FDA Grants De Novo Clearance for Z-Medica ’s QuikClot Control+ Only Non-Absorbable Hemostatic Dressing for Severe Bleeding in Internal Organ Space
Wallingford, Conn. - Z-Medica, LLC, a leading developer and marketer of hemostatic devices, announces that QuikClot Control+ has been cleared for use by the US Food and Drug Administration (FDA) under the de novo classification process and is designated as a Class II medical device. QuikClot Control+ is the first and only non-absorbable hemostatic dressing cleared for internal organ space use in severely bleeding patients. QuikClot Control+ is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wound...
Source: JEMS Patient Care - July 13, 2017 Category: Emergency Medicine Authors: Dave Schemelia Tags: Patient Care Industry News Source Type: news

FDA Grants De Novo Clearance for Z-Medica ’s QuikClot Control+ Only Non-Absorbable Hemostatic Dressing for Severe Bleeding in Internal Organ Space
Wallingford, Conn. - Z-Medica, LLC, a leading developer and marketer of hemostatic devices, announces that QuikClot Control+ has been cleared for use by the US Food and Drug Administration (FDA) under the de novo classification process and is designated as a Class II medical device. QuikClot Control+ is the first and only non-absorbable hemostatic dressing cleared for internal organ space use in severely bleeding patients. QuikClot Control+ is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wound...
Source: JEMS: Journal of Emergency Medical Services News - July 13, 2017 Category: Emergency Medicine Authors: Dave Schemelia Tags: Patient Care Industry News Source Type: news

An Approach to Acute Lower Gastrointestinal Bleeding An Approach to Acute Lower Gastrointestinal Bleeding
This clinical review covers the assessment, etiology, imaging, and management of acute lower GI bleeding.Frontline Gastroenterology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 13, 2017 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Z-Medica wins FDA de novo nod for QuickClot Control+
Hemostatic device developer Z-Medica said today it won FDA de novo clearance for its QuickClot Control+, now indicated for temporary control of internal organ space bleeding for patients displaying Class III or Class IV bleeding. The Wallingford, Conn.-based company touted its QuickClot Control+ as the 1st and only non-absorbable hemostatic dressing with clearance for internal organ space in severely bleeding patients, and added that it may also be used for control of severely bleeding wounds including surgical wounds and traumatic injuries. “This clearance marks another major milestone in the growth of our comp...
Source: Mass Device - July 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance Z-Medica Source Type: news

Nerve Blockade vs. Intrathecal Morphine for TKA Nerve Blockade vs. Intrathecal Morphine for TKA
For patients undergoing total knee arthroplasty, which provides better analgesia and control of post-op bleeding: intrathecal morphine or a continuous femoral plus single-shot sciatic nerve block?BMC Anesthesiology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 12, 2017 Category: Consumer Health News Tags: Anesthesiology Journal Article Source Type: news

Treatment rapidly reverses the effect of blood thinner dabigatran
At least 28 million prescriptions for blood thinners are filled by pharmacists yearly for the irregular heartbeat of atrial fibrillation, deep vein thrombosis, and other indications, according to the Department of Health and Human Services. However, on rare occasions, anticoagulants can present risks of accidental bleeding and hemorrhage or can delay emergency surgery. A newly completed phase III clinical study demonstrates the safety and efficacy of idarucizumab, a novel therapy that acts as an antidote to the blood thinner dabigatran. (Source: World Pharma News)
Source: World Pharma News - July 11, 2017 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

Disruptive technology reduces bleeding in hemophilia by 87 percent
Researchers at Children's Hospital Los Angeles developed a new therapy called emicizumab that decreases bleeding episodes by nearly 90 percent. (Source: Health News - UPI.com)
Source: Health News - UPI.com - July 10, 2017 Category: Consumer Health News Source Type: news

Book Review: Scared Selfless
Dr. Michelle Stevens’ new book, Scared Selfless: My Journey from Abuse and Madness to Surviving and Thriving, powerfully weaves the story of a survivor of a child sex ring with the astounding facts about one of society’s most cloaked secrets. “I had noticed that we, as a society, are fed a steady stream of news of stories about abductions, fallen clergy, and child pornography. But despite all the TV ratings and magazine sales these stories garner, we seem to know very little about sexual abuse and why it occurs,” writes Stevens. Sex is a taboo subject. But sex with a child – unspeakable. And y...
Source: Psych Central - July 10, 2017 Category: Psychiatry Authors: Claire Nana Tags: Abuse Book Reviews Dissociative Trauma Child Abuse Dissociative Identity Disorder Dr. Michelle Stevens Molestation Rape Sexual Abuse Sexual Trauma Source Type: news

