FDA reclassifies female condoms to reduce regulatory burden

The products will be categorized as Class II devices eligible for the 510(k) pathway.

By Nick Paul Taylor • Sept. 27, 2018

FDA expands use of Baxter bone graft to spinal fusion

Rivals Medtronic, Johnson & Johnson, Stryker and Zimmer are all competing for the bone graft substitute piece of the advanced surgery market. 

By Nick Paul Taylor • Sept. 27, 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

Global device industry set to grow 5.6% a year through 2024: report

In vitro diagnostics is projected to remain as the No. 1 specialty in 2024 with annual sales of $79.6 billion and a 13.4% share of the medical device industry.

By Susan Kelly • Sept. 26, 2018

Medtronic launches Infinity spine fusion system

The company's product launch comes on the heels of its $1.64 billion acquisition of Mazor Robotics.

By Susan Kelly • Sept. 26, 2018

FDA's Patel touts promise of software precertification program

Despite concern from the Clinical Decision Support Coalition​ that FDA may not have the legal ability to launch the pilot, the agency says it will work through its current authorities.

By David Lim • Sept. 26, 2018

Venus to buy Keystone, moving into Boston Sci's TAVR turf

The move furthers Venus' aspirations to grow into a global transcatheter heart valve company and, by extension, advance China's bid to supercede the U.S. as the dominant medtech force.

By Nick Paul Taylor • Sept. 26, 2018

Industry lobbying CMS for speedy Medicare coverage of breakthrough devices

The Center for Medicare and Medicaid Innovation may launch a demonstration project to examine how to balance speeding devices to Medicare patients with the cost implications.

By David Lim • Sept. 25, 2018

Medtech companies race to adapt amid vertical integration, new tech threats

The industry is increasingly sharing the risk with payers as a way to prove product value.

By Kim Dixon • Sept. 25, 2018

AdvaMed chief: Success in warding off tariffs, but impact rising

While medical devices aren't explicitly on the most recent list of tariffs, the list likely includes component parts used by members of the industry.

By Kim Dixon • Sept. 25, 2018

Medtronic CoreValve proves durable in longer-term data

Severe hemodynamic structural valve deterioration was 0.8% for CoreValve versus 1.8% for surgery across five years, with similar rates of mortality and major stroke in both patient samples.

By Susan Kelly • Sept. 25, 2018

FDA gives final guidance on device benefits, risks in 510(k) submissions

The recommendations will help in determining substantial equivalence for devices with different characteristics that don't raise new questions of safety and effectiveness, the FDA said.

By Susan Kelly • Sept. 25, 2018

FDA approves Cook PAD stent as competition heats up

The approval comes shortly after Boston Scientific received clearance to sell a rival device.

By Nick Paul Taylor • Sept. 25, 2018

EY warns stagnant R&D, data use threatens medtech growth

Medtech R&D investment of $15.9 billion remained "relatively unchanged" in 2017 — roughly $1 billion less than the $16.4 billion companies gave back to investors through share buybacks and dividends.

By David Lim • Sept. 24, 2018

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

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