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7 medtech stories we missed this week: Sept. 15, 2017
[Image from unsplash.com]From Acera Surgical and Telos Medical’s partnership to Xtant Medical’s 510(k) clearance, here are seven medtech stories we missed this week but thought were still worth a mention. 1. Acera Surgical partners with Telos Medical for Restrata wound matrix trial Telos Partners announced in a Sept. 14 press release that Acera Surgical has chosen Telos to lead its Restrata wound matrix study. The study will surgery the clinical outcomes of Restrata treatments for diabetic foot ulcers and test for effectiveness and safety. Restrata is a fully synthetic wound matrix that is FDA-cleared for ...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Business/Financial News Clinical Trials Dental Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Surgical Acera Surgical Contego Medical Fresenius MedTech OBP Medical Pinnacle Sciences Plusoptix Telos Source Type: news

Nutritional Considerations for Older Patients on Dialysis Nutritional Considerations for Older Patients on Dialysis
This report highlights the special considerations regarding the nutritional needs of aging hemodialysis patients.Nephrology Dialysis Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 15, 2017 Category: Consumer Health News Tags: Nephrology Journal Article Source Type: news

AlloSource touts completion of bioengineered blood vessels for Humacyte trial
Tissue-provider AlloSource said this week it completed production of investigational bioengineered blood vessels designed for Humacyte‘s Phase III clinical trial exploring the use of the vessels to improve vascular access for hemodialysis patients with end-stage renal failure. The trail aims to compare the efficacy of the bioengineered human-tissue vessels to current synthetic vessels made from expanded polytetrafluoroethylene, Centennial, Colo.-based Allosource said. “AlloSource’s partnership with Humacyte supports our focus on regenerative medicine. Our organizations share a deep commitment to developin...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Research & Development Vascular allosource Humacyte Source Type: news

Predictors of acute kidney injury after paraquat intoxication - Weng CH, Chen HH, Hu CC, Huang WH, Hsu CW, Fu JF, Lin WR, Wang IK, Yen TH.
Paraquat intoxication is characterized by multi-organ failure, causing substantial mortality and morbidity. Many paraquat patients experience acute kidney injury (AKI), sometimes requiring hemodialysis. We observed 222 paraquat-intoxicated patients between... (Source: SafetyLit)
Source: SafetyLit - September 13, 2017 Category: International Medicine & Public Health Tags: Poisoning Source Type: news

High-Protein Meals and Lanthanum Carbonate in Hemodialysis High-Protein Meals and Lanthanum Carbonate in Hemodialysis
What benefits might an increased protein intake combined with lanthanum carbonate offer hemodialysis patients?Nephrology Dialysis Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 8, 2017 Category: Consumer Health News Tags: Nephrology Journal Article Source Type: news

FDA Fast Tracks New Blood Filtration System
ExThera Medical, a developer of blood filtration systems and biotechnologies, has received Expedited Access Pathway (EAP) designation from FDA for its latest technology, the Seraph 100 blood filter. The EAP designation indicates that the use for the technology will be an adjunctive treatment for bacteremia, in addition to antibiotics for patients receiving hemodialysis when the source of the infection is heparin-binding bacteria. ExThera applied for the EAP designation in June, and the company said FDA granted the designation within an accelerated timeframe. The company said its technology differs from other blood filter s...
Source: MDDI - August 31, 2017 Category: Medical Devices Tags: Business Source Type: news

Vascular access device maker Stent Tek closes Series A
Medical device firm Stent Tek said today it closed an undisclosed Series A financing round to support the development of its ePath AVF minimally invasive catheter technology. The ePath AVF device is designed for vascular access as an alternative to surgical fistulas for hemodialysis patients. Money in the round came from institutional investors Julz and Deepbridge Capital, the London-based company said. Stent Tek has previously received $1.6 million (GBP £1.2 million) in grant funding from the National Institute of Health Research, Innovate UK and the Royal Academy of Engineering Enterprise Hub. “I was thorough...
Source: Mass Device - August 30, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Stents Vascular stenttek Source Type: news

