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.
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.
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.
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.
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.
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.
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.
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.
Cala Health Inc. expanded availability of its next-generation bioelectronic Kiq device for relief of action tremors to include individuals with Parkinson’s disease as well as essential tremor. The broad commercial launch of the FDA-cleared wrist-worn device will enable more patients to use the transcutaneous afferent patterned stimulation (TAPS) therapy, which studies show reduces tremors and improves performance of activities of daily living.
Biosency SA's Bora Care remote monitoring solution can predict acute chronic obstructive pulmonary disease (COPD) exacerbations on average three days prior to hospitalization, according to initial results from an ongoing study. The results show that the technology can help prevent hospital admission and reduce the severity of acute exacerbation of COPD (AECOPD) leading to a better quality of life for COPD patients.