Liver transplant 'game changing' treatment approved
It's hoped perfusion machines that "warm livers" will increase the number of viable donated organs. (Source: BBC News | Health | UK Edition)
Source: BBC News | Health | UK Edition - January 16, 2019 Category: Consumer Health News Source Type: news

Perfusion technique could boost number of viable donor livers
Slows rate of tissue deterioration and lengthens storage time, says NICE Related items fromOnMedica Primary sclerosing cholangitis New drive launched to trace hepatitis C patients Hepatocellular carcinoma risk, cirrhosis and hepatitis C Deaths from hepatitis C drop 11% in past year Alcohol consumption in late teens can predict risk of liver problems later (Source: OnMedica Latest News)
Source: OnMedica Latest News - January 16, 2019 Category: UK Health Source Type: news

IschemaView wins expanded FDA nod for Rapid neuroimager
Medical imaging dev IschemaView said today that it won expanded FDA clearance for its Rapid neuroimaging platform intended for use in selecting patients likely to benefit from endovascular thrombectomy. With the clearance, the Menlo Park, Calif.-based company said that its Rapid CT-Perfusion and Rapid MR-Perfusion devices can now be used to aid in selecting acute stroke patients with known occlusions of the internal carotid artery or proximal middle cerebral artery for a clot removal procedure. IschemaView touted its Rapid system as the only imaging platform approved for selecting stroke patients for clot removal. “T...
Source: Mass Device - January 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Imaging Neurological Regulatory/Compliance ischemaview Source Type: news

iSchemaView wins new FDA clearance for Rapid platform
Cerebrovascular imaging software developer iSchemaView has received an additional...Read more on AuntMinnie.comRelated Reading: iSchemaView reports rapid sales growth iSchemaView lands FDA nod for CTA software Perfusion imaging expands window for stroke treatment (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 15, 2019 Category: Radiology Source Type: news

Start-up BURL develops ultrasound-based 'ECG for stroke'
SAN FRANCISCO - A California start-up is developing an ultrasound-based device...Read more on AuntMinnie.comRelated Reading: Study reveals steep cost of delaying stroke treatment 3 CTA signs show which stroke patients can skip surgery 5 risk factors help predict brain hemorrhage on CT AI algorithm can triage head CT exams for urgent review Perfusion imaging expands window for stroke treatment (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 9, 2019 Category: Radiology Source Type: news

Temporal neurophysiological dynamics in traumatic brain injury - the role of pressure reactivity and optimal cerebral perfusion pressure for predicting outcome - Svedung Wettervik TM, Howells T, Enblad P, Lew én A.
Intracranial pressure (ICP), cerebral perfusion pressure (CPP) and the pressure reactivity index (PRx) have been shown to correlate with outcome after traumatic brain injury (TBI), but their temporal evolution is less studied. Optimal CPP (CPPopt), i.e. th... (Source: SafetyLit)
Source: SafetyLit - January 3, 2019 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Early Administration of Intravenous Fluids in Sepsis: Pros and Cons.
Fluid resuscitation in the management of patients with sepsis and severe sepsis has been considered the standard of care for almost 2 decades. The rationale for fluid resuscitation is related to improvement in cardiac output and organ perfusion. Recent research evidence challenges the use of fluid resuscitation in patients diagnosed with sepsis. Research is needed to determine the timing of fluid administration, as well as the volume and type of fluid to achieve positive patient outcomes. This journal article discusses the pros and cons of early fluid administration in the management of patients with sepsis. (Source: Curre...
Source: Current Awareness Service for Health (CASH) - December 28, 2018 Category: Consumer Health News Source Type: news

Fertility Tracker Guarantees Pregnancy Within One Year
Until recently, detecting the time during a woman’s cycle when she is most likely to conceive has been imprecise. Methods included measuring basal temperature spikes, which only detect ovulation after the fact, or urine tests that indicate a surge in luteinizing hormone, which predict ovulation is imminent within 12-36 hours. Both require meticulous recording of data by the user. Ava Science offers a fertility tracker that requires much less effort on the part of the user. Ava, a device that is worn on the wrist like a bracelet while the woman is sleeping, measures key physiological parameters to detect s...
Source: MDDI - December 14, 2018 Category: Medical Devices Authors: Susan Shepard Tags: Digital Health Source Type: news