Exthera Medical wins FDA EAP designation for Seraph 100 blood filter
Exthera Medical said today that the FDA granted its Seraph 100 blood filter an expedited access pathway designation. The approval comes with an initial indication for use “as an adjunctive treatment for bacteremia in addition to antibiotics for patients receiving hemodialysis when the source of the infection is heparin- or heparin sulfate-binding bacteria, including antibiotic resistant bacteria MRSA, VRE, ESBL, CRE and MRSE,” the company said. “We submitted our EAP application in early June. FDA responded by requesting additional information and clarifications, and Seraph was granted EAP designation with...
Source: Mass Device - August 30, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance ExThera Medical Source Type: news

Stent Tek Closes Series a Investment Round for its ePATH AVF Device, Aiming to Improve Vascular Access for Haemodialysis
LONDON, August 30, 2017 -- (Healthcare Sales & Marketing Network) -- Stent Tek, a medical device company that is developing a minimally invasive catheter system for dialysis patients, announced today it has successfully closed a Series A funding round wit... Devices, Venture Capital Stent Tek, ePATH AVF, haemodialysis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 30, 2017 Category: Pharmaceuticals Source Type: news

FDA clears NxStage Medical's System One, allowing for solo home hemodialysis
NxStage Medical, a medical technology outfit focused on advancing renal care, has received clearance from the FDA for its System One, which allows for solo home hemodialysis, without a care partner, during waking hours.   (Source: mobihealthnews)
Source: mobihealthnews - August 28, 2017 Category: Information Technology Source Type: news

NxStage Medical wins expanded FDA nod for System One home hemodialysis system
NxStage Medical (NSDQ:NXTM) said today it won expanded FDA clearance for its System One home hemodialysis system, clearing it for use without a care partner during waking hours. The system won initial clearance in 2005 and added clearance for home nocturnal hemodialysis in 2014, the Lawrence, Mass.-based company said, but has always required a care partner be present during hemodialysis. “Patients have been asking for an FDA-cleared solo option for years,. Many patients have been turned away from home hemodialysis simply because they did not have a care partner.  The ability to train and treat solo provides a br...
Source: Mass Device - August 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance NxStage Medical Inc. Source Type: news

NxStage Medical Announces FDA Clearance for Solo Home Hemodialysis Using NxStage(R) System One(TM)
First clearance of its kind gives trained NxStage patients freedom to dialyze without a care partner LAWRENCE, Mass., Aug. 28, 2017 -- (Healthcare Sales & Marketing Network) -- NxStage Medical, Inc. (Nasdaq: NXTM), a leading medical technology company... Devices, FDA NxStage Medical, System One, home hemodialysis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 28, 2017 Category: Pharmaceuticals Source Type: news

Angola: Cuando Cubango General Hospital Unveiled
[ANGOP] Menongue -The new General Hospital of the southern Cuando Cubango province, fully equipped with high technological equipment to serve various services, especially hemodialysis, was inaugurated on Saturday by the Health Minister, Lu ís Gomes Sambo. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - August 21, 2017 Category: African Health Source Type: news

New research shows promise for improving vascular access for hemodialysis patients
(Elsevier) Hemodialysis requires repeated access to the blood. Failure to maintain adequate access to the vasculature is a major cause of medical complications and, potentially, death for these patients. A new study in The American Journal of Pathology provides information about the mechanisms underlying failure of the most common type of hemodialysis vascular access, the arteriovenous fistula. Despite being the preferred approach, there is currently limited understanding of the mechanisms involved in fistula maturation failure. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 16, 2017 Category: International Medicine & Public Health Source Type: news

