Responding to the burgeoning field of digital health, the U.S. FDA reported the creation of a new Digital Health Advisory Committee that it expects to be up and running in 2024.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Neoss, Orthofix Medical, Sentiar.
As it continues its crackdown on accelerated approval, the FDA continues to stress that successfully completing confirmatory trials should be the top priority for sponsors of drugs that enter the U.S. market via accelerated approval.
Concerns over the EU’s agonizingly clunky roll-out of the Medical Device Regulation (MDR) has largely focused on the capacity of notified bodies to manage the task of recertifying CE marks for legacy devices, but a new problem has emerged that promises to add yet more drag to the process. Amie Smirthwaite, senior vice president for innovation at RQM+, said EU member states’ competent authorities seem bent on pressing notified bodies (NBs) to treat guidance by the Medical Device Coordination Group (MDCG) as regulation, with the net result that “you almost need guidance for the guidance” in order to successfully navigate the EU market.
The U.S. FDA 510(k) clearance of Airamed GmbH’s Airascore software could see millions of people benefitting from early accurate diagnosis of Alzheimer’s disease and other types of dementia. Airascore is a medical image management and processing system that uses deep learning and artificial intelligence (AI) to assess brain volumetry data on MRI scans in as little as five minutes.
The U.S. FDA’s final guidance for clinical decision support (CDS) systems may be the subject of two citizen’s petitions requesting the agency scrap the guidance and start over, but that doesn’t mean the agency is not enforcing the terms of the guidance. Danvers, Mass.-based Abiomed Inc., took in a Sept. 19 warning letter stating that the company’s Impella Connect system qualifies as a CDS product because it provides “patient-specific medical information to detect a life-threatening condition,” an interpretation that is sure to intensify the larger debate about whether the CDS final guidance is an extra-statutory exercise in regulatory engineering.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Intelivation Technologies.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Annexon, Immpact, Inovio, Supernus.
Hoping to find a niche where it can be a pacesetter in biopharma development, the Canadian government is investing CA$49 million (US$36 million) in the new Conscience Open Science Drug Discovery Network. The investment will be used to accelerate drug R&D “by leveraging Canadian strengths in artificial intelligence and employing open science principles to drive efficiencies in building Canadian innovation capacity and delivering the medicines that Canadians need,” François-Philippe Champagne, minister of Innovation, Science and Industry, said in announcing the funding Oct. 5.
The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is one of the more innovative regulatory proposals in recent memory, although the FDA is not statutorily required to limit this policy to artificial intelligence (AI) and machine learning (ML) products. Nonetheless, the PCCP concept is starting to show signs of being consumed by the debate over AI and ML medical software, so much so that industry may be losing sight of the opportunities the PCCP concept offers in other types of medical technologies.
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