Diabetes, heart device sales drive strong Medtronic Q1

Demand for the artificial pancreas, the world's first device that monitors blood glucose and administers insulin, led growth in the diabetes business.

By Susan Kelly • Aug. 21, 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

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

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

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

In pursuit of new insulins, Novo may drop more than $800M on Ziylo

Pricing pressures and competition have pushed diabetes drugmakers to innovate. Novo's looking to do just that in buying the University of Bristol spinout and its glucose-binding molecules.

By Jacob Bell • 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

AngioDynamics buys biopsy sealant technology from Surgical Specialties

The acquisition will expand the company’s portfolio of oncology devices.

By Nick Paul Taylor • 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

Healthix switching software vendors for patient matching

The nation's largest public health information exchange will switch to software vendor Verato in a bid to improve its patient-matching capabilities.

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

With Mylan reeling, Kaléo touts its EpiPen rival for back-to-school season

Manufacturing delays at a Pfizer-owned EpiPen plant have created an opportunity for Kaléo.

By Nick Paul Taylor • Updated Aug. 15, 2018

BARDA, J&J team to crowdsource respiratory device ideas

The HHS arm will work with the drugmaker's JLabs, which runs a program challenging scientists, companies and entrepreneurs to come up with bankable ideas.

By Susan Kelly • Aug. 14, 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

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

NuVasive, Siemens partner on spine surgery imaging

Makers of spinal fusion devices are looking to differentiate themselves in a crowded market.

By Susan Kelly • 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

Medtronic begins study of ICD with leads outside the heart

The device, called the Extravascular Implantable Cardioverter Defibrillator, will provide the same therapies as traditional transvenous ICDs.

By Susan Kelly • Aug. 10, 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

Boston Scientific inks Veniti takeover to access untapped stent market

The $160 million buy moves the company into the nascent venous stent sector.

By Nick Paul Taylor • Aug. 9, 2018

Senseonics rolls out 90-day continuous glucose monitoring

The Eversense system will compete with Abbott's FreeStyle Libre monitor, which last month cleared FDA approval.

By Susan Kelly • 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

Varian acquires maker of patient monitoring system

The radiation therapy company said the buy expands its motion-management portfolio, part of its cancer care strategy.

By Susan Kelly • Aug. 7, 2018