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Home » Topics » Medical devices and technologies » Medical devices

Medical devices
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Osteopore 3D skull implant

Osteopore’s 3D regenerative implants could revolutionize orthopedic surgery

July 17, 2023
By Tamra Sami
Tissue regeneration company Osteopore Ltd. is on the cusp of dramatically changing the way orthopedic surgery is conducted globally, with Australia playing a crucial role. Osteopore was the first company to successfully develop and commercialize 3D-printed bioresorbable implants for surgical use, reducing post-surgery complications compared to permanent implants.
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Artificial intelligence and digital health icons

JAMA authors see problems with failures to acknowledge the use of AI in medical devices

July 10, 2023
By Mark McCarty
Device makers are often cited in U.S. FDA warning letters for making claims not seen in the approved labeling, but the authors of a recent review of artificial intelligence (AI) products cleared by the FDA suggest that FDA documents and marketing materials should disclose the presence of AI in these products. The authors of an article in the Journal of the American Medical Association said that only about 80.6% of the products were represented with accurate statements about the presence of AI, although FDA regulation does not require that marketing materials make such disclosures.
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Alfapump system from Sequana Medical

Sequana reports promising results for its automatic pump to control ascites

July 5, 2023
By Bernard Banga
Sequana Medical NV has reported additional data on safety, survival and quality of life from its POSEIDON pivotal study in North America, evaluating its Alfapump device used in the treatment of patients with recurrent or refractory ascites caused by liver cirrhosis. The data were recently presented at the European Association for the Study of the Liver 2023 congress in Vienna.
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Aveir DR dual-chamber leadless pacemaker

Abbott snares FDA approval for leadless, dual-chamber Aveir pacemaker

July 5, 2023
By Mark McCarty
Leadless cardiac electrophysiology devices have been around for a while now, but Abbott Laboratories of Abbott Park, Ill., has managed to beat the competition in the market for dual chamber pacing via two leadless devices. The company reported July 5 that the U.S. FDA has approved the Aveir DR, a two-unit device configuration that provides pacing for both the right ventricle and the right atrium and which some analysts believe helps to make Abbott shares an underappreciated asset for investors.
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UK’s MHRA formally accepts extended timeline for acceptance of CE mark

July 3, 2023
By Mark McCarty
The difficulties in rolling out the EU’s Medical Device Regulation are well known, but the attendant delays continue to exert ripple effects in other markets. The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has formally extended the time frame for acceptance of existing CE marked devices into the U.K. market, another demonstration of the ongoing turmoil associated with the herky-jerky deployment of the MDR.
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Cerevasc Inc.'s eshunt system

Cerevasc and Lianmedical partner in Asia’s neurology device market

July 3, 2023
By Doris Yu
Cerevasc Inc. has formed a partnership with Lianmedical Co. Ltd. to introduce Cerevasc’s medical devices for neurological diseases in the Asian market. Shanghai-based Lianmedical will help market Cerevasc's eshunt system and related products in mainland China, Hong Kong, Taiwan, and Macau. It’s eshunt system provides percutaneous transvenous-transdural access to the central nervous system.
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Valkky nursing robot

Touchlab initiates nurse robot pilot study

July 3, 2023
By Nuala Moran
To date the use of robots in nursing has been limited to getting them to fetch and carry supplies, take samples to the lab, remotely measure temperatures, or maybe provide social stimulation. Now in Laakso Hospital, Helskini, Finland, a robot is getting hands on to patients on a stroke ward, in a three-month pilot designed to assess which of 350 tasks in a nurse’s job description it is best suited to perform.
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Shoni Health Ventures launches fund for startups focusing on digital health and medical devices

June 29, 2023
By Shani Alexander
Israeli venture capital fund, Shoni Health Ventures, launched a new fund focused on startups specializing in digital health and medical devices. Recognizing that innovative solutions with the potential to improve global health may go unrealized as health tech startups struggle to attract early-stage investors, the fund is focused on investing in companies at the pre-seed and seed-stage.
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Flag of India

New Indian medical device policy aims to boost local manufacturing

June 27, 2023
By T.V. Padma
With a new medical device policy, India is laying the groundwork for a spurt in domestic manufacturing and to emerge as an innovative and globally competitive in the space, which is currently heavily reliant on imports. The new National Medical Devices Policy 2023, approved by the government at the end of April and notified in May, aims to place the Indian medical devices sector on an accelerated growth path.
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Bioactive glass

Silver-infused glass improves wound healing

June 19, 2023
By Annette Boyle
Saturating bioactive glass with silver sustains the metal’s antimicrobial properties and reduces biofilm formation, researchers at the University of Birmingham, U.K., found. Their study, published in Biofilm, demonstrated that specific preparation, storage and application techniques minimize the transformation of silver ions to silver chloride that typically reduces silver’s healing properties over time.
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