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

InfoBionic, Inc. today 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.

BD Sold Respiratory Business to Apax Partners

BD (Becton, Dickinson and Company) sold her Respiratory Solutions business to Apax Partners, with the latter as the majority owner of new Company.

BD announced in a press release, that --

‘BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced a definitive agreement to sell 50.1 percent of its Respiratory Solutions business to funds advised by Apax Partners, a leading global private equity firm, and form a joint venture that will operate as a new, independent Company.

The new company will include all business lines within BD’s Respiratory Solutions business including Ventilation, Respiratory Diagnostics, Vital Signs and AirLife, and have estimated annual revenue of approximately $900 million. BD’s Respiratory Solutions facilities will transfer to the new company, including locations in Yorba Linda, Calif.; Palm Springs, Calif.; Plymouth, Minn.; Mexicali, Mexico; Cotia, Brazil; Hoechberg, Germany and Shenzen, China. The new company will employ more than 5,000 associates around the world. BD will retain 49.9 percent of the company as a significant but non-controlling minority owner.

The completion of the transaction is subject to pending regulatory approval, consultations with employee representative bodies in Europe and customary closing conditions.'

The press release can be found from BD Website by clicking this link.

Avita Medical signs Distributor Deal with China’s largest healthcare Group

As per Avita Medical News release, Avita medical signs distributor contract with Sinopharm, China's biggest healthcare group.

Avita Medical announced in the news release:

Avita Medical Ltd, (ASX: AVH), (OTCQX: AVMXY), a regenerative medicine company specialising in new Treatments for wounds and skin defects, has signed an exclusive distribution deal for China with the country’s leading healthcare group, Sinopharm.

The deal, signed in Beijing on Thursday with Sinopharm’s MedTech subsidiary, grants exclusive distribution of the Avita range of medical devices, which rapidly deliver a cellular suspension to trigger healing in burns, chronic wounds and aesthetic conditions. Avita has been active in the China market for five years, with sales in the main cities of Beijing, Shanghai and Guangzhou. Avita’s Focus to date has primarily been in the fields of plastics and repigmentation, with a presence in several leading hospitals, including Peking Union Medical College Hospital, Zhongshan University No.1 hospital, Shanghai No 9 Hospital and Beijing Air Force Hospital.

State-owned Sinopharm is the largest medical and healthcare group in the world’s most populous country. It is involved in distribution, retail sales, R&D and the manufacture of various healthcarerelated products, generating sales of RMB 200 billion (US$ 30 billion) in 2014. Sinopharm is the first Chinese pharmaceutical company to be listed in the Fortune Global 500 list, and the company is publicly traded on the Hong Kong exchange (Stock code: 01099. HK).

Avita said it had been drawn towards Sinopharm in part because of the group’s wide reach, as it has offices in all main Chinese cities, and representation in 31 of the country’s provinces and regions. The Company said achieving strong distribution in China was a key goal of its global commercialization strategy, given the size of the Chinese market, which has about 3.4 million people hospitalized with burns each year 1 and around 1.4 million afflicted by vitiligo. 2 Outside of these core markets, there was also great scope for expansion into cosmetic surgery and chronic wounds, the Company said.

“Sinopharm MedTech have a proven track record of building up strong recurrent sales of medical devices, and we greatly look forward to supporting their efforts in growing the China market,” said Avita CEO Adam Kelliher. “Avita has already done a lot of the hard work in China and now is the time to build on this and work with a strong partner to address the clear need for our regenerative medicine products.”

Ms. Qiu Shiru, General Manager of Sinopharm Group Med-Tech’s Beijing office, said the company viewed ReCell® to be a “significant milestone product in the field of regenerative medicine, as it not only heals physical wounds, but also supports mental health. We regard it as a great honor to be the exclusive distributor of ReCell® in China, as it aligns with our business philosophy of “Caring for Life, Caring for Health".