Medical News Today: Bleeding ulcer: What causes it and is it serious?
What are the symptoms of a bleeding ulcer and what causes peptic ulcers? Learn about the diagnosis, treatment, outlook, and myths about bleeding ulcers. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - July 10, 2017 Category: Consumer Health News Tags: GastroIntestinal / Gastroenterology Source Type: news

Disruptive technology for the treatment of hemophilia
(Children's Hospital Los Angeles) An international team of hematologists including Guy Young, MD, of Children's Hospital Los Angeles, has found that in patients with hemophilia A with inhibitors, a novel therapy called emicizumab, decreases incidence of bleeding episodes by 87 percent. Results of this multicenter phase III study called HAVEN 1, will be presented at the International Society of Thrombosis and Hemostasis and published in the New England Journal of Medicine on July 10. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 10, 2017 Category: International Medicine & Public Health Source Type: news

WHO issues warning about rise of drug-resistant gonorrhoea
Conclusion The increase in antimicrobial resistance towards drugs used to treat gonorrhoea is reaching a critical stage, especially given how common the infection is worldwide, with an estimated 78 million new cases in 2012. This study raises concerns around an important topic while also proposing strategies to help address the slow pace of research and development of new drugs. The prevention of gonorrhoea is equally, if not more, important. The most effective way to prevent gonorrhoea is to always use a condom during sex, including anal and oral sex. Read more advice about sexually transmitted infections and how to prev...
Source: NHS News Feed - July 7, 2017 Category: Consumer Health News Tags: Medication QA articles Source Type: news

FDA updates on Baxter Vascu-Guard patch recall
The FDA today released an update on Baxter‘s (NYSE:BAX) voluntary recall of its Vascu-Guard peripheral vascular patch, saying that it is working with the company but that neither group has discovered a root cause for the issues, which led to a number of adverse events and 3 potential patient deaths. The Vascu-Guard patch is designed for use in vascular reconstruction surgeries including carotid, renal, iliac, femoral, profund and tibial blood vessels and arteriovenous access revisions, the FDA said. While the federal watchdog said it has yet to discover the cause of the issue, it did offer that so far, there have bee...
Source: Mass Device - July 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Recalls Vascular Baxter Source Type: news

The Risk of Lower GI Bleeding in Low-dose Aspirin Users The Risk of Lower GI Bleeding in Low-dose Aspirin Users
How significant is the risk of lower gastrointestinal bleeding in low-dose aspirin users?Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 6, 2017 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Johnson & Johnson fields Aussie class action over pelvic mesh
(Reuters) – Australian women have brought a class-action case against Johnson & Johnson (NYSE:JNJ) over complications arising from vaginal mesh implants – a lawsuit that follows many others in the United States, Canada and Europe. The claim, which is being heard in Australia’s Federal Court, said patients had suffered chronic pain, bleeding and severe discomfort during sexual intercourse since having the mesh surgically implanted. The devices are used to treat stress urinary incontinence and pelvic organ prolapse. The Australian action was brought on behalf of more than 700 claimants. Johnson &am...
Source: Mass Device - July 5, 2017 Category: Medical Devices Authors: MassDevice Tags: Legal News Women's Health johnsonjohnson Source Type: news

Death From Bleeding After Cancer-Related VTE in Elderly Death From Bleeding After Cancer-Related VTE in Elderly
The rates are low, but the risk for death from a major bleeding event following a cancer-related thromboembolism (VTE) is much higher than the risk associated with a recurrent VTE in older patients.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 5, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

Heartburn drugs linked to premature death
Conclusion This larger set of observational data finds that PPI drugs are associated with an increase in the risk of early death compared with either H2 blockers or no acid suppression drugs. This was the case for participants both with and without gastrointestinal problems. It also appears as though the longer the PPIs drugs are taken, the greater the risk of death. Considering that these drugs are widely used in the UK, these findings may cause concern. But the research has a number of important limitations: The study was conducted in a population of mostly white, older US male veterans, which might limit the abi...
Source: NHS News Feed - July 4, 2017 Category: Consumer Health News Tags: Medication Source Type: news

