Antibiotic Administration Prior to Central Venous Catheter Removal in Neonates
Conclusion(s): Administration of one-time doses of vancomycin and cefazolin did not reduce the incidence of PCRCS when administered to critically ill neonates prior to umbilical venous catheter or peripherally inserted central catheter removal. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - July 1, 2020 Category: Consumer Health News Source Type: news

Family integrated care in single family rooms for preterm infants and late-onset sepsis: a retrospective study and mediation analysis
Conclusion(s): SFRs were associated with decreased incidences of LOS and shorter length of hospital stay. The positive effect of SFRs on LOS was mainly mediated through a decreased use of PN in SFRs. Impact: Family integrated care (FICare) in single family rooms for preterm infants was associated with less late-onset sepsis events during hospital stay and a shorter length of hospital stay after birth.FICare in single family rooms was associated with less use of peripheral or central venous catheters and parenteral nutrition.Mediation analysis provided insights into the mechanisms underlying the effect of FICare in single f...
Source: Current Awareness Service for Health (CASH) - May 6, 2020 Category: Consumer Health News Source Type: news

FDA Grants De Novo Clearance to Bluegrass Vascular Technologies for the Surfacer(R) Inside-Out(R) Access Catheter System
First device to reliably and repeatedly achieve central venous access from the inside-out in patients with venous obstructions SAN ANTONIO, Feb. 11, 2020 -- (Healthcare Sales & Marketing Network) -- Bluegrass Vascular Technologies (Bluegrass Vascular),... Devices, FDA Bluegrass Vascular Technologies, Surfacer System, Surfacer Inside-Out (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 11, 2020 Category: Pharmaceuticals Source Type: news

Risk for Blood Clots Increased With PICC Placement in Children
TUESDAY, Jan. 7, 2020 -- Central venous catheter (CVC) placement with peripherally inserted central catheters (PICCs) in children is associated with increased risks for venous thromboembolism (VTE), central line-associated bloodstream infection... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 7, 2020 Category: Pharmaceuticals Source Type: news

Thrombolysis Effective for Treating Occluded Central Venous Catheters in Kids Thrombolysis Effective for Treating Occluded Central Venous Catheters in Kids
Thrombolysis, particularly with alteplase, appears to be effective and likely safe for treating occluded central venous catheters in children with cancer, according to a meta-analysis.Reuters Health Information (Source: Medscape Pathology Headlines)
Source: Medscape Pathology Headlines - December 10, 2019 Category: Pathology Tags: Hematology-Oncology News Source Type: news

AI Beats Out Clinicians in Triaging Postoperative Patients for ICU
How good is artificial intelligence in decision-making? Not bad according to findings from a pilot study that was recently presented at the American College of Surgeons Clinical Congress 2019. Findings from the study show AI in the form of a machine-learned algorithm correctly triaged the vast majority of postoperative patients to the intensive care unit in its first proof-of-concept application in a university hospital setting. As it stands now surgical teams typically rely on clinical judgment to decide which patients need postoperative intense care because there is no single set of fixed criteria to make the determinati...
Source: MDDI - October 30, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Digital Health Source Type: news

What Are Pulmonary Embolism Risk Factors?
Discussion Pulmonary embolism (PE) is potentially life-threatening but fortunately rare event especially in the pediatric population. It was first described in children in 1861. PE is likely underreported because of minimal or non-specific clinical symptoms. The incidence is estimated at 0.05-4.2% with the 4.2% based on autopsy reports. It is probably also increasing as more central venous catheters (CVC) are used, and more children are surviving previously poor prognostic diseases. There is a bimodal distribution with cases
Source: PediatricEducation.org - September 23, 2019 Category: Pediatrics Authors: Pediatric Education Tags: Uncategorized Source Type: news

Antimicrobial central venous catheters do not reduce infections in pre-term babies
Expert commentary states CVCs impregnated with antimicrobials (n=430) are no better than standard CVCs (n=431). Time from allocation to first bloodstream infection was similar (HR 1.11, p=0 · 63) and 46/430 (10%) or 44/431 (11%) babies developed bloodstream infection, respectively. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - June 27, 2019 Category: Consumer Health News Source Type: news

