The US Food and Drug Administration’s plan to exercise more authority over lab-developed tests came one step closer to fruition this week, as the White House Office of Management and Budget announced on 22 April that it had completed its review of the final rule. OMB review is the last step before a document can be officially published.
News We're Watching: LDT Final Rule Near Publication, Zimmer ROSA Used In Shoulder Surgery, $60M For Menopause Clinic
This week, the US FDA's proposed final rule on lab-developed tests cleared another hurdle on the path to release; Zimmer Biomet announced that its ROSA surgical robot had been used in shoulder replacement surgery for the first time; and a virtual menopause clinic closed out a $60M fundraising round.
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Only 16% of venture capital general partners in Europe are women, and only 9% of those have actual investment power. Thena Capital is aiming to "redefine the image of a venture capitalist."
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Cambridge, UK-based breath biopsy company Owlstone Medical will apply its volatile organic compound analysis platform in an attempt to develop a test for the identification and monitoring of pseudomonas aeruginosa in patients with cystic fibrosis.
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Dublin-based Neuromod has closed a €10m ($10.9m) series B funding round to bring a "new standard of care" to patients with tinnitus.
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During a panel discussion at HIMSS, experts highlighted the shift in digital health funding in 2024 with “mega funds” dominating the space and big tech companies developing foundational models that large health care customers use to address multiple use cases. They noted, however, there is ample room for smaller companies to develop technologies adjacent to incumbent systems.
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This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
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This week, the FDA announced a new head of its device evaluation office; synthetic genomics firm Constructive Bio landed $58m in funding; and Natera got a permanent injuction against NeoGenomics Labs' RaDaR assay.
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This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.