Concussion Can Spur Short-Term Change in Women's Periods
Odds of abnormal menstrual bleeding jump 6 times after serious head injury, study says Source: HealthDay Related MedlinePlus Pages: Concussion, Menstruation, Teen Health (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - July 3, 2017 Category: Consumer Health News Source Type: news

Is concussion associated with abnormal menstrual patterns in young women?
(The JAMA Network Journals) A study of nearly 130 girls and young women suggests concussion was associated with increased risk of having two or more abnormal menstrual bleeding patterns, according to an article published by JAMA Pediatrics. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 3, 2017 Category: International Medicine & Public Health 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

Hologic files infringement suit against Fujifilm Medical over mammogram tech
Fujifilm Holdings (TSE:4901) subsidiary Fujifilm Medical Systems is facing a patent infringement suit from Hologic (NSDQ:HOLX), which claims that the company infringed on 5 of its mammogram technology patents, according to a Connecticut Law Tribune report. The suit, filed in the US District Court for the District of Connecticut on Monday claims that Japan-based Fujifilm “had specific intent to infringe the ‘296 patent or were willfully blind to such infringement,” according to the report. The patents relate to Hologic’s Selenia Dimensions digital breast tomosynthesis system, which was issu...
Source: Mass Device - June 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Legal News Mammography Patent Infringement Women's Health Hologic Source Type: news

Oral Anticoagulation in ESRD and AF: Just Say No to Drugs? Oral Anticoagulation in ESRD and AF: Just Say No to Drugs?
The presence of CKD in patients with AF is associated with increased stroke risk--but also a heightened risk of bleeding. Are anticoagulants safe for stroke prevention in these patients?Heart (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 27, 2017 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Channel Medsystems wins CE Mark for Cerene cryotherapy device
Channel Medsystems said today it won CE Mark approval in the European Union for its Cerene cryotherapy endometrial ablation device designed for treating women with heavy menstrual bleeding due to benign causes. The Emeryville, Calif.-based company said that current endometrial ablation procedures can be painful and require general anesthesia, but its Cerene device and associated procedure are comfortable and usable in an office setting with no post-procedure downtime. “Finding the right treatment can be a challenge for women. The introduction of the Cerene procedure in Europe will allow gynecologists t...
Source: Mass Device - June 26, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Women's Health Channel Medsystems Source Type: news

Channel Medsystems(R) Earns CE Mark Approval for the Cerene(R) Cryotherapy Device
EMERYVILLE, Calif., June 26, 2017 -- (Healthcare Sales & Marketing Network) -- Channel Medsystems, the developer of an innovative, physician office-based therapy for heavy menstrual bleeding, announced today that it has earned CE Mark approval, allowing t... Devices, Regulatory Channel Medsystems, Cerene Cryotherapy, endometrial cryoablation (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 26, 2017 Category: Pharmaceuticals Source Type: news

DIY kit given to patients for bowel cancer tests
The kit is being issued by GPs to NHS patients suffering lower abdominal pain and bleeding, after trials found the test was so accurate that it ‘ruled out’ tumours in more than 95 per cent of cases. (Source: the Mail online | Health)
Source: the Mail online | Health - June 24, 2017 Category: Consumer Health News Source Type: news

Bruising in children: evaluation in cases of suspected non-accidental injuries in children (physical child abuse) - Igwe WC, Igwebuike VO.
BACKGROUND: Bruises commonly occur in children and are often due to minor accidental injuries. However, they can also occur in bleeding disorders or inflicted injuries (physical abuse) and is often the most common visible manifestation of child physical ab... (Source: SafetyLit)
Source: SafetyLit - June 24, 2017 Category: International Medicine & Public Health Tags: Age: Infants and Children Source Type: news

Rectal cancer victim discovered disease after declutter
Michelle Forde, from Cork, Ireland, had been suffering from a lack of energy, bursts of acne and bleeding when she went to the toilet - but had put her symptoms down to her stressful job. (Source: the Mail online | Health)
Source: the Mail online | Health - June 23, 2017 Category: Consumer Health News Source Type: news

A Novel Evidence-Based Periodontal Prognosis Model
ConclusionsPLMs must be considered when determining the prognosis of a tooth with periodontal disease. The model proposed in this report is based on the best available evidence for factors affecting tooth survival and has been designed to be as simple and objective as possible to facilitate its adoption in clinical practice. It will be retrospectively and prospectively validated to determine its ability to accurately predict the course of disease. (Source: Dental Technology Blog)
Source: Dental Technology Blog - June 23, 2017 Category: Dentistry Source Type: news

