DarioHealth touts updated diabetes management software

DarioHealth updated logo

DarioHealth (NSDQ:DRIO) said yesterday it launched a new version of its Dario system and DarioEngage platform.

The new V4.2.0 update to both digital health programs are intended to improve user engagement, lower barriers to behavioral change and to streamline the experience and process efficiency for both users and their coaches, the Israel-based company said.

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Philips wins $450m DoD patient monitor supply contract


Royal Philips (NYSE:PHG) has won a $450 million contract to supply the U.S. Department of Defense with patient monitoring systems, accessories and training, according to a recently released DoD posting.

The deal comes through a five-year base contract with a single five-year option period. A total of 36 different companies competed for the contract that Amsterdam-based Philips won, according to the DoD release.

Patient monitoring systems, accessories and training will be supplied to the Army, Navy, Air Force, Marine Corps and other federal civilian agencies, with the location of performance noted as Massachusetts. The contract has a performance completion date of March 28, 2024, according to the release.

The contracting was performed through the Defense Logistics Agency Troop Support, the DoD said.

Last week, Philips said that it acquired teleradiology platform developer Direct Radiology for an undisclosed amount.

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ACC 2019 Roundup – ReCor touts six-month Paradise renal denervation study results

ReCor Medical this week released “on-medication” results from the RADIANCE-HTN-SOLO clinical trial of its Paradise renal denervation system intended to treat uncontrolled hypertension, touting medication and blood pressure reductions at six months.

Results from the trial was presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans and were simultaneously published in the journal Circulation.

Study investigators said that the six month “on-meds” results followed two month “off-meds” results that had been previously released after patients met their blood pressure primary outcomes. Patients in that trial remained blinded to treatment assignment and were put back on medications following a recommended, pre-set, stepped care, medical titration protocol.

“Professor Michel Azizi, my Co-PI for the RADIANCE-HTN study, the RADIANCE-HTN Steering Committee and I are very pleased to report the 6 month ‘on-meds’ results from the SOLO cohort of the study. These results are unique in that they represent blinded randomized data demonstrating that ultrasound renal denervation may have the potential to serve as an important adjunct to medications to lower blood pressure. We believe that in addition to the previously presented SOLO results in patients who were ‘off’ medications, these new data contribute to the growing body of evidence demonstrating that the Paradise System can lower blood pressure, either alone or in combination with anti-hypertensive medications. If confirmed in the larger and ongoing RADIANCE II trial, this therapy would have the potential to help patients and physicians reach their blood pressure goals – something that is frequently not achieved in clinical practice,” co-principal investigator Dr. Ajay Kirtane of Columbia University Irving Medical Center said in a prepared statement.

Results indicated that patients treated with the ReCor Paradise Ultrasound denervation system were prescribed fewer anti-hypertensive medications than those treated with a sham procedure, ReCor Medical said.

Treated patients also experienced greater blood pressure drops than those in the sham arm, with reductions maintained at six months and no reports of major adverse events.

“ReCor is encouraged by the SOLO 6 month outcome data as it is the first randomized, blinded, sham-controlled evidence of the effectiveness of the Paradise renal denervation system in combination with added anti-hypertensive medication.  These data demonstrate the 6 month durability of the blood pressure lowering effect of the Paradise renal denervation system, either alone or in combination with medications. We are also excited that we have begun to randomize subjects in our RADIANCE-II pivotal study, which we plan to complete in 2020.  The combination of our independent, blinded and sham-controlled RADIANCE-HTN SOLO and TRIO studies, the REQUIRE study being run in Japan and Korea, and our pivotal RADIANCE-II study will provide safety and efficacy outcomes on more than 600 patients, covering a broad range of patients with hypertension.  If successful, we hope that, in the future, these studies may support an important new treatment option for millions of hypertensive patients worldwide,” CEO Andrew Weiss said in a press release.

 HeartFlow touts ADVANCE FFRct trial data

HeartFlow this week presented results from the ADVANCE trial of its FFRct Analysis system, touting its ability to identify patients at low risk of cardiovascular events to reduce invasive testing.

