Report offers framework for assessing EHR usability, safety

The voluntary roadmap includes criteria examples for developers and providers to use in testing EHR products at each lifecycle stage.

By Meg Bryant • Aug. 29, 2018

FDA warns Zimmer Biomet about quality violations at Indiana plant

The former Zimmer Holdings has struggled to integrate Biomet since acquiring its cross-town rival for $13 billion in 2015.

By Susan Kelly • Aug. 28, 2018

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

Patients getting needed supplies under DME bidding: GAO

The GAO found that the number of durable equipment suppliers decreased 8% in 2016, consistent with the years before the rate adjustments went into effect.

By Susan Kelly • Aug. 27, 2018

HHS asks for advice on anti-kickback rules as industry files Stark Law input

While device makers, physicians, labs and hospitals all agree changes should be made to the Stark Law to boost value-based care, the industry is split on what revisions should be made.

By David Lim • Aug. 27, 2018

HHS calls for feedback on criteria for EHR reporting program

The comments will inform assessments of the interoperability and security of electronic health systems.

By Nick Paul Taylor • Aug. 24, 2018

Dthera gets FDA breakthrough device status for Alzheimer's digital therapeutic

The device delivers reminiscence therapy to counter anxiety and depression.

By Nick Paul Taylor • Aug. 24, 2018

FDA posts guidance on endpoints in osteoarthritis trials

The draft guide says more research is needed before the agency accepts structural endpoints.

By Nick Paul Taylor • Aug. 23, 2018

Gynesonics gets FDA nod for fibroid ablation device

The minimally-invasive device uses radiofrequency to reduce the volume of uterine fibroids.

By Nick Paul Taylor • Aug. 23, 2018

Mobile phones, smartphone apps could help boost patient matching, RAND report finds

There's "no magic bullet" for incentivizing patients to improve record matching, according to lead author Robert Rudin.

By Meg Bryant • Aug. 22, 2018

FDA approves Keytruda companion test for bladder cancer

Measuring levels of PD-L1 expressed in patients' tumors can help doctors determine who is likely to benefit from immunotherapy treatment.

By Susan Kelly • Aug. 22, 2018

Australia starts accepting FDA reports in device filings

The change allows companies to use U.S. documents to seek authorizations in Australia.

By Nick Paul Taylor • Aug. 22, 2018

FDA extends EpiPen expiration date to ease shortages

Current supply issues stemming from ongoing manufacturing delays could put children at risk as the school year approaches.

By Suzanne Elvidge • Aug. 22, 2018

FDA finds higher death, stroke rates for latest SynCardia artificial heart driver

The agency said it will work with SynCardia to ensure product labeling addresses the post-approval findings.

By Susan Kelly • Aug. 20, 2018

Noninvasive magnetic stimulation for OCD wins FDA nod

The agency's clearance for OCD is an extension of a 2008 approval of transcranial magnetic stimulation to treat major depression.

By Susan Kelly • Aug. 20, 2018

Doctors often fail to list conflicts in device studies: JAMA report

Doctors got the highest payouts from Medtronic, which accounted for more than $187.4 million, followed by Stryker and Intuitive Surgical, according to a JAMA analysis.

By Susan Kelly • Aug. 20, 2018

US agencies pitch efforts to spur gene therapy development

The chiefs of the FDA and NIH laid out proposals in a New England Journal of Medicine editorial aimed at pushing forward advances in the fast-expanding field.

By Suzanne Elvidge • Aug. 17, 2018

FDA details export certificate appeal process in draft guidance

The document sets out why the agency may deny requests and how manufacturers can respond.

By Nick Paul Taylor • Aug. 17, 2018

FDA OKs quarterly reporting of device malfunction summaries

The change is intended to reduce regulatory burdens by lowering reporting requirements.

By Nick Paul Taylor • Aug. 17, 2018

Teva granted FDA approval for first EpiPen generic

It's the latest blow to Mylan, which came under fire for hiking EpiPen's price over the last decade and is now facing manufacturing challenges for the flagship product.

By David Lim • Aug. 16, 2018

Medtronic starts selling drug-coated balloon in Japan

Studies have linked the device to lasting improvements in patients with peripheral artery disease.

By Nick Paul Taylor • Aug. 16, 2018

Maryland failed to secure its Medicaid data: OIG

Exploitation could have resulted in unauthorized access to data and disruption of critical operations, but the inspector general did not identify evidence that the system was compromised.

By Susan Kelly • Aug. 15, 2018

AdvaMed pushes back against FDA humanitarian device guidance

The trade group thinks the guidance will deter development of devices to treat rare conditions.

By Nick Paul Taylor • Aug. 15, 2018

FDA approves one-year contraceptive ring

The product, developed by the nonprofit Population Council, will be made available in the U.S. through a license agreement with women's health company TherapeuticsMD.

By Susan Kelly • Aug. 14, 2018

Verma touts interoperability, corporate partnerships at Blue Button 2.0 conference

Microsoft, Google and Amazon pledged at the event they are committed "to removing barriers for the adoption of technologies for healthcare interoperability, particularly those that are enabled through the cloud and AI."

By David Lim • Aug. 14, 2018

FDA sets out vision to use real-world data in product evaluations

The agency wants insights into safety and efficacy outside of controlled research environments.

By Nick Paul Taylor • Aug. 14, 2018