Ibero-LatinAmerican clinical practical guidelines on pediatric caustic esophagitis: physiopathology and clinical-endoscopic diagnosis (1st part) - Pierre R, Neri S, Contreras M, V ázquez R, Ramírez LC, Riveros JP, Rondón L, Bautista Casasnovas A, Rodríguez-Herrera A, Navalón M, Soto P, Iglesias C, Fernández G, Dias JA, Ruiz CJ, Spolidoro J, Jorge J, Vila V.
Caustic ingestion represents a serious social-medical problem due to the devastating and irreversible consequences it can produce in the upper digestive tract. In Ibero-America, there are no published reliable data on the incidence or prevalence of caustic... (Source: SafetyLit)
Source: SafetyLit - August 3, 2020 Category: International Medicine & Public Health Tags: Age: Infants and Children Source Type: news

Risk of SARS-CoV-2 transmission during flexible laryngoscopy
(JAMA Network) Researchers review evidence on the risks of aerosolization and transmission of SARS-CoV-2 from patients to health care workers during endoscopy of the upper aerodigestive tract. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - July 30, 2020 Category: Infectious Diseases Source Type: news

Quiz: When to Use Endoscopy for Acute Upper Gastrointestinal Bleeding
In our gastrointestinal cancer quiz, you ’ll get a chance to test your knowledge on the use of endoscopy for acute upper gastrointestinal bleeding. (Source: CancerNetwork)
Source: CancerNetwork - June 5, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news

BSG Guidance on recommencing GI Endoscopy in the deceleration & early recovery phases of the COVID-19 pandemic, BSG .
Early in the COVID-19 epidemic, the BSG advised a pause in endoscopic services (6 weeks) for all but emergency and essential procedures. This pause was to protect patients and the workforce and permit time to plan service reconfiguration. Five weeks after the initiation of this pause, the following guidance is being issued to guide the safest possible restart of service. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - May 1, 2020 Category: Consumer Health News Source Type: news

Endoscopy Within Six Hours Does Not Lower Mortality in GI Bleed
WEDNESDAY, April 1, 2020 -- Endoscopy within six hours versus six to 24 hours after consultation is not associated with lower 30-day mortality in patients with acute upper gastrointestinal bleeding who are at high risk for further bleeding or death,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 2, 2020 Category: Pharmaceuticals Source Type: news

Doxapram for Low SpO2 During Gastrointestinal Endoscopy Doxapram for Low SpO2 During Gastrointestinal Endoscopy
IV propofol anesthesia is widely used for painless GI endoscopy, but low oxygen saturation may result. Can doxapram alleviate low SpO2 in this scenario?BMC Anesthesiology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 16, 2019 Category: Consumer Health News Tags: Anesthesiology Journal Article Source Type: news

Boston Scientific Wins FDA Clearance for the World & #039;s First Fully Disposable Duodenoscope
Contamination on duodenoscopes after reprocessing continues to be a major concern in the United States, but a recent FDA clearance represents a major step toward combating the problem. Boston Scientific snagged clearance to sell its Exalt-D single-use duodenoscope in the United States to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. The Exalt-D is the first fully disposable duodenoscope to reach the market. The company is planning a limited U.S. market release of the device during the first quarter of 2...
Source: MDDI - December 13, 2019 Category: Medical Devices Tags: Business Regulatory and Compliance Source Type: news

AGA releases guideline on management of gastric intestinal metaplasia
(American Gastroenterological Association) This guideline will aid health care provider decision-making for patients who are undergoing upper endoscopy in North America (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - December 10, 2019 Category: Cancer & Oncology Source Type: news

Guideline Inclusion Could Open More Doors for WATS3D
CDx Diagnostics has some extra firepower behind the WATS3D diagnostic platform. The Suffern, NY-based company said the diagnostic has been included in the American Society for Gastrointestinal Endoscopy’s Standards of Practice Committee’s guideline for the screening and surveillance of Barrett’s esophagus. Since esophageal dysplasia is both highly focal and typically invisible, the effectiveness of upper endoscopy is widely recognized to be limited by the high rate of false-negative sampling error associated with standard 4-quadrant random biopsy. WATS3D, or Wide Area T...
Source: MDDI - October 4, 2019 Category: Medical Devices Authors: Omar Ford Tags: Imaging Source Type: news