MassDevice.com +5 | The top 5 medtech stories for August 7, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. How slugs are creating better medical adhesives Slug mucus is the inspiration behind a new adhesive to close surgical wounds and reduce the use of surgical staples, according to new research out of Harvard. Some of the current ...
Source: Mass Device - August 7, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Fresenius to pay $2B for NxStage Medical
Fresenius Medical Care (NYSE:FMS; ETR:FRE) said today that it agreed to pay $2 billion to acquire NxStage Medical (NSDQ:NXTM) and the home hemodialysis technology it developed. The $30-per-share deal, which is expected to close this year, represents a 29.6% premium on the August 4 closing price of $23.14 for NXTM shares. The stock was up 25.5% to $29.04 today in pre-market trading. FRE shares were down -1.2% to €69.14 apiece today in Frankfurt. Fresenius said it plans to fund the deal with cash and debt and expects Lawrence, Mass.-based NxStage to add to net income and earnings per share within three ye...
Source: Mass Device - August 7, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Dialysis Mergers & Acquisitions Wall Street Beat Fresenius Medical Care NxStage Medical Inc. Source Type: news

Fresenius to buy Lawrence-based ​NxStage Medical for $2B
NxStage Medical Inc., a Lawrence-based medical device maker that largely pioneered the market for home hemodialysis, will be acquired for $2 billion by Fresenius Medical Care, a German dialysis giant with its North American headquarters in Waltham. The purchase price of $30 per share represents a 30 percent increase from NxStage’s (Nasdaq: NXTM) closing share price on Friday, and is 22 percent higher than the company’s 90-day moving average share price, according to Reuters. NxStage shares were… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - August 7, 2017 Category: American Health Authors: Don Seiffert Source Type: news

Laminate Medical wins FDA IDE nod for VasQ fistula device trial
Laminate Medical Technologies said this week it won FDA investigational device exemption approval to launch a trial of its VasQ implanted blood vessel device designed for patients requiring arteriovenous fistulas as vascular access for hemodialysis. The Israel-baesd company’s VasQ device is designed to aid kidney failure patients in need of dialysis by providing external support to reduce fistula failure. The device regulates flow by constraining and shaping the fistula and reinforces and shields the perianastomotic vein against high pressure, wall tension and flow levels, the company said. Laminate Medical plans to ...
Source: Mass Device - August 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Food & Drug Administration (FDA) Vascular Laminate Medical Technologies Source Type: news

Intermittent versus continuous renal replacement therapy in acute methanol poisoning: comparison of clinical effectiveness in mass poisoning outbreaks - Zakharov S, Rulisek J, Nurieva O, Kotikova K, Navratil T, Komarc M, Pelclova D, Hovda KE.
BACKGROUND: Intermittent hemodialysis (IHD) is the modality of choice in the extracorporeal treatment (ECTR) of acute methanol poisoning. However, the comparative clinical effectiveness of intermittent versus continuous modalities (CRRT) is unknown. During... (Source: SafetyLit)
Source: SafetyLit - July 25, 2017 Category: International Medicine & Public Health Tags: Alcohol and Other Drugs Source Type: news

Radiological Case: External Iliac Artery Pseudoaneurysm Radiological Case: External Iliac Artery Pseudoaneurysm
What was the cause of hematuria in this patient on hemodialysis for ESRD and a history of kidney transplant which failed 15 years prior?Applied Radiology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 17, 2017 Category: Consumer Health News Tags: Radiology Journal Article Source Type: news

Strategies used by nursing staff in situations of workplace violence in a haemodialysis unit - Cordenuzzi ODCP, Lima SBS, Prestes FC, Beck CLC, Silva RMD, Pai DD.
OBJECTIVE: To identify strategies that nursing staff use at a haemodialysis unit in situations of violence by patients during care. METHOD: Qualitative descriptive and exploratory research with focus groups and the participation of eight workers of... (Source: SafetyLit)
Source: SafetyLit - July 10, 2017 Category: International Medicine & Public Health Tags: Occupational Issues Source Type: news

