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Brainlab releases VersaHD high-res planning algorithm
Brainlab said today it launched a new high-res planning algorithm within its Brainlab Elements software to improve radiation dose conformity for treating brain tumors, and added that the algorithm is a result of its strategic collaboration Elekta (STO:EKTA B). The Munich-based company’s Elements system operates with Elekta’s Agility multileaf collimator to compensate for the width of selected leaves and allow for better conformation to tumor shapes, and to reduce radiation dosing to organs at risk. The new algorithm in the Elements software allows support of virtual leaf width capability with Agility on th...
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Oncology Radiosurgery Software / IT Brainlab Elekta Source Type: news

Varian wins FDA nod for Calypso anchored beacon transponder for SBRT therapy
Varian Medical (NYSE:VAR) said today it won FDA 510(k) clearance for its Calypso anchored beacon transponder designed for use with its TruBeam, Edge and Clinac C-series medical linear accelerators. The Calypso system and the anchored beacon transponder are designed to detect tumor movement to aid in the delivery of lung stereotactic body radiotherapy with more precision, the Palo Alto, Calif.-based company said. The anchored beacon transponders are designed to be implanted in small airways within or near the tumor target and emit non-ionizing electromagnetic signals which are tracked in real time to keep the treatment...
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Varian Medical Systems Source Type: news

Nephros releases preliminary Q1 earnings, raises $3m
Nephros (OTC:NEPH) this week released the preliminary earnings for its first quarter of 2018 including plans to move its headquarters, and released information on a $2.9 million equity round of financing. The South Orange, N.J.-based company said it expects to post sales of $958,000 for its first quarter, up 39% from the same quarter last year. Total revenue for the quarter is expected to be $985,000, up 34% from the same quarter last year, the company said. “The first three months of 2018 reflected our typical seasonal pattern, yet still recorded robust growth compared to the same period of 2017. The first quar...
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Nephros Source Type: news

Olympus inks endoscope image sharing deal with InterSystems
Olympus (TYO:7733) said yesterday it inked a deal with InterSystems to enhance Olympus’ Knowledge Exchange System with InterSystems HealthShare, which allows for the sharing of images taken during endoscopy procedures. Olympus said its KE system is a software platform for centralized reprocessing record and image management that connects to its Olympus devices. The company added the system eliminates the need to transfer images to external devices to share with patients and other providers, and that with the addition of HealthShare it will now be able share endoscopic images and to directly connect to electronic...
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Endoscopic / Arthroscopic Imaging Software / IT intersystems Olympus Source Type: news

FDA approves IDE trial for Urotronic ’s drug-coated balloon
Minneapolis-based Urotronic said this week that the FDA approved an investigational device exemption trial for its Optilume drug-coated balloon catheter, which is designed to treat urethral strictures in men. The 200-patient pivotal trial is slated to start enrolling participants immediately. Get the full story at our sister site, Drug Delivery Business News. The post FDA approves IDE trial for Urotronic’s drug-coated balloon appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Urology Vascular urotronic Source Type: news

FDA approves Angel Medical System ’ s AngelMed Guardian cardiac monitor
The FDA this week approved Angel Medical Systems AngelMed Guardian implantable cardiac monitor system after the device had previously been rejected unanimously by an FDA advisory panel in 2016. The initial rejection came after the Tinton Falls, N.J.-based company presented partial data from its pivotal trial of the device in after having pulled the plug on it before completion, according to a Healio report from 2016. The panel voted 4 to 8 that the system was safe, and unanimously that the device was ineffective and that the benefits did not outweigh the risk, according to Healio. Angel Medical eventually won approval, how...
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Patient Monitoring Pre-Market Approval (PMA) Regulatory/Compliance Angel Medical Systems Inc. Source Type: news

Curetis launches diagnostic cartridge for urinary tract infection
Curetis said today that it won CE-IVD marking for its Unyvero cartridge designed to diagnose severe urinary tract infections. The cartridge covers 103 diagnostic targets and can detect 88 pathogens, according to Curetis, including a multi-drug-resistant pathogenic fungus that is of particular concern to hospitalized patients with compromised immune systems. Unyvero UTI can also detect 15 genetic markers of antibiotic resistances. Get the full story at our sister site, Drug Delivery Business News. The post Curetis launches diagnostic cartridge for urinary tract infection appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diagnostics Pharmaceuticals Regulatory/Compliance curetis Source Type: news