Endoscopic Services in the US: By Whom, for What, and Why? Endoscopic Services in the US: By Whom, for What, and Why?
Over the last 3 years, the percentage of colonoscopies, sigmoidoscopies, and upper endoscopies performed by FPs has declined. Why is this, and should FPs continue to perform these procedures?Journal of the American Board of Family Medicine (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 16, 2019 Category: Consumer Health News Tags: Family Medicine/Primary Care Journal Article Source Type: news

Could Revita DMR be an Alternative to Insulin Use?
Fractyl Laboratories made a pretty bold statement with its interim data from the INSPIRE trial at the American Diabetes Association's 79th Scientific Sessions in San Francisco this past weekend. The investigator-initiated INSPIRE clinical study showed that Fractyl’s Revita Duodenal Mucosal Resurfacing (DMR) System can help eliminate the need for daily insulin injections for type 2 diabetes patients. “[Revita DMR] … is now showing real promising efficacy in patients who are taking daily injections for their type 2 diabetes already,” Harith Rajagopalan...
Source: MDDI - June 10, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

When possible, upper and lower GI endoscopies should be done on same day
(Johns Hopkins Medicine) If your car needs work on its front and rear axles, it's obviously more convenient, efficient and cost effective to have both repairs done at the same time. Now, researchers at Johns Hopkins Medicine have shown similar benefits from 'bundling' upper and lower gastrointestinal endoscopies on the same day to remedy what they say is the 'disturbingly' large number of older Americans currently being scheduled for the procedures on two different days. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 13, 2019 Category: International Medicine & Public Health Source Type: news

Takotsubo Cardiomyopathy After an Upper and Lower Endoscopy Takotsubo Cardiomyopathy After an Upper and Lower Endoscopy
This case presents management approaches which can be used when treating at-risk patients who have experienced symptoms of stress cardiomyopathy after undergoing endoscopy.Journal of Medical Case Reports (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 1, 2019 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

J & J ’ s Ethicon touts economic study of magnetic Torax GERD device
This study suggests that perception may be short-sighted in that insurance plans can provide better care for their GERD patients at a similar cost to laparoscopic Nissen fundoplication when you factor in the greater reductions in medical costs after the procedure.” “This study demonstrated that the Linx System was cost effective and should be more widely covered by insurers,” added Ethicon endomechanical president Tom O’Brien. “Ethicon will continue to help support studies that enable clinicians, patients, insurers and health systems to make the best possible decisions about which treatments w...
Source: Mass Device - April 9, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Weight loss Ethicon johnsonandjohnson Torax Medical Inc. Source Type: news

Nothing Tough to Swallow About This Data
This study suggests that perception may be short-sighted in that insurance plans can provide better care for their GERD patients at a similar cost to laparoscopic Nissen fundoplication when you factor in the greater reductions in medical costs after the procedure.”  The study, presented this week at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) meeting in Baltimore, MD, found that the reduced medical costs associated with the Linx procedure compared to LNF more than offset the higher cost the cost difference. The study was partially funded by Ethicon, part of Johnson...
Source: MDDI - April 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news

What Are the Types of Tracheoesophageal Fistulas?
Discussion Respiratory problems in infants can caused by many things including any type of obstruction from the nose to lung. Neonates and infants are particularly susceptible to changes in the size of the airway because of the physics of airflow resistance. Important reminders about infant airways: Resistance = 1/radius4 (Poiseuille’s equation) therefore even a 1 mm decrease in the airway circumferences increases the airflow resistance x16. Increased airflow causes less pressure along the walls, which can lead to collapse of the walls (Bernoulli’s and Venturi effects). Neonates have smaller lungs relative to ...
Source: PediatricEducation.org - March 4, 2019 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news

Mauna Kea Nixes Deal with Cook Medical
Citing a lack of commercial progress, Mauna Kea Technologies is calling off an agreement with Cook Medical that was signed a little over three years ago involving Mauna Kea's Cellvizio platform. Paris, France-based Mauna Kea said the decision to terminate the development and distribution agreements with Cook was mutual. Cook has not officially commented on the news. Cellvizio is a multidisciplinary probe and needle-based confocal laser endoscopy platform. The device enables direct visualization of human tissues at the cellular scale and allows doctors to detect anomalies invisible with standard techniques, part...
Source: MDDI - February 21, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