Avita Medical will provide clinical support to the Sinopharm MedTech sales team and extended agent network, to help with interactions with medical professionals. The Company said the support strategy would also involve backing new research into Avita’s regenerative medicine approach, given the positive interactions with Chinese researchers to date. Investigators in Guangzhou last year delivered the first randomized controlled trial to use the device on chronic wounds, which showed superior wound closure amongst those treated with ReCell®

The Chinese distributor deal is the eighth territory to be signed by Avita in the past three months, as the Company escalates its commercialization activities and expands its sales footprint.

Here is the link to the news release on Avita website.

Whom will Toshiba marry?

Strapped by cash problem, Japanese Toshiba will sell the medical device unit in order to improve their finance situation after the accounting scandal.

Not many details are disclosed, it is believed that the value of the deal is between $6 billion to $6,5 billion. Fuji Film, Canon and a consortium form by Konica Minolta and an UK private equity fund are in the second round bidding.

The negotiation of the deal should not last very long, but whom will Toshiba marry in the end?

Another Japanese firm, Sharp Inc. was also trying to sell the business to potential buyers. Sharp was very close to closing a deal with Foxconn, but the deal is suspended. Foxconn-Sharp marriage is the best solution interm of product and business integration, but there are strong voices against this deal: a Japanese firm should stay in hands of Japanese, or some Japanese would rather leave Sharp in bankruptcy. A Japanese government endorsed investment fund was trying to acquire Sharp but eventually withdrew.

Hence now a Japanese company, Canon or Fuji, buys Toshiba medical device unit shall be the most possible and logical result. For the sake of saving the pride and dignity of the Japanese manufacturing industry, Toshiba has to marry a Japanese as a bitter happy end of the story.

Med Tech to be listed in China's 13th 5-year-plan

Chinese Central Government proposed 100 most important projects in the 13^th 5-year-plan, the National People’s Congress (NPC) is reviewing the plan.

Among the 100 most important projects defined by the top leaders, 4 are from med tech cluster including:

- R&D of high performance medical devices such as nuclear medical imaging equipment, superconductor resonance imaging equipment and non-invasive life-supporting machine,

- Development and application of medical devices having Chinese traditional medicine advantages,

- Accelerating large scale application bio science, for instance genomics,

- Development of robotic surgical system

This proposal reflects the industry upgrading strategy of China at national level.

Opportunities for cancer diagnostics and treatment devices

It is believed that many patients suffering from cancer could be treated if the tumor can be detected at very early stage.


Number of newly diagnosed cancer patients in China

As per statistics, number of newly diagnosed cancer patients keeps growing in China, which escalates the demand of medical devices and in-vitro products such as early screening devices, diagnostic devices, bio-markers, imaging devices and radiology equipment. This also generates opportunities for medical examination centers as well as independent medical imaging centers.

ISO 13485:2016 published

The International Organization for Standardization (ISO) published ISO 13485:2016 for medical devices on 01 March 2016.

The update of the standards will have impact on medical devices including in-vitro products.

An Abstract of the requirements could be found here, by clicking this link. 

A preview to ISO 13485:2016 could be found from ISO website by clicking this link.

CFDA Shandong accepts online application

As from 01 March 2016, CFDA Shandong China starts to accept online application of medical device production license, which falls under their administration. Medical device manufacturers can submit application documents in the form of electronical files through the online platform of CFDA Shandong.

The process also applies to production license for foodstuffs in Shandong Province. An applicant can also track and trace the progesss and result of the application in a real time manner, which brings conveniences to manufacturers.

Medtec Europe 2016 to open in Stuttgart Germany

Medtec Europe is a good sourcing place for medical device companies. The event brings device companies and technology providers under the same roof.

During Medtec Europe 2015, some 640 exhibitors and 6,200 visitors attended the fair in Stuttgart Germany.

Medtec Europe 2016 is to open on 12-14 April 2016 in Stuttgart, admission is free of charge for professional visitors.