CMS proposes improved ambulatory BP coverage

The U.S. Centers for Medicare & Medicaid Services recently released a proposed decision memo stating that it believes there is evidence sufficient to support the use of ambulatory blood pressure monitoring for diagnosing and treating hypertension in its beneficiaries.

The agency laid out circumstances for reimbursement coverage, including white coat hypertension verified through at least two separate clinic or office visits with separate measurements three months apart or suspected masked hypertension, measured similarly.

To qualify for coverage, the devices must be quality certified and validated for use in the intended patient population, capable of producing standardized plots of blood pressure measurements for 24 hours, include written and oral instructions and be read by treating physicians or a treating non-physician practitioner, according toe the release.

CMS said that ambulatory blood pressure monitoring will be covered once a year, and that other indications for it would come at the discretion of the Medicare Administrative Contractors.

The agency said that it is seeking comments on the proposed decision, and that it will respond to public comments in a final decision memorandum, according to the release.

Loop Medical lands $3.2M grant for blood collection device

Loop Medical said today that it has received a $3.2 million grant from the Bill & Melinda Gates Foundation to support pre-production and clinical trials required for the global registration of its blood collection device. The foundation had previously given the company a $400,000 grant.

Based at the Swiss Institute of Technology (EPFL) in Lausanne, Switzerland, Loop Medical designed the device to be painless, easy-to-use and able to collect samples that are large enough for common high-throughput blood analyzers. The device was also designed to improve safety, particularly in countries with low medical resources.

In the standard venipuncture procedure, a long needle is used to collect blood from the vein. Loop accesses blood in capillaries that are just below the skin, through a minimally invasive and painless manner, according to its website.

Loop has been working with clinical pathology and histocytopathology company Cerba HealthCare since 2017 to design a device that can be fully integrated into existing centralized laboratories’ infrastructures and processes. The device targets clinical pathology laboratories, clinics, pharmacies, physician offices and patients at home. The technology addresses the need to empower patients, communities and healthcare professionals through a safe and effortless solution in a highly commoditized blood collection market under significant price pressure, according to Loop.

“We are thrilled to have received this second grant from the Bill & Melinda Gates Foundation. It shows trust in our project and is a recognition that our early development activities are well managed,” said Loop Medical founder & CEO Arthur Queval in a prepared statement. “We are convinced our painless and easy-to-use device is a major breakthrough. It will benefit both the blood collection procedure itself and the safety and convenience of the end-to-end diagnostic process for a variety of health conditions and geographies around the world.”

Report: Drones are delivering blood samples in N.C.

UPS Drone

Autonomous drones have begun to ferry blood samples between clinics and labs in the skies over North Carolina, according to a recent report from Wired.

The drone service, run by UPS with drone technology from Matternet, made its first flight last Tuesday at Raleigh’s WakeMed Hospital, according to the report.

The drone can carry up to five pounds and completes its flight in approximately three minutes, a significant reduction from the 30 minutes it would take for a driver to make the journey by car, according to Wired.

While the drone is designed to work autonomously, all flights are monitored by a remote pilot-in-command who can intervene if necessary, according to the report.

The blood-sample toting drones will take about 10 flights daily to start, according to Wired, with the chance to increase if service picks up.

The service was born from the FAA’s Unmanned Aircraft System Integration Pilot Program which aims to test the safe integration of drone tech into commercial airspace, according to the report. And while the service is new to UPS, Matternet has reportedly executed more than 3,000 similar flights in Switzerland.

WakeMed is hopeful that the service will lower cost and hasten deliveries, and both UPS and Matternet said they hope to expand the service to other areas in the country, according to the Wired report.

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Magnolia Medical files another suit against Kurin

Magnolia Medical Technologies, Kurin

Magnolia Medical Technologies said yesterday that it filed another legal action against blood-culture-focused device developer Kurin, this time claiming the company has infringed on patents related to its Steripath technology.

The Seattle-based company asserts that Kurin is infringing upon four patents related to its Steripath blood collection technology with its Kurin Lock product.

Magnolia Medical said that the “four patents represent and cover years of Magnolia’s research and development,” and added that it plans to “vigorously defend its technology.” The company said that it is seeking damages and a permanent injunction barring the production, use and selling of the Kurin Lock device.

“Magnolia uses its technology to decrease patient risk by reducing misdiagnosis and mistreatment of sepsis, which also strongly supports antibiotic stewardship. Dr. Richard Patton and I have spent more than a decade developing unique medical innovations that deliver scientifically proven results, and we are committed to making sure Steripath and its future are appropriately protected, ensuring that patients and hospitals will benefit from Magnolia’s technology,” CEO Greg Bullington said in a press release.

Last August, Magnolia said it filed a suit agianst Kurin claiming the company “mischaracterized its clinical data as well as the functionality and ease of use of its device.”

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Tasso lands $6m to launch home blood-collection device

Tasso OnDemand would allow at-home blood collection. (Image from Tasso)

Blood-collection startup Tasso said it has completed a $6.1 million financing round led by Vertical Venture Partners (VVP), with participation from Techstars and Cedars-Sinai. The funding will help Tasso scale its first product, Tasso OnDemand, which enables self-collection of blood samples, and to add personnel to support commercial growth.

Tasso OnDemand allows people to collect blood at home and mail the samples to the laboratory for analysis. The Seattle-based company said its inaugural product may transform how patients engage with blood testing, optimizing drug efficacy, safety, and adherence, as well as enabling frequent data on vital blood markers for drug development and care management.

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Safety board OKs continuation of CytoSorbents endocarditis trial

CytoSorbents (OTC:CTSO) said this week it the Data Safety Monitoring Board of its REMOVE trial gave the company the green light to continue the study after analyzing data from the first 50 patients.

