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

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

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FDA details export certificate appeal process in draft guidance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

Medical device industry caught in US-China trade war

"If this keeps escalating … a tit-for-tat game without any end in sight, that's very concerning to our industry and ultimately to patient care," a top industry imaging official said.

By Meg Bryant • Aug. 13, 2018

Most recalled foot, ankle devices are 501(k) approved, study finds

The less-demanding 510(k) process "may cause the devices to carry a greater risk to patients" due to a lack of clinical data, researchers said.

By Susan Kelly • Aug. 13, 2018

FDA OKs marketing of contraceptive app

The Natural Cycles app has generated controversy in Europe, where women have reported unplanned pregnancies while using it.

By Susan Kelly • Aug. 13, 2018

Burn treatment earns expanded compassionate use approval

The suspension offers a way to achieve permanent closure in burns and other wounds while reducing the amount of skin harvested at the time of surgery.

By Susan Kelly • Aug. 10, 2018

TGA seeks industry input on cybersecurity, medtech software guidance

The agency has commissioned reports to inform approaches that support companies and protect patients.

By Nick Paul Taylor • Aug. 10, 2018

FDA warns overreliance on membrane tests could up fetal death risk

The rupture test results could be misinterpreted, leading to serious adverse events.

By Nick Paul Taylor • Aug. 9, 2018

UnityPoint's second data breach this year could prompt expanded lawsuit

The Des Moines-based nonprofit notified 1.4 million people last week that a phishing attack may have compromised their information.

By Meg Bryant • Aug. 8, 2018

Regs, patient perceptions threaten to throttle neuromodulation growth

Analysts think electrical stimulation devices may struggle to fulfill their commercial potential, challenging the perception that they will soon address a range of unmet neurological medical needs.

By Nick Paul Taylor • Aug. 8, 2018

CMS' Verma stands firm on 2015 EHR deadline, move to open APIs

Meanwhile, the coalition Health IT Now sent a letter to ONC chiding the government for failing to implement information blocking provisions of the 21st Century Cures Act.

By Meg Bryant • Aug. 7, 2018