FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps
By Dave Muoio 02:50 pm September 26, 2019
The new guidances are intended to provide clarity on which products are or are not subject to regulatory enforcement, and to bring the agency’s efforts into compliance with provisions of the 21st Century Cures Act.
By Dave Muoio 02:53 pm September 20, 2019
As politicians and their constituents grapple over Medicare for All, these well-funded startups hope to capitalize on the public’s appetite for new, consumer-friendly approaches to health insurance.
By Dave Muoio 03:37 pm September 10, 2019
Amidst the unveiling of its newest consumer smartphones, tablets and smartwatches, the tech company said it will begin enrolling consumers into its hearing, cardiovascular and women's health studies later this year through an upcoming app.
By Dave Muoio 02:48 pm September 10, 2019
Optum Ventures and Premera Blue Cross led the Series B round.
By Dave Muoio 02:53 pm November 26, 2018
Here’s a look at how artificial intelligence can enhance dashboards to help users separate bold claims from reality.
By Dave Muoio 10:33 am November 16, 2018
As AI cements its role in healthcare, more and more intelligent software offerings are pursuing 510(k) and De Novo approvals.
By Dave Muoio 11:49 am October 11, 2018
Skipping out on comprehensive device documentation and risk assessment will cripple an organization's cybersecurity program, experts say.
By Dave Muoio 12:51 pm August 29, 2018
Studies supported the groundbreaking IDx artificial intelligence tool, which can detect diabetic retinopathy with medical imaging – but the investigation of its validity wasn't above critique.
By Dave Muoio 11:05 am August 27, 2018
Omkar Kulkarni, innovation chief at Children's Hospital Los Angeles, says adoption of tech requires commitment, focus.
By Dave Muoio 10:16 am August 24, 2018
Collecting data outside clinical practice, deploying analytics, improving the patient experience and educating clinicians could help improve mental healthcare.
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