Results from the trial were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans and simultaneously published in the Journal of the American College of Cardiology: Cardiovascular Imaging.

“These findings provide reassurance regarding the safety of patient management utilizing a FFRct-guided decision pathway, particularly in lower-risk patients who did not undergo an invasive evaluation. By adding the HeartFlow FFRct to our available resources for diagnosing stable coronary disease, we are able to provide patients with better care as we efficiently evaluate risk in patients getting a coronary CTA, more precisely stratify patients and improve efficiency in the cath lab,” Dr. Manesh Patel, of Duke University School of Medicine said in a prepared statement.

Study investigators in the more than 5,000-patient registry trial evaluated the use of FFRct values derived from the HeartFlow analysis to help determine patient’s risk of adverse cardiovascular events and for treatment planning. Patients in the trial underwent a coronary computed tomography angiogram with HeartFlow Analysis to follow when needed.

The majority of patients in the trial who received a negative HeartFlow Analysis received medical therapy and did not have to undergo invasive testing and treatment, HeartFlow said.

Study researchers reported a 0.2% rate of cardiovascular death or heart attack amongst the negatively-screened patients at one year, four times lower than patients who received a positive HeartFlow Analysis. Negatively-screened patients also had a low rate of revascularization through 90 days and negligible need for revascularization afterwards, the company said.

“The one-year results from ADVANCE are largely unchanged from the previously-presented 90-day results, which reinforces the durable utility of using coronary CTA as a front-line diagnostic test and incorporating the HeartFlow Analysis in a real-world patient population. By providing functional information, the HeartFlow Analysis is able to complement the anatomical information provided by a coronary CTA and enable the physician to have a more complete picture of the patient’s heart health, and thus provide more personalized care for the patient,” chief medical officer Dr. Campbell Rogers said in a prepared release.

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 AliveCor releases data from multiple KardiaMobile ECG studies

AliveCor yesterday released data from three new studies of its KardiaMobile mobile electrocardiogram technology, touting its clinical utility and ability to streamline workflows.

Data from two trials were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans while another was published in Lancet’s EClinicalMedicine journal, Mountain View, Calif.-based AliveCor said.

Results from the EClinicalMedicine-published 243-patient trial performed at the University of Edinburgh and NHS Lothian indicated that ECGs taken with the KardiaMobile after discharge allowed doctors to diagnose 56% of patients in 9.5 days on average, higher than a 10% diagnosis rate and an average of 43 days reported with standard-of-care treatment. Data also indicated a cost-per-patient reduction of approximately $1,200, AliveCor said.

In one ACC 2019 presentation, AliveCor said that it touted the capabilities of its remote patient monitoring platform and its ability to integrate images from the KardiaPro mobile ECG into an EPIC electronic health records platform. The company also presented the latest version of the KardiaPro, which it says now supports reimbursement under the newest remote patient monitoring CPT codes.

The company also presented data on its KardiaMobile Gen 2 six-lead mobile ECG that is currently pending FDA 510(k) clearance, touting its ability to accurately measure the QT interval, which is associated with sudden cardiac death when prolonged. The company said that the system was trained off of data from over 200,000 Mayo Clinic patients to predict the QT interval.

AliveCor said that the QT prediction from the KardiaMobile Gen 2 ECG data was comparable to QT measured from a traditional 12-lead ECG.

“KardiaMobile is the most clinically validated mobile ECG in the world,” said Dr. Jacqueline Shreibati, Chief Medical Officer at AliveCor. “Every day, physicians and patients around the globe reaffirm AliveCor’s role in improving patient outcomes. AliveCor is proud to be involved in high-quality clinical research, including randomized controlled trials, and prospective validation studies of AI algorithms.”

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 Livongo touts BP drops in Livongo for Hypertension trial

Livongo late last week presented results from a study exploring the use of its Livongo for Hypertension solution’s ability to reduce blood pressure in patients with diabetes and uncontrolled high blood pressure.

Data from the trial was presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans, the Mountain View, Calif.-based company said.