Candida Bloodstream Infections Among Persons with Injection Drug Use --- Denver Metropolitan Area, Colorado, 2017--2018
Candidemia, a bloodstream infection caused by Candida species, is typically considered a health care-associated infection, with known risk factors including the presence of a central venous catheter, receipt of total parenteral nutrition or broad-spectrum antibiotics, recent abdominal surgery, admission to an intensive care unit, and prolonged hospitalization. (Source: CDC Morbidity and Mortality Weekly Report)
Source: CDC Morbidity and Mortality Weekly Report - March 28, 2019 Category: American Health Tags: MMWR Morbidity & Mortality Weekly Report Candida Source Type: news

St. Paul firm pursuing easier hemodialysis treatments closes on nearly $6 million round
St. Paul-based Phraxis Inc.'s device offers an alternative to a central venous catheter. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - March 13, 2019 Category: American Health Authors: Alex Wittenberg Source Type: news

St. Paul firm pursuing easier hemodialysis treatments closes on nearly $6 million round
St. Paul-based Phraxis Inc.'s device offers an alternative to a central venous catheter. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - March 13, 2019 Category: Biotechnology Authors: Alex Wittenberg Source Type: news

Results of ABATE infection trial published
(Harvard Pilgrim Health Care Institute) Daily bathing with an antiseptic soap, plus nasal ointment for patients with prior antibiotic resistant bacteria, reduced hospital acquired infections among patients with central venous catheters and other devices that pierce the skin, according to results of the ABATE Infection Trial. The study, " Chlorhexidine versus Routine Bathing to Prevent Multi Drug-Resistant Organisms and All-Cause Bloodstream Infection in General Medical and Surgical Units: The ABATE Infection Cluster Randomized Trial, " was published March 5 in The Lancet, Online. (Source: EurekAlert! - Infectious...
Source: EurekAlert! - Infectious and Emerging Diseases - March 5, 2019 Category: Infectious Diseases Source Type: news

Just in Time Preparedness Training Videos
Source: National Ebola Training and Education Center (NETEC). Published: 2/9/2019. These three just in time training videos were produced to support preparedness training activities and provide training for all frontline, assessment, and treatment facilities in the event they are required to care for a patient suspected or confirmed to be infected with Ebola virus disease or other special pathogens. The videos, all shorter than 14 minutes long, cover Portable Isolation Unit in a Special Pathogen Isolation Area, Containment Wrap in a Special Pathogen Isolation Area, and Central Venous Catheter in a Special Pathogen Isolati...
Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - February 9, 2019 Category: International Medicine & Public Health Source Type: news

Compromised microbiome found to predict blood infections in pediatric cancer patients
(Natural News) Long, flexible tubes called central venous catheters, or central lines, are used to give cancer patients the blood, fluids, medicines, and nutrients that they need. However, in the U.S. these central lines are linked with at least 400,000 blood infections annually. A lot of these blood infections are deadly and they cost the healthcare system... (Source: NaturalNews.com)
Source: NaturalNews.com - November 8, 2018 Category: Consumer Health News Source Type: news

Uninsured Patients Experience Delays in Obtaining Arteriovenous Access for Hemodialysis Uninsured Patients Experience Delays in Obtaining Arteriovenous Access for Hemodialysis
Uninsured patients who start in-center hemodialysis with a central venous catheter are less likely than those already on Medicare or Medicaid to obtain arteriovenous fistulas (AVF) or grafts (AVG) by their fourth month of dialysis, when they become Medicare eligible, according to a new study.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 5, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news

Anticoagulation for people with cancer and central venous catheters
This review found moderate-certainty evidence that LMWH reduces catheter ‐related venous thromboembolism (CR-VTE); evidence was inconclusive for LMWH effects on mortality and effects of vitamin K antagonists (VKA) on mortality or CR-VTE, and for LMWH versus VKA. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - September 28, 2018 Category: Consumer Health News Source Type: news

Routine X-Ray Not Needed After US-Guided Central Line Insertion
TUESDAY, Aug. 7, 2018 -- Pneumothorax and catheter misplacement after ultrasound-guided central venous catheter (CVC) insertion are rare and thus do not justify post-procedural chest X-ray (CXR), according to a study published in the July issue of... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - August 7, 2018 Category: Pharmaceuticals Source Type: news