Hologic touts study comparing NovaSure to Minerva ’ s endometrial ablation device
Hologic (NSDQ:HOLX) yesterday released results from a study comparing its NovaSure endometrial ablation system to Minerva Surgical‘s endometrial ablation device, touting a higher one-year rate of amenorrhea and higher quality of life for women treated with the NovaSure , despite experiencing a higher rate of perioperative adverse events. Results from the trial were published in the International Journal of Women’s Health, Marlborough, Mass.-based Hologic said. In the 189-patient study, researchers compared the use of endometrial ablation with either the NovaSure or Minerva device. The study’s primary...
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Women's Health Source Type: news

How Minnesota got a Pediatric Device Innovation Consortium
FDA funds a handful of pediatric device innovation groups around the United States. But Dr. Gwenyth Fischer, director of The Pediatric Device Innovation Consortium at the University of Minnesota, thinks there’s something that sets the seven-year-old group apart. The Minnesota group, Fischer said, is focused not only on funding but on getting doctors and other academics with innovative ideas linked with the host of product development, regulatory, reimbursement and other experts around Minneapolis-St. Paul who can help get the concepts commercialized — versus the inventors “spinning their wheels.&rdqu...
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Pediatrics Research & Development devicetalksminnesota pediatricdeviceinnovationconsortium University of Minnesota Source Type: news

5 medtech stories we missed this week: April 20, 2018
[Image from unsplash.com]From CHF Solutions’ new Italian distribution deal to Masimo’s CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning. 1. CHF Solutions signs Italian distribution deal CHF Solutions announced in an April 17 press release that it has signed a new distribution agreement with TRX Italy to distribute its Aquadex FlexFlow System in Italy. The financial terms of the agreement were not disclosed. The agreement helps CHF Solutions further expand its market into European markets. 2. Varian touts expanded Halcyon 2.0 features Varian ha...
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Diagnostics Hospital Care Imaging Implants Surgical CHF Solutions Inc. CoreLink Konica Minolta Masimo MedTech Varian Medical Systems Source Type: news

FDA OKs Opus breast implant line from Sientra
The FDA this week granted a pre-market approval supplement to Sientra (NSDQ:SIEN) for its Opus line of silicone breast implants. The implants are made in Wisconsin by Lubrizol LifeSciences subsidiary Vesta, which inked a contract manufacturing deal with Sientra back in August 2016. Sales of Sientra’s silicone breast implants ground to a halt in the autumn of 2015, when Brazilian authorities suspended production at Silimed, its supplier there, and the U.K.’s Medicines & Healthcare Products Regulatory Agency halted sales. The products were back on th...
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cosmetic/Aesthetic Food & Drug Administration (FDA) Regulatory/Compliance Women's Health Sientra Source Type: news

Sollis lands $50m for long-acting pain-relief drug
Sollis Therapeutics closed a $50 million round to support a pivotal trial of its non-opioid pain-reliever, according to Ohio-based translator NeuroTechnology Innovations Translator. Deerfield Management led the funding round and was joined by NIT collaborators, including Medtronic (NYSE:MDT), Cardinal Health and Ohio State University. Get the full story at our sister site, Drug Delivery Business News. The post Sollis lands $50m for long-acting pain-relief drug appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Funding Roundup Pain Management Pharmaceuticals sollistherapeutics Source Type: news

Chinese investor group acquires Esaote
Esaote yesterday announced it was acquired by a consortium of Chinese investors composed of several major companies in the medical field and investment funds. Genoa, Italy-based Esaote produces medical devices with a focus on ultrasound, dedicated magnetic resonance imaging and diagnostic management software. The acquiring consortium includes Chinese medical equipment maker Wandong, private equity fund Yufeng Capital, Chinese free trade zone fund Shanghai FTZ Fund, investment group Tianyi, Chinese home medical equipment maker holding company Yuyue and OEM manufacturer Kangda. Esaote said that with the acquisition, it will ...
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Esaote Source Type: news