Livongo said that its Livongo for Hypertension solution includes a smartphone app for remote blood pressure monitoring, tips on healthy living and the ability to connect with a health coach.

Participants in the trial measured their blood pressure on average four times a week, with data automatically transmitted to Livongo’s Applied Health Signals platform, the company said.

Study researchers said that they recruited 708 individuals with diabetes and a starting blood pressure of greater than 130/80 mm HG for the trial, and that patients had an average reduction of 11.2 mm Hg for their systolic pressure and a decline of 5.2mm Hg to their diastolic pressure at six weeks.

“By giving our Members the opportunity to monitor their blood pressure readings at home and offering personalized insights and coaching to help them better understand their health, together we were able to drive meaningful behavior change that led to significant clinical outcomes at six weeks without the use of medication. This study effectively shows that by giving health consumers the tools they need to better manage their health, we can empower them to live healthier lives,” senior study author and chief medical officer Dr. Bimal Shah said in a prepared statement.

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 Neovasc presents Reducer data

Neovasc (NSDQ:NVCN) said today that it released data on its Neovasc Reducer device during the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans.

During the session, researchers explored the treatment of refractory angina in patients with no options, Vancouver-based Neovasc said, touting its Reducer’s ability to narrow the coronary sinus in refractory angina patients.

“We are pleased that today’s ACC.19 session included an overview of our Reducer and its efficiency in narrowing the coronary sinus in refractory angina patients, which has resulted in an improvement in symptoms and quality of life for patients with refractory angina who were not candidates for revascularization.  A portion of the data discussed during the session was originally published in the New England Journal of Medicine in February 2015. Looking at the participants in this session, we see growing interest for the Reducer among leading cardiologists; Professor Thomas Luscher, who has treated patients with Reducer within his practice in Europe and co-authored a published paper on the Reducer, presented the Reducer data at ACC.19 and Dr. Tim Henry of Cedars-Sinai, who has been a strong supporter of generating additional data for the Reducer in the U.S., chaired the session,” CEO Fred Colen said in a press release.

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GE’s Datex-Ohmeda wins another DoD patient monitoring contract, this time for $100m

General Electric

General Electric (NYSE:GE) division Datex-Ohmeda has won a $100 million contract to supply the U.S. Department of Defense with patient monitoring systems, accessories and training, according to a recently released DoD posting.

The deal comes through a five-year base contract with a single five-year option period, according the release. The contract was competitive, with a total of 36 responses received.

Patient monitoring equipment, accessories and training from the Madison, Wisc.-based company will be supplied to the Army, Navy, Air Force, Marine Corps and federal civilian agencies, according to the DoD release. The location of performance is listed as Wisconsin, with a March 5, 2024 performance completion date.

Last March, Datex-Ohmeda won a $19.9 million modification to an existing contract to supply the DoD with patient monitoring systems, subsystems, accessories, consumables and training.

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Saranas’ Early Bird catches nod from FDA

Saranas said today that FDA has granted its Early Bird endovascular bleed monitoring system de novo designation.

The Early Bird device includes a vascular access sheath with embedded sensors that are designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedures, such as TAVR, large-bore hemodynamic support device placement, or other complex cardiovascular interventions in which the femoral artery or vein is used to obtain vascular access. The technology was invented at the Texas Heart Institute.

A recent study of more than 17,000 large-bore transcatheter interventions from the National Inpatient Sample Database revealed that one in five patients experienced a bleed complication, according to the Houston, Texas-based company. A 2017 article in the Journal of the American Medical Association (JAMA) reported a three times increase in mortality, two times increase in length of hospital stay and 60 percent increase in healthcare costs of procedural bleeding after percutaneous interventions using large-bore catheters, it added.

“Gaining FDA approval for the Early Bird is a significant milestone for Saranas as it demonstrates our continued commitment to address an unmet need for real-time detection and monitoring of endovascular bleed complications,” said company president and CEO Zaffer Syed in a prepared statement. “As the first and only device on the market for early bleed detection, we have the potential to significantly reduce bleeding complications and related healthcare costs, while improving clinical outcomes in patients undergoing endovascular procedures.”