A Silver Bullet in Reducing Infections?
Silver is precious not only for its beauty and monetary value, but it may also have significant benefits in fighting off bacterial infections. Although silver is not new in the medical world—Hippocrates described its use in wound care as far back as 400 BC—the reason silver is so effective in infection control has only recently been identified. Turns out it is not the silver itself that is antimicrobial, Raul Brizuela, president and CEO of Argentum Medical, told MD+DI. Rather, it is the silver ions that are released when it is exposed to moisture. What makes these ions so effective in fighting infection is that...
Source: MDDI - July 2, 2018 Category: Medical Devices Authors: Susan Shepard Tags: Materials & D Source Type: news

Central Venous Catheter-Related Bloodstream Infection Caused by Brevibacterium casei in a Hematology Patient
We report a case of B. casei catheter-related bacteremia in a severely immunocompromised hematology patient. Our experience and data from other reported cases indicate that hematology patients with indwelling catheters are at increased risk for infection with unusual bacterial pathogens. These unusual pathogens should be identified accurately, especially in immunocompromised patients. (Source: Clinical Microbiology Newsletter)
Source: Clinical Microbiology Newsletter - June 29, 2018 Category: Microbiology Authors: Giorgio Piccinelli, Enrico Morello, Valeria Cancelli, Alessandro Turra, Michele Malagola, Giuseppe Ravizzola, Francesca Caccuri, Domenico Russo, Arnaldo Caruso, Maria Antonia De Francesco Tags: Case Report Source Type: news

Rigorous study finds widely used treatment for infection fails young cancer patients
(St. Jude Children's Research Hospital) St. Jude Children's Research Hospital found ethanol-lock therapy failed to prevent new or recurring infections in cancer patients with central venous catheters and was associated with increased complications. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - June 5, 2018 Category: International Medicine & Public Health Source Type: news

Antibiotics at the time of removal of central venous catheter to reduce morbidity and mortality in newborn infants
This Cochrane Review identified only 1 RCT which was underpowered to address the question. It compared 2 doses of cephazolin at time of removal of catheter vs. no antibiotics, and found no infant on antibiotic developed late-onset sepsis vs. 5 in the control group. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - June 1, 2018 Category: Consumer Health News Source Type: news

Pursuit Vascular wins expanded indication for antimicrobial device
ClearGuard HD antimicrobial caps [Image courtesy of Pursuit Vascular]Pursuit Vascular (Maple Grove, Minn.) today announced that it has won FDA clearance for a broader indication of its ClearGuard HD antimicrobial caps. The new indication for the caps — used as an antimicrobial device for catheter-based dialysis patients — includes reduction in the incidence of central-line associated bloodstream infection in hemodialysis patients with central venous catheters. Get the full story on our sister site Medical Design & Outsourcing.  The post Pursuit Vascular wins expanded indication for antimicrobial d...
Source: Mass Device - May 30, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: 510(k) Business/Financial News Catheters Dialysis Food & Drug Administration (FDA) News Well Regulatory/Compliance infections Pursuit Vascular Source Type: news

Cathflo Activase (Alteplase Powder for Reconstitution for Use in Central Venous Access Devices) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 19, 2018 Category: Drugs & Pharmacology Source Type: news

Boston Children ’ s, Boston Pediatric Device Consortium announces device challenge winners
The Boston Pediatric Device Strategic Partner Challenge recently announced its winners, including cardiovascular devices that expand to keep pace with growing child, a nitric oxide generator, a cardiovascular diagnostic device and other novel pediatric devices. The challenge, run by the Innovation and Digital Health Accelerator at Boston Children’s Hospital and the Boston Pediatric Device Consortium, announced a total of five winners for the challenge. Winners will receive a combination of up to $50,000 in funding per grant award and possible mentorship programs with medical device strategic partners, including Bosto...
Source: Mass Device - January 25, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Research & Development Boston Children's Hospital Boston Scientific CryoLife Edwards Lifesciences johnsonandjohnson Medtronic Ximedica LLC Source Type: news

Bluegrass Vascular launches pivotal study for Surfacer vascular access catheter
Bluegrass Vascular Technologies said it enrolled the first patients in a pivotal trial of its Surfacer “inside-out” vascular access catheter. 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 in August 2016; Bluegrass later inked an EU distribution deal with Merit Medical (NSDQ:MMSI) that included an equity stake. Surfacer is designed to be threaded through the femoral vein up to and into blockages in the jugular, which acts as a stabi...
Source: Mass Device - January 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Vascular Bluegrass Vascular Technologies Source Type: news