GE Healthcare ’ s sales, profits up in Q1
GE Healthcare (NYSE:GE) posted gains to its top and bottom lines during the first quarter, as its corporate parent topped Wall Street’s earnings forecast despite lower-than-expected sales. Little Chalfont, U.K.-based GE Healthcare posted profits of $735 million for the three months ended March 31, up 11.2% compared with Q1 2017, on sales growth of 9.2% to $4.70 billion. The Boston-based industrial conglomerate said orders were up 4.3% to $4.73 billion for the healthcare business, with the profit growth driven by volume and productivity. Earlier this month the company said it agreed to sell its value-based h...
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat GE Healthcare Source Type: news

Qiagen wins FDA nod for point-of-care PartoSure test
Qiagen (NYSE:QGEN) today touted the FDA’s approval of its PartoSure diagnostic test, designed to assess the risk of spontaneous preterm birth in patients with symptoms of preterm labor. The non-invasive strip test detects placental alpha microglobulin-1 and can provide results in less than five minutes, according to Germany-based Qiagen. Get the full story at our sister site, Drug Delivery Business News. The post Qiagen wins FDA nod for point-of-care PartoSure test appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Wall Street Beat Women's Health Qiagen N.V. Source Type: news

Valeritas taps Glooko ’ s data management platform for next-gen insulin delivery device
According to a newly-inked deal between the two companies, Glooko plans to provide its diabetes data management platform to Valeritas (NSDQ:VLRX) for use with the medtech company’s next-gen V-Go insulin delivery device. Valeritas’ V-GO SIM device is an investigational accessory that the company said will snap onto its existing insulin delivery devices. The product is designed to transmit data from the delivery device to an app on the user’s smartphone. Get the full story at our sister site, Drug Delivery Business News. The post Valeritas taps Glooko’s data management platform for next-gen insul...
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Software / IT Wall Street Beat Valeritas Source Type: news

Arthrosurface wins FDA nod for OVOMotion shoulder arthroplasty system
Arthrosurface said yesterday it won FDA 510(k) clearance for its OVOMotion shoulder arthroplasty system. The Franklin, Mass.-based company said the newly cleared stemless total shoulder system is designed to minimize bone removal specifically for patients with painful or severely disabled shoulder joints from arthritis, traumatic events or avascular necrosis. “This truly is a revolutionary stemless total shoulder, which combines the concept of anatomic restoration with an aspherical head design that more closely replicates patient anatomy but also allows improved joint access for ease of preparation of the glenoid,&r...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Arthrosurface Source Type: news

Biotronik inks distro deal with Aziyo for CanGaroo cardiac device envelope
Biotronik inked a US-based co-distribution deal with Aziyo Biologics to distribute the company’s CanGaroo bio-envelopes designed to hold cardiovascular implantable devices, according to a release from Aziyo posted today. Silver Spring, Md.-based Aziyo Biologic’s CanGaroo bio envelope is designed to reduce the risk of device migration and erosion and simplify device removal during revisions or exchanges, the company said. The system is available in five sizes and are made out of a natural extracellular matrix. “Biotronik is trusted and respected by hospitals, physicians and patients, and our distribut...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Distribution aziyobiologics Biotronik Source Type: news

Sensus Healthcare inks multiple distro deals, launches global expansion project
Superficial radiation therapy device developer Sensus Healthcare (NSDQ:SRTSU) today released plans for a global expansion, including new distribution agreements in China, Germany, Mexico, Cuba and Costa Rica. Sensus makes low-energy photon X-ray systems for treating non-melanoma skin cancers, including basal cell and squamous cell carcinomas, and keloids. The Boca Raton, Fla.-based company refers to the technology as superficial radiation therapy, and claims that the tech has been sued to “effectively and safely treat oncological and non-oncological skin conditions.” “Following our new partnersh...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Oncology Sensus Healthcare LLC Source Type: news