OAC Can Continue, With Cautions, During CIED Lead Extractions OAC Can Continue, With Cautions, During CIED Lead Extractions
No heparin bridging needed, says a study from one experienced center. Bleeding complications at lead extractions were so rare that any oral anticoagulation could be maintained. Prospective trials are lacking.Heartwire from Medscape (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 20, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

£ 1.8m for major study into management of bleeding after childbirth
The UK National Institute of Health Research (NIHR) has awarded a collaboration led by Liverpool, Bristol and Sunderland £ 1.8m to run a large study into the drug treatment of bleeding after childbirth (also called postpartum haemorrhage or PPH). (Source: University of Bristol news)
Source: University of Bristol news - June 20, 2017 Category: Universities & Medical Training Tags: Grants and Awards, Health, International, Research; Faculty of Health Sciences, Faculty of Health Sciences, School of Clinical Sciences, Faculty of Health Sciences, Bristol Medical School, Institutes, Elizabeth Blackwell; Press Release Source Type: news

Inspired by War Zones, Balloon Device May Save Civilians From Fatal Blood Loss
Developed to save victims of battlefield trauma, a plastic tube with a balloon at its tip can give doctors precious time to halt internal bleeding. (Source: NYT Health)
Source: NYT Health - June 19, 2017 Category: Consumer Health News Authors: DENISE GRADY Tags: Medical Devices Surgery and Surgeons Pelvis Bellevue Hospital Center ER-Reboa catheter Source Type: news

Jun 16 Cardiology News Jun 16 Cardiology News
Bleeding risk of ASA in the elderly, stopping statins, ADA wrap-up, and the importance of education level for CV health are the topics discussed by Dr John Mandrola in this week's podcasttheheart.org on Medscape (Source: theHeart.org)
Source: theHeart.org - June 16, 2017 Category: Cardiology Tags: Cardiology News Source Type: news

Rectal bleeding
(Source: MayoClinic.com Full Feed)
Source: MayoClinic.com Full Feed - June 16, 2017 Category: Consumer Health News Source Type: news

Painful teeth and bleeding gums? THIS could be the hidden cause
TEETH are essential for an appealing smile, but stress can cause them damage. (Source: Daily Express - Health)
Source: Daily Express - Health - June 15, 2017 Category: Consumer Health News Source Type: news

Aspirin Bleeding Risk Higher Than Thought
Aspirin Bleeding Risk in Over 75s Higher Than Thought (Source: eMedicineHealth.com)
Source: eMedicineHealth.com - June 15, 2017 Category: General Medicine Source Type: news

Antiplatelet Bleeding Risk Higher Than Expected for Older Patients
Research suggests proton - pump inhibitors should be co - prescribed in patients age 75 + years (Source: Pulmonary Medicine News - Doctors Lounge)
Source: Pulmonary Medicine News - Doctors Lounge - June 15, 2017 Category: Respiratory Medicine Tags: Cardiology, Family Medicine, Geriatrics, Gastroenterology, Gynecology, Internal Medicine, Emergency Medicine, Neurology, Nursing, Pharmacy, Pulmonology, Journal, Source Type: news

New Oxford study indicates bleeding risk by aspirin in elderly patients
A new study by scientists at Oxford University, UK, showed that long-term use of aspirin may lead to a high risk of disabling or fatal bleeding in patients aged 75 or older. (Source: Drug Development Technology)
Source: Drug Development Technology - June 14, 2017 Category: Pharmaceuticals Source Type: news

Abbott Broadens Product Offering in Coagulation with Expanded Launch of the Sekisui CP3000 Fully Automated Coagulation System
- Coagulation tests measure a person's blood clotting ability, which can help clinicians assess risks of excessive bleeding or clotting (Source: Abbott.com)
Source: Abbott.com - June 14, 2017 Category: Pharmaceuticals Source Type: news

Daily aspirin bleeding risk may increase with age
Aspirin can help prevent a heart attack or stroke; experts caution against stopping any medication without consulting a doctor first (Source: Health News: CBSNews.com)
Source: Health News: CBSNews.com - June 14, 2017 Category: Consumer Health News Source Type: news

