3-in-1 Cardiac Arrhythmias Remote Monitoring System gets FDA Clearance

InfoBionic, Inc. announced that it received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for MoMe® Kardia, a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac Monitoring.

MoMe® Kardia is the first 3-in-1 single piece device that acquires and stores ECG and motion data and transmits that data via embedded cellular technology to the MoMe® Software System, a cloud-based platform with proprietary algorithms for analysis, using the MoMe® Device Communications Protocol. The transmitted data is then analyzed by the MoMe® Software Platform via completely new and robust server-based algorithms and when indicated, data identified by these algorithms is flagged for physician review. MoMe® Kardia requires no patient intervention to capture or analyze data, however it does provide a patient event trigger.

InfoBionic news release could be found from this link.

MedTec China South 2016 Opens

MEDTEC China South serve as China’s only exclusively dedicated exhibition of design and manufacturing technology for China medical device industry. Unlike other shows that focus entirely on finished products and target hospital personnel visitorship, the target visitor profile of MEDTEC China comprises senior management, R&D engineers, production engineers and QA professionals who are searching for components, materials, technologies and solutions for their production lines.

This 2 days event is open to professional visitors from 16-17 March 2016.

More information could be found from the event’s website.

St. Jude obtains CE approval for MRI Compatible Nanostim Leadless Pacemaker

St. Jude announced CE Mark approval for magnetic resonance (MR) conditional labeling for 1.5 T scans for the company’s Nanostim™ leadless pacemaker. With the approval, throughout Europe both existing patients implanted with a Nanostim leadless pacemaker and new patients receiving a Nanostim leadless pacemaker in the future can safely undergo full-body MRI diagnostic scans.

Product information could be found from this link.

Further news: FDA Approves World’s Smallest yet Leadless Pacemaker

Iran Japan Medical Devices Pack, Business or Politics?

It was reported that Iran and Japan concluded a package based on grant-aid, that Japan will supply to Iran medical devices valuing ca. US$ 10 million. Companies like Fuji Film and Toshiba Medical System will participate this program, devices like ultrasonic diagnostic equipment, endoscopes, and other offerings which Japanese firms are strong in will be involved.

Tokyo is to resume yen loans after a 15-year hiatus. Infrastructure work involving Japanese companies, including repairs to fossil-fuel-fired power plants, is also under consideration.

The Japanese Prime Minister Abe is also eager to visit Teheran.

It is not clear which motive is stronger behind this medical device deal, business or politics. Japan may use this medical device aid, which sounds moral, to knock the door of the Iranian market open, and squeeze Russia and China out of Iran. By doing so, Japan could uplift their political influence in Iran over Russia, China, US and Europe.

Suppose some day in the future, when USA imposes sanctions to Iran again for whatever reason(s), should Iran worry about the after-sales-service, update/upgrade, spare parts supply, maintenance and etc, for the medical devices they bought from Japanese firms?

FDA OKs Parker Hannifin’s Indego Exoskeleton for Both Clinic and Home Use

After receiving CE mark in late 2015, Parker Hannifin announced that FDA has also cleared Indego Exoskeleton for clinic and personal use.

Indego is a robotic exoskeleton or powered orthotic device that allows users to stand and walk and holds great promise for affording people with paraplegia a new level of independence. “For individuals who sustain spinal cord injuries, this is a milestone that could have a meaningful impact on their lives,” said Tom Williams, chairman and CEO of Parker Hannifin.

Indego system is now available in European market, Parker Hannifin plans to offer the device in USA market as well in a few months.

Please go to Indego product page by clicking this link.

Further news: FDA Cleared Robotic Exoskeleton for Patients from Stroke & Spinal Cord Injury

Innovative interventional resection device approved for CE

The EndoRotor™ System is intended for the removal of alimentary tract mucosa during olonoscopy.

This innovative single resection tool designed for mucosal lesions, which has the potential to replace the need for multiple instruments with 1 and eliminate the time necessary 
for the exchange of multiple instruments.

Interscope, a med tech startup based in USA, declared that their EndoRotor system has obtained CE Mark approval in Europe, however the device is not yet FDA cleared.

The EndoRotor product brochure can be viewed from Interscope website by clicking this link.