Allergan, Takeda spar for Shire
Allergan (NYSE: AGN) today confirmed that it’s in the running to acquire Shire (NSDQ:SHPGY), which rejected a $63 billion offer from Takeda Pharmaceutical (TYO:4502). Dublin-based Allergan, which is in the process of slashing 1,400 jobs from its payroll and exploring “strategic actions,” said there’s no guarantee it will make an offer for Shire. Get the full story at our sister site, Drug Delivery Business News. The post Allergan, Takeda spar for Shire appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Pharma Wall Street Beat Allergan Spire Corp. Takeda Pharmaceuticals Source Type: news

Check-Cap initiates 1-for-12 reverse split
Check-Cap (NSDQ:CHEK) said that earlier this month it initiated a 1-for-12 reverse stock split as it looked to regain compliance with the NASDAQ stock market’s minimum bid pricing requirement. With the move, which was effected on April 4, the Israel-based company put a single share into the hands of every shareholder for each 12 shares they held previously. Check-Cap said that after it completed the split, it has been able to maintain a $1 or greater price share and regained compliance with NASDAQ, according to a press release. Shares of Check-Cap have dropped 9.7% today, currently at $3.91 as of 1:00 p.m. ...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Check-Cap Source Type: news

Emboline raises $10m Series B for TAVR embolism filter
Emboline said today that it pulled in a $10 million Series B round for the namesake embolic protector it’s developing for heart valve replacement procedures. The Emboliner catheter is designed to prevent blood clots from passing into the cerebral vasculature during transcatheter aortic valve replacements. Santa Cruz, Calif.-based Emboline said the round includes $3 million from a consortium led by SV Tech Ventures and Shangbay Capital and $7 million in already-issued convertible notes. The cash is earmarked for Emboline’s SafePass clinical trial, submission for CE Mark approval and initial commerciali...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Vascular Wall Street Beat Emboline Source Type: news

Senators urge HHS to seek lower price for naloxone
U.S. Sens. Debbie Stabenow (D-MI) and Gary Peters (D-MI) penned a letter to the Dept. of Health and Human Services, urging the agency to demand that manufacturers lower the price of the opioid overdose reversal drug, naloxone. The lawmakers wrote that the price of naloxone has climbed dramatically since it was first approved by the FDA decades ago – a two-pack of the drug’s nasal spray formulation, Narcan, costs $150, according to the senators. Get the full story at our sister site, Drug Delivery Business News. The post Senators urge HHS to seek lower price for naloxone appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Healthcare Reform Pharmaceuticals Source Type: news

Philips inks collab software integration deal with Sun Nuclear
Royal Philips (NYSE:PHG) said today it inked a collaborative deal with Sun Nuclear to integrate its PlanIQ software into Philips’ Pinnacle 16.2 auto-planning software. Amsterdam-based Philips said that the PlanIQ software is designed to provide clinicians with patient-specific goals and treatment plans for oncology treatments, adding that integration with its Pinnacle auto-planning software will improve the efficiency of creating personalized treatment plans. “Today’s radiation oncology treatment planning processes are still fragmented, labor-intensive and time-consuming, potentially producing i...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Oncology royalphilips sunnuclear Source Type: news

FDA warns against endoscope connectors
The FDA yesterday warned healthcare providers against using endoscope connectors in more than one patient without reprocessing, saying it hasn’t seen any acceptable tests demonstrating their safety. The federal safety watchdog said the connectors, which are used in more than one patient for gastrointestinal endoscopies over the course of 24 hours, connect the endoscope to a water supply. The agency recommended that providers use connectors that prevent patient fluid back-flow into the ‘scope, either as a one-time use or reprocessed after every patient. Erbe USA is the only company marketing a 24-hour multi-pati...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Erbe USA Source Type: news