US improves success rate of pediatric artery cannulation
Ultrasound-guided radial artery cannulation in children is twice as successful...Read more on AuntMinnie.comRelated Reading: $10 microchip transforms ultrasound from 2D to 3D Point-of-care ultrasound helps find fluid Use of ultrasound to guide central venous catheters lags ASE, SCA issue vascular cannulation US guideline US guidance keeps central catheter placement on target (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - December 20, 2017 Category: Radiology Source Type: news

Could CDC ’s New Catheter-Site Dressing Advice Curb Infections?
To help prevent intravascular catheter-related infections, the Centers for Disease Control (CDC) has updated its guidelines on catheter-site dressing regimens. The CDC now advises that for patients aged 18 years and older, “Chlorhexidine-impregnated dressings with an FDA-cleared label that specifies a clinical indication for reducing catheter-related bloodstream infection (CRBSI) or catheter-associated bloodstream infection (CABSI) are recommended to protect the insertion site of short-term, non-tunneled central venous catheters (1A)." Previously, according to its 2011 guidelines, the CDC recommended the use of ...
Source: MDDI - November 15, 2017 Category: Medical Devices Authors: Daphne Allen Tags: Medical Device Business Source Type: news

Initiatives to Reduce Catheter-Related Complications Drive U.S. Vascular Access Devices and Accessories Market
Conclusion The U.S. market for vascular access devices will continue to grow through 2024, and will be spurred by new catheter technology and accessories intended to improve patient outcomes. Going forward, healthcare workers will follow appropriate usage guidelines in greater numbers, and purchasers will exercise preference towards catheters and other products that reduce complications. The specialized catheter securement market is poised to benefit considerably from these trends. References U.S. Vascular Access Device Market – 2018. iData Research. Chopra V, Flanders S, Saint S, Woller S, O'Grady N, Safdar N et al...
Source: MDDI - November 7, 2017 Category: Medical Devices Tags: Tubing Medical Device Business Source Type: news

Fighting for the next family: Mom ’s experience inspires nutrition support guidelines
As Michelle Marti watched her twin sons, Nicholas and Max, run around the playground, she worried. To a stranger — like the representative of their local school’s Planning and Placement Team (PPT), there to evaluate the boys’ eligibility for special needs services in kindergarten — they looked like any other kids having fun. But their playfulness masked a serious illness: short bowel syndrome, the result of a condition called Hirschsprung’s disease. “They look healthy on the outside because all of their medical differences are under their clothes,” admits Michelle. Those difference...
Source: Thrive, Children's Hospital Boston - October 24, 2017 Category: Pediatrics Authors: Jessica Cerretani Tags: Diseases & Conditions Our Patients’ Stories Parenting Center for Advanced Intestinal Rehabilitation Hirschsprung's disease Jessica McCaig short bowel syndrome (SBS). total parenteral nutrition Source Type: news

Ultrasound-Guided Central Venous Catheter Placement Ultrasound-Guided Central Venous Catheter Placement
What are the latest recommendations for the use of ultrasound during central venous catheter placement?Critical Care (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 29, 2017 Category: Consumer Health News Tags: Critical Care Journal Article Source Type: news

Biopatch for venous or arterial catheter sites
This medtech innovation briefing covers Biopatch, a hydrophilic foam dressing impregnated with chlorhexidine gluconate (CHG), and is used for covering central venous or arterial catheter sites. It releases CHG to reduce the risk of catheter-related bloodstream infections (CRBSIs), while the absorbent foam draws discharge away from the catheter site. The intendedplace in therapy would be as an addition to standard sterile semipermeable transparent dressings to reduce the risk of a CRBSI in people with venous or arterial catheters. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - August 18, 2017 Category: Consumer Health News Source Type: news

7 medtech stories we missed this week: August 4, 2017
[Image from unsplash.com]From MDCorp inking a European distribution deal to Align Technology’s North Carolina expansion, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. MDCorp inks distribution deal with Smart Endoscope Systems MDCorp announced in a July 31 press release that it has signed a distribution agreement with Smart Endoscope Systems, giving MDCorp permission to sell Smart’s G-Eye system throughout its European market. Neuraxon, which is in the process of merging with MDCorp, is going to be responsible for distributing the G-Eye system in Europe and a netw...
Source: Mass Device - August 4, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Food & Drug Administration (FDA) Imaging Ultrasound Vascular Weight loss Access Scientific Inc. aligntechnology Central California Blood Center Cerus Corp. FujiFilm Medical Systems MDCorp MedTech Smart Endoscope Systems Standard Source Type: news

