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According to the official website of China's National Medical Products Administration (NMPA), three innovative medical devices were approved by the NMPA in October, including Abernoord's aspherical diffraction multifocal intraocular lens, Eco Medical's blood flow-directed dense mesh stent and Qianglian Zhichuang company's intracranial aneurysm surgery planning software
.
All three medical devices have previously been approved for the NMPA special review process
for innovative medical devices.
This article will combine public information to see what are the characteristics of
these products.
Ebonord: Aspherical diffraction type multifocal intraocular lens indication: cataract
Ebonord: Aspherical diffraction type multifocal intraocular lens indication: cataractOn October 31, the official website of the NMPA announced that it approved the launch of the innovative product "aspheric diffraction multifocal intraocular lens" produced by Abonord for vision correction in adult cataract patients, which is expected to provide two focal points
: far and near.
According to the announcement of Abonod, the product belongs to a high-end refractive intraocular lens, which uses the principle of diffractive optics to achieve spectroscopy, combined with aspheric depth expansion technology, while treating cataracts, it can make up for the lack of poor vision of monofocal intraocular lenses to a certain extent, so that patients can obtain better postoperative vision and quality of life
.
According to the NMPA, the innovation of the product lies in the combination of diffraction spectroscopy and aspheric design in its optical part, and diffraction technology is the core of
multi-focus.
: far and near.
It uses the principle of diffractive optics to achieve spectroscopy, combined with aspheric depth expansion technology, which can make up for the lack of monofocal intraocular lens vision to a certain extent while treating cataracts, so that patients can obtain better postoperative vision and quality of life
According to public information, Abonord focuses on the research and development of ophthalmic medical devices, and its current products cover two major fields of surgery and optometry, mainly targeting cataracts and refractive errors, two major types of ophthalmic diseases
that cause blindness and cause visual impairment.
The company's intraocular lens products and orthokeratology lenses have been approved for marketing, and it is currently developing high-end ophthalmic medical device products
such as phakic intraocular lenses.
Eco Medical: Indications for blood flow directed dense mesh stents: aneurysm
Eco Medical: Indications for blood flow directed dense mesh stents: aneurysmOn October 26, the NMPA official website announced that it approved the marketing of the innovative product "blood flow-directed dense mesh stent" produced by Eco Medical for adult patients with internal carotid artery (petrous segment to end) and vertebral artery unruptured sac-shaped or spindle-shaped wide neck (tumor neck width ≥4mm or tumor/tumor neck ratio <2) aneurysm, and the diameter of the tumor vessel ≥ 2.
0mm and ≤ 5.
6mm
。 According to the Eco Medical press release, the approved product is a mechanical balloon delivery blood flow directed dense mesh stent, which innovatively uses a mechanical balloon delivery stent to actively assist expansion from the inside of the stent, push the stent to the treatment site, and realize the recovery
of the stent when needed.
In addition, the implant and delivery balloon of this product are surface treated with MIROR technology (metal interface modification to optimize stenosis within stents), which can reduce thrombogenicity and uniformly endothelialize
.
0 mm and ≤ 5.
6 mm directed to the dense mesh stent
According to public information, Eco Medical was established in 2017 and is committed to developing a series of innovative neurointerventional devices and related pathway devices for the diagnosis and treatment of hemorrhagic stroke and ischemic stroke
.
At present, the company has three products approved for marketing in China, including distal access catheters, microcatheters and this approved blood flow guided dense mesh stent
.
Qianglian Zhichuang: Intracranial aneurysm surgery planning software Indications: intracranial aneurysm
Qianglian Zhichuang: Intracranial aneurysm surgery planning software Indications: intracranial aneurysmOn October 11, the NMPA official website announced that it approved the listing of the "intracranial aneurysm surgery planning software" produced by Qianglian Zhichuang Company, which is used for the display, segmentation, measurement and processing of X-ray angiography three-dimensional body image in patients with cerebrovascular disease, and assists doctors in performing microcatheter path and shaping planning
for aneurysm spring ring embolization during neurointerventional surgery 。 According to the NMPA announcement, the product uses medical image processing technology to process X-ray angiography three-dimensional tomography images of patients with intracranial aneurysms to realize three-dimensional vascular reconstruction, aneurysm segmentation and automatic measurement, as well as microcatheter path and shape planning of shaping needles, to help doctors plan preoperative programs
.
Compared with traditional neurointerventional surgery, the product can improve the one-time arrival rate of microcatheters, shorten the delivery time of microcatheters, reduce the probability of complications caused by repeated intraoperative microcatheters pushing on blood vessels, and reduce the X-ray radiation time
of doctors and patients.
Founded in 2016, Qianglian Zhichuang focuses on the intelligent diagnosis and treatment
of acute and chronic cerebrovascular diseases.
According to the press release of Qianglian Zhichuang Company, the approved Uknow surgical planning software is an innovative medical device of "AI+ treatment", which applies AI technology to brain surgery and upgrades aneurysm intervention from two-dimensional perspective of artificial surgery to three-dimensional perspective of innovative technology
.
The data of pre-marketing clinical research shows that with the assistance of this software, the success rate of doctors with different surgical experience has been greatly improved, and the success rate is not significantly different
.
.
Resources:
Resources:
[1] China National Medical Products Administration (NMPA) official website.
from
from [2] Announcement of EBONOLD (Beijing) Medical Technology Co.
, Ltd.
on the approval of aspheric diffraction multifocal intraocular lenses through the special review process for innovative medical devices.
Retrieved Nov 1 , 2022.
From https://static.
sse.
com.
cn/disclosure/listedinfo/announcement/c/new/2022-11-02/688050_20221102_1_BwORoPEP.
pd [2] Announcement of EBONOLD (Beijing) Medical Technology Co.
, Ltd.
on the approval of aspheric diffraction multifocal intraocular lenses through the special review process for innovative medical devices.
Retrieved Nov 1 , 2022.
From https://static.
sse.
com.
cn/disclosure/listedinfo/announcement/c/new/2022-11-02/688050_20221102_1_BwORoPEP.
pd
f[3] The first mechanical balloon-mounted blood flow directed dense mesh stent approved by NMPA.
Retrieved Oct 31, 2022.
From
Retrieved Oct 31, 2022.
From [4] A new breakthrough in medical AI! Qianglian Intelligent ® Innovation Products was approved as China's first AI+ treatment NMPA innovative medical device Class III certificate, creating a precedent for AI-assisted surgical treatment.
Retrieved Oct 11 , 2022.
From https://mp.
weixin.
qq.
com/s/fdOPISETyV9YJyxX-vJsvQ [4] A new breakthrough in medical AI! Qianglian Intelligent ® Innovation Products was approved as China's first AI+ treatment NMPA innovative medical device Class III certificate, creating a precedent for AI-assisted surgical treatment.
Retrieved Oct 11 , 2022.
From https://mp.
weixin.
qq.
com/s/fdOPISETyV9YJyxX-vJsvQ
