FDA extends comment period for draft guidance on magnetic resonance safety

The recommendations are expected to replace a 2014 document and come amid a rapid rise in the use of MRI-compatible medical devices.

By Susan Kelly • Updated Sept. 3, 2019

US to slap 10% tariffs on $300B in Chinese goods as medtech seeks details

The tariffs are set to take effect on Sept. 1. AdvaMed said it "strongly opposes tariffs by both sides on medical technology products" and is lobbying U.S. trade negotiators.

By Shefali Kapadia • Aug. 2, 2019

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

Abiomed investors spooked by drop in heart pump adoption

After losing more than 25% of its stock value last week, shares in Abiomed inched up Monday morning on news that CMS will not cut reimbursement in fiscal year 2020 for the primary code covering Impella heart pump procedures.

By Maria Rachal • Updated Aug. 5, 2019

Hill-Rom picks up wearable ventilator maker in $130M deal

The medical equipment and systems company announced it's adding Breathe Technologies to its respiratory care business, part of a unit that contributed to Hill-Rom's 3% quarterly revenue growth reported Friday.

By Maria Rachal • Aug. 2, 2019

Japan to reimburse TransEnterix's robotic surgery system

The decision positions the company to compete with Intuitive Surgical in one of the largest markets for the platforms.

By Nick Paul Taylor • Aug. 2, 2019

Cardiac device complications vary 'substantially' by implanting hospital, study finds

The analysis of 98 hospitals, published this week in the Annals of Internal Medicine, uncovered an up-to-threefold difference in cardiac implant complication rates.

By Nick Paul Taylor • Aug. 1, 2019

Dexcom CGM adoption booms as it looks to 'aggressively' pursue Type 2 market

Coming off another beat-and-raise quarter, the company remains focused on adding users via the pharmacy benefit channel, Medicare population and international markets as a potential iCGM rival from Abbott looms.

By Maria Rachal • Aug. 1, 2019

'Political challenges' drag on Hologic's breast health sales in Latin America

Performance in other parts of Hologic's business like molecular diagnostics counteracted some of those challenges, enabling the company to post above-guidance results for the third quarter.

By Nick Paul Taylor • Aug. 1, 2019

FDA grants breakthrough status to Procyrion's cardiac device

Procyrion's Aortix aims to offer physicians a minimally invasive, lower-risk alternative to left ventricular assist devices when treating patients with acute decompensated heart failure and worsening renal function. 

By Nick Paul Taylor • Aug. 1, 2019

FDA announces fiscal 2020 device user fee rates

The fees, which cover medical device registration, submissions and certain periodic reports, show slight increases from the 2019 rates.

By Susan Kelly • July 31, 2019

Slow spine market growth to persist as insurers push back, UBS survey suggests

The investment bank's survey of spine surgeons indicates Medtronic and Globus Medical may get a boost from their robotic and navigation offerings while Johnson & Johnson is expected to continue to lose market share.

By Susan Kelly • July 31, 2019

Sports medicine drives Q2 growth at Smith & Nephew

Strength in U.S. shoulder repair device sales helped offset declining revenues from arthroscopic enabling technologies.

By Nick Paul Taylor • July 31, 2019

CMS pitches add-on payment for new renal care tech, DME fee adjustments

The agency projects total payments to hospital-based ESRD facilities to rise 1.9% year to year while payments to freestanding renal care facilities like DaVita and Fresenius are set to increase 1.5%.

By David Lim , Maria Rachal • July 30, 2019

Mayo, Boston Scientific deepen ties with medtech accelerator launch

The joint venture, called Motion Medical, is expected to open in Rochester, Minnesota this fall with the purpose of bringing minimally invasive treatments to market for unmet health needs.

By Susan Kelly • July 30, 2019

Humana accuses Abbott of duping it to pay to remove dodgy heart devices

The suit alleges St. Jude, now a part of Abbott, knew about a battery depletion defect in its heart rhythm devices for four years before notifying FDA, and then schemed to have the insurer pay for surgeries to remove patients' implants.

By Susan Kelly • July 30, 2019

ResMed discloses tentative DOJ settlement, sets aside $41.2M

A resolution to a DOJ probe, disclosed during the sleep apnea device maker's fourth quarter earnings call, would settle an investigation into marketing and financing practices related to the company's resupply program.

By Susan Kelly • July 29, 2019

Australia on watch for possible EU notified body shortage

The country's Therapeutic Goods Administration has issued new guidance to aid device makers seeking overseas marketing authorization.

By Susan Kelly • July 29, 2019

New delivery system for sinus stent gains FDA approval

Intersect ENT's line of steroid-releasing stents are the first and only dissolvable sinus implants approved by FDA, according to the company.

By Susan Kelly • July 29, 2019

Stryker says Mako robot driving orthopaedic share gains

The orthopaedics giant said the robotic surgery system is supporting above-market growth in hip and knee implants, but pressure may soon increase as Zimmer Biomet expands the rollout of Rosa Knee.

By Susan Kelly • July 26, 2019

Zimmer Biomet to increase robotics R&D as new CFO takes helm

The company saw its best growth in its knee business in three years during the second quarter, even without contributions from the limited launch of the Rosa Knee system, executives said.

By Maria Rachal • July 26, 2019

FDA finalizes biliary stent guide after Cook, Boston Scientific feedback

The final guidance hews closely to the draft released for consultation last year, despite Cook calling for a variety of changes.

By Nick Paul Taylor • July 26, 2019

Healthcare the lone growth driver for 3M in Q2

The unit posted 5.8% sales growth, providing some relief for the beleaguered conglomerate, which expects its $6.7 billion buyout of wound care company Acelity to close in the fourth quarter.

By Nick Paul Taylor • July 26, 2019

Baxter predicts pouring $500M into US renal care expansion

Potential increased demand for peritoneal dialysis technologies amid a federal push for at-home kidney care drove optimism, as did rising revenues in the medication delivery business after several quarters of disappointing growth.

By Maria Rachal • July 25, 2019

Verb Surgical names CEO to shepherd J&J, Verily digital surgery partnership

The startup tapped medtech vet Kurt Azarbarzin as president and CEO Wednesday. He'll be tasked with leading Verb's digital surgery platform toward commercialization.

By David Lim • July 25, 2019

Recalled heart balloon pumps linked to 5 patient deaths

Problems have dogged the products, which shut down while running on battery and had design flaws that allowed fluid to seep into the devices.

By Dana Elfin • July 25, 2019