Cathflo Activase (Alteplase Powder for Reconstitution for Use in Central Venous Access Devices) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - July 12, 2017 Category: Drugs & Pharmacology Source Type: news

Bio2 touts pivotal data on Angel catheter-filter combo
This study of a combined IVC filter/central venous catheter was the culmination of a panel of dedicated investigators with careful guidance by the FDA,” primary investigator Dr. Victor Tapson said in prepared remarks. “The efficacy and safety of the device, simple bedside placement, and the need to remove it before discharge make it very appealing. Nearly the entire cohort had crucial, yet short-term filter needs so that discharge without a filter was preferred.” The device is the 1st to be cleared by the FDA for PE prophylaxis in critically ill patients contraindicated to anticoagulation. “The publ...
Source: Mass Device - June 30, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Catheters Clinical Trials Vascular BiO2 Medical 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

Bio2 Medical raises $1.5m, looking for $6.5m more
Bio2 Medical raised $1.5 million in a new round of debt and option financing, according to an SEC filing posted this week. Money in the round came from 1 unnamed investor, with the date of the sale noted as March 18, according to the filing. The company has not yet stated how it plans to spend funds raised during the offering. Bio2 is looking to raise an additional $6.5 million before closing the round. A portion of the proceeds from the round will be used to pay the salaries of certain company officers, according to the filing. Last August, Bio2 Medical pulled in $3 million from a 2nd tranche of financing from O...
Source: Mass Device - April 1, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Catheters BiO2 Medical 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

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

Catheter impregnation, coating or bonding for reducing central venous catheter-related infections in adults
This Cochrane Review informed a practice changing update on Dynamed Plus. It found that antimicrobial coatings that appear to reduce risk of central venous catheter-related bloodstream infection include minocycline-rifampicin, chlorhexidine silver sulfadiazine, silver, and heparin, but antimicrobial coatings do not appear to reduce risk of sepsis or mortality (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - December 2, 2016 Category: Consumer Health News Source Type: news

Staphylococcus saprophyticus Bacteremia in a Pediatric Patient with Central Venous Catheter-Associated Infection
We report a case of S. saprophyticus central venous catheter (CVC)-associated bacteremia identified by matrix-assisted laser desorption ionization-time-of-flight (MALDI-TOF) mass spectrometry and provide a review of how to report and interpret antimicrobial susceptibility results for coagulase-negative staphylococci (CoNS) when species identification is warranted. (Source: Clinical Microbiology Newsletter)
Source: Clinical Microbiology Newsletter - September 21, 2016 Category: Microbiology Authors: Peera Hemarajata, Kristina Adachi, Lynn Ramirez-Avila, Romney M. Humphries Source Type: news

FDA nod for Angel catheter triggers $3m tranche for Bio2 Medical
The 510(k) clearance Bio2 Medical won from the FDA in July for its Angel catheter triggered a 2nd, $3 million tranche from Oxford Finance last week, the company said yesterday. The Angel catheter is designed to provide access to the central venous system and to trap blood clots before they can reach the lungs, according to the Golden, Colo.-based company. The FDA cleared the device July 28, Bio2 said August 24. Bio2 said it plans to use the funds to commercialize the Angel device in the U.S. by hiring sales reps, building up inventory and working on market development. The tranche is part of an $8 million secured...
Source: Mass Device - August 31, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Catheters Funding Roundup Wall Street Beat BiO2 Medical Source Type: news

MassDevice.com +5 | The top 5 medtech stories for August 30, 2016
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. Vention Medical boosts footprint in Ireland Vention Medical said today that it boosted its footprint on the Emerald Isle with the opening of a new facility on the National University of Ireland’s Galway campus. Read ...
Source: Mass Device - August 30, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Bluegrass Vascular wins CE Mark for Surfacer vascular access device
Bluegrass Vascular Technologies said today that it won CE Mark approval in the European Union for its Surfacer vascular access device and plans a limited commercial launch in 7 countries there. Surfacer is designed to restore central venous access in patients with occluded veins. San Antonio-based Bluegrass Vascular, which drummed up a $4.5 million Series A round 2 years ago to back its CE Mark bid, said it plans to put Surfacer on the market in the U.K., Germany, Austria, Italy, Holland, Belgium and Luxembourg. The company said it’s also set to begin a post-market registry study of the device. &l...
Source: Mass Device - August 30, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Regulatory/Compliance Vascular Bluegrass Vascular Technologies Source Type: news