Outset Medical raises $4m
Outset Medical has raised $4.3 million in a new round of mixed financing, according to an SEC filing posted this week. The San Jose, Calif.-based company develops and produces the Tablo hemodialysis system, an all-in-1 dialysis machine designed to handle water purification and dialysate production and be used in a variety of different settings. Money in the round came from a single investor, with the 1st sale recorded on June 30, according to the filing. Sales in the round included debt, options and securities from exercisable options. Outset Medical has not yet stated how it plans to use funds raised in the round. The fun...
Source: Mass Device - July 5, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Outset Medical Source Type: news

Measuring Fluid Overload and Mortality Risk in ESRD Patients Measuring Fluid Overload and Mortality Risk in ESRD Patients
Dr Bansal comments on a study examining the use of bioimpedance spectroscopy to assess the association between fluid overload and risk of mortality among hemodialysis patients, published in JASN.Medscape Nephrology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 22, 2017 Category: Consumer Health News Tags: Nephrology Viewpoint Source Type: news

Baxter touts Sharesource in-home peritoneal dialysis patient monitoring study data
Baxter (NYSE:BAX) today released data from multiple studies of its Sharesource remote patient monitoring technology used for peritoneal dialysis patient care. Data from the study was presented at the 54th Congress of the European Renal Association and European Dialysis and Transplant Association meeting this week. Sharesource is a 2-way cloud-based technology offered with the company’s Homechoice Claria automated PD system to allow providers to connect with patients using the device and verify patient adherence, the company said. Data from the 1st study study, which included 399 APD patients using remote patient...
Source: Mass Device - June 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Patient Monitoring Baxter Source Type: news

Efficacy and Safety of Nicotinamide in Hemodialysis Patients Efficacy and Safety of Nicotinamide in Hemodialysis Patients
Is nicotinamide a safe and effective alternative to sevelamer for the treatment of hyperphosphatemia in chronic hemodialysis patients?Nephrology Dialysis Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 6, 2017 Category: Consumer Health News Tags: Nephrology Journal Article Source Type: news

Baxter touts HDx Theranova data for ‘ extended ’ hemodialysis
Baxter (NYSE:BAX) today released data from 2 independent studies of its novel HDx therapy using the Theranova dialyzer, touting the effective removal of small and mid-sized toxins at similar rates compared to hemodiafiltration. Results from the trial were presented at the 54th Congress of the European Renal Association and European Dialysis and Transplant Association this week, the company said. The Deerfield, Ill.-based company’s HDx therapy uses a Theranova dialyzer designed to extend the range of molecules that it filters from the blood, claiming it “more closely mimics the natural kidney,” accord...
Source: Mass Device - June 5, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Baxter Source Type: news

A California Bill Could Totally Disrupt The Dialysis Industry
HBO’s John Oliver took on the dialysis industry a couple of weeks ago, highlighting a pair of companies that have a near-monopoly on keeping your kidney functions going. Between them, these two businesses ― one based in Colorado and one in Germany ― control 70 percent of all the dialysis centers in the U.S. In 2015, they saw a combined $2.9 billion in profit, in no small part thanks to a 45-year-old Medicare amendment that guarantees dialysis coverage for everyone and costs the nation a full 1 percent of the federal budget each year.  But Oliver neglected to mention the biggest thing happening in dial...
Source: Healthy Living - The Huffington Post - May 24, 2017 Category: Consumer Health News Source Type: news

Hemodialysis and the intubated salicylate-toxic patient
3.5 out of 5 stars The association of hemodialysis and survival in intubated salicylate-poisoned patients. McCabe DJ, Lu JJ. Am J Emerg Med 2017 Apr 10 [Epub ahead of print] Abstract [Disclosure: the co-authors of this paper are members of the Toxikon Consortium in Chicago, as am I.] This retrospective observational study looked at cases from the Illinois Poison Center over 12 years (2003 thru 2015) to identify intubated patients with recorded serum salicylate levels> 50 mg/dL. The goal was “to describe the impact of hemodialysis on survival rates of salicylate-intoxicated patients . . .”...
Source: The Poison Review - May 20, 2017 Category: Toxicology Authors: Leon Gussow Tags: Medical aspirin poisoning enhanced elimination hemodialysis salicylate toxicity Source Type: news

