RAQA NEWS ROUND UP - (wc 05.08.19)
Voluntis Gains FDA Clearance for Oleena App
Voluntis has been given FDA clearance for its Oleena mobile app which allows cancer patients to manage and monitor their own symptoms, as well as letting physicians to remotely monitor their patients.
The device analyses clinical algorithms to make recommendations to help the user cope with their symptoms, offers personalised coaching and provides information about supportive therapy based on each individuals treatment plan.
The company hopes to assist patients across a multitude of cancer therapies including chemotherapy, radiotherapy, and immunotherapy in order to keep unpleasant side effects such as diarrhoea and nausea to a minimum. The remote monitoring will hopefully cut the number of stressful hospitalisations and A&E visits required and improve patient care.
Voluntis CEO Pierre Leurent said: “Beyond monitoring their symptoms, we believe that empowering patients via the digital delivery of real-time and personalised therapeutic interventions offers the opportunity for significant clinical and economic outcomes.
“We are delighted to introduce Oleena, the first prescription digital therapeutic in oncology, to transform patients’ experience throughout their cancer journey.”
Baxter Wins FDA Clearance for its Continuous Renal Replacement Therapy System
Baxter has gain FDA clearance for its PrisMax continuous renal replacement and organ support therapy system and also its TherMax blood warmer.
The new system, which is based on previous Prismax devices and technology, is designed to work in conjunction with hospital EMRs and includes a smart pump feature that allows the correct levels of fluid to be drained and prescriptions to be delivered.
“We looked at every detail during the PrisMax design process. Our team reviewed every piece of feedback from nephrologists, nurses and intensive care specialists, and then designed a system that can help simplify therapy administration and maximize efficiency,” said Gavin Campbell, general manager of Baxter’s U.S. renal business,
“We put our 20 years of expertise in continuous renal replacement therapy and blood filtering technology to design an advanced system that allows for clinicians to customize treatment parameters to meet the needs of their patients.”
The TherMax blood warmer ensures that blood, once treated, is returned to the patient’s body at the right temperature. The device also has leak detection sensors and a close temperature control which will make the whole set up more efficient when used.
SeQuent Please ReX Drug-coated Balloon Catheter Wins FDA Breakthrough Nod
B Braun has received breakthrough device designation for its SeQuent Please ReX drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis (ISR).
The designation is the result of 10 years of studies completed on the SeQuent Please drug-coated PTCA catheters in various indications such as in-stent restenosis for bare metal stents (BMS) and drug-eluting stents (DES) and for detecting initial stenosis in lesions.
Peter Flosdorf, engineering manager at B. Braun Interventional Systems said, “The paclitaxel-coated SeQuent Please PTCA balloon catheter has a proven track record of safety and efficacy for BMS- and DES-ISR in randomized clinical trials as well as in the largest international DCB registry with a clinical endpoint”
“This device is the gold standard coronary DCB based on the available clinical evidence. We are excited that the latest generation SeQuent Please DCB has received breakthrough device designation, which will streamline the review process and timeline for bringing this important treatment option to appropriate patients in the U.S.”
Masimo Gains CE Mark for Infant and Neonatal Haemoglobin Monitor
Masimo has announced it received CE Mark European approval for its SpHb®, non-invasive and continuous haemoglobin monitor for neonatal and infant patients weighing less than 3kg (6.61lbs).
The monitor, which uses the company's rainbow® sensors, will allow the monitoring of multiple non-invasive vitals such as total haemoglobin (SpHb), oxygen saturation (SpO2) and methaemoglobin (SpMet).
Currently haemoglobin can only be monitored intermittently causing delayed and inaccurate results. The new system provides real-time haemoglobin monitoring enabling clinicians to manage any instabilities quickly and effectively.
“We are thrilled to be able to bring the power of non-invasive haemoglobin monitoring with SpHb to the youngest, most fragile patients of all,” said Masimo CEO Joe Kiani.
“We have long been dedicated to helping improve the lives of neonatal and infant patients, and this latest clearance significantly furthers that mission. SpHb is already used to monitor adult patients in more than 75 countries. We look forward to witnessing the impact that SpHb will now be able to have on neonatal and infant patients.”
RenalSense Gains CE Mark for Urine Flow Monitoring System
RenalSense has received CE Mark approval for its critical care and pre-operative urine flow monitoring system, Clarity RMS.
The system is designed to continuously monitor the flow of urine in patients and notifies care teams should any fluctuations occur that may need quick intervention. The data is transmitted in real time and helps to determine treatment effectiveness and manage fluid levels.
Since gaining approval, the company as teamed up with Fresenius Medical Care to distribute the system across Europe.
“The CE Mark is a significant milestone for RenalSense, enabling our distribution partner, Fresenius Medical Care, to launch sales to European medical centers, where urine output will now be able to be monitored electronically in real-time, as is the standard practice for other vital signs in the OR and ICU,” CEO Avi Kleiman said