Zoll Medical wins US Army contract for Propaq M vital signs monitors

Zoll Medical said this week it won a sole-source contract from the US Defense Logistics Agency to supply Propaq M deployable vital signs monitors to the US Air Force and US Army.

The Chelmsford, Mass.-based company’s Propaq M is an advanced vital signs transport monitor designed for military operations. The system can be equipped with an integrated defibrillator and pacer and an integrated printer.

The Propaq M is also equipped with Masimo‘s (NSDQ:MASI) rainbow SET technology which includes total hemoglobin and pleth variability index monitoring.

“We are very pleased to see the continued commitment to the Zoll Propaq platform. This recent award demonstrates the DoD’s confidence in Zoll’s monitoring and monitoring/defibrillation technology that is currently deployed throughout the services today,” Zoll resuscitation biz prez A. Whiton said in a press release.

Early last month, Zoll Medical won a contract with the US Department of Defense worth up to $400 million for vital sign monitors, according to a DoD release.

The post Zoll Medical wins US Army contract for Propaq M vital signs monitors appeared first on MassDevice.

Lexington Biosciences moves forward with its affordable heart diagnostic device

Lexington Biosciences HeartSentry

[Image courtesy of Lexington Biosciences]

Lexington Biosciences (Vancouver, British Columbia) said today that it has brought on reimbursement experts as it seeks FDA clearance for its HeartSentry device.

The strategic business relationship with a San Francisco arm of Chicago-based Navigant Consulting, is meant to help Lexington(CSE: LNB) (OTCQB: LXGTF) better work with relevant authorities to develop a coverage policy to support the commercial rollout of HeartSentry, an endothelial function measurement product that holds the promise of better pinpointing of people at risk of heart attacks.  The San Francisco arm was previously Quorum Consulting, which Navigant recently acquired.

Lexington Bioscience is moving ahead quickly to start its HeartSentry pilot clinical research to support FDA clearance, according toLexington’s President Eric Willis.

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

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Philips is expanding its radiology offerings: Here’s how


PhilipsPhilips today announced three new products and services related to its radiology offerings, including 3D printed models, a new CT scanner and an extension of a partnership with Banner Health.

On the 3D printing front, agreements with industry leaders 3D Systems and Stratasys will enable Philips customers through Philips’s IntelliSpace Portal 10 to have a seamless connection to 3D Systems and Stratasys solutions. The agreement is meant to allow radiologists to more quickly produce 3D printed models to better understand patient anatomy.

“Enhancing how we visualize anatomy and diseases, like cancerous tumors, can profoundly affect the level of personalized care we can deliver to patients,” Yair Briman, business leader for healthcare informatics at Philips, said in a news release.

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

Masimo wins FDA nod for NomoLine capnography sampling lines



Masimo (NSDQ:MASI) said today it won FDA clearance for its NomoLine capnography sampling lines.

The newly cleared NomoLine sampling lines are compatible with both Masimo and third-party OEM NomoLine monitors to allow for sidestream capnography and gas monitoring the Irvine, Calif.-based company said. The lines are designed for both intubated and non-intubated patients in low and high humidity applications.

Masimo touted that the NomoLine sampling lines feature no-moisture sampling technology designed to eliminate issues associated with conventional sidestream gas sampling line systems. The NomoLines feature the company’s patented polymer and allow water in sampling lines to continuously evaporate into the surrounding air and leave oxygen, carbon dioxide and anesthetic gases unaffected.

“With NomoLine, we’ve developed innovative moisture-wicking technology – and then applied that breakthrough to an entire line of cannulas, including neonatal airway adapter sets. Masimo continues to automate noninvasive monitoring with solutions such as NomoLine that are reliable and easy to use,” founder & CEO Joe Kiani said in a press release.

Earlier this month, Masimo reported third-quarter results that crushed the consensus earnings forecast and raised its sales and earnings outlook for the rest of the year.

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  • 7 medtech stories we missed this week: Nov. 17, 2017

    missed medtech

    [Image from unsplash.com]

    From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning.

    1. Skyline Medical launches JV deal with Helomics

    Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics. The agreement comes after a strategic collaboration between the companies that allows Skyline to reach more markets. The joint venture leverages the Helomics D-Chip platform to develop and market new approaches for personalized cancer diagnostics and care.