NxStage wins FDA nod for next-gen System One hemodialysis system
NxStage Medical (NSDQ:NXTM) said today it won FDA 510(k) clearance for its next generation System One hemodialysis system. The newly cleared system includes a new touchscreen user interface and integrated blood pressure monitor designed to enhance ease of use for home hemodialysis patients, the Lawrence, Mass.-based company said. “Early customer and patient feedback in the UK on our next generation system has been very positive, validating many of the benefits we expected. We are very excited to bring these new features and capabilities that are designed to significantly improve our patients&rsquo...
Source: Mass Device - May 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Blood Management Food & Drug Administration (FDA) Regulatory/Compliance NxStage Medical Inc. Source Type: news

DaVita buys Delafield dialysis clinic operator
DaVita Kidney Care said Monday that it has purchased a Delafield operator of dialysis clinics less than one week after reporting a tough quarter and two other acquisitions. DaVita Kidney Care, a division of Denver-based DaVita Inc. (NYSE: DVA), acquired Purity Dialysis, which has 10 centers in the Milwaukee area. Purity Dialysis clinics also provide outpatient hemodialysis and in-home peritoneal dialysis training. Terms of the deal were not disclosed. DaVita operat es about a dozen clinics in Milwaukee… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - May 9, 2017 Category: Pharmaceuticals Authors: Caitlin Hendee Source Type: news

DaVita scoops up Wisconsin operator of dialysis clinics
DaVita Kidney Care announced Monday that it has scooped up a Wisconsin operator of 10 dialysis clinics less than one week after reporting a tough quarter and two other acquisitions. DaVita Kidney Care, a division of Denver-based DaVita Inc. (NYSE: DVA), acquired Purity Dialysis, which has 10 centeres in the greater Milwaukee area. Purity Dialysis clinics also provide out-patient hemodialysis and in-home peritoneal dialysis training. Terms of the deal were not disclosed. "We look forward to providing… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - May 8, 2017 Category: American Health Authors: Caitlin Hendee Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 3, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. 10 companies with interesting technology at BIOMEDevice Boston BIOMEDevice Boston is an opportunity for over 4,000 engineers and executives and 400 suppliers in New England’s design and manufacturing industry to connect. ...
Source: Mass Device - May 3, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Outset Medical raises $76.5m Series C to support Tablo all-in-1 hemodialysis system
Outset Medical said today it raised $76.5 million in a Series C equity funding round to support its Tablo hemodialysis system. The Tablo system is an all-in-one dialysis machine which handles both water purification and dialysate production and is designed to be used in a variety of settings, CEO Leslie Trigg told MassDevice.com. The system is equipped with a touch screen interface and designed to be used by even the most basic user, Trigg said, something that sets it apart from other hemodialysis systems on the market. “We designed it so that it’s acceptable for the average patient user to set up and mana...
Source: Mass Device - May 3, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Business/Financial News Outset Medical Source Type: news

Combination of hemodialysis and hemofiltration in severe caffeine intoxication - Colin-Benoit E, Friolet R, Rusca M, Teta D, Gobin N.
A 21-year-old man ingested 75g of pure caffeine, in an attempt to commit suicide. This represents 7.5 times the minimal lethal dose. Caffeine, 1,3,7-trimethylxanthine, is the most widely consumed psychoactive compound worldwide. It is mostly found in coffe... (Source: SafetyLit)
Source: SafetyLit - May 2, 2017 Category: Global & Universal Tags: Alcohol and Other Drugs Source Type: news

Vonapanitase Boosts Secondary Patency for Hemodialysis
(MedPage Today) -- Recombinant human elastase also improved fistula use (Source: MedPage Today Meeting Coverage)
Source: MedPage Today Meeting Coverage - April 22, 2017 Category: Journals (General) Source Type: news

