The Latest Pediatrics Technology News: Medgadget

Pediatrics

October 18th, 2018

Pediatrics

Tyto Lets Primary Care Docs Examine Patients Remotely, Now Cleared in Europe

Tyto Care, based in Israel, won the European CE Mark, allowing it to introduce its telemedicine system on the continent. This product lets people perform exams on each other under the guidance of a physician who is able to see and hear what's...

October 11th, 2018

Pediatrics

MIT's Non-Invasive Glucometer as Accurate as Finger Pricks In Early Clinical Study

Non-invasive blood glucose measurement remains one of the most intriguing challenges for medical technology. While we've been promised prick-free glucometry by various companies and institutions, researchers at MIT are getting close to the...

October 9th, 2018

Pediatrics

MedAware Uses AI to Detect Potential Medication Errors: Interview with Dr. Gidi Stein, CEO

Medical errors are the third-leading cause of death in the US and they are probably the most common and preventable. MedAware, an Israeli company, is using the power of artificial intelligence to detect potential errors before they happen. The...

October 8th, 2018

Pediatrics

Aptar Pharma Releases New Portable Ready-to-Go Upper Respiratory Inhaler

Aptar Pharma, a company based outside of Chicago, is releasing a new portable and easy to use inhaler for upper respiratory conditions. The PureHale device comes ready to use, and the tank can take saline or other solutions designed to clean,...

October 8th, 2018

Pediatrics

Unique Nebulizer and Drug Combo Approved for MAC Lung Disease

PARI Pharma, a German manufacturer of aerosol delivery products, won FDA approval of its LAMIRA nebulizer along with Insmed's ARIKAYCE (amikacin liposome inhalation suspension) drug for treating lung infections caused by the mycobacterium avium...

October 1st, 2018

Pediatrics

Abbott's New FreeStyle Libre 2 Continuous Glucometer with Level Alarms Cleared in EU

Abbott won the European CE Mark for its FreeStyle Libre 2 continuous glucose monitor that features low and high glucose level alarms, letting patients know in real-time that they're falling outside of their normal range. The system...

September 26th, 2018

Pediatrics

Philips Unveils Augmented Infant Resuscitator for Safe Rescue of Asphyxiated Newborns

A collaboration between Philips, and researchers at Massachusetts General Hospital, Mbarara University of Science and Technology in Uganda, and MIT, has developed a device that helps to safely resuscitate asphyxiated newborns. The...

September 21st, 2018

Pediatrics

First Blood Pressure Monitor with Cellular Connectivity Now Available in U.S.

Livongo, a Silicon Valley firm, is releasing in the U.S. its cellular-based blood pressure monitor, along with a smartphone app and accompanying online platform for managing and sharing the readings. The blood pressure unit uploads its...

September 14th, 2018

Pediatrics

Philips Trilogy Evo Portable Ventilator Platform Makes Transitions Easy

Being on a ventilator can be a frightening experience for many patients, and switching between different ventilators for transport, or when going home, can be emotionally challenging as well. To make transitions such as these easier for patients...

September 14th, 2018

Pediatrics

Paper Test for Monitoring Phenylalanine and Other Metabolites in Blood

People with congenital phenylketonuria, a condition in which the amino acid phenylalanine is overproduced, have to undergo regular blood testing. This is important in part because maintaining a proper diet can reduce phenylalanine levels, so...

September 13th, 2018

Pediatrics

Flexible Stick-On Ultrasound Patch Measures Central Blood Pressure

Scientists at the University of California San Diego created a flexible ultrasonic patch that can measure the blood pressure in major vessels such as the jugular vein and carotid artery. The technology has already shown, in a proof-of-concept...

Upcoming conferences

october

18octallday19alldayWorld Congress on Polycystic Ovarian Syndrome and Fertility, 2018Abu Dhabi, UAE

18octallday19alldayManaging Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an InspectionMinneapolis, MN, USA

Event Details

Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

By attending this seminar, you will discover:

How to overcome one of the biggest obstacles device manufacturers face
How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

**New course materials have been added, updated content will include:

Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
What to expect from the changes in ORA with Inspection Structure Realignment

This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that only Rita Hoffman, a former FDA CDRH Recall Branch Chief with experience across the device, drug and veterinary industries can provide.

Spend one and a half days in an interactive course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief with over 36 years with FDA and leading Industry Expert, who will provide the participants with tools to minimize risk of regulatory enforcement actions.

Time

october 18 (Thursday) - 19 (Friday)

Organizer

Compliance Online 80068SEM

Learn More

Calendar GoogleCal

18octallday19allday18th Global Ophthalmology, Optometry and Glaucoma Conference, 2018Helsinki, Finland

18octallday19alldayBiology and Pathology of Infectious Disease Conference, 2018Helsinki, Finland

18octallday19allday14th Global Biomarkers Summit, 2018Amsterdam, Netherlands

22octallday23alldayInternational Conference on Breast Cancer, 2013Vancouver, British Columbia, Canada