    2. iReliev launches wearable arthritis-treatment EMS/Tens patch

    iReliev recently introduced its PlayMakar Wireless EMS + TENS Unit that helps treat chronic pain from arthritis on the go, according to a Nov. 15 press release. The device features two functions that include transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS). TENS helps block pain signals from the brain to provide pain relief while EMS stimulates muscles for conditions, strengthening and recovery using gentle electrical impulses. It has two rechargeable receivers that connect to electrode pads to allow for it to work wirelessly. The device has 14 preset therapy mode for personalized treatment and additional receivers can be added on for treating bigger areas.

    3. Mortise Medical gets FDA clearance

    Mortise Medical announced in a Nov. 14 press release that it has received FDA 510(k) clearance for its SyndesMetrics Syndesmosis Repair System. The system addresses clinical needs for syndesmotic disruption injuries like predictable and repeatable anatomic reduction, restoration of physiological motion and restoration of ankle stability. The SyndesMetrics implant system has minimal hardware prominence, no suture prominence and a reversible locking mechanism that secures high strength suture that that connects tibial and fibular implant components.

    4. InnerScope announces new distribution deal

    InnerScope Hearing Technologies has announced that it has signed an exclusive distribution deal with Speechlab Advanced Technologies, according to a Nov. 14 press release. The deal allows for resell rights of InnerScope’s BlackCat Personal Sound Amplifier Product (PSAP). The BlackCat is a personal audio controller that is designed to help people understand speech better in noisy environments.

    5. Mevion receives CE Mark for proton therapy system

    Mevion announced in a Nov. 13 press release that it has achieved CE Marking clearance for its Mevion S250i Proton Therapy System. The system features Hyperscan technology and pencil beam scanning (PBS) for faster, sharper and more robust proton treatments. It also uses the fastest energy layer switching, optimized spot sizes and the Adaptive Aperture proton multi-leaf collimator system.

    6. Nexstim wins FDA nod for NBT depression device

    Nexstim has been cleared by the FDA to market and distribute its Nexstim NBT system, according to a Nov. 13 press release. The system is designed to treat major depressive disorder through stimulation of the brain using repetitive transcranial magnetic stimulation (TMS), which has been proven to be effective in treating depression. The company plans to begin to market and sell its system in early 2018.

    7. Lensar gets FDA clearance, CE Mark for laser eye surgery marker

    Lensar announced in a Nov. 10 press release that it has received FDA 510(k) clearance and CE Mark for its IntelliAxis-L. It is a unique reference mark that uses the company’s integrated pre-operative diagnostic capabilities, iris registration and intraoperative imaging to identify the location of steep corneal axis at the capsular plane for toxic IOL alignment.

    G Medical Innovaions raises $10m to support Prizma medical smartphone case


    G-Medical Innovations

    Mobile health dev G Medical Innovations said today it raised $10.3 million (AUSD $13.5 million) to support commercialization of its Prizma medical smartphone accessory and case.

    The Australian company said the round was “substantially oversubscribed,” with funds raised through the sale of 31.4 million shares at 33¢ (AUSD 43¢) per share.

    G Medical’s Prizma medical smartphone case is designed to allow users to use their smartphone as a mobile medical monitor to measure a wide range of vital signs and record the data into a cloud-based storage solution. Data collected from the Prizma can then be shared with other parties including healthcare professionals and caretakers.

    “I am extremely pleased to welcome our new institutional partners as shareholders to the Company, as well as receiving additional support from our existing and some new sophisticated and strategic shareholders. We are moving to commercialisation of our medical devices and ancillary support service offerings at a rapid pace, and this expansion capital allows us the flexibility to capitalise on our opportunities at hand,” CEO Dr. Yacov Geva said in a press release.

    The company won CE Mark approval in the European Union for the Prizma case in mid-September, having won FDA clearance earlier in the same month.

    Pentax adds ASHA’s voice problem assessment tools into voice and speech software


    Pentax Medical

    Hoya‘s Pentax Medical said today it inked a licensing agreement with the American Speech-Language-Hearing Association to incorporate a tool it designed to help assess voice problems into a software modules used in Pentax’s voice and speech assessment products.