Antimicrobial Catheter Cap Cuts Bloodstream Infections in Dialysis Patients
(MedPage Today) -- Trial compared use of two catheter caps at hemodialysis facilities (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - April 21, 2017 Category: Primary Care Source Type: news

MERS Causes New Saudi Hospital Outbreak - WHO MERS Causes New Saudi Hospital Outbreak - WHO
Ten people have caught the MERS coronavirus after an outbreak in a haemodialysis unit in a hospital in Saudi Arabia, the World Health Organization said on Tuesday, without giving details of how the virus was able to spread within the hospital.Reuters Health Information (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 5, 2017 Category: Consumer Health News Tags: Nephrology News Source Type: news

Retrospective Study Confirms Bovine Carotid Artery Biologic Graft Outperforms Expanded Polytetrafluoroethylene for Hemodialysis Access
North Brunswick, N.J.--April 3, 2017--(Healthcare Sales & Marketing Network)--A retrospective review of 120 consecutive hemodialysis grafts placed in 98 patients was evaluated for patency and graft complications. Conducted between 2011 and 2014, the result... Devices, Surgery Artegraft, Bovine Carotid Artery Biologic Graft, hemodialysis access (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 3, 2017 Category: Pharmaceuticals Source Type: news

Depression and anxiety disorders in chronic hemodialysis patients and their quality of life: a cross-sectional study about 106 cases in the northeast of Morocco - El Filali A, Bentata Y, Ada N, Oneib B.
Hemodialysis (HD) has a severe impact on the life of HD patients. The aim of this work was to assess the prevalence of depression and anxiety disorders, suicidal ideation, and the quality of life among HD patients. Associated factors were also studied. A c... (Source: SafetyLit)
Source: SafetyLit - March 31, 2017 Category: Global & Universal Tags: Suicide and Self-Harm Source Type: news

Low-dose Apixaban May Be Safe Anti-stroke Option for Dialysis Patients Low-dose Apixaban May Be Safe Anti-stroke Option for Dialysis Patients
Low-dose apixaban achieves blood levels that appear to be safe and might be a “ reasonable alternative ” to warfarin for preventing stroke in patients with atrial fibrillation who are on hemodialysis, new research suggests.Reuters Health Information (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - March 24, 2017 Category: Intensive Care Tags: Neurology & Neurosurgery News Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 21, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. IV safety valve dev Linear Health wins GCMI accelerator grant Medical device accelerator the Global Center for Medical Innovation has issued its 1st grant to Linear Health Sciences, developer of the Orchid safety release valve ...
Source: Mass Device - March 21, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Humacyte wins expedited review designation for acellular vessel
Humacyte said today that the FDA granted its investigational human acellular vessel, Humacyl, the regenerative medicine advanced therapy designation. The regulatory win means that the FDA will expedite its review of the HAV for patients in need of life sustaining hemodialysis. The designation is new and follows the model of other FDA programs such as the breakthrough therapy designation. “Being 1 of the first companies to receive the regenerative medicine advanced therapy designation from the FDA is an honor and a testament to the significant potential for Humacyl to address a great unmet medical need for patien...
Source: Mass Device - March 20, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Regulatory/Clearance Vascular Wall Street Beat Humacyte Inc. Source Type: news

Kidney Patients Left in the Wind: A Heartfelt Story Kidney Patients Left in the Wind: A Heartfelt Story
Dr Szczech provides a sobering view on what extreme actions uninsured immigrants are taking to push their symptom boundaries to near death every week in order to get emergent hemodialysis.Medscape Nephrology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - March 10, 2017 Category: Consumer Health News Tags: Nephrology Commentary Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 6, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Via Surgical inks distro deal with Progressive Medical for FasTouch Via Surgical said today it inked an exclusive US distribution deal with Progressive Medical to distribute Via’s FasTouch soft tissue suture device. Amiri...
Source: Mass Device - March 6, 2017 Category: Medical Equipment Authors: MassDevice Tags: Blog News Well Plus 5 Source Type: news

