. We are pleased that Tela Bio can now build on their growing success in the United States and begin a commercial rollout in Europe,” Aroa Biosurgery CEO Brian Ward said in a press release.

Results from a retrospective study of the OviTex RBSs, presented at the Americas Hernia Society International Hernia Congress 2018, showed that use of the devices led to a low recurrence rate and a low complication rate. Tela Bio said it has launched a post-market clinical study of the scaffolds to continue evaluation their safety and efficacy.

“We are excited to announce that our strategic partner has received a CE Mark for OviTex RBSs and look forward to bringing the benefits of this innovative solution to the European market. Historically, biologic products have had limited success in Europe due to their high price points, but our unique supply chain enables us to deliver OviTex RBSs at a significant cost reduction that is well-suited for the healthcare landscape overseas,” Tela Bio prez & CEO Antony Koblish said in a prepared statement.

In March, Tela Bio said that it landed a $1 million investment from ProMedica, a not-for-profit healthcare group serving northwest Ohio and southern Michigan.

The post Tela Bio, Aroa Biosurgery win CE Mark for OviTex bioscaffolds appeared first on MassDevice.

from MassDevice https://ift.tt/2kFsfF3

Common Sensing, Flex partner to redesign digital insulin pen sensor

Image courtesy of Common Sensing

Common Sensing said today that it has enlisted design company Flex to help redesign its Gocap insulin pen device.

Flex is tasked with finding materials to help extend the product’s battery life, as well as boost measurement accuracy and prepare for high volume manufacturing.

Get the full story at our sister site, Drug Delivery Business News.

The post Common Sensing, Flex partner to redesign digital insulin pen sensor appeared first on MassDevice.

from MassDevice https://ift.tt/2H8Rd8y

LivaNova touts CMS reconsideration of VNS therapy treatment for TRD

LivaNova (NSDQ:LIVN) today announced that the US Centers for Medicare & Medicaid Services are reconsidering a National Coverage Determination covering the use of vagus nerve stimulation technology for treating treatment-resistant depression.

CMS last considered covering VNS treatment for TRD in 2007, but declined the coverage due to “insufficient evidence.”

“In 1999, CMS established coverage of vagus nerve stimulation for patients with medically refractory partial onset seizures for whom surgery is not recommended or for whom surgery has failed. In 2007, CMS reconsidered the NCD and determined that, at that time, there was insufficient evidence to conclude that vagus nerve stimulation was reasonable and necessary for treatment resistant depression, and VNS for TRD was therefore non-covered,” CMS wrote in its newly posted tracking sheet.

The agency is now reconsidering coverage at the urging of LivaNova, who recommended it based on a wealth of new data which emerged since CMS last declined covering VNS treatment for TRD.

“In the intervening years since the NCD was considered in 2007, a significant body of new evidence has emerged about TRD and the role of VNS Therapy in its treatment. This compelling new evidence addresses the concerns expressed by the Centers for Medicare and Medicaid Services,” LivaNova wrote in its letter to CMS.

LivaNova goes on to provide evidence it believes supports reconsideration of VNS therapy for TRD “as reasonable and necessary for a defined patient subpopulation of medicare beneficiaries,” according to the company’s letter to CMS.

Evidence used to support coverage includes TRD being defined and characterized, that methods to study the effectiveness of TRD treatments have been defined and that new scientific data supports that VNS therapy can be beneficial to patients with TRD.

LivaNova is hopeful that Medicare will change its coverage status to include treatment of TRD, and encouraged others to comment and add evidence towards a shift in coverage.

“Over the last decade, a significant body of new evidence has emerged showing that the addition of VNS Therapy is effective in reducing symptoms in patients with TRD. We look forward to working with CMS as they consider a change in Medicare coverage,” LivaNova wrote in a press release.

Earlier this month, LivaNova saw shares fall despite beating the Street on earnings per share and sales with its first quarter earnings results.

The post LivaNova touts CMS reconsideration of VNS therapy treatment for TRD appeared first on MassDevice.

from MassDevice https://ift.tt/2ss4lAr

Propeller raises $20m and prepares to extend reach beyond digital inhalers

Digital therapeutics company Propeller Health and drug-delivery device-maker Aptar Pharma are teaming up, yet again, to develop an array of connected drug-delivery devices.

The pair has worked together in the past – in 2016, the companies launched the world’s first fully-integrated connected metered dose inhaler.

Get the full story at our sister site, Drug Delivery Business News.

The post Propeller raises $20m and prepares to extend reach beyond digital inhalers appeared first on MassDevice.

from MassDevice https://ift.tt/2J49sh9

Terumo’s MicroVention wins PMA for LVIS neuro stents

Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today that it won pre-market approval from the FDA for a line of neurovascular stents.

Aliso Viejo, Calif.-based MicroVention said the federal safety watchdog approved its low-profile visualized intraluminal support devices for stent-assisted coil embolization of intracranial aneurysms.

Previously approved under a humanitarian device exemption, the LVIS and LVIS Jr. stents are designed to stabilize the blood vessel around the opening to a wide-neck aneurysm while a coil is deployed within the aneurysm and then retrieved after the coil is in place.

“The LVIS and LVIS Jr. stents address the growing preference of physicians for highly conformable braided stents for aneurysm treatment. Thousands of patients globally have benefited from this technology and we are pleased to have achieved the most rigorous standard of FDA approval to support our customers’ usage,” MicroVention president & CEO Richard Cappetta said in prepared remarks.

“With their low-profile and consistent visibility, LVIS and LVIS Jr. stents expand the treatment options for patients with challenging, wide-necked aneurysms. The pivotal trial shows that these stents are safe and effective for patients with aneurysms that may be challenging to treat with other devices,” added principal investigator Dr. David Fiorella of the Stony Brook University Cerebrovascular & Stroke Center.

The post Terumo’s MicroVention wins PMA for LVIS neuro stents appeared first on MassDevice.

from MassDevice https://ift.tt/2snre8N

Trump tariffs leave medical device companies in the dark

U.S. medical device industry representatives, for now, appear to be taking a wait and see approach as President Donald Trump’s administration wrangles over trade policy and threatens tariffs against China. The status of China tariffs on medical devices is unknown at this time as the Trump administration continues to make changes to its trade policies with China.