In an animal study to support FDA review of the device’s effectiveness, the Early Bird was able to detect internal bleeds with 100% sensitivity and 100% specificity, according to the company.

“Bleeding remains an Achilles’ heel of advancing minimally-invasive, catheter-based procedures,” said Dimitrios Karmpaliotis, M.D., director of chronic total occlusions, complex and high-risk angioplasty at Columbia University Medical Center, in the statement. “The Early Bird will play a key role in making these procedures safer in the future by providing physicians bleed monitoring in real-time.”

“Peri-procedural bleeding associated with endovascular procedures has a significant impact on patient safety and adds incremental costs to the healthcare system with longer hospital stays and additional interventional treatment,” added Saranas chief medical officer Philippe Généreux, M.D. “I firmly believe the Early Bird bleed monitoring system will help protect, and in some cases, save the lives of patients undergoing an endovascular procedure by allowing physicians to detect the onset of bleeding early and take appropriate steps to address the bleed before detrimental, irreversible and life-threatening consequences occur.”

The Early Bird is currently being piloted in multiple centers to assess its ability to potentially increase patient safety with improved bleed status monitoring during and after endovascular access procedures. Saranas plans a limited commercial launch of the device in the U.S.

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Sotera Wireless adds tools to patient monitoring system

Sotera Wireless said it has upgraded its ViSi Mobile patient monitoring system to detect atrial fibrillation, ventricular fibrillation and ventricular tachycardia, and to provide asystole analysis.

Often asymptomatic, atrial fibrillation may remain undiagnosed until or even after the development of complications, such as stroke. Post-operative atrial fibrillation is the most common arrhythmia that occurs after both cardiac and noncardiac surgery and is associated with increased morbidity, longer hospital stays and higher hospital costs.

ViSi Mobile was previously FDA-cleared to monitor continuous noninvasive blood pressure (cNIBP), functional oxygen saturation of arterial hemoglobin (SpO2), heart rate, pulse rate, ECG activity, respiration rate and skin temperature in hospital-based facilities.

The upgrade, ViSi Mobile 1.5G, was also cleared to track and alert medical personnel to undesirable patient positions, patient immobility, and patient falls as well as display patient movement and posture (stationary, reclined, lying-down or walking), the company said.

San Diego-based Sotera Wireless emerged from bankruptcy protection in 2017 with nearly $32 million in hand, after a lawsuit brought by rival Masimo (NSDQ:MASI) drained its coffers.

Sotera filed for Chapter 11 bankruptcy protection in September 2016, saying it owed its main creditors roughly $13.1 million. Sotera reported raising about $20.7 million back in April 2014 and acquired sensor developer Reflectance Medical for an undisclosed amount the next year.

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Masimo wins CE Mark for next-gen SedLine pediatric brain monitor


Masimo (NSDQ:MASI) said today that it won CE Mark approval in the European Union for its next-gen SedLine brain function monitor intended for pediatric patients.

The Irvine, Calif.-based company said that with the clearance, its next-gen SedLine monitoring tech is now available for all patients one year and older in CE Mark countries.

Masimo said that the SedLine system is designed to allow clinicians to monitor the state of the brain while patients are under anesthesia. The company added that the system features a pediatric-specific signal processing engine intended to improve the performance of the company’s processed electroencephalogram parameter when monitoring pediatric patients.

The newly cleared system also features improvements over the first-gen SedLine including a reduced susceptibility to electromyography interference and a multitaper density spectral array.

“Next Generation SedLine is doing for brain function monitoring what Masimo SET did for pulse oximetry. We believe Next Generation SedLine is the best and most advanced way to monitor depth of sedation, crucial to helping ensure patients with even the most challenging brains are appropriately anesthetized. We are gratified that its benefits are now available to those younger patients whose brains are particularly delicate and to whose wellbeing Masimo has always been so committed,” founder & CEO Joe Kiani said in a press release.

