The U.S. FDA granted Renalytix plc de novo marketing authorization for its prognostic test for chronic kidney disease (CKD). Kidneyintelx is an artificial intelligence-enabled prognostic testing platform to guide treatment decisions for adults with type 2 diabetes and diabetes-related early stage chronic kidney disease.
The U.S. FDA’s draft guidance for predetermined change control plans (PCCP) is a groundbreaking document for med-tech regulation, but stakeholders see a few holes in the draft version. One of the issues for device manufacturers is that the guidance seems to exclude any possibility of inclusion of a new intended use or indication for use in a PCCP, while others seek more detail on how this policy can be applied to the device component of a combination product, two elements that may prove complicated to address in the final guidance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Amneal, Ayala, Biocardia, C4, Clarity, Impact, Incyte, Infant, Jacobio, Moderna, Poseida, Rarestone, Taiho, Tiumbio, Vertex.
South Korean pharmaceutical giant Yuhan Corp. gained Korea’s MFDS approval to expand indications for its potent oral third-generation tyrosine kinase inhibitor Leclaza (lazertinib) as a first-line treatment for EGFR T790M mutation-positive non-small-cell lung cancer (NSCLC).
The U.K. National Institute for Health and Care Excellence (NICE) released several draft and final health technology assessments on July 5, including a review of the use of artificial intelligence (AI) to aid in the detection of lung nodules in CT images. The agency said that more research is needed before it will be able to provide an unqualified endorsement because of a relative lack of data that could be reliably generalized from clinical study subjects to the broader U.K. population at large.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Dexcom.
Rapid point-of-care diagnostics company Lumos Diagnostics Inc. saw its stock shoot up 327% on the news that it finally gained U.S. FDA 510(k) clearance for its Febridx rapid, point-of-care test for bacterial infections. Febridx is a finger prick blood test that can indicate if a person has a bacterial or viral acute respiratory infection within 10 minutes.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Iaso, Mediwound, Moderna, Nevakar, Injectables, Skyline, Systimmune, Zealand.
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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