The U.S. is set to impose a 25% tariff on about $50 billion worth of goods imported from China containing industrially significant technology, including those related to the “Made in China 2025” program. The final list of imports will be announced by June 15.

White House officials recently put out a statement that said China has been taking advantage of the American economy and that is not part of the fair and reciprocal trade that the U.S. expects. According to the White House, China has previously imposed higher tariffs on U.S. exports than what the U.S. imposes on China.

Get the full story on our sister site Medical Design & Outsourcing.

The post Trump tariffs leave medical device companies in the dark appeared first on MassDevice.

from MassDevice https://ift.tt/2Jjw5kV

JC Medical touts first-in-human use of transfemoral J-Valve TAVI

JC Medical today announced the first clinical procedure using its transfemoral J-Valve TF transcatheter aortic valve implant system designed to treat aortic regurgitation.

The procedure, performed at Vancouver’s St. Paul’s Hospital by Dr. John Webb, marks the first in-human use of the transfemoral TAVI device, the China-based company said.

JC Medical’s J-Valve System is designed to restore normal blood flow out of the heart and into the body, which may improve symptoms of heart failure such as shortness of breath, fatigue and chest pain, the company said. The devices feature a proprietary anchor mechanism that does not require calcification for fixation and that is flexibly linked to a self-expanding stent frame to uniquely attach to the failing native heart valve.

“We are very pleased that our J-Valve could help this patient. We developed the J-Valve to be reliable and easy to use. We thank the physician group who has recognized this unique clinical solution. With approximately 2% of the elderly population having heart failure due to a defective stenotic aortic valve and 1% due to a regurgitant valve, this leads to a significant decrease in the quality of life, the loss of life for many, and costs the healthcare system billions of dollars annually. We look forward to further exploring the promise of J-Valve and its role in treating failing aortic heart valves,” founder & CEO Dr. Ji Zhang said in a prepared statement.

The company’s J-Valve system won Chinese FDA approval last April, and is currently only available for sale in China.

The post JC Medical touts first-in-human use of transfemoral J-Valve TAVI appeared first on MassDevice.

from MassDevice https://ift.tt/2JlVURx

Boston Scientific, IRS finalize $608m settlement over transfer pricing beef

Boston Scientific (NYSE:BSX) and the U.S. Internal Revenue Service yesterday finalized their settlement of a tax beef dating back to the $26 billion acquisition of Guidant in 2006, which would see the company pay nearly $610 million in taxes and interest.

In transfer pricing, income is allocated among branches in different countries. It’s a legal tax maneuver companies can use to attribute profits from a product made and sold in the U.S. to a unit in a foreign country.

In July 2016, Marlborough, Mass.-based Boston Scientific agreed to pay the IRS $275 million plus interest to put to bed a dispute over the agency’s tally of transfer pricing between domestic and foreign Guidant subsidiaries, plus charges related to a 2006 deal in which Abbott (NYSE:ABT) bought Guidant’s stent business from Boston Scientific.

The deal aimed to settle the transfer pricing issue before the IRS Office of Appeals and a related case in the U.S. Tax Court for Guidant’s 2001 through 2006 tax years and 2006 and 2007 for Boston Scientific, but was contingent on the bureau’s appeals board agreeing to apply the same basis to transfer pricing issues for 2008 through 2010 and a potential review by the Joint Committee on Taxation in Congress.

Those contingencies were satisfied May 24 and yesterday the parties inked the final settlement, Boston Scientific said today in a regulatory filing. Boston will pay $303 million in taxes and some $305 million more in estimated interest within the next three months, meaning $225 million to $250 million in tax benefits for the second quarter, according to the filing.

“We currently expect to resolve the IRS examination of the company’s 2011 through 2013 tax years before the end of 2018,” Boston Scientific said, noting that it believes it’s already set aside enough reserves to cover that settlement.

The settlement is a bargain for Boston Scientific, which faced at least $1.26 billion in bitterly disputed transfer-pricing charges from the IRS. The controversy dates back to late 2010, when the bureau slapped Boston Scientific with a $525 million tax bill over the Guidant transfer pricing. The federal tax bureau hit BSX with another $154 million dunning in September 2011, followed by a $581 million tab in December of that year.

The company isn’t the only medical device giant with an IRS beef. In June 2015, Medtronic (NYSE:MDT) took a nearly $330 million charge to cover an IRS settlement related to its $4.2 billion acquisition of Kyphon in 2007. One year later a federal judge found for Medtronic in a lawsuit against the tax agency involving transfer pricing among its units during 2005 and 2006, ruling that Medtronic proved the IRS was “arbitrary, capricious, or unreasonable” in its interpretation of the transfer pricing for its Puerto Rico subsidiary.

The same judge in early 2017 found that Medtronic’s net tax tab was just $14.3 million; the IRS last July asked an appeals court to give it another bite at the $1.4 billion apple it alleges it’s owed by Medtronic.

The post Boston Scientific, IRS finalize $608m settlement over transfer pricing beef appeared first on MassDevice.

from MassDevice https://ift.tt/2kEBNzS

Baxter updates Sharesource dialysis monitoring platform

Baxter (NYSE:BAX) today announced the launch of two updates for its Sharesource remote patient monitoring platform designed to monitor home peritoneal dialysis patients including the addition of a new modeling software tool and improvements to the clinical portal.

The Deerfield, Ill.-based company announced the updates at the 55th Congress of the European Renal Association and European Dialysis and Transplant Association meeting this week.

Baxter said that the first of its updates introduced the new Sharesource Adequest kinetic modeling software tool designed for direct integration into the platform to allow for improved modeling regimens for nephrologists and nurses. The addition allows for the identification of peritoneal membrane characteristics, the calculation and prediction of PD adequacy measures and the creation of APD and CAPD prescriptions.

The software suite’s clinical portal also received an update allowing the system to be used with Baxter’s Homechoice Claria APD system, and provides clarified data for ultrafiltration.