NeuroMetrix inks Quell ownership deal with GlaxoSmithKline, posts Q1 earnings
NeuroMetrix (NSDQ:NURO) today saw shares fall despite announcing an exclusive deal giving GlaxoSmithKline (NYSE:GSK) ownership of its Quell technology for commercialization outside the US and releasing Street-beating first quarter earnings. In its deal with GlaxoSmithKline, Waltham, Mass.-based NeuroMetrix said it will receive payments totaling $26.5 million, with $5 million paid at closing and up to $21.5 million payable upon achievement of milestones. The companies also agreed to co-fund Quell development starting next year, NeuroMetrix reports. The company will also retain ownership of the Quell technology ins...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Pain Management Wall Street Beat GlaxoSmithKline plc Neurometrix Source Type: news

Quest Diagnostics posts mixed Q1
Shares in Quest Diagnostics (NYSE:DGX) held steady today after the company met earnings expectations on Wall Street but missed analysts’ sales estimates with its first-quarter results. The Secaucus, N.J.-based company posted profits of $177 million, or $1.27 per share, on sales of $1.88 million for the 3 months ended March 31, for bottom-line growth of 7.9% on sales growth of 3.7% compared with the same period last year. Get the full story at our sister site, Drug Delivery Business News. The post Quest Diagnostics posts mixed Q1 appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diagnostics MassDevice Earnings Roundup Wall Street Beat Quest Diagnostics Inc. Source Type: news

HeartStitch wins CE Mark for CoAp Pro mitral valve repair device
HeartStitch said today it won CE Mark approval in the European Union for its CoAp Pro device designed for mitral valve remodeling and repair. The Fountain Valley, Calif.-based company said its CoAp Pro device is designed to allow physicians to remodel mitral valve leaflets to re-establish proper coaptation. “I am especially pleased to see HeartStitch receive this approval, because it provides the ability to use suture to remodel the mitral valves rather than the need to place a prosthetic device in the leaflets. In my opinion it is a significant advancement to the treatment of mitral regurgitation. Personally, I...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Regulatory/Compliance HeartStitch Source Type: news

Pear Therapeutics, Sandoz ink deal for prescription digital therapeutics
Pear Therapeutics revealed yesterday that it agreed to deal commercialization rights of its digital therapeutics to Novartis (NYSE:NVS) division Sandoz. The company’s reSET substance use disorder therapy became the first prescription digital therapeutic approved by the FDA in September last year. reSET-O, a digital therapeutic designed for people suffering from opioid use disorder, is under review at the FDA. Get the full story at our sister site, Drug Delivery Business News. The post Pear Therapeutics, Sandoz ink deal for prescription digital therapeutics appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Patient Monitoring Wall Street Beat Novartis peartherapeutics sandoz Source Type: news

Cadence snapped up by private equity firm Kohlberg & Co.
Officials at high-precision components and finished devices maker Cadence are selling the Staunton, Va.–based company to private equity outfit Kohlberg & Co. Financial terms of the definitive agreement, announced yesterday, were not disclosed. Cadence makes components and devices for advanced surgical and specialty industrial applications. Get the full story on our sister site Medical Design & Outsourcing. The post Cadence snapped up by private equity firm Kohlberg & Co. appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 18, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Contract Manufacturing Mergers & Acquisitions cadenceinc kohlberg&Co. Source Type: news

Google unveils prototype augmented-reality, AI-powered light microscope system
Google (NSDQ:GOOG) this week presented initial data from a prototype augmented reality microscope platform it’s developing for advanced cancer detection, according to a research blog post from the tech giant. The platform consists of a modified light microscope for real-time image analysis and presents analysis from a machine-learning algorithm directly into the users field of view, Google said. Google said the platform could be retrofitted into existing light microscopes generally used in hospitals and clinics using low-cost, readily-available components without the need for digital versions of the scopes. The ...
Source: Mass Device - April 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Imaging Research & Development google Source Type: news

Israeli healthcare fund aMoon II raises $200m
Israeli healthcare fund aMoon II said this week it raised $200 million as it looks to invest in mid to late stage life science companies, according to a Reuters report. The fund, run by billionaire cybersecurity firm Check Point Software co-founder Marius Nacht, will focus on companies in the digital health, medical tech and biopharma industries in India and other health tech hubs, according to the report. Initial funding came from both strategic and private investors, with new money expected from private investors who have reportedly showed interest in the fund, according to Reuters. The fund has a target goal of $500 mil...
Source: Mass Device - April 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Source Type: news

