The European Commission has granted CE mark approval to Medtronic plc for its Inceptiv closed-loop rechargeable spinal cord stimulator (SCS). The device is the first Medtronic SCS to sense an individual’s biological cues and make adjustments in real time to control pain all day long. Dublin-based Medtronic plans to launch Inceptiv in Europe in the coming months.
Australia’s Therapeutic Goods Administration (TGA) has issued a regulatory proposal regarding the agency’s approach to audits for devices, a proposal that might reduce the number of these audits. TGA said it may limit audits to the highest-risk devices and may eliminate them for devices that have been granted market access in other regulatory jurisdictions.
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.
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.
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.
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