“We designed Sharesource to help transform and simplify home renal care, so more patients can access and stay on PD longer with confidence and fewer complications. We are committed to both generating clinical evidence to support the best real-world use of the platform, and to making continual improvements to the platform to ensure optimum value for healthcare providers and patients,” renal care biz GM Laura Angelini said in a press release.

Earlier this month Baxter said it inked a partnership deal with the International Society of Nephrology looking to advance awareness and therapy for patients with chronic kidney disease, primarily in low and middle-income countries where the disease is growing the fastest.

The post Baxter updates Sharesource dialysis monitoring platform appeared first on MassDevice.

from MassDevice https://ift.tt/2J4iGtI

FDA launches medical device innovation challenge to combat opioid crisis

The U.S. FDA today announced that it has launched an innovation challenge to encourage the development of medical devices to help reduce the country’s opioid abuse crisis.

The hope is that the challenge will result in new medtech including digital health technologies and diagnostic tests to help detect, treat and prevent addiction, according to FDA.

Go to FDA’s website to find out more about submitting applications for the challenge.

Companies selected by the FDA under the new program will work closely with the agency, with accelerated development and review of their products. In addition, FDA will grant breakthrough device designation to those devices that meet the statutory criteria for designation, without the companies having to submit a separate application.

Get the full story on our sister site Drug Delivery Business News. 

The post FDA launches medical device innovation challenge to combat opioid crisis appeared first on MassDevice.

from MassDevice https://ift.tt/2xt03hO

Strata Skin Sciences raises $17m, refreshes exec roster

Strata Skin Sciences (NSDQ:SSKN) said today it raised $17 million in a new round of financing and announced a number of changes to its executive roster, including an incoming CEO, new board chair and new chief financial officer.

The Horsham, Penn.-based company said that the $17 million round of financing was led by Accelmed Growth Partners and was joined by existing investors Broadfin Capital and Sabby Management and its incoming CEO Dr. Dolev Rafaeli. The company specified that of the $17 million, $3 million will be used to pay down a portion of its current loan with MidCap financial.

The remaining proceeds from the financing will be used to support the company’s core recurring revenue business and to search for and develop new technologies, Strata Skin Sciences said.

Following the closing of the financing round, the company said that Dr. Dolev Rafaeli has assumed the position of CEO, and that Accelmed managing partner Dr. Uri Geiger has assumed the position of board chair. The company also announced the appointment of Matthew Hill as its chief financial officer.

“I am thrilled to lead Strata at this extraordinary time. The Xtrac device is a best-in-class UV technology for the treatment of psoriasis, vitiligo and other skin conditions. Our business model is differentiated by a combination of clinical superiority, unique value-added services – including a direct-to-patient engine that accelerates awareness and drives consigned Xtrac device utilization – and a reimbursement support team that confirms insurance benefits, thereby expediting the patient experience. Our immediate priority is to execute a comprehensive turnaround strategy to restore the growth potential of the business. The initial steps will include: 1) rebuilding the Xtrac business’ value creation proposition for our physician partner accounts, 2) improving patient retention through improved clinical outcomes and protocol compliance, and 3) re-engaging our proven direct-to-consumer, end-to-end patient acquisition strategy to drive more patients into the dermatology practices. We believe that stricter adherence to protocol compliance will lead to better clinical outcomes for patients, resulting in a higher patient retention rate for physicians. We also believe that our Optimal Therapeutic Dose technology for Xtrac, currently in development, will jump start adherence to the preferred protocol, once deployed. Our nationwide network of Xtrac partner clinics offers a significant opportunity to increase market penetration in psoriasis and to broaden our market penetration with other approved indications, including vitiligo and atopic dermatitis. Lastly, we are formulating a strategy that is expected to drive revenue growth outside the U.S., where we currently enjoy significant market penetration in such markets as China, South Korea and the Middle East, to name a few,” board chair Dr. Rafaeli said in a prepared release.

“We are excited to become the majority shareholder of Strata and confident that the combination of Dr. Rafaeli’s leadership and Accelmed’s proven track record of creating successful medtech platform companies will provide tremendous value to patients, physicians and shareholders,” CEO Dr. Geiger said in a prepared statement.

“I am thrilled to join Strata at this exciting time and believe that the company’s portfolio of skin science technologies has enormous potential. I look forward to growing with the company and working with the management team to help Strata become one of the leaders in the dermatology space,” CFO Hill said in a press release.

Last month, Strata announced that it raised $17 million in a round of financing alongside plans to make Dr. Rafaeli its future CEO.

The post Strata Skin Sciences raises $17m, refreshes exec roster appeared first on MassDevice.

from MassDevice https://ift.tt/2IYPqIU

Australia delays new 3D-printed regulatory changes

Australia’s Therapeutic Goods Administration is pausing plans to implement new regulatory changes intended to manage devices and products produced through the use of additive manufacturing, according to a new report from the Regulatory Affairs Professionals Society.

The decision to delay the regulatory changes came after the agency received a number of comments asking for clarifications, according to the report.

The TGA reportedly received a total of 24 comments on the changes, with 15 coming from industry groups including trade associations and major players in the medtech field.

Requests included clarity on the differences between custom-made devices and patient-centric devices and the inclusion of anatomical models, according to RAPS.

“The TGA plans to further explore other areas that were identified as requiring additional clarity prior to implementing regulatory change,” the TGA wrote in a notice, according to the report. “The need for clarification was especially evident regarding the boundary between the proposed ‘custom-made’ and the proposed ‘patient-specific’ definitions.”

Industry stakeholders also opposed proposed limitations on the number of custom-made devices a manufacturer can supply annually, according to RAPS, and voiced concerns about the defined differences between a manufacturer and a production environment.

About half of the comments agreed with the changes while the other half raised issues and sought further clarification, according to the report.

Stakeholders had positive things to say about a number of newly proposed regulations, including changes to custom-made device conformity assessment procedures, inspections of custom-made device manufacturing sites and the regulation of scaffolds containing human-originated materials, RAPS reports.