The German gov’t-funded randomized, controlled, multi-center 250-patient REMOVE trial, which was launched in late 2017, looked to explore the safety and efficacy of intraoperative CytoSorb in patients with dangerous bacterial heart valve infections during valve replacement surgeries and cardiopulmonary bypass procedures, the Monmouth, N.J.-based company said.

The study’s goal is to demonstrate improved hemodynamic stability and reduced organ injury, primarily measured by change in the sequential organ failure assessment score, with secondary endpoints of 30-day mortality, need for supportive care therapies and length of intensive care and in-hospital stays.

“The Scientific Advisory Board of the Center of Sepsis Control and Care and the Data Safety Monitoring Board of the REMOVE study recommended continuation of the study, based upon results of a pre-specified interim analysis that analyzed cytokine and vasoactive mediator levels as an indicator of the mechanistic mode of action of the device in 28 CytoSorb-treated patients and 22 control patients.  There were no device-associated adverse events in the CytoSorb group,” Dr. Frank Brunkhorst of Jena University Hospital’s Center for Clinical Studies and Dr. Torsten Doenst of Jena University’s Clinic for Cardiac and Thoracic Surgery said in a joint statement.

“We are pleased to have passed this significant milestone for the REMOVE endocarditis trial and thank all of the participating centers for their continued contributions to this important study. We are eager to continue the trial so that we will get important information on the clinical end points in these critically-ill patients. We thank the German government for support. Currently, enrollment is in-line with our goals, and we are confident in being able to advance this trial to completion,” principal investigator Dr. Mahmoud Diab of Jena University’s Clinic for Cardiac and Thoracic Surgery

Last August, Cytosorbents said that it won another round of funding from the U.S. government to commercialize its HemoDefend red blood cell transfusion filter.

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Magnolia Medical closes $20m Series C

Magnolia Medical Technologies

Magnolia Medical Technologies said today that it closed a $20 million Series C financing round slated to help grow the company’s infrastructure and market initiatives to meet demand for its Steripath Gen2 initial specimen diversion device.

The next-generation device, launched last August, features mechanical initial specimen diversion and improved usability based on input from end users, the Seattle-based company said.

Financing in the round was led by RTW Investments and joined by existing investors HealthQuest Capital, SightLine Partners and Canepa Healthcare. As part of the funding round, RTW Investments partner Dr. Naveen Yalamanchi will join the company’s board of directors as an observer, Magnolia said.

“RTW is committed to supporting innovative healthcare companies that both improve patients’ lives and enable cost-effective delivery of care. Magnolia is uniquely positioned to deliver on both of these requirements with Steripath’s demonstrated clinical performance and financially-backed guarantee. Accurate sepsis diagnosis is a critical priority for every acute care hospital, so we’re excited to partner with Magnolia as the company accelerates adoption of this new standard of care,” Yalamanchi said in a press release.

Funds will also be used to advance the company’s blood and bodily fluid collection and contamination prevention devices, Magnolia Medical added.

“Our mission as a company is to eradicate inaccurate laboratory test results that lead to harmful patient mistreatments and significant avoidable costs. We have made very strong progress in establishing a new standard of care for sepsis testing accuracy and look forward to repeating our proven process with other critical, yet frequently inaccurate, laboratory tests. We are delighted to partner with RTW as we accelerate expansion of the Steripath platform and advance efforts with policymakers to change national blood culture guidelines and contamination benchmarks to improve patient safety and quality of care,” CEO Greg Bullington said in a prepared statement.

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Abbott inks deal to test blood donations in Japan

Abbott (NYSE:ABT) said today that it has been selected by the Japanese Red Cross Society (JRC) to partner in screening the country’s blood donations.

The eight-year contract is for the exclusive supply of serological instrumentation, tests, and consumables used for blood and plasma screening. The JRC screens approximately 5 million blood donations each year, helping ensure a safe supply of products needed for blood transfusions and plasma therapies. Abbott products are used to screen more than 60% of the world’s blood and plasma supply, according to a company statement.

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RFPi wins FDA nod for non-contact blood flow imaging tech

RFPi’s iCertainty shows images of blood flow and perfusion without contact with the patient.

FDA has cleared RFPi’s iCertainty real-time, noninvasive blood flow and perfusion imaging medical device for use during surgical procedures, the company said.

iCertainty is the first medical imaging device to show blood flow without interrupting a surgical procedure or requiring injections, dyes, radiation or direct patient contact, according to the Greenville, N.C. company. Use of iCertainty during surgery could reduce procedural complications or repeat surgeries, reduce hospital costs, and objectively measure and help to improve clinical outcomes, the company said in a prepared statement.

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Awak Technologies wins FDA breakthrough designation for portable PD device

Awak Technologies

Awak Technologies said today that it won a breakthrough device designation from the FDA for its wearable Awak Peritoneal Dialysis system.

The Awak PD system is a portable, wearable peritoneal dialysis system which allows dialysis to be performed “on-the-go”, the Singapore-based company said.

The breakthrough designation was granted based on results from the first-in-human safety trial of the Awak PD device, which completed last October.

Data from the trial indicates that the system was able to efficiently remove the accumulation of toxins from the body with no serious adverse events experienced by patients using the device, the company said.

“Breakthrough Device Designation is an important milestone in the development of Awak PD following the recent positive clinical study results. The designation reinforces our belief that Awak PD has the potential to revolutionize the way in which peritoneal dialysis can be delivered and we look forward to collaborating closely with the FDA on the next stages of our development pathway,” CEO Suresha Venkataraya said in a prepared statement.

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