The FDA has struggled to revise a guidance related to cybersecurity in medical devices, but developers now have more than just lagging FDA guidances to worry about where cybersecurity is concerned. The U.S. Department of Justice (DoJ) has unveiled a program designed to leverage the False Claims Act to pursue entities that come up short of regulatory expectations for cybersecurity, constituting a new vector for liability for makers of devices and medical software.
Diacarta Inc.’s diagnostic assay, Coloscape, could be the first to meet the Centers for Medicare and Medicaid Service (CMS)’s strict standards for Medicare coverage of a liquid biopsy for colorectal cancer screening if results seen in a Plos One study are borne out in larger trials and the test gets the nod from the FDA. That is a lot of ifs, but the study posted strong results: 100% specificity and 92.2% sensitivity for cancer and 95% specificity and 62.5% sensitivity for precancerous lesions.
Negotiations between the FDA’s device center and the med-tech industry over the next device user fee schedule are dragging on, but the gap between the two sides may have narrowed. The FDA had previously proposed a package that ran more than double the current total user fee volume, and industry has responded with a proposal that would provide the agency with $1.65 billion in user fees over five years, leaving the two sides with a gap of more than $800 million to bridge.
PERTH, Australia – Singular Health Group Ltd. was awarded AU$50,000 (US$37,000) in funding from Australia’s Commonwealth Scientific and Industrial Research Organization’s (CSIRO) Kick-Start program to undertake a research project to develop artificial intelligence (AI)-based tools to automatically design patient-specific cranial implants. The AI will be integrated into Singular Health’s surgical planning software for editing before the cranial implants are 3D printed.
Alivecor Inc. is partnering with blockchain technology company Solve.Care to connect users of its Kardiamobile device to physicians through a telehealth network. Tallinn, Estonia-based Solve.Care’s blockchain platform, the Global Telehealth Exchange (GTHE), is an open global cross-border telehealth network currently available in 27 countries. Alivecor’s Kardiamobile 6L device is the first and only six-lead personal ECG cleared by the FDA. Through the partnership, Kardiamobile devices will be integrated with GTHE where physicians will be able to access a user’s electrocardiogram (ECG) reading upon their consent through teleconsultations.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Sibel Health.
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