The post Australia delays new 3D-printed regulatory changes appeared first on MassDevice.

from MassDevice https://ift.tt/2LMlGwu

Pursuit Vascular wins expanded indication for antimicrobial device

ClearGuard HD antimicrobial caps [Image courtesy of Pursuit Vascular]

Pursuit Vascular (Maple Grove, Minn.) today announced that it has won FDA clearance for a broader indication of its ClearGuard HD antimicrobial caps.

The new indication for the caps — used as an antimicrobial device for catheter-based dialysis patients — includes reduction in the incidence of central-line associated bloodstream infection in hemodialysis patients with central venous catheters.

Get the full story on our sister site Medical Design & Outsourcing. 

The post Pursuit Vascular wins expanded indication for antimicrobial device appeared first on MassDevice.

from MassDevice https://ift.tt/2IUTb1W

Titan, Braeburn end commercialization deal for Probuphine drug-delivery implant

Titan Pharmaceuticals (NSDQ:TTNP) and Braeburn Pharmaceuticals said today that they plan to end a 2012 licensing agreement that gave Braeburn exclusive rights to commercialize Probuphine in the U.S. and Canada.

Probuphine, which was developed using Titan’s ProNeura continuous drug-delivery tech, is an implant that can be placed in a patient’s upper arm in an outpatient office procedure. The FDA approved Probuphine in May 2016 to deliver buprenorphine as a long-term maintenance treatment for people suffering from opioid addiction.

Get the full story at our sister site, Drug Delivery Business News.

The post Titan, Braeburn end commercialization deal for Probuphine drug-delivery implant appeared first on MassDevice.

from MassDevice https://ift.tt/2xBrp5F

Ancora Heart raises $18m to support AccuCinch ventricular repair system

Heart-focused medtech developer Ancora Heart said today it raised $17.8 million in a new financing round to support its AccuCinch ventricular repair system designed for treating heart failure and functional mitral regurgitation.

The funding round was led by Savitr Capital and other existing investors, the Santa Clara, Calif.-based company said. The company added that the financing round is not yet closed, and that it hopes to raise a total of $30 million in the round.

Ancora Health is developing the AccuCinch ventricular repair system, an investigative device designed for the minimally invasive treatment of heart failure and functional mitral regurgitation. The system is designed to reduce the size of the left ventricle to improve left ventricular function and reduce the symptoms of heart failure, the company said.

“Effectively treating heart failure and FMR is incredibly challenging today, and there are enormous unmet needs for these patients. This funding represents an important milestone that will advance the AccuCinch system as an alternative option that addresses the shortcomings of current heart failure and FMR treatments. We have been encouraged by early clinical results and engagement from leading heart centers participating in studies of the AccuCinch system and look forward to continuing to work with them to better understand the potential benefits of our innovative technology,” prez & CEO Jeff Closs said in a press release.

Funds from the round will help support clinical trials exploring the safety and efficacy of the AccuCinch and product development.

The post Ancora Heart raises $18m to support AccuCinch ventricular repair system appeared first on MassDevice.

from MassDevice https://ift.tt/2xtaLVt

On second try, TherapeuticsMD lands FDA nod for vaginal capsule

TherapeuticsMD (NSDQ:TXMD) said today that it won FDA approval for its applicator-free estradiol vaginal capsule, TX-004HR.

The soft-gel capsule is designed to treat moderate-to-severe vaginal pain experienced during sex, a symptom of vulvar and vaginal atrophy in women who have undergone menopause.

Get the full story at our sister site, Drug Delivery Business News.

The post On second try, TherapeuticsMD lands FDA nod for vaginal capsule appeared first on MassDevice.

from MassDevice https://ift.tt/2J2kQKs

Fertility wearable dev Ava raises $30m in Series B

Reproductive-focused patient monitoring developer Ava said today it raised $30 million in a Series B round of funding to support its cycle-tracking sensor bracelet.

The majority of the financing in the round came from existing investors, the Switzerland-based company said, and was joined by European VC firm Btov and SVC Ltd.

The company’s flagship device is the Ava bracelet which uses sensor technology to monitor a woman’s menstrual cycle or pregnancy in real time. Ava is currently engaged in clinical studies of the device and its sensor technology with hopes of using its algorithms as a non-hormonal contraceptive device.

“It’s exciting to work with a company that is literally reshaping the way we think about menstrual cycles, hormones and women’s health. Combining the best in science, data insights and technology is not only  helping to create families, but improving women’s lives around the world,” Brigitte Leeners of the University Hospital of Zurich said in a press release.

Funds from the financing round will help support further product research and development as the company looks to enhance existing products and explore new applications.

“Ava’s long-term vision is to accompany women through all stages of their reproductive life by providing data-driven, clinically proven technology that will make a woman’s life easier, healthier and better — be it when they just want to understand their body, while they are trying to prevent pregnancy, trying to get pregnant, are pregnant or entering menopause,” Ava co-founder Pascal Koenig said in a prepared statement.

The post Fertility wearable dev Ava raises $30m in Series B appeared first on MassDevice.

from MassDevice https://ift.tt/2Jgm08E

Report: IBM Watson Health slashes workforce

International Business Machine (NYSE:IBM) reportedly laid off 50% to 70% of the workforce at its Watson Health operation, primarily at recent acquisitions for which the tech giant paid at least $3.6 billion.

The layoffs, according to a May 25 report in The Register, involve Cleveland-based Explorys and Dallas-based Phytel, which IBM acquired in April 2015 for undisclosed amounts. Cleveland Clinic spinoff Explorys developed a secure cloud-computing platform used by 26 healthcare systems to identify patterns in diseases, treatments and outcomes; Phytel provides cloud-based services to healthcare providers to coordinate care to meet new healthcare quality requirements and reimbursement models.

Employees at medical image and clinical systems company Merge Healthcare, acquired for $1 billion in December 2015, and the Truven Health Analytics business acquired for $2.6 billion the following February, are also subject to the layoffs, according to the website, which cited “inside sources” and posts on Facebook and TheLayoff.com.

Workers in Ann Arbor, Mich., and Denver were also affected, the site reported, although Worker Adjustment & Retraining Notification listings in Texas, Ohio, Michigan and Colorado showed no notices from IBM about layoffs this year.