    The Consensus Auditory-Perceptual Evaluation of Voice tool was developed by the ASHA to “provide a standardized protocol and assessment form for speech-language pathologists to describe and document clinical auditory-perceptual assessments of voice quality,” according to a press release.

    The iCAPE-V tool will be integrated into a new software module from Pentax of the same name. The new tool will be loaded into the company’s Visi-Pitch and Computerized Speech Lab.

    “Pentax Medical is dedicated to working with ASHA and the speech-language pathologist, voice scientist, and logopedist communities to develop products that further the field and help the patient population. We are extremely excited to have partnered with ASHA to develop a meaningful advancement to the industry,” Pentax Medical global management VP Jim Cavanaugh said in a press release.

    Last month, Pentax said it won CE Mark approval in the European Union for its DEC duodenoscope featuring a disposable elevator cup.

    HeartFlow wins CMS new tech payment classification for FFRct analysis


    HeartFlow said today that the Centers for Medicare & Medicaid Services finalized a new technology ambulatory payment classification for its HeartFlow FFRct analysis designed to help diagnose suspected coronary artery disease.

    Under the newly finalized payment decision, Medicare-enrolled hospitals will be eligible for reimbursements of $1,450.50 for each technical component of the FFRct analysis. The new rules are set to take effect on January 1, 2018.

    “CMS’s decision to assign a New Technology APC for FFRct technology for Medicare recipients is a recognition of the value of this technology and its demonstrated ability to reduce the number of invasive diagnostic coronary angiography procedures and help medical centers reduce costs. The HeartFlow Analysis is an important tool in helping us assess patients with suspected coronary artery disease and better understand how their coronary blockages affect blood flow to the heart,” Dr. Pamela Douglas of Duke University said in a press release.

    Redwood City, Calif.-based HeartFlow’s FFRct technology works by taking the data from a standard CT scan and applying algorithms that result in a color-coded 3D “map” detailing the changes in flow across coronary lesions.

    “The decision by CMS will help in the diagnosis and treatment of patients with suspected CAD and means the number of patients over age 65 who will have access to this technology will significantly increase. At our center, the use of the HeartFlow FFRct Analysis is transforming how we diagnose and treat patients with coronary artery disease, helping us move closer to achieving the triple aim of improving the patient experience, improving the health of our patients, and reducing healthcare costs at our institution.” Dr. Daniel Simon of the Cleveland Medical Center said in a prepared statement.

    In late August, HeartFlow said it won positive medical policies for its HeartFlow FFRct fractional flow reserve analysis system from 3 separate Blue Cross Blue Shield providers.

    LabCorp invests in, inks collab deal with sensor dev MC10


    MC10, Labcorp

    Wearable sensor developer MC10 said this week it inked a collaborative deal with LabCorp that included an equity investment of an undisclosed amount.

    Through the collaborative deal, Lexington, Mass.-based MC10 said that LabCorp will use MC10s proprietary sensor technology for its Covance Drug Development business in clinical trials and research studies, with the possibility of adapting it for use in patient testing and monitoring.

    MC10 produces the BioStamp sensor, released last March, which is designed as wearable sensors that collect and transmit biometric data.

    The companies said they are hopeful that MC10s sensor technology could be used to to open up trial participation to more subjects and provide more precise information during treatments.

    “Our collaboration with LabCorp focusing first on Covance, will accelerate the delivery of MC10’s innovative digital health solutions to our shared customer base in the pharmaceutical industry. We are optimistic for the growing portfolio of projects that will leverage LabCorp’s differentiated diagnostic expertise and MC10’s medical-grade wearable systems to advance our mission of reshaping healthcare with digital solutions,” MC10 corporate dev VP Ben Schlatka said in a prepared statement.

    MC10 said that as a start to the collaborative deal, LabCorp’s Covance will support the adoption of the BioStamp system in research studies which necessitate mobile monitoring of patients.

    “LabCorp is very excited about the potential applications for MC10’s BioStamp technology in clinical trials and research. We are confident that our collaboration with the great team at MC10 will help to bring new medicines to patients faster, advancing our mission to improve health and improve lives,” Covance chief development officer William Hanlon, Ph.D said in a prepared statement.