EndoGastric Solutions raises $25m
EndoGastric Solutions has raised $25.4 million in equity from 28 investors as part of a $35.5 million offering, according to a document filed with the SEC this week. The Washington-based company has not yet publicly stated what it plans to do with its newly-acquired funds. EndoGastric Solutions sells a device designed to reconstruct the gastroesophageal valve and restore the valve’s function as a reflux barrier for people with severe gastroesophageal reflux disease. The system, called EsophyX, is deployed transorally, resulting in an incision-less fundoplication. EndoGastric Solutions’ first version o...
Source: Mass Device - July 5, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Funding Roundup Otolaryngology Ear, Nose & Throat Surgical endogastricsolutions Source Type: news

A Resident ’s Right to Appeal a Facility-Initiated Discharge
On May 12, 2016, Mrs. D was admitted to an acute care facility after she was found collapsed in her home, unresponsive, covered with melenic stool, and with dried blood around her mouth. She could not provide a history, and her daughter (her caregiver) was unavailable. She was noted to have possible upper gastrointestinal bleeding, rhabdomyolysis (from a fall), and a urinary tract infection (UTI). She was hydrated aggressively, and her rhabdomyolysis and kidney injury resolved. Her upper endoscopy examination showed severe esophagitis and Barrett ’s esophagus. (Source: Caring for the Ages)
Source: Caring for the Ages - July 1, 2018 Category: Health Management Authors: William C. Wilson Tags: lEGAL iSSUEs Source Type: news

Breath test can save money and catch cancer early
This test is a cheaper and less invasive alternative to an upper endoscopy. (Source: ABC News: Health)
Source: ABC News: Health - May 20, 2018 Category: Consumer Health News Tags: Health Source Type: news

Cook Medical wins FDA de novo nod for Hemospray
Cook Medical said yesterday it won FDA de novo clearance for its Hemospray endoscopic hemostat designed for treating bleeding in the gastrointestinal tract. The Hemospray product won indications from the FDA for treating non-variceal GI bleeds, the Bloomington, Ind.-based company said. Hemospray is a single-use device designed to deliver an aerosolized spray of a mineral blend to a bleeding site during endoscopic procedures, and can cover large areas including ulcers and tumors, according to an FDA release. “We are extremely pleased to receive this approval to market from FDA. We have worked diligently to bring ...
Source: Mass Device - May 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Cook Medical Source Type: news

CDx & #039;s WATS3D Highly Effective in Real World Setting
CDx Diagnostics said results from a recent multicenter prospective trial show the use of its WATS3D test increases the detection of both Barrett’s esophagus and esophageal dysplasia by more than 80%. The results were published in the latest issue of United European Gastroenterology Journal and featured in the American Society for Gastrointestinal Endoscopy (ASGE’s) Scope Tech Talk Video Series. The trial was conducted at 25 community-based gastrointestinal (GI) centers across the U.S. In the study, 4,203 patients were tested for esophageal disease. The findings show that with the inclusion of WATS3D overal...
Source: MDDI - March 26, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Design News Source Type: news

Urgent Endoscopy Predicts Lower Death Rate in UGIB (CME/CE)
(MedPage Today) -- But did not impact rebleeding rate in high-risk acute nonvariceal upper GI bleeding (Source: MedPage Today Gastroenterology)
Source: MedPage Today Gastroenterology - March 21, 2018 Category: Gastroenterology Source Type: news

Quality Standards in Upper Gastrointestinal Endoscopy Quality Standards in Upper Gastrointestinal Endoscopy
This position statement presents the minimum expected standards in diagnostic upper gastrointestinal endoscopy, with a focus on technical competence and procedural safety.Gut (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 5, 2017 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Standards for Upper GI Endoscopy Released Standards for Upper GI Endoscopy Released
The BSG and AUGIS jointly released recommendations to improve the quality of upper gastrointestinal endoscopy and reduce the risk for missed early cancerous lesions.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 19, 2017 Category: Consumer Health News Tags: Gastroenterology News Source Type: news