FDA grants breakthrough status to joint Merck-Bayer AI program
Merck and Bayer have been granted FDA Breakthrough Device Designation for the collaborative Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Artificial Intelligence Pattern Recognition software. CTEPH can be difficult to diagnose because its symptoms are similar to asthma and chronic obstructive pulmonary disease symptoms. CTEPH affects five people per million annually worldwide. Computed tomography pulmonary angiography and a ventilation/perfusion scan can be used to determine if thromboembolic occlusion is causing pulmonary hypertension in patients. Get the full story on our sister site, Medical Design & Outsour...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Food & Drug Administration (FDA) Bayer Merck Source Type: news

' De-Fatting' Tx May Give Discarded Livers New Life
(MedPage Today) -- Ex vivo perfusion system plus therapy reduced fat in steatotic livers (Source: MedPage Today Gastroenterology)
Source: MedPage Today Gastroenterology - November 11, 2018 Category: Gastroenterology Source Type: news

FDA grants de novo clearance to AI Biomed, FluoOptics parathyroid tissue detection devices
The FDA today granted de novo clearance to parathyroid tissue detection devices from both Fluoptics and AI Biomed. The systems are intended to provide the real-time location of parathyroid tissue during surgical procedures including thyroidectomy and parathyroidectomy, the federal watchdog said. FluOptics won approval for its Fluobeam 800 clinic imaging device which can be used as a companion to assist in locating parathyroid tissue during surgery, the FDA said. Parathyroid tissue emits a fluorescent glow when exposed to the Fluobeam’s light source, which eliminates the need for a contrast agent. The system previousl...
Source: Mass Device - November 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Imaging Regulatory/Compliance Surgical aibiomed Fluoptics Source Type: news

FDA warns of battery shutdown issues with Getinge ’ s Maquet/Datascope IABPs
The FDA this week posted a letter to healthcare providers warning of reports that Getinge‘s (PINK:GETI B) Datascope and Maquet  intra-aortic balloon pumps are shutting down while running on battery power, which could result in serious injury or death. The company’s intra-aortic balloon pump is designed to be implanted in the descending aorta distal to the left subclavian artery. The system is intended to provide temporary support to the heart’s left ventricle using an electromechanical system to inflate and deflate the balloon, increasing coronary perfusion and reducing left ventricular work, the agency said....
Source: Mass Device - November 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Featured Food & Drug Administration (FDA) Datascope Corp. Getinge Maquet Cardiovascular LLC Source Type: news

Masimo Q3 beats The Street
Masimo (NSDQ:MASI) today released third quarter earnings that topped expectations on Wall Street and lifted its guidance for the remaining year. The Irvine, Calif.-based company posted profits of $57.1 million, or $1.02 per share, on sales of $210.6 million for the three months ended September 29, for bottom-line growth of 59.3% on sales growth of 8.9% compared with the same period last year. Adjusted to exclude one-time items, earnings per share were 71¢, ahead of the 69¢ consensus on The Street, where analysts were looking for sales of $207.6 million, which the company also topped. “We are happy to report result...
Source: Mass Device - October 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat Masimo Source Type: news

Masimo wins FDA nod for improved RD SET sensors
Masimo (NSDQ:MASI) said today it won FDA 510(k) clearance for its RD SET sensors with measure-through motion and low perfusion SET pulse oximetry. The newly cleared sensors feature improved SpO2 accuracy specifications for patients under 3kg, the Irvine, Calif.-based company said, and are designed to improve accuracy, patient comfort and clinician workflows. “We’re delighted to be able to announce our continued innovation in our foundational SET pulse oximetry. Thanks to the brilliance and dedication of our engineers and the continuing support of our customers, we’ve been able to once again raise the standard f...
Source: Mass Device - October 25, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Masimo Source Type: news

Ditch the Machine to Improve Accuracy in Blood Pressure Measurement and Diagnostics
Conclusion For the patient in this case, the decision to forego the convenience of a machine in favor of the skills of a knowledgeable paramedic was lifesaving. Much like the comparison often drawn between the old-fashioned barbell and more sophisticated exercise machines, newer, more complex, and more expensive might make a process more comfortable, but doesn’t always equate to superior results. As we surrender more and more of our hands-on skills to the ease of automated technology, we risk more than the loss of the aptitudes that form the foundation of sound patient assessment—we place our patients in jeopardy of mi...
Source: JEMS Special Topics - October 24, 2018 Category: Emergency Medicine Authors: Mark Rock, NRP Tags: Exclusive Articles Cardiac & Resuscitation Source Type: news