In late January, Masimo said it won FDA clearance for its respiration rate measurement from the pleth RRp on its MightySat Rx spot-check fingertip pulse oximeter.

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FDA clears Current Health’s patient monitoring system

Current Health

Wearable medical device developer Current Health said today it won FDA clearance for its its wireless wearable patient monitor.

The Edinburgh, Scotland-based company’s wearable monitor tracks vital signs and is intended to provide extra information to clinicians to allow for earlier interventions.

Current touted the device as “the most accurate, all-in-one wireless wearable currently approved for use in the EU and the U.S.,” and added that its algorithms continuously analyze data along with relevant contextual patient data to provide actionable insights.

“The Mount Sinai Health System works with innovative and leading-edge companies like Current to support our commitment to providing world-class patient care. Current’s continuous and proactive monitoring platform has the potential to alert us to patient deterioration faster and give our team data insights they can act on earlier,” Dr. Scott Lorin of Mount Sinai Brooklyn said in a press release.

The device is currently being used in post-acute settings with UK-based healthcare providers, the company said.

“At Current, we’re a small team of individuals committed to changing the world through proactive healthcare. Our team worked hard to get here, and it’s just the first step toward monitoring the health of every human being to identify sickness earlier with the goal of saving lives. Today, we’re in the hospital, tomorrow the home, and in the near future, we’ll be everywhere. We are just getting started,” CEO Christopher McCann said in a prepared statement.

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Vectorious starts trial of implantable wireless heart monitor

Vectorious Medical Technologies said it has begun a first-in-human trial of its left atrial pressure monitoring device.

Tel Aviv-based Vectorious is developing the V-Lap implantable wireless heart monitor, which is designed to monitor pressure in the heart’s left atrium. The Vector-HF trial will enroll up to 30 patients at six sites across Germany, Israel, Italy and the U.K. The prospective, multicenter, single-arm clinical trial was designed to assess the safety and performance of the V-LAP system in preparation for receiving the CE Mark.

Vectorious said its V-LAP sensory device is the world’s first digital, wireless, battery-less device that can communicate from deep within the body using high-resolution waveform morphology. Because the pressure of the heart’s left atrium is the earliest and most accurate real-time indication of heart failure exacerbation, company officials believe the feedback provided by the V-LAP will enable a significant improvement in heart failure management. Patients implanted with the V-LAP will be able to measure left atrial pressure at home via a non-invasive method using a small, portable, external unit.

Horst Sievert, M.D., director of the CardioVascular Center in Frankfurt, Germany, performed the first implantation, completing it in just six minutes, the company said. Sievert fixated V-LAP within the interatrial septum of the patient’s heart using a standard, minimally-invasive percutaneous procedure under fluoroscopy and echocardiographic guidance, under local anesthesia.

“This technology will really change the way we manage patients with severe heart failure,” Sievert said in a prepared statement. “This is the first device that specifically enables us to monitor pressure within the left side of the heart, and because of its cloud-based system, we can access patient data on-demand, monitoring the atrial pressure and managing dosages, medications and overall quality of life consistently and remotely.”

“Implanting our first patient in the Vector-HF trial is a significant achievement that moves us closer to our goal of enabling optimal management for heart failure patients,” said Vectorious CEO and co-founder Oren Goldshtein. “This is very advanced technology that we hope will improve the future of chronic cardiac disease treatment.”

Investors in Vectorious include Fresenius Medical Care, Broadview Ventures, GoCapital, and China’s GEOC. The company has also received a $2.2 million grant from the European Union’s Horizon 2020 R&D program and the Israel Innovation Authority.

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Could this device replace pacemaker batteries?

Rendering of the two designs of Dartmouth University researchers’ cardiac energy-harvesting device. (Art by Patricio Sarzosa.)

The heart’s motion is so powerful that it can recharge lifesaving cardiac devices, according to new research from Dartmouth College.

Engineers at Dartmouth’s Thayer School of Engineering developed a dime-sized device to convert the heart’s kinetic energy into electricity to power a wide range of implantable devices, according to the Hanover, N.H.-based college.

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

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