Duodenal Biopsies in Celiac Disease: Adhering to Guidance? Duodenal Biopsies in Celiac Disease: Adhering to Guidance?
Guidelines recommend taking at least four duodenal biopsy specimens at the time of upper GI endoscopy if celiac disease is suspected, but this study indicates some centers are falling short.BMJ Open Gastroenterology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 4, 2017 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

7 medtech stories we missed this week: August 11, 2017
[Image from unsplash.com]From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention. 1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions for the Calix-C cervical inter body cages. The clearance allows for two larger footprints to be added for use with allograft. The Calix-C Cervical Interbody Spacer is designed for spinal fusion procedures at level one in patients who are skeletally m...
Source: Mass Device - August 11, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Clinical Trials Food & Drug Administration (FDA) Oncology Regulatory/Compliance Spinal Surgical Apifix Cardiac Science Hip Innovation Life Spine Inc. MedTech Pentax Medical Varian Medical Systems Xtant M Source Type: news

FDA clears updated labeling, design for FujiFilm ED-530XT duodenoscopes
Fujifilm Medical (TSE:4901) today issued a select voluntary recall for its model ED-530XT duodenoscopes after the FDA cleared an update to the design and labeling of the device, intending to supply customers with new forceps elevator mechanism, O-ring seals, distal end caps and updated operations manuals. The company said it won FDA clearance for the updated design and labeling today, with the intention of implanting them to reduce potential health risks during reprocessing of the device. Duodenoscopes have been linked in the past to superbug outbreaks, with the FDA issuing specific warnings in an attempt to curb such...
Source: Mass Device - July 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Recalls Regulatory/Compliance Fujifilm Holdings Source Type: news

Role of early endoscopic evaluation in decreasing morbidity, mortality, and cost after caustic ingestion: a retrospective nationwide database analysis - Abbas A, Brar TS, Zori A, Estores DS.
Caustic substance ingestion (CSI) is a serious medical problem with potentially devastating short- and long-term consequences. Early upper gastrointestinal endoscopy (EaEn) is recommended to evaluate the extent of injury and guide management but there has ... (Source: SafetyLit)
Source: SafetyLit - May 9, 2017 Category: International Medicine & Public Health Tags: Burns, Electricity, Explosions, Fire, Scalds Source Type: news

Upper endoscopy
(Source: MayoClinic.com Full Feed)
Source: MayoClinic.com Full Feed - May 9, 2017 Category: Consumer Health News Source Type: news

Crospon wins FDA 510(k) for next-gen Endoflip system
Endoscopic diagnostic company Crospon said today it won FDA 510(k) clearance for its next-gen Endoflip system with Flip topography module, designed to allow clinicians to assess patient motility disorders during endoscopy. The newly cleared Endoflip 2.0 system includes imaging software that displays esophageal contractility patterns in real time on a touch screen display, the Ireland-based company said. “This clearance represents a significant milestone for our organization as we can now offer physicians an additional tool that can be used during endoscopy, along with other diagnostic methods, to evaluate patients wi...
Source: Mass Device - May 6, 2017 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Endoscopic / Arthroscopic Food & Drug Administration (FDA) Imaging Regulatory/Compliance Crospon Source Type: news

Endoscopy for Upper GI Bleeding: Where Are We in 2017? Endoscopy for Upper GI Bleeding: Where Are We in 2017?
What are the latest recommendations on endoscopic management of acute upper gastrointestinal bleeding?Frontline Gastroenterology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 13, 2017 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Parasite Wonders: What's that in the scope?
This week's case?involves a young man with a two-week history of epigastric pain and vomiting. Physical examination was normal, and a complete blood count showed only mild anemia. An ultrasound of the abdomen was normal, so an upper gastrointestinal endoscopy was performed. What is it? https://www.youtube.com/watch?v=Z8LVZtLdkmM Every week, Mayo Clinic microbiologist Dr. Bobbi Pritt?posts a [...] (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - March 7, 2017 Category: Databases & Libraries Source Type: news