IBM Watson Health general manager Deborah DiSanzo did not respond to a request for comment.

“Wanted to share anonymously about a massive layoff in Watson Health, potentially limited to Provider acquisitions (Phytel, Explorys, Truven). They are laying off 50-70% of staff today. Not sure about total affected since there’s no transparency, but our Dallas office has 230 people. Cleveland and Truven have more, I believe. I was laid off this morning,” read a post on the Watching IBM Facebook page.

“Axed last week. Watson Health… They are keeping about 15 people to close the shop, will happen in early 2019…. This round of cuts is much bigger than anyone is reporting, they care cutting deep and wide, there is no recovery from this one. I am talking, dev freezes, project shutdowns, deadlines and SLAs breached, etc… We all knew it was coming but nobody expected it’ll be this fast and rampant…,” read another post, on TheLayoff.com.

“can confirm, wife was laid off. there is a similar anon update WIBM as well. they cut everyone except the sceleton [sic] crew,” another poster responded.

Anonymous sources told The Register that IBM launched a “resource action” affecting multiple sites.

“IBM Watson Health has initiated a significant RA across multiple offices. The provider division in Dallas has seen at least 80 per cent affected, and 30 per cent in the Truven customer experience group. Awaiting confirmation of details on severance packages, but can confirm this was broad and not targeted at a specific demographic,” one source told the site.

“Over 50 years old. IBMer over 30 years,” said another. “The message was that there are about 7,000 people in Watson Health today and this was a cost-cutting exercise. 90 days’ notice with 30 days’ severance.”

“I just got notified that I am affected by a resource action. I am in the Platform for Health, LSC Infrastructure DevOps group, and have been working at IBM for two years and 11 months now,” a third told the website. “It looks like a lot of other people in Watson Health were affected. This could be huge.”

The post Report: IBM Watson Health slashes workforce appeared first on MassDevice.

from MassDevice https://ift.tt/2LIQSNe

Adherium looks to give doctors a window into their patients’ lives

To control an asthma patient’s symptoms, doctors will prescribe an inhaler to stop symptoms from cropping up and a rescue inhaler to be used if patients find themselves in the middle of an asthma attack.

“But if your rescue inhaler doesn’t give you the relief that you need, your next recourse is to go to the emergency room and get a breathing treatment. When you walk in that emergency room, the costs start at about $1,500,” medtech veteran Arik Anderson told Drug Delivery Business News. “These are avoidable healthcare costs.”

The root of the issue is that people are not properly taking their medications, according to Anderson. It’s not just affecting patient outcomes, either – medication nonadherence is a $300 billion problem in the U.S., he said.

Get the full story at our sister site, Drug Delivery Business News.

The post Adherium looks to give doctors a window into their patients’ lives appeared first on MassDevice.

from MassDevice https://ift.tt/2sj99IW

ResMed to acquire home and hospice software dev HealthcareFirst

ResMed (NYSE:RMD) said today it inked a deal to acquire healthcare software developer HealthcareFirst for an undisclosed amount.

The soon-to-be acquired company develops software and services for both home health and hospice agencies, San Diego-based ResMed said. Offerings include electronic health record software, billing and coding services and advanced analytics for home and hospice settings.

“Joining ResMed, with their purpose of changing lives with every breath, is an exciting opportunity for our HealthcareFirst team, as our joint mission is linked to improving quality of life for patients in out-of-hospital healthcare. We believe our combined resources and investment capabilities will make an even more impactful improvement on the patient experience and our customers’ business outcomes at a time when they’re under increased reimbursement and regulatory pressures,” HealthcareFirst prez & CEO J. Porter said in a prepared statement.

ResMed said the acquisition will compliment its existing software solutions provided by Brightree, which it acquired in 2016. The company said that the acquisition will be immaterial to its financial results and that it expects to close the purchase before the end of the first quarter of its 2019 fiscal year on September 30.

“The home health and hospice segments are large and growing fast, due to the rising prevalence of chronic conditions and an aging population shifting to homecare and other lower-cost care settings. HealthcareFirst’s solutions suite enables ResMed to help efficiently and effectively manage this growing population, benefiting patients, their families, agencies and payers,” ResMed SaaS biz prz Raj Sodhi said in a press release.

Earlier this month, ResMed released data from two clinical analyses exploring combined home oxygen therapy and non-invasive ventilation therapy for patients with persistent hypercapnia following a life-threatening exacerbation of chronic obstructive pulmonary disorder, touting an increase in cost efficiency with the combined therapy.

The post ResMed to acquire home and hospice software dev HealthcareFirst appeared first on MassDevice.

from MassDevice https://ift.tt/2J45dCs

Intuitive Surgical goes direct in India

Intuitive Surgical (NSDQ:ISRG) said yesterday that it’s shifting to a direct sales model in India and named a general manager to oversee its business in that country.

The Sunnyvale, Calif.-based robot-assisted surgery pioneer said some 60 workers from its longtime distributor in India, Vattikuti Technologies, joined its operation there for an undisclosed amount, to be led by GE Healthcare veteran Mandeep Singh Kumar. The Bengaluru-based India business is Intuitive’s sixth international office, the company said, noting that it’s sold 65 of its flagship da Vinci systems in the country.

“The adoption and advancement of robotic-assisted surgery has been enabled by critical contributions from health care professionals from India,” CEO Gary Guthart said in prepared remarks. “As Intuitive continues to grow to serve patients, surgeons, and hospitals in India, we look forward to deepening our support of, and work with, health care professionals in their pursuit of the clinical and economic benefits robotic-assisted surgery offers.”

“It is a privilege to be part of Intuitive’s journey in India, and we are committed to working with surgeons across the country to bring the benefits of robotic-assisted surgery to their patients,” Mandeep added.

“Our customers can expect a smooth transition and even deeper collaboration opportunities between Intuitive and India’s surgical community,” global distribution SVP Jeroen van Heesewijk said in a press release. “We look forward to welcoming our new colleagues to the Intuitive team, as well.”

