Researchers develop biodegradable nerve stimulation device

The hope of reducing risks with permanent implants drove stent makers such as Abbott to develop absorbable versions, but it halted sales after its version failed to catch on with interventional cardiologists.

By Susan Kelly • Oct. 9, 2018

Eximo Medical gains FDA clearance for atherectomy laser

The device is the first 355 nm laser system cleared in the United States to treat peripheral artery disease and is designed to address unmet clinical needs for multiple vascular conditions.

By Susan Kelly • Oct. 9, 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

FDA takes aim at lack of pediatric devices

"Funding is a huge challenge because of the inherently small market," Reed McCarty, co-founder and partner at SandBox Medical, told MedTech Dive.

By Meg Bryant • Oct. 8, 2018

1 in 5 health IT execs say malware has hit devices

Out-of-date operating systems and unavailability of patch solutions remain major cybersecurity risks for medical devices.

By Susan Kelly • Oct. 8, 2018

Bose self-fitting hearing aid gets FDA approval

The product is the first to be cleared by the agency that can be purchased and programmed without a doctor's prescription.

By Susan Kelly • Oct. 8, 2018

Remote patient monitoring cuts hospital admissions, ER visits, report finds

Heart disease and COPD are the most popular uses, but other less acute chronic conditions are starting to find traction with the technology, the industry and KLAS report found.

By Meg Bryant • Oct. 8, 2018

Blackberry announces healthcare applications for Spark platform, blockchain ledger

The tech company also announced a secure, real-time software program to assist developers of connected medical devices.

By Meg Bryant • Oct. 5, 2018

CMS tweaks local coverage policy to speed access to medical devices

AdvaMed CEO Scott Whitaker said that the CMS actions are commendable, but more should be done.

By David Lim • Oct. 4, 2018

European Parliament passes device-friendly changes to draft HTA law

The amendments will limit the types of devices that undergo joint clinical assessments.

By Nick Paul Taylor • Oct. 4, 2018

Regulatory professionals working in devices paid far less than pharma peers

Reg managers in the drug industry take home around 75% more than their device counterparts.

By Nick Paul Taylor • Oct. 4, 2018

Baxter, Mayo team up on outpatient kidney care center

The health system and device company will open a renal care center at Mayo's campus in Jacksonville, Florida, the first initiative to come out of a broader five-year agreement announced in 2017.

By Susan Kelly • Oct. 3, 2018

Artificial pancreas has edge over insulin pump therapy in study

New research adds to evidence that a hybrid closed-loop insulin delivery system, also known as the artificial pancreas, offers better blood sugar control than sensor-augmented pump therapy in patients with type 1 diabetes.

By Susan Kelly • Oct. 3, 2018

US pays 6 times more than Germany for cardiac implants, study finds

A dramatic divergence in the prices of stents and pacemakers was the most striking finding from an analysis of what hospitals in five countries pay.

By Nick Paul Taylor • Oct. 3, 2018

Stryker settles foreign corrupt practice charges, makes small acquisition

The company will pay $7.8 million to settle with the Justice Department. Separately, the medical device maker said it would acquire HyperBranch Medical Technology.

By Susan Kelly • Oct. 2, 2018

FDA, ECRI, device group keep up drumbeat on cybersecurity risks

The agency is launching a cybersecurity playbook for healthcare providers and said it will publish a "significant update" to its 2014 premarket guidance.

By Susan Kelly • Oct. 2, 2018

5 themes from The MedTech Conference

Mergers and acquisitions, digital health, FDA pilot programs and Netflix's The Bleeding Edge were among the hot topics in Philadelphia.

By David Lim , Kim Dixon • Oct. 1, 2018

FDA exploring potential for IMDRF Medical Device Single Review Program

The idea is for the marketing authorization for a medical device by one country to be relied on in part or in whole by other participating jurisdictions, according to FDA device chief Jeff Shuren.

By David Lim • Oct. 1, 2018

Ready or not, medtech braces for new EU landscape

Companies should not assume they'll get extra time to adapt, warned Vicki Anastasi, VP for medical device and diagnostics research at ICON.

By Kim Dixon • Oct. 1, 2018

AngioDynamics posts bigger net loss, looks to oncology

Executives said the company's two recent acquisitions signal a shift in investment to the oncology section of the business.

By Tyler Woods • Oct. 1, 2018

FDA finds fault with some insulin pen use directions

The agency is asking manufacturers to review their directions for use and training materials and consider adding a label warning about the need to remove both the outer and inner needle covers.

By Susan Kelly • Oct. 1, 2018

Doctor survey finds strong interest in new urology devices

Jefferies analysts polled 50 high-volume urologists and reported Teleflex's UroLift device accounted for 15% of procedures for an enlarged prostate while Boston Scientific's Rezum was used in 10%.

By Susan Kelly • Oct. 1, 2018

Hologic acquires developer of breast cancer surgery marker

The company agreed to pay $125 million for Focal Therapeutics, the latest addition to its breast health product portfolio, two months after purchasing digital imaging systems maker Faxitron Bioptics in an $85 million deal.

By Susan Kelly • Sept. 28, 2018

Butterfly raises $250M in bid to upend ultrasound market

The goal is to replace large, cart-based ultrasound devices that cost tens of thousands of dollars and upend a sector dominated by the likes of GE Healthcare, Philips and Fujifilm.

By Nick Paul Taylor • Sept. 28, 2018

New IMDRF committee to tackle cybersecurity threats

The FDA device chief laid out takeaways from the group's Beijing meeting.

By Kim Dixon • Sept. 27, 2018

FDA reopens comments on decade-old stent guidance

It comes days after physicians writing in The Lancet used data from a head-to-head comparison of Medtronic's Resolute Onyx and Biotronik's ultra-thin-strut stent Orsiro to highlight the limitations of noninferiority clinical trial designs.

By Nick Paul Taylor • Sept. 27, 2018