Saranas raises $4M for bleeding detection device for use in cardiac procedures
Houston, Texas-based medical device company Saranas has raised $4M to support continued development on their sensor-enabled bleeding detection device intended for use during cardiac procedures. (Source: mobihealthnews)
Source: mobihealthnews - June 14, 2017 Category: Information Technology Source Type: news

Internal bleeding detection device dev Saranas raises $4m in Series B
Internal bleeding detection device developer Saranas said today it has raised $4 million in a Series B round of financing to support its Early Bird bleed detection device. The Early bird device is designed as a standard vascular access sheath which is embedded with sensors which detect bleeding from accidentally ruptured blood vessels during cardiac procedures, including transcatheter aortic valve replacements, the Houston, Texas-based company said. Funds from the round will support product testing and eventual FDA submission which is slated for some time this year, Saranas said. “The Early Bird system is potentially...
Source: Mass Device - June 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Cardiovascular saranas Source Type: news

Risk of aspirin-related bleeding is higher in the over-75s
Conclusion This valuable cohort study helps to quantify the extent of bleeding risk in people taking aspirin for secondary prevention of cardiovascular disease. Aspirin is well known to carry bleeding risk – particularly in older adults – but this study suggests the risk may be higher than previously thought. The researchers say that for adults under the age of 75, the annual bleeding risk at around 1% is similar to that suggested by previous trials, as is the ratio of bleeds to the number of cardiovascular events. However, this risk increases for older adults, especially for major bleeds of the stomach and upp...
Source: NHS News Feed - June 14, 2017 Category: Consumer Health News Tags: Medication Older people Source Type: news

Smog linked to bleeding stomach ulcers in elderly
(Reuters Health) - - Older adults may be more likely to have bleeding stomach ulcers on days when the air has higher levels of nitrogen dioxide, a pollutant produced by car exhaust and power plants, a recent study in Hong Kong suggests. (Source: Reuters: Health)
Source: Reuters: Health - June 14, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Aspirin Bleeding Risk in Over 75s Higher Than Thought Aspirin Bleeding Risk in Over 75s Higher Than Thought
The authors of a new study suggest that all older patients taking daily aspirin for secondary prevention should also be prescribed a PPI to protect against gastrointestinal bleeding.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 14, 2017 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news

Call to co-prescribe PPIs with daily aspirin for older patients
Long-term daily aspirin use is linked to a higher than expected risk of “disabling or fatal” bleeding in adults aged 75 or over, according to researchers in Oxford. (Source: Nursing Times)
Source: Nursing Times - June 14, 2017 Category: Nursing Source Type: news

Daily aspirin use linked to elevated bleeding risk in patients over 75
Patients over 75 taking aspirin daily have a 10 times greater risk of disabling or fatal bleeding and should be co-prescribed a protein-pump inhibitor to mitigate this risk, researchers have said. (Source: GP Online News)
Source: GP Online News - June 14, 2017 Category: Primary Care Tags: 15.1 Cardiovascular Problems Source Type: news

Risk of bleeds and death with daily aspirin use higher than thought
Research suggests 3,000 people die a year in UK from long-term use of aspirin or similar drugs, but also taking heartburn medication could help reduce riskThe risk of long-term aspirin use causing major bleeding and death is higher than previously thought, with over-75s particularly vulnerable, a study suggests.Around 40% of adults aged 75 or over in the UK take a daily aspirin and lifelong treatment is recommended for patients who have previously had a heart attack or stroke.Continue reading... (Source: Guardian Unlimited Science)
Source: Guardian Unlimited Science - June 14, 2017 Category: Science Authors: Haroon Siddique Tags: Aspirin Health Society Science Medical research Source Type: news

Bleeding risk with long-term aspirin increases substantially with age
GPs should prescribe PPIs to elderly people to cut risk, researchers suggest Related items fromOnMedica Benefits of taking aspirin highest in women aged 65 plus Aspirin boosts cancer immunotherapy, study shows Long-term aspirin use linked to lower risk of gastrointestinal tract cancers Aspirin after mini-stroke reduces risk of major stroke (Source: OnMedica Latest News)
Source: OnMedica Latest News - June 14, 2017 Category: UK Health Source Type: news

CardioBrief: Serious Bleeding Risk With Aspirin Soars With Age
(MedPage Today) -- Routine PPI use might cut the risk of major bleeds in people over 75 (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - June 13, 2017 Category: Primary Care Source Type: news