The post Intuitive Surgical goes direct in India appeared first on MassDevice.

from MassDevice https://ift.tt/2su5rM6

Sage Therapeutics wins priority review for intravenous postpartum depression drug

Sage Therapeutics (NSDQ:SAGE) said today that the FDA accepted its new drug application for an intravenous formulation of brexanolone as a treatment for postpartum depression.

The application was accepted under priority review status, according to the Cambridge, Mass.-based company. If approved, the drug would be the first therapy specifically indicated to treat postpartum depression – the most common medical complication of childbirth.

Get the full story at our sister site, Drug Delivery Business News.

The post Sage Therapeutics wins priority review for intravenous postpartum depression drug appeared first on MassDevice.

from MassDevice https://ift.tt/2ISLVng

Saranas raises $3m in Series C to support Early Bird bleed monitor

Internal bleeding detection device developer Saranas said today it raised $2.8 million in a Series C funding round slated to support its Early Bird bleeding monitor system.

The Early bird device is designed as a standard vascular access sheath which is embedded with sensors which detect bleeding from accidentally ruptured blood vessels during cardiac procedures, including transcatheter aortic valve replacements, the Houston, Texas-based company said.

Funds from the round will be used to support a multicenter clinical pilot trial of the Early Bird system in the US, as well as the company’s continued commercialization plan.

“We are pleased to bring additional investment and appreciate the confidence shown by so many returning investors. We continue our work to deliver a product to market that has the potential to significantly reduce bleeding complications while reducing related costs to providers and the healthcare system. Since our last round of financing, we have completed design verification and validation activities, continued to build our growing intellectual property portfolio, and submitted a De Novo application to the FDA. With this investment, we are well positioned to initiate a multicenter clinical pilot and extend access to this innovative device to patients in the U.S.,” prez & CEO Zaffer Syed said in a press release.

Saranas did not announce any participants in the round.

Late last month, Saranas said that it submitted an FDA application seeking de novo classification for its Early Bird bleed monitoring system.

The post Saranas raises $3m in Series C to support Early Bird bleed monitor appeared first on MassDevice.

from MassDevice https://ift.tt/2L5LOkX

BD prices $677 in EU-based debt offerings

Becton Dickinson (NYSE:BDX) today priced a set of European debt offerings totaling $677 million.

In the first offering, the Franklin Lakes, N.J.-based company issued $346.3 million (EU €300 million) in 1.401% notes due May 24, 2023 in a public offering between it and The Bank of New York Mellon Trust Company.

Becton Dickinson said that it can redeem the Euro Notes in whole or in part any time prior to April 24, 2023 at a price equal to 100% of the principal amount or at any time on or after April 24, 2023 for the price of the notes plus accrued and unpaid interest.

The company also issued $331.1 million (GBP £250 million) in U.K.-based 3.02% notes due May 24, 2025 in a separate underwritten public offering, according to an SEC filing.

BD specified that it can redeem the notes at any time prior to February 24, 2025 at a redemption price equal to the greater of 100% of the principal amount to be redeemed and a “make-whole” amount described in the notes, plus accrued interest, or at any time after February 24, 2025 with that value plus accrued and unpaid interest.

In March, Becton Dickinson said it closed a $460.7 million offer to repurchase outstanding 3% notes due 2026.

The post BD prices $677 in EU-based debt offerings appeared first on MassDevice.

from MassDevice https://ift.tt/2xoOQ1K

RenalGuard touts ADHF treatment feasibility study data

RenalGuard Solutions late last week released results from a feasibility study of its RenalGuard-guided diuretic therapy intended to improve fluid management in patients with acute decompensated heart failure and alleviate related symptoms.

Results from the study were presented at the European Society of Cardiology’s Heart Failure 2018 conference in Vienna, the Milford, Mass.-based company said.

The company said its RenalGuard-guided diuretic therapy is intended to allow for the use of an increased dose of diuretics without increasing the risk of diuretic resistant to allow for the safe and effective removal of excess fluids from ADHF patients, alongside alleviating certain symptoms.

A total of nine patients were evaluated in the feasibility study, with patients undergoing 24 hours of standard diuretic therapy with intravenous furosemide followed by 24 hours of diuretics in conjunction with its guided diuretic therapy.

Results indicated that patients in the experiment were able to achieve a safe rate of fluid loss through the induction of high urine rates, and that intravascular volume was maintained during treatment, the company said.

Study data also showed a significant improvement in breathing patterns and diuretic efficiency among RenalGuard patients, touting the creation of more than 2.5 times the amount of urine produced. The average change in estimated kidney function at 30 days post-treatment was reported as 8%, while three patients showed an increase of more than 25%, RenalGuard said.

“We are thrilled to reveal late-breaking data that demonstrates a promising step towards a new therapy for patients suffering from Acute Decompensated Heart Failure. RenalGuard-Guided Diuretic Therapy has the potential to establish a new front-line standard of care for heart failure patients, allowing physicians to maximize fluid removal while protecting patients from the potential negative impact of excessive fluid loss,” CEO Jim Dillon said in a press release.

In January, RenalGuard released results from a first-in-man feasibility study of its RenalGuard System designed to manage fluids during diuretic therapy to treat congestive heart failure in patients suffering from fluid overload.

The post RenalGuard touts ADHF treatment feasibility study data appeared first on MassDevice.

from MassDevice https://ift.tt/2ISCB2O

Neurent Medical sniffs out $11m for rhinitis device

Neurent Medical reportedly sniffed out a funding round of nearly $12 million for the minimally invasive rhinitis treatment it’s developing.

The €9.3 million round for Oranmore, Ireland-based Neurent was led by Irish venture capital shop Fountain Healthcare Partners and included participation from Atlantic Bridge, Ireland’s Western Development Commission, Enterprise Ireland and a syndicate of U.S. and Irish medical device veterans, the Irish Times reported.

According to its website, the single-use Neurent device uses radiofrequency energy to “interrupt the autonomic function within the mucosal structures of nasal cavities which will reverse the inflammatory cascade” in a minimally invasive, outpatient procedure to treat chronic runny nose. The technology, designed to deliver three years of relief without medication, is based on a high-risk but effective treatment from the 1950s, co-f0under & CEO Brian Shields told the newspaper.