CardioFocus raises $13m
CardioFocus has raised $13 million in a new round of mixed financing, according to an SEC filing posted this week. Money in the round comes from a single unknown investor, according to the filing, with the first sale noted as having occurred on April 4. The Marlborough, Mass.-based company said that $2.6 million from the offering will go towards sales commissions and finders fees, according to the filing. CardioFocus is seeking an additional $8 million before closing the offering, bringing the total it hopes to raise up to $21 million. In February, CardioFocus said that it launched a clinical trial for the latest iteration...
Source: Mass Device - April 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat CardioFocus Inc. Source Type: news

Siemens wins more FDA nods for Somatom CT platform, clearing go.All and go.Top scanners
Siemens (NYSE:SI) Healthineers said today it won another FDA nod for its Somatom portfolio, this time for its Somatom go.All and go.Top computed tomography systems. The company said its go. CT platform devices are controlled via tablet and remote, and that its go.ALL CT scanner features a 0.33-second rotation time, 75 kW generator and 64-slice capabilities. The go.Top system has an acquisition speed of up to 175 mm per second, and features 128-slice capabilities, the company added. Siemens said that both newly cleared devices are powered by its Athlon X-ray tube which offers high mA at a low kV, and adjustable tu...
Source: Mass Device - April 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Imaging Regulatory/Compliance Siemens Healthineers Source Type: news

Livongo Health acquires weight-management, disease-prevention dev Retrofit
Livongo Health said yesterday it acquired weight-management and disease-prevention program developer Retrofit for an undisclosed amount. With the acquisition, Mountain View, Calif.-based Livongo Health said it will make Retrofit’s Diabetes Prevention program available as Livongo DPP, powered by Retrofit. Livongo said the acquisition acts as a compliment to its Livongo for Diabetes and Livongo for Hypertension programs. Read the whole story on our sister site, Drug Delivery Business The post Livongo Health acquires weight-management, disease-prevention dev Retrofit appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diabetes Patient Monitoring Software / IT Livongo Retrofit Source Type: news

Italian robotic surgery dev Medical Microinstruments raises $25m
Italian robotic surgery dev Medical Microinstruments said today it raised approximately $24.5 million (EU €20 million) to support the development of its robotic microsurgery platform. The financing round was led by Andera Partners and joined by Panakes Partners, Fountain Healthcare, Sambatech and industry veterans Gus Castello, formerly of Intuitive Surgical (NSDQ:ISRG), and John Engels, AxoGen (NSDQ:AXGN) founder. As part of the funding, Andera Partners’ Olivier Litzka, Panakes’ Alessio Beverina, Fountain’s Justin Lynch, Gus Castello, John Engels and former Esaote CEO F...
Source: Mass Device - April 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics Surgical medicalmicroinstruments Source Type: news

Cantel Medical wins FDA nod for Advantage Plus endoscope reprocessor
Cantel Medical (NYSE:CMD) said today it won FDA 510(k) clearance for its Advantage Plus pass-thru automated endoscope reprocessor, making it the first AER available in the US, the company claims. The newly cleared device is designed for the high-level disinfection of commonly used endoscopes, including duodenoscopes, the Little Falls, N.J.-based company said. “We strive to deliver real life infection prevention solutions to address the complexities our customers face in setting up successful endoscopy departments. We believe the Advantage Plus pass-thru AER’s availability will transform our custo...
Source: Mass Device - April 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Cantel Medical Corp. Source Type: news

Report: Amazon abandons drug distribution and supply plans
Amazon‘s (NSDQ:AMZN) Business division has dropped plans to sell and distribute pharmaceutical products to hospitals, according to a new report from CNBC. The shift comes due to the online mega-retailer being unable to convince large hospital groups to change their purchasing process and break existing deals and relationships with distributors, according to the report. Read the whole report on our sister site, Drug Delivery Business   The post Report: Amazon abandons drug distribution and supply plans appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Pharmaceuticals Amazon Source Type: news

