Another Device Gets Added to the Peritoneal Dialysis Mix
AWAK Technologies has been granted a breakthrough device designation from FDA for a wearable and ultra-portable peritoneal dialysis (PD) device. The Singapore-based company’s AWAK PD device allows dialysis to be performed "on-the-go", overcoming the challenge of long hours of therapy and connection to large-size dialysis machines, currently faced by renal patients. The company said FDA’s designation was granted after reviewing the results from the First-In-Human safety trial of AWAK PD device, which was successfully completed in October 2018 at the Singapore General Hospital, Singapore's...
Source: MDDI - January 11, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Awak Technologies wins FDA breakthrough designation for portable PD device
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 usin...
Source: Mass Device - January 11, 2019 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance Awak Technologies Pte. Source Type: news

USFDA grants breakthrough designation for AWAK ’s Peritoneal Dialysis device
Earlier this week, AWAK Technologies (AWAK), a Singapore-headquartered medical technology company focused on dialysis using regeneration technology for end-stage renal disease, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to its AWAK Peritoneal Dialysis (AWAK PD) device, a wearable and ultra-portable PD system that incorporates AWAK ’s patented sorbent technology. (Source: mobihealthnews)
Source: mobihealthnews - January 11, 2019 Category: Information Technology Source Type: news

Baxter launches on-demand peritoneal dialysis solution device trial
Baxter (NYSE:BAX) said yesterday that it launched an FDA-cleared clinical trial of its on-demand peritoneal dialysis solution generation system intended to allow patients to make peritoneal dialysis solutions in small batches at home. The system is designed to use a small water filtration device, concentrates and Deerfield, Ill.-based Baxter’s Amia automated peritoneal dialysis system to turn a patient’s tap water into dialysis solution as needed for therapy sessions. Baxter said that it has enrolled the first patient in the trial, which looks to assess the efficacy and safety of the new system for participan...
Source: Mass Device - January 8, 2019 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Dialysis Baxter Source Type: news

Outcomes of Importance ID'd for Peritoneal Dialysis Patients
FRIDAY, Dec. 21, 2018 -- Patients undergoing peritoneal dialysis (PD) and their caregivers report that PD-related infection, mortality, and fatigue are outcomes of the highest importance, according to a study published online Dec. 20 in the Clinical... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - December 21, 2018 Category: Pharmaceuticals Source Type: news

Peritoneal Dialysis Offers Flexibility in Austere Environments Peritoneal Dialysis Offers Flexibility in Austere Environments
Dr Desai highlights a number of unique aspects of peritoneal dialysis that make it attractive in difficult situations.Medscape Nephrology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - October 26, 2018 Category: Consumer Health News Tags: Nephrology Viewpoint Source Type: news

What Causes Hyperkalemia?
Discussion Potassium (K+) is an alkali metal (Group 1 of periodic table with Hydrogen, Lithium and Sodium) with an anatomic number of 19. Its chemical symbol K, comes from the medieval Latin, kalium which means potash (mainly potassium carbonate or potassium hydroxide), the substance it was first isolated from. Potassium is an important cation and it mainly resides in the intracellular fluid with only a small amount in the extracellular fluid. Potassium regulates cell volume, pH and enzyme functions. Hyperkalemia is defined as a potassium level > 5.5 mEq/L in children and > 6.0 mEq/L in newborns. Hyperkalemia inc...
Source: PediatricEducation.org - September 24, 2018 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news

Do You Know How to Manage Japan ’s Revised Reimbursement Approach?
One significant change in Japan’s revised reimbursement process for new medical devices involves pricing. Applicants have been required for some time to provide pricing for their medical devices in other primary markets such as the United States, the United Kingdom, Germany, France, and Australia. Pricing has been based on list price, not market price, and the intention was to cap the reimbursement of medical devices. Given the typical differences between U.S. pricing and European pricing, the high U.S. price tended to pull the average up. (Please see the example below in Table 1; each price is converted ...
Source: MDDI - July 27, 2018 Category: Medical Devices Authors: Keisuke Suzuki Tags: Regulatory and Compliance Source Type: news

Baxter touts Theranova HDx dialysis tech study data
Baxter (NYSE:BAX) today released new data from studies exploring expanded hemodialysis with its Theranova dialyzer, touting the device’s ability to clear large middle molecules at a higher rate than standard hemodialysis and equal or faster removal rates compared to high-volume hemodiafiltration. Results from a number of studies and poster presentations on the Theranova dialyzer were presented at the 55th Congress of the European Renal Association and European Dialysis and Transplant Association meeting this month, Baxter said. The Deerfield, Ill.-based company’s Theranova dialyzer is designed to extend the range...
Source: Mass Device - May 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Dialysis Baxter Source Type: news

Baxter updates Sharesource dialysis monitoring platform
Baxter (NYSE:BAX) today announced the launch of two updates for its Sharesource remote patient monitoring platform designed to monitor home peritoneal dialysis patients including the addition of a new modeling software tool and improvements to the clinical portal. The Deerfield, Ill.-based company announced the updates at the 55th Congress of the European Renal Association and European Dialysis and Transplant Association meeting this week. Baxter said that the first of its updates introduced the new Sharesource Adequest kinetic modeling software tool designed for direct integration into the platform to allow for improved ...
Source: Mass Device - May 30, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blog Source Type: news

Readmissions High Among Peritoneal Dialysis Patients
(MedPage Today) -- Nearly a quarter readmitted within a month (Source: MedPage Today Nephrology)
Source: MedPage Today Nephrology - April 12, 2018 Category: Urology & Nephrology Source Type: news

CVS is diving into the dialysis market
Drug store operator CVS Health (NYSE:CVS) said today it plans to expand into the dialysis market, launching a program focused on early identification of kidney disease and unveiling plans to develop a new home hemodialysis system. CVS said it will approach its entry into the dialysis market in stages, focusing on early disease identification and education, followed by the development of a home dialysis program for both hemodialysis and peritoneal dialysis. As part of its program, the company said it will launch a pivotal trial of a new home hemodialysis system in support of planned FDA submission, though it has not yet re...
Source: Mass Device - April 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Research & Development CVS Health Source Type: news

Brooks Memorial to close dialysis unit, transition patients to new DaVita clinic
Three years after first proposing to close its dialysis service, Brooks Memorial Hospital is now moving forward with that plan just as a privately-owned national dialysis company prepares to open a clinic in Dunkirk. The hospital filed plans with the state Department of Health to discontinue outpatient dialysis services in the hospital and discontinue home peritoneal dialysis training and support. The program currently serves 33 patients. The decision also affects seven nurses who run the program.  The… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - November 6, 2017 Category: Health Management Authors: Tracey Drury Source Type: news

Adverse reaction with suvorexant for insomnia: acute worsening of depression with emergence of suicidal thoughts - Petrous J, Furmaga K.
A 59-year-old woman on daily peritoneal dialysis for end-stage renal failure received care at an outpatient psychiatric clinic for her diagnoses that include major depressive disorder, generalised anxiety disorder and insomnia disorder. Although there was ... (Source: SafetyLit)
Source: SafetyLit - October 30, 2017 Category: International Medicine & Public Health Tags: Alcohol and Other Drugs Source Type: news

Initiating Peritoneal Dialysis After Catheter Insertion Initiating Peritoneal Dialysis After Catheter Insertion
Dr Desai discusses the uncertainty that remains about commencement of dialysis after catheter insertion.Medscape Nephrology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - October 26, 2017 Category: Consumer Health News Tags: Nephrology Viewpoint Source Type: news