“The outcome was brilliant back then, if you weren’t blinded by the procedure or dead,” Shields said, adding that the cash infusion is enough to hire 25 workers and see the company through to a bid for FDA approval. The company hopes to launch the first of a pair of clinical studies in 2019, according to the paper.

The post Neurent Medical sniffs out $11m for rhinitis device appeared first on MassDevice.

from MassDevice https://ift.tt/2ITkWbk

NanOlogy touts preclinical data for inhaled NanoPac cancer drug

NanOlogy touted results today from preclinical studies of its inhaled submicron particle formulation of paclitaxel, NanoPac.

The company said animal studies have shown prolonged retention of the cancer drug in lung tissue and significant tumor regression without adverse drug-related side effects.

Get the full story at our sister site, Drug Delivery Business News.

The post NanOlogy touts preclinical data for inhaled NanoPac cancer drug appeared first on MassDevice.

from MassDevice https://ift.tt/2J10XUg

Lumendi wins FDA nod for DiLumen IS endoscopic scissors

Lumendi said today it won FDA 510(k) clearance for its DiLumen IS endolumenal interventional scissors, now indicated for cutting, dissecting and cauterizing tissue within the digestive tract during endoscopic procedures.

The Westport, Conn.-based company touted the sterile, single-use disposable, monopolar electrosurgical device as the fourth it’s developed, and said that it and its recently cleared DiLumen CT are intended to help improve access and therapy in the colon and reduce the need for surgical interventions.

The recently cleared C2  is a second-gen Endolumenal interventional platform designed to ensure complete positioning of an endoscope in the large intestine while also assisting with optical visualization, diagnosis and endoscopic treatment, the company said.

“The DiLumen platform of devices, now complemented by DiLumen Is, is designed to further facilitate and improve technically difficult and time-consuming endoscopic interventions for colonic lesions, such as polyps, a common condition that affects millions worldwide, and may replace invasive open surgical or laparoscopic procedures for patient benefit and potentially reducing healthcare costs,” CEO Dr. Peter Johann said in a press release.

Lumendi said that to date, its DiLumen EIP system has been used in more than 400 procedures with no reports of serious adverse device related adverse events, and added that three studies of the device have been completed with publication dates in the near future.

The post Lumendi wins FDA nod for DiLumen IS endoscopic scissors appeared first on MassDevice.

from MassDevice https://ift.tt/2xovud5

Covalon is on the prowl, posts Q2 earnings

Covalon Technologies yesterday announced it is on the hunt for potential acquisitions alongside second quarter earnings results.

The Ontario-based company said it formed a special board committee looking to evaluate possible strategic alliances, partnerships and acquisitions as a response to a $100 million contract the company recently won.

“The board believes that the capital markets have not yet fully appreciated the impact of the highly transformative recent announcement of $100 million of contracted revenue over the next three years in addition to many other significant initiatives underway,” the company wrote in a press release.

Covalon said that it has already made steps towards a potential acquisition, having identified “a clear set of criteria for potential acquisitions” that would complement its internal growth. The company also announced plans for a potential buy-back of common shares, though the plans are subject to regulatory approval.

In its earnings release, Covalon posted losses of $479,082 on sales of $5.7 million for the three months ended March 31.

“Based on second quarter results and anticipated business in the second half of the fiscal year, the Company is very much on track to achieve year-over-year revenue growth for fiscal 2018, compared to fiscal 2017’s $27.3 million in revenue. Our revenue in the United States has more than doubled in the first six months of fiscal 2018, compared to last year. Our Middle East contracted deliveries are unfolding according to our delivery expectations, without taking into account any of the $100 million of contracted revenue over the following three years. I am very pleased with our performance year-to-date. More importantly, Covalon has never been on better financial and operational footing in its entire history. The Company currently has a clean balance sheet with no debt, has secured significant future contracted revenues, and has more than 150 United States FDA-cleared products and over 30 patents to protect its world-class technology platforms. We are working on many positive initiatives and are exploring many different expressions of interest,” prez & CEO Brian Pedlar said in a press release.

The post Covalon is on the prowl, posts Q2 earnings appeared first on MassDevice.

from MassDevice https://ift.tt/2xnqfdJ

LuxCath eyes the atrial fibrillation market

One problem with using ablation to treat atrial fibrillation is determining when the resulting lesion is sufficient to block the electric signals underlying the arrhythmia.

LuxCath thinks its OmniView catheter solves the dilemma by using an optical technology to assess metabolic activity in the ablated tissue, CEO Dr. Omar Amirana told MassDevice.com earlier this month during the annual Heart Rhythm Society meeting in Boston.

Amirana, a senior vice president at Allied Minds (LON:ALM), also helms Allied Minds subsidiaries SciFluor and Signature Medical and is a board member at CardioFocus. What drew him to LuxCath, he told us, is its ability to both visualize the ablated tissue and assess its viability.

“I’ve been an electrophysiologist since 1992 and I have not been able to find a technology that actively can see a lesion, in real time,” Amirana said. “This looks into the tissue, whereas everything else we’re looking at is right on the surface of the tissue, so you don’t have an idea of what’s going inside the wall of the muscle, and that’s really where recurrences occur.

“It’s kind of like a stud finder. If you’re looking for where to put the nail, basically, we tell you where the stud is,” he explained.

OmniView uses an optic fiber threaded through the catheter to shine light into the myocardium. If there’s poor contact with the catheter, the device doesn’t return a signature, Amirana explained. But if there’s good contact, the returning light excites a specific molecule that delivers information on tissue composition and lesion quality.

“It tells us whether we’ve got collagen and elastin in the tissue or whether we’ve got a healthy dose of viable myocardium that’s capable of conducting,” he said. “The way we determine that is we’re looking at the fluorescence properties of collagen which fluoresces at one wavelength and the fluorescence of [nicotinamide adenine dinucleotide], which is a molecule that’s inside metabolically active cells that’s required for basic metabolic activity.”

