ThisWeek in MedTech – September 2, 2024
ThisWeek in MedTechThisWeek in MedTech is part of the MTI Newswire service for MTI subscribers and followers providing linked original content from leading industry sources as indicated. MedTech Intelligence nor the MTI Staff are involved with the writing of content shared below. Embecta’s insulin delivery system gains FDA nodThe FDA has given 510(k) clearance to Embecta for its open-loop disposable insulin delivery system for adults with type 1 and type 2 diabetes who require insulin. The patch pump has a 300-unit insulin reservoir. Read the story > Drug Delivery Business NewsAidoc’s AI algorithms for CT scans secure CE markEuropean regulators have given Aidoc CE mark for four new artificial intelligence algorithms for its aiOS platform for analyzing CT images. The company also secured CE mark for three quantification solutions for standardized quantitative assessments of neurological and cardiovascular conditions. Read the story > Medical Device NetworkMedtronic Has Positive Long-Term Extravascular ICD Study DataMedtronic has positive long-term extravascular ICD study data. Read the story > Medical Product OutsourcingFDA releases final guidance on voluntary malfunction summary reportingThe FDA has released the final guidance for the Voluntary Malfunction Summary Reporting program, which permits medical device manufacturers to submit certain device malfunction reports quarterly in summary form instead of every 30 days in individual reports. In response to a clarification request from AdvaMed, the guidance also includes a new line stating that companies can leave the program and resume submitting 30-day malfunction reports whenever they choose. Read the story > MedTech DiveFunding round brings in $10.75M for Melodi HealthAn oversubscribed Series A funding round has brought in $10.75 million for Melodi Health. The company, which develops the Matrix mesh technology for soft tissue, plans to use the funds for product development and to support clinical activities. Read the story > MassDevice
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