Release date: 2017-01-17
The arrival of the new year also means that a series of new medical devices will appear in the United States. Products that are highly anticipated include diabetes devices, new transcatheter aortic valves, and new surgical robot systems. In this inventory, this year, the patients expect to see the top 10 medical devices in the United States.
NO.1 Portor's Lotus Edge
Poco's new generation of transcatheter aortic valve, Lotus Edge, is expected to receive FDA certification in the fourth quarter of 2017. The new valve can be repositioned and re-recovered, and early data have shown a low incidence of paravalvular leaks and permanent pacemaker implantation.
The REPRISE III experiment compared Lotus Edge with Medtronic's CoreValve, which is expected to be released in May 2017. This experimental data will be used for valve 21-, 23-25, and 27-mm models to receive FDA approval in the fourth quarter. The 29-mm model is expected to be approved later.
As of January 4, 2017, this product has not been approved or approved by the US FDA regulatory authorities.
NO.2 Porco's Vercise Deep Brain Stimulation System
Poco's Vercise Deep Brain Stimulation (DBS) system is being tested in the United States for Parkinson's syndrome. Neuromodulation systems have been used in Europe for indications including Parkinson's disease, idiopathic tremor, primary and secondary dystonia.
When the management commented on the company's third quarter 2016 revenue, it reiterated that it will launch Vercise in the US later in 2017.
As of January 4, 2017, this product has not been approved or approved by the US FDA regulatory authorities.
NO.3 Johnson & Johnson's OneTouch Via
The OneTouch Via system for insulin on demand, earlier when the technology belonged to Calibra Medical, received FDA approval. Currently, Calibra Medical is a Johnson & Johnson diabetes care company. The device is a wearable device for insulin control. Bridget Kimmel, senior manager of OneTouch and Johnson & Johnson Diabetes Care's North American region, said that in late November 2016, the 510(k) application for the equipment update process was resubmitted to the FDA. She hopes that OneTouch Via will be available in the US market in the first half of this year.
As of January 4, 2017, this product has not been approved or approved by the US FDA regulatory authorities.
NO.4 Medtronic's MiniMed 670G system
Medtronic's MiniMed 670G is the first hybrid closed-loop system for insulin delivery, known as the first artificial insulin, and was approved by the FDA in September 2016. The system is designed to help patients maximize their free time within a reasonable range of blood glucose levels.
The FDA approval came earlier than expected, and Medtronic plans to launch the system in the US market in the spring of 2017.
NO.5 Medtronic's Resolute Onyx Drug Eluting Stent
Drug-eluting stent (DES) giant Medtronic expects to release Resolute Onyx DES in the US market before the end of the most recent fiscal year (end of April). Resolute Onyx has received European CE certification in November 2014 and other sizes and indications in February 2016. As of January 4, 2017, this product has not been approved or approved by the US FDA regulatory authorities.
The arrival of the new year also means that a series of new medical devices will appear in the United States. Products that are highly anticipated include diabetes devices, new transcatheter aortic valves, and new surgical robot systems. In this inventory, this year, the patients expect to see the top 10 medical devices in the United States.
NO.6 Neuronix Medical's neuroAD treatment system
According to NeuroNews, Neuronix Medical's neuroAD treatment system is expected to receive FDA certification in 2017. This device is designed to help patients with Alzheimer's disease to combine Transcranial Magnetic Stimulation (TMS) with cognitive training to improve their cognitive ability.
The neuroAD treatment system is already available in Europe. As of January 4, 2017, this product has not been approved or approved by the US FDA regulatory authorities.
NO.7 St. Jude's HeartMate 3 left ventricular assist system
St. Jude's acquisition of Thoratec in October 2015 continued to develop Thoratec's HeartMate 3 left ventricular assistive technology. The latest generation of HeartMate 3 Left Ventricular Assist System (LVAS) has been CE certified and is undergoing MOMENTUM 3 IDE clinical trials. In November 2016, the tracking data for the experiment was announced within 6 months.
At present, there is no news about the timeline of HeartMate 3 in the public domain. However, in February 2016, the company's investors stated that the management promised to submit short-term data to the FDA in the second half of 2016. If the approval time is estimated to take 12 months, the device is expected to be FDA-approved by the end of 2017.
As of January 4, 2017, this product has not been approved or approved by the US FDA regulatory authorities.
NO.8 St. Jude's ICDs and CRT-Ds for Magnetic Resonance
In the third quarter earnings report conference in October 2016, the company's management indicated to analysts that documents for MRI safety high voltage devices will be submitted to the FDA in the fourth quarter of 2016. It is expected to receive FDA certification in the first half of 2017.
The company said on the investor's report date in February 2016 that if it is successfully approved by the FDA, the mark representing MRI safety will be available for the existing Ellipse and Fortify Assura ICDs, as well as the Quadra Assura CRT-D.
As of January 4, 2017, this product has not been approved or approved by the US FDA regulatory authorities.
NO.9 Stryker Triathlon total knee for MAKO system
Stryker's Triathlon Total Knee for the Mako Robotic system has received FDA approval.
According to the 2016 report, although the FDA approved the use of the Triathlon total knee Mako system in August 2015, the company decided to postpone the product launch in 2017 to optimize the patient experience. It is expected to be released in the spring of 2017.
NO.10 TransEnterix's Senhance Surgical Robot System
TransEnterix's focus shifted from the SurgiBot system to the Senhance surgical robot system (formerly known as the ALF-X system). According to reports, the availability study of the product has been completed and the company plans to submit 510(k) documents in early 2017.
Senhanc is expected to receive FDA certification in 2017. As of January 4, 2017, this product has not been approved or approved by the US FDA regulatory authorities.
Source: Kexun Medical Network
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