Mass. medical device industry sees growth in VC funding, PMA approvals
Venture capital funding, PMA approvals and granted patents grew for Massachusetts-based medical device companies last year, according to a new report from firm Grant Thornton. The report, presented by managing principal George Serafin at MassMedic’s annual meeting, found that the Bay State’s medical device sector is second only to California for VC funding – reeling in $3.7 billion between 2014 and 2017. Massachusetts is also ranked just behind California for the most approved medical device patents, garnering 7% of total approvals in the U.S. The number of 510(k) applications approved in the Commonwealth...
Source: Mass Device - April 18, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Wall Street Beat MassMEDIC Source Type: news

Abbott shares down on shrinking Q1 profits
Shares in Abbott (NYSE:ABT) fell today after the medical device maker met expectations on Wall Street but saw profits shrink in its first quarter earnings release. The Abbott Park, Ill.-based company posted profits of $418 million, or 23¢ per share, on sales of approximately $7.4 billion for the three months ended March 31, seeing the bottom line shrink 0.2% while sales grew 16.7%. Adjusted to exclude one-time items, earnings per share were 59¢, just ahead of the 58¢ consensus on Wall Street where analysts expected to see sales of $7.3 billion for the quarter. “We’re off to a strong start to...
Source: Mass Device - April 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Abbott Source Type: news

10 BIOMEDevice Boston exhibitors you need to know
BIOMEDevice Boston is an opportunity for more than 4,000 engineers and executives and 400 suppliers in New England’s design and manufacturing industry to connect and network. The annual event is being held at the Boston Convention and Exhibition Center, April 18-19. Hundreds of supplier booths will be showcasing their latest technologies and capabilities. Here are 10 companies that are exhibiting at BIOMEDevice Boston that you should know. Next>> The post 10 BIOMEDevice Boston exhibitors you need to know appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 18, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Catheters mHealth (Mobile Health) Outsourcing Patient Monitoring alanbairdindustries auerprecision BIOMEDevice Boston brunkindustries fisba MedTech npimedical optinova precomedical qosina xcentricmoldandengineering Zoe Medica Source Type: news

LVAD Efficiency and the Criticality of Accurate Blood Pressure Measurement
What is a LVAD? How does it work? A left ventricular assist device (LVAD), also called a ventricular assist system or VAS, is a mechanical pump that is attached to the left ventricle of the heart to augment the function of the heart’s main pumping chamber. The left ventricle pumps blood from the heart to the rest of the body. It is important to note that a LVAD is different from an artificial heart. An artificial heart replaces a failing heart completely, whereas a LVAD, such as the one pictures at left developed at Proven Process, assists the heart to help pump more blood to the body with less work. The post LVAD E...
Source: Mass Device - April 18, 2018 Category: Medical Devices Authors: MassDevice Tags: White Papers Proven Process Source Type: news

Intuitive Surgical shares up on Street-beating Q1
Shares in Intuitive Surgical (NSDQ:ISRG) have risen in after-hours trading today after the robotic surgery giant posted first quarter 2018 earnings that beat expectations on Wall Street. The Sunnyvale, Calif.-based company posted profits of $287.3 million, or $2.44 per share, on sales of $847.5 million for the three months ended March 31, seeing the bottom line grow 58.9% while sales grew 24.7% compared with the same period last year. After adjusting for one-time items, earnings per share were still at $2.44, well ahead of the the $2.09 consensus on The Street, where analysts were looking for sales of $783.3 mill...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Robotics Wall Street Beat Intuitive Surgical Source Type: news

FDA releases new action plan looking to improve device cybersecurity, streamline approvals
FDA Commissioner Scott Gottlieb today released a statement laying out the federal watchdog’s plans for improving medical device regulation, including plans to improve cybersecurity and monitor the total product life cycles of devices. The announcement came as part of the FDA’s newly released  “Medical Device Safety Action Plan”. The plan focuses on five key areas, including improving medical device cybersecurity, integrating premarket and postmarket activities to monitor the total product lifecycle of products, establishing a medical device patient safety net in the US, exploring regulatory opt...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Source Type: news

