Boston Scientific's Eluvia wins FDA nod, seen as effective as Cook's Zilver in study

Results of the first head-to-head clinical trial to compare the two drug-eluting stents to treat leg artery blockages were presented at a scientific meeting this weekend. On Monday, the FDA cleared the Boston device.

By Susan Kelly • Sept. 24, 2018

Medtronic heart stent works as well as thin-strut Orsiro: study

The device giant's Resolute Onyx coronary stent was found to be as effective and safe as the Orsiro ultra-thin-strut stent made by privately held Berlin-based Biotronik.

By Susan Kelly • Sept. 24, 2018

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Abbott's MitraClip keeps more heart valve patients alive in study

The device for minimally invasive repair of the mitral heart valve in patients with advanced heart failure and severe mitral regurgitation significantly reduced both hospitalizations and mortality.

By Susan Kelly • Sept. 24, 2018

GeekWire: Google's Nest has healthcare ambitions

Nest secretly acquired Senosis Health, maker of smartphone-based monitoring systems for conditions like osteoporosis and newborn jaundice, according to internal communications and financial documents.

By Meg Bryant • Sept. 21, 2018

OIG advisory opinion cracks door open for device bundle warranties

The guidance comes as HHS awaits feedback on ways to improve the Anti Kickback Statute to ease obstacles to coordinated or value-based care.

By David Lim • Sept. 21, 2018

Fitbit pushes deeper into wellness with connected platform

The move comes as regulators tout the potential of wearables to improve health and on the heels of Apple's latest splash.

By Meg Bryant • Sept. 20, 2018

Heparin device guidance to cut overdose risk finalized

The text addresses the labeling and safety testing of heparin-containing devices and combination products.

By Nick Paul Taylor • Sept. 20, 2018

BioSig uplists to small-cap Nasdaq exchange amid cardiac device push

The company's device for acquiring cardiac signals recently won 510(k) clearance from the FDA.

By Nick Paul Taylor • Sept. 20, 2018

Medtronic to study TAVR in low-risk bicuspid patients

FDA also approved a revised label for the Evolut valve that removes a precaution for patients with aortic stenosis at intermediate or greater mortality risk from surgical aortic valve replacement.

By Susan Kelly • Sept. 19, 2018

Ra Medical amends IPO plan

The maker of a laser-based treatment for restoring blood flow in arteries and clearing chronic skin conditions said it expects to use the proceeds on its direct sales force, marketing and clinical trials. 

By Susan Kelly • Sept. 19, 2018

Device lobby backs FDA combo product GMP plan

AdvaMed is pushing to add a section on the annual stability expectations for drug-device products and clarify rules on sampling before finalizing the text.

By Nick Paul Taylor • Sept. 18, 2018

Stent to seal coronary artery perforations gets FDA nod

Biotronik's device is the first treatment for the potentially life-threatening emergency in 17 years.

By Susan Kelly • Sept. 17, 2018

FDA defends its work on breast implant safety

The agency said new research from MD Anderson Cancer Center linking silicone breast implants to a higher risk of connective tissue diseases such as rheumatoid arthritis and scleroderma has "significant shortcomings."

By Susan Kelly • Sept. 17, 2018

FDA tests new way to shorten 510(k) review times

The agency hopes a pilot program will make submissions more efficient, cutting time to a final decision to as little as 60 days.

By Susan Kelly • Sept. 17, 2018

Pilot delivers defibrillators via FAA-approved drone

During the test, a single pilot simultaneously flew several drones to deliver automated external defibrillators.

By Jason Plautz • Sept. 17, 2018

FDA rolls out plan to reduce third party 510(k) re-reviews

Commissioner Scott Gottlieb said outsourcing review of low-risk devices can enable FDA to focus more resources on high-risk and more complex devices.

By David Lim • Sept. 14, 2018

AngioDynamics to buy RadiaDyne for radiotherapy devices

RadiaDyne thinks AngioDynamics' commercial infrastructure will help it to grow sales beyond the $6 million achieved over the past 12 months.  

By Nick Paul Taylor • Sept. 14, 2018

FDA delays Inbrija drug-device combo

Regulators need more time to assess the biotech's Parkinson's drug-device combination, adding another layer of complexity to manufacturing and approval processes.

By Jacob Bell • Sept. 13, 2018

J&J buys EIT for 3D-printed titanium spinal implants

The devices are designed to increase the number of surgeries that are successful the first time.

By Nick Paul Taylor • Sept. 13, 2018

New Apple Watch adds FDA-cleared ECG application

Agency officials touted the clearance as heralding a new age of digital health. Still, risks include false positives and negatives, which could lead to unneeded procedures or misdiagnosis.

By David Lim • Sept. 12, 2018

FDA advised to step up device cybersecurity checks premarket

In response to the watchdog report, FDA said it is already working on implementing the recommendations.

By Susan Kelly • Sept. 12, 2018

Medtronic plants hit with FDA warning letters

The notices relate to two facilities that made recalled implantable cardioverter-defibrillators.

By Nick Paul Taylor • Sept. 12, 2018

Cook resolves FDA warning letter that slammed quality processes

The close-out letter follows four years of work to improve quality management.

By Nick Paul Taylor • Sept. 12, 2018

Medtronic to study one month of DAPT in high-bleeding-risk patients

The study will look at whether a shortened dual antiplatelet therapy regimen is enough to minimize stent thrombosis and other complications in patients.

By Susan Kelly • Sept. 11, 2018

AliveCor snags FDA breakthrough device status for bloodless hyperkalemia test

The agency has granted the designation, which fast tracks review, to 83 devices as of the end of July.

By David Lim • Sept. 11, 2018