Doppler Probe-guided Hemostasis Improves Outcomes in Nonvariceal Upper GI Bleeding Doppler Probe-guided Hemostasis Improves Outcomes in Nonvariceal Upper GI Bleeding
Using a Doppler probe to guide endoscopic hemostasis improves outcomes of patients with severe nonvariceal upper gastrointestinal (UGI) bleeding, researchers report.Reuters Health Information (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - February 27, 2017 Category: Radiology Tags: Gastroenterology News Source Type: news

Upper Endoscopy Screening in Koreans Reduces Risk of Gastric Cancer Death Upper Endoscopy Screening in Koreans Reduces Risk of Gastric Cancer Death
Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - February 21, 2017 Category: Consumer Health News Tags: Medscape Today News Source Type: news

Breath Test for Early Diagnosis of Upper GI Cancer Breath Test for Early Diagnosis of Upper GI Cancer
An exhaled breath test that measures just five chemicals could offer an inexpensive alternative to endoscopy in the diagnosis of esophageal and gastric cancers.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 31, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

Breath test shows potential for detecting cancer
Conclusion This study aimed to see whether a breath test could be used to detect stomach and oesophageal cancers. The researchers found that the breath test was fairly accurate in distinguishing between those with and without cancer. The lead researcher, Dr Markar, said: "Because cancer cells are different to healthy ones, they produce a different mixture of chemicals. This study suggests that we may be able detect these differences and use a breath test to indicate which patients are likely to have cancer of the oesophagus and stomach, and which do not." However he went on to say that the findings of this study ...
Source: NHS News Feed - January 30, 2017 Category: Consumer Health News Tags: Cancer Source Type: news

This GI test could help patients avoid a hospital stay
(American Society for Gastrointestinal Endoscopy) Symptoms of possible upper GI bleeding are a leading cause of hospital admissions through emergency departments. But according to a new study, use of capsule endoscopy can avoid many unnecessary hospital admissions in patients with these symptoms. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 16, 2016 Category: Global & Universal Source Type: news

FDA releases June 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD June 2016 TOTAL 510(k)s THIS PERIOD 258 TOTAL WITH SUMMARIES 235 TOTAL WITH STATEMENTS 23 DEVICE: ORAL BOND STEINER LABORATORIES 510(k) NO: K142130(Traditional) ATTN: GREGORY G STEINER PHONE NO : 866 3171348 1051 Olsen Street, Building 3611 SE DECISION MADE: 06-JUN-16 Henderson NV 89011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QiF Blood and Fluid Warmer Quality in Flow Ltd. 510(k) NO: K150404(Traditional) ATTN: Neta Sherman PHONE NO : 972 54 6600146 3A Bazel St. POB 10159 SE DECISION MA...
Source: Mass Device - August 31, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

All bleeding stops — but does idarucizumab (Praxbind) make it stop faster?
3.5 out of 5 stars Persistent life-threatening hemorrhage after administration of idarucizumab. Alhashem HM et al. Am J Emerg Med 2016 June 30 [Epub ahead of print] Reference Dabigatran (Pradaxa) is a direct thrombin inhibitor approved for stroke and embolism prophylaxis in patients with non-valve-related atrial fibrillation. When it was first released in 2008, a major disincentive to widespread use was the lack of a reliable reversal agent to treat major bleeds, or to administer before necessary invasive procedures. In October 2015, the U.S. Food and Drug Administration approved idarucizumab (Praxbind), a monocl...
Source: The Poison Review - July 27, 2016 Category: Toxicology Authors: Leon Gussow Tags: Medical anticoagulant hemorrhage idarucizumab pradaxa praxbind reversal agent Source Type: news

Caustics injuries in the upper gastrointestinal tract: clinical and endoscopic features - Rodríguez Vargas BO, Monge Salgado E, Montes Teves P, Salazar Ventura S, Guzmán Calderón E.
OBJECTIVE: To describe the clinical and endoscopic features of caustics injuries in the upper gastrointestinal tract in patients of the National Hospital Daniel Alcides Carrión. MATERIALS AND METHODS: A descriptive study was conducted; the study p... (Source: SafetyLit)
Source: SafetyLit - July 16, 2016 Category: Global & Universal Tags: Burns, Electricity, Explosions, Fire, Scalds Source Type: news