How to protect your medtech startup ’s innovations
Building a strategic patent portfolio is crucial to success for a medtech startup.  David J. Dykeman, Greenberg Traurig [Image from Unsplash]When it comes to starting and building a medical device company, a strong patent strategy tied to business goals can be the driving force behind venture capital investment, strategic collaborations, and mergers and acquisitions. In order to safeguard its intellectual property (IP), every medtech startup should consider these five tips for protecting and leveraging its innovations. 1. File early and file often Fundamental to a strong patent portfolio is establishing solid patent p...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Legal News Patent Infringement Research & Development Greenberg Traurig intellectualproperty patents startups Source Type: news

Glooko names digital health veteran as CEO | Personnel Moves – April 17, 2018
Glooko named health tech veteran Russ Johannesson as its new chief executive this month, adding that the diabetes data management company’s former CEO, Rick Altinger, is slated to become EVP of corporate development. Johannesson previously served as the chief operating officer of Sharecare, a digital health and wellness platform. Before that he led sales, marketing and client management activities as chief client officer at OptumHealth. Get the full story at our sister site, Drug Delivery Business News. The post Glooko names digital health veteran as CEO | Personnel Moves – April 17, 2018 appeared first on...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Diagnostics Drug-Device Combinations Pharmaceuticals Wall Street Beat Aerie Pharmaceuticals Glooko Glytec natera Nemaura Medical PerkinElmer Inc. pneumarespiratory Source Type: news

Medtronic launches OptiSphere embolization spheres
Medtronic (NYSE:MDT) said today it launched its OptiSphere embolization spheres designed for embolization of hypervascular tumors. The Fridley, Minn.-based company said that the embolization spheres, which are manufactured by the Vascular Solutions subsidiary of Teleflex (NYSE:TFX), are designed as a resorbable embolic alternative treatment option to permanent embolics. “Teleflex is very pleased to have Medtronic as a strategic distribution partner for our novel platform of embolic spheres. The development of unique resorbable implants, particularly in the field of embolization, has become one of our core t...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Oncology Medtronic Source Type: news

How these Boston Marathon runners kept their diabetes in check with Abbott ’ s FreeStyle Libre monitor
When Courtney Duckworth was first diagnosed with Type I diabetes, her glucometer was the size of a cell phone and she pricked her fingers nearly 12 times each day to keep track of her blood sugar. “I couldn’t feel the things that I touched because I had so many scabs,” she told Drug Delivery Business News. This week, she ran the Boston Marathon using Abbott‘s (NYSE:ABT) FreeStyle Libre – a continuous glucose monitor that allows her to test her blood sugar simply by swiping her phone over a small sensor worn on her upper arm. Duckworth was diagnosed with Type I diabetes when she was just 1...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Patient Monitoring Wall Street Beat Abbott Source Type: news

Sotera Health to sell its Nordion medical isotopes biz
Sotera Health said today it inked a deal to sell the medical isotopes segment of its Nordion business to a subsidiary of BWX Technologies for an undisclosed amount. Through the deal, Broadview Heights, Ohio-based Sotera Health will divest itself of all of Nordion’s medical isotope assets, including its radiochemical operation and contract manufacturing services in Kanata and its medical isotope operation in Vancouver. “The world’s need for gamma technology has expanded dramatically as the demand for sterilization of medical and non-medical applications has accelerated in response to increasing global regu...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions soterahealth Source Type: news

LivaNova wins CE Mark for SenTiva VNS epilepsy treatment
LivaNova (NSDQ:LIVN) said today it won CE Mark in the European Union for its Vagus Nerve Stimulation Therapy system, now indicated for treating patients with drug-resistant epilepsy. The VNS Therapy system is composed of the London-based company’s SenTiva implantable generator and a next-gen VNS therapy programming system. LivaNova touted the SenTiva generator as the smallest and lightest responsive therapy for epilepsy on the market. The system features a wireless wand and tablet-based interface to allow for physician-directed therapy for patients with drug-resistant epilepsy. “CE Mark combined with recen...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Neurological Neuromodulation/Neurostimulation Regulatory/Compliance LivaNova Source Type: news