Fresenius slips 1st Naturalyte bellwether trial
Fresenius Medical Care (NYSE:FMS) last week won the 1st bellwether trial in a series of product liability lawsuits brought over its GranuFlo and NaturaLyte dialysis drugs, after a Massachusetts jury found that the plaintiff’s estate failed to prove its case. The trial was the 1st case to go to trial among a group of plaintiffs who declined to enter a $250 million settlement struck a year ago in the multi-district litigation proceeding in federal court in the Bay State. The GranuFlo and Naturalyte products were used to lower the acidity of patients’ blood during dialysis treatm...
Source: Mass Device - March 6, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Dialysis Legal News Product Liability Fresenius Medical Care Source Type: news

Nephros wins FDA nod for EndoPur endotoxin dialysis filter
Nephros (OTC:NEPH) said today it won FDA 510(k) clearance for its EndoPur 10″ endotoxin filter designed for dialysis systems. The River Edge, N.J.-based company said the newly cleared EndoPur 10″ filter is designed to produce hemodialysis quality water for dialysis systems, and fits into existing filter cartridge housings. Nephros touted the device as having the smallest pore size of any endotoxin barriers on the market. “With the FDA clearance of the EndoPur, we have achieved a significant milestone in the expansion of our dialysis water filter portfolio We now can provide our industry-leading 5 nan...
Source: Mass Device - March 6, 2017 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Blood Management Food & Drug Administration (FDA) Regulatory/Compliance Nephros Inc. Source Type: news

Merit Medical backs Bluegrass Vascular ’ s Surfacer ‘ inside-out ’ catheter
Bluegrass Vascular Technologies said today that it entered a “strategic relationship” with Merit Medical (NSDQ:MMSI) for its Surfacer “inside-out” catheter that includes an equity stake and a distribution agreement. The Surfacer device is designed to provide access to the jugular vein to restore central venous access in hemodialysis patients with blocked neck veins; it won CE Mark approval in the European Union last August. The catheter is threaded through the femoral vein up to and into blockage in the jugular, which acts as a stabilizer. The head of the catheter is then al...
Source: Mass Device - March 6, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Distribution Funding Roundup Vascular Wall Street Beat Bluegrass Vascular Technologies Merit Medical Systems Inc. Source Type: news

Nephros Receives FDA 510(k) Clearance of EndoPur(TM) Endotoxin 10" Filter
RIVER EDGE, NJ--(Healthcare Sales & Marketing Network) - Nephros, Inc. ( OTCQB : NEPH ) (the "Company"), a commercial stage medical device company that develops and sells high performance liquid purification ultrafilters and an on-line mid-diluti... Devices, FDA Nephros, hemodiafiltration, hemodialysis, EndoPur (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 6, 2017 Category: Pharmaceuticals Source Type: news

NxStage wins CE Mark for next-gen System One hemodialysis system
NxStage Medical (NSDQ:NXTM) said today it won CE Mark approval in the European Union for its next-gen System One hemodialysis system. The newly cleared system incldues a new touchscreen user interface and integrated blood pressure montior designed to enhance ease of use for home hemodialysis patients, the Lawrence, Mass.-based company said. “Our next generation system was developed with extensive patient and customer feedback and builds on our decade long experience in providing life-changing therapy with the NxStage System One to over 30 thousand patients in their homes around the world. We are very excited to ...
Source: Mass Device - March 3, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Regulatory/Compliance NxStage Medical Inc. Source Type: news

Avenu Medical raises $13m
Vascular access system maker Avenu Medical has raised $13.1 million in a new round of equity financing, according to an SEC filing posted this week. The company has not yet stated how it plans to spend funds raised in the round or when it plans to close the round. Money in the round came from 77 unnamed sources, with the first sale officially dated today, according to the SEC filing. The company is looking for an additional $3 million, bringing the total raised to $16.1 million, before closing the round. Last June, Avenu Medical said it won CE Mark approval in the European Union for its Ellipsys vascular access i...
Source: Mass Device - February 15, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Catheters Vascular Avenu Medical Source Type: news