Outpatient Surgery Centers
Source: center representatives. Rank Name / prior (* not ranked) / URL Number of outpatient surgeries performed in 2015 Type(s) of surgeries performed Number of physicians Employees Operating rooms Top local executive, title/ 1 Cypress Surgery Center, 9300 E. 29th St. N, Ste. 100, Wichita, KS 67226, 316-634-0404, cypresssurgerywichita.com 10227 Gynecology; orthopedic; otolaryngology; ophthalmology; dental, oral and maxillofacial; plastic and reconstructive; urology; general; GI endoscopy; pain… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 24, 2016 Category: Biotechnology Source Type: news

FDA releases April 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD April 2016 TOTAL 510(k)s THIS PERIOD 239 TOTAL WITH SUMMARIES 224 TOTAL WITH STATEMENTS 15 DEVICE: Applanation Tonometer SHANGHAI MEDIWORKS PRECISION INSTR510(k) NO: K142263(Traditional) ATTN: Weida Zhan PHONE NO : 8621 542 60421 Zone A, 2nd Floor, No. 69, Lane 19SE DECISION MADE: 15-APR-16 SHANGHAI CN 200237 510(k) STATEMENT DEVICE: Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test Sugentech, Inc. 510(k) NO: K142754(Traditional) ATTN: Mijin Sohn PHONE NO : 82 42 3645001 Daejeon Bioventure Town, 1662, YusSE DECISION MADE: 07-A...
Source: Mass Device - May 9, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

200 Upper GI Endoscopies ‘Appropriate’ Requirement for Competency200 Upper GI Endoscopies ‘Appropriate’ Requirement for Competency
The requirement of 200 esophago-gastro-duodenoscopies (EGDs) to achieve competency, as defined by the unassisted ability to pass the endoscope into the second part of the duodenum, seems reasonable, according to an analysis of the U.K. national training database. Reuters Health Information (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - April 11, 2016 Category: Radiology Tags: Gastroenterology News Source Type: news

Don't Trust the Conventional Wisdom in Health Care -- Part 1
While he may not have been the first to say it, Steven D. Levitt, co-author of Freakonomics: A Rogue Economist Explores the Hidden Side of Everything (2005) is credited with the quotation: "The conventional wisdom is often wrong." Levitt bundles this concept with a distinction between positive and normative analysis. In the purest sense, positive economics is objective and fact based, while normative economics is subjective and value based. However, this clear distinction can become muddied. As Investopedia reminds us, "Positive economic statements do not have to be correct, but they must be able to be teste...
Source: Healthy Living - The Huffington Post - April 11, 2016 Category: Consumer Health News 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

Solving the 5,000-Year-Old Murder of Otzi the Iceman
In 1991, the mummified body of a 5,000-year-old murder victim was discovered in melting ice at a rock-gully crime scene high in the Italian Otzal Alps. Nicknamed "Otzi", the estimated 45-year-old man and his possessions were incredibly well preserved. His skin, hair, bones, and organs were cryopreserved in time, allowing archeological researchers a phenomenal insight into human life in the Copper Age. The frozen corpse also gave modern science the opportunity to forensically investigate and positively determine how Otzi the Iceman was killed. The story began on a sunny September day, when two hikers were traversi...
Source: Science - The Huffington Post - February 11, 2016 Category: Science Source Type: news

What Are Risk Factors for Cholelithiasis?
Discussion Bile is produced by the liver to aid absorption of fat soluble vitamins and lipids from the gastrointestinal tract and to transport bilirubin, cholesterol and other substances to the gastrointestinal tract. Bile is the main form of cholesterol excretion. Gallstones or cholelithiasis form when the balance of substances within the hepatobiliary tract favors supersaturation with crystal formation and gallstone formation. It is a dynamic state of affairs as gallstones can form and also have a high rate of resorption of up to 50%. Gallstones 3 mm are called gallstones. Gallstones, while not as common as adult popula...
Source: PediatricEducation.org - January 4, 2016 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news

MassDevice.com +3 | The top 3 medtech stories for September 29, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.   3. House advances reconciliation bill to dismantle Obamacare The U.S. House of Representatives Committee on Ways and Means said yesterday it is advancing legislation targeting the Affordable Care Act with a provision to repeal the medical device tax. The legislation will operate through a budget ...
Source: Mass Device - September 29, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news