Skin antisepsis for reducing central venous catheter-related infections
This review concludes that it is not clear whether cleaning skin around CVC insertion sites with antiseptic reduces catheter related blood stream infection vs. no skin cleansing. Very low quality evidence suggests chlorhexidine may reduce rates of infection and catheter colonisation vs. povidone iodine. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - August 24, 2016 Category: Consumer Health News Source Type: news

NIH announces winners of undergraduate biomedical engineering design competition
(NIH/National Institute of Biomedical Imaging& Bioengineering) In a nation-wide competition, six teams of undergraduate engineering students produced prize-winning designs for technological advances to improve human health. The Design by Biomedical Undergraduate Teams (DEBUT) Challenge winning teams designed tools for a myriad of health care challenges, including diagnosing tuberculosis (TB) in children and a safer alternative for central venous catheter placements. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - August 23, 2016 Category: Cancer & Oncology Source Type: news

Lungpacer Medical hits the FDA fast track with phrenic nerve pacer
Lungpacer Medical said it won an expedited access pathway designation from the FDA for the diaphragm pacing system it’s developing to treat patients who can’t be weaned from mechanical ventilation. The Lungpacer DPS device is a neurostimulation system designed to exercise and strengthen the diaphragm via the temporary, transcatheter stimulation of the phrenic nerve. The FDA’s EAP designation is for breakthrough therapies aimed at unmet clinical needs and seeks lower the cost and amount of time it takes to get the treatment to market. “Our team is thrilled that the Lungpacer DPS was granted EAP ...
Source: Mass Device - May 11, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance Respiratory Expedited Access Program (EAP) Lungpacer Medical Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 29, 2016
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. Hill-Rom slides on Q2 revenues miss Hill-Rom shares took a hit today after the company reported that fiscal 2nd-quarter sales missed expectations despite the contribution of new acquisition Welch Allyn. Chicago-based Hill-Rom s...
Source: Mass Device - April 29, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Merit Medical looks to capitalize on rival Cook’s recall
Merit Medical (NSDQ:MMSI) chief Fred Lampropoulos said his company is ready to take advantage of the worldwide recall of rival Cook Medical‘s central catheter sets. The FDA in March slapped the Cook recall with a Class I label, denoting the risk of serious injury or death. It covers Cook’s single lumen central venous catheter sets and trays, single lumen pressure monitoring sets and trays, femoral artery pressure monitoring catheter sets and trays and radial artery pressure monitoring catheter sets and trays. During a conference call with analysts yesterday discussing Merit’s 1st-quart...
Source: Mass Device - April 29, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Catheters Food & Drug Administration (FDA) MassDevice Earnings Roundup Recalls Regulatory/Compliance Cook Medical Merit Medical Systems Inc. Source Type: news

FDA releases February 2016 510(k) clearances
February 2016 510(k) Clearances 510(k) summaries or 510(k) statements for final decisions rendered during the period February 2016. TOTAL 510(k)s THIS PERIOD 224 TOTAL WITH SUMMARIES 213 TOTAL WITH STATEMENTS 11 February 2016 510(k) Clearances 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD February 2016 DEVICE: ANI Monitor MDOLORIS MEDICAL SYSTEMS SAS 510(k) NO: K142969(Traditional) ATTN: MATHILDE COLLET PHONE NO : 011 333 62092081 6, RUE DU PR LAGUESSE SE DECISION MADE: 23-FEB-16 LILLE FR 59037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DBSWIN and VistaEasy Imaging Software Durr Dental...
Source: Mass Device - April 5, 2016 Category: Medical Equipment Authors: MassDevice Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

FDA: Cook Medical central venous cath recall is Class I
The FDA today labeled Cook Medical‘s recall of its central venous catheter and pressure monitoring sets and trays as Class I over issues with tip splitting and separation. The devices being recalled are used to monitor pressure in a patient’s vein or artery, to sample blood and to administer drugs or fluids. Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The devices are being recalled over issues with device tips splitting or separating from the catheter...
Source: Mass Device - March 30, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Food & Drug Administration (FDA) Recalls Cook Medical Source Type: news