“What we’ve done essentially is added ports to the end of the catheter tip, so that we’re not only interrogating tissue that’s perpendicular, we’re interrogating all angles of contact. The big take-away for that is we’re not only going to assess catheter stability at all angles of contact and assess tissue composition, but also measure progression,” added LuxCath GM Arun Jaganathan.

With enough funding to carry through to CE Mark approval in the European Union, expected some time next year, and an 11-case first-in-human series under its belt using a prototype, Luxcath is developing the next iteration of OmniView and a clinical program to back the CE Mark bid and a parallel application with the FDA, Amirana said.

Dr. Vivek Reddy, who performed the first-in-human study, told us that although it’s early days yet, the OmniView catheter addresses an important gap in the EP toolbox.

“We assume that we’re ablating tissue based on the fact that electrograms diminish. But that’s a very crude way of interrogating information,” Reddy explained. “LuxCath is using a very clever way. Myocardium has a lot of [nicotinamide adenine dinucleotide]. So when you’re touching tissue, you suddenly see this peak of [nicotinamide adenine dinucleotide] and then when you ablate the tissue, that disappears. It’s an approach that will give you both contact information, as well as following lesion progression. I think it’s a very interesting, exciting one.”

The post LuxCath eyes the atrial fibrillation market appeared first on MassDevice.

from MassDevice https://ift.tt/2IUeUTS

Getinge touts results from IABP study in MI patients with persistent ischemia

Getinge (PINK:GETI B) late last week released results from a pilot study of its intra-aortic balloon pump exploring its use with patients with extensive myocardial infarction complicated by persistent ischemia following primary percutaneous coronary interventions.

Results from the pilot study were presented by co-principal investigator Dr. Lokien van Nunen of Eindoven, The Netherlands’ Catharina Hospital at the EuroPCR 2018 annual meeting in Paris last week, the company said.

The prospective, randomized, comparative single-center Semper Fi pilot study aimed to evaluate the use of IABP in patients with extensive MI complicated by persistent ischemia after a PCI procedure, and included 100 patients with acute STEMI and insufficient ST-segment resolution as determined by an ECG 10 to 30 minutes after PCI in a cath lab.

Patients in the study were randomized to IABP for 12 to 24 hours or no IABP, and were followed up with at six months, Getinge said.

Results from the study indicated that those who presented with large acute MI trended towards decreased mortality, LVAD use and hospital readmission for heart failure within six months after IABP use. A total of 2% of patietns in the IABP arm experienced the primary endpoint versus 8% in the non-IABP group.

“Determining which STEMI patients will benefit from IABP has been difficult because of varying results from retrospective and prospective studies. We are encouraged by the results of the Semper Fi pilot study, which showed a strong signal that IABP may be beneficial in patients with extensive acute MI who continue to experience ischemia even after stenting. We expect that these results will bear out in a trial adequately powered to demonstrate a statistically significant reduction in the composite endpoint if this trend were to continue,” Dr. van Nunen said in a prepared statement.

“The trend toward a mortality benefit with the use of IABP observed in the Semper Fi pilot study is encouraging because the study was well controlled and did not allow crossover from the conventionally-treated group to IABP, which could have confounded the results. This pilot study is a testament to Getinge’s commitment to support clinical research to increase the body of knowledge for our life-saving therapies,” acute care therapies chief medical officer Dr. Claudius Diez said in a press release.

Earlier this year, Getinge said it won FDA 510(k) clearance for its PulsioFlex Monitoring System and PiCCO Module.

The post Getinge touts results from IABP study in MI patients with persistent ischemia appeared first on MassDevice.

from MassDevice https://ift.tt/2xo8Lhi

Report: Trump to sign controversial law granting patients access to experimental drugs

President Donald Trump is slated to approve legislation this week that will give terminally-ill patients access to experimental drugs that haven’t yet been cleared by the FDA.

The “right-to-try” bill has sparked a great deal of controversy among policymakers and patient groups. While some, including the president, describe the effort as offering hope to patients with limited options, others argue that it undermines the FDA’s authority as the regulatory body charged with protecting patients.

Get the full story at our sister site, Drug Delivery Business News.

The post Report: Trump to sign controversial law granting patients access to experimental drugs appeared first on MassDevice.

from MassDevice https://ift.tt/2LHguKn

MIT researchers send drug-ferrying nanoparticles across the blood-brain barrier

Image courtesy of MIT

Researchers at the Massachusetts Institute of Technology demonstrated in an animal study that nanoparticles shuttling two different cancer drugs could effectively cross the blood-brain barrier and target tumor cells.

The team of scientists evaluated the drug combination in mice that had gliobastoma – an aggressive form of brain cancer that is notoriously hard to treat.

Get the full story at our sister site, Drug Delivery Business News.

The post MIT researchers send drug-ferrying nanoparticles across the blood-brain barrier appeared first on MassDevice.

from MassDevice https://ift.tt/2ITSF4x

TransEnterix surges on expanded indications for Senhance robot-assisted surgery device

TransEnterix (NYSE:TRXC) said today that it won expanded indications from the FDA for its Senhance robot-assisted surgery device, which is now cleared for hernia and gallbladder procedures.

The federal safety watchdog’s expanded 510(k) decision doubles the Research Triangle Park, N.C.-based company’s addressable market, president & CEO Todd Pope said in prepared remarks.

“These expanded procedures are commonly performed at over 95% of hospitals in the United States. We believe this indication expansion will significantly increase the applicability of Senhance to more institutions, particularly those with a busy general surgery practice,” Pope said.

“We have utilized Senhance broadly across a wide range of general surgery, upper GI surgery and colorectal procedures at our institution,” added Dr. Frank Willeke of Germany’s St. Marien Hospital. “We believe this procedural expansion for the U.S. will allow surgeons there to incorporate the Senhance, as we have, as a highly-efficient, enabling and very promising technology that can impact the vast majority of surgeries commonly performed by general surgeons and their sub-specialties.”

The news sent TRXC shares up 28.8% to $4.03 apiece today in pre-market trading.

The post TransEnterix surges on expanded indications for Senhance robot-assisted surgery device appeared first on MassDevice.

from MassDevice https://ift.tt/2sgKkxt