Spine devices, recalls and endovascular stents on FDA's fall meeting lineup

Other topics include Integra's bid for approval of a device used as soft tissue support in post-mastectomy breast reconstruction and a workshop on artificial intelligence and machine learning. 

By Nick Paul Taylor • Sept. 8, 2021

COVID-19 seems to skew Abbott heart failure monitor study results

The clinical trial of the CardioMEMS implantable sensor in a wider patient population missed its primary goal, but the company is moving forward based on an analysis adjusted for the pandemic.

By Susan Kelly • Aug. 30, 2021

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

Abbott's Amulet trial results could lift LAA closure market: analysts

Wall Street analysts were not surprised by the results given the recent FDA approval for Amulet, but agreed that the data was strong enough to boost the left atrial appendage closure products from Abbott and Boston Scientific.

By Nick Paul Taylor • Updated Aug. 31, 2021

'Evidence gaps' spur CMS to call meeting to discuss cerebrovascular devices

The agency said the "shorter term data with greater reliance upon intermediate and surrogate outcomes" used to bring devices to market is "generally less helpful" for its assessments.

By Nick Paul Taylor • Aug. 11, 2021

TransMedics stock halted in Nasdaq trading ahead of FDA advisory panel meeting

The company's stock price was down more than 5% at the close of trading on Tuesday. An FDA panel on Wednesday is evaluating data concerning the safety and effectiveness of TransMedics' device for preserving donor livers.

By Nick Paul Taylor • Updated July 14, 2021

Dexcom CEO on the Type 2 population, the Super Bowl ad and pandemic momentum

Kevin Sayer called Type 2 a "tremendous market opportunity" and said direct-to-consumer advertising is worth some controversy.

By Ricky Zipp • July 6, 2021

Roundup: Trial results, looming product releases fuel diabetes tech competition

In the first half of the year, the space is meeting Wall Street's high expectations for 2021. Here's a roundup of MedTech Dive's coverage of the market, including from this week's American Diabetes Association meeting.

June 30, 2021

Robotic abdominal surgery has no advantage over open, laparoscopic surgeries: meta-analysis

The review found of 39 studies reporting surgical complications, just 10% showed fewer complications with robot-assisted surgery. The analysis was published in the Annals of Internal Medicine.

By Greg Slabodkin • June 29, 2021

Medtronic smart insulin pen improved time in target blood glucose levels: study

The medtech giant's trial results come as competition in the space is intensifying. Eli Lilly and Bigfoot Biomedical, partnered with Abbott, are also prioritizing the technology.

By Ricky Zipp • June 29, 2021

FDA nod in sight, Insulet's Omnipod 5 boosts time in range in diabetes subset

The trial results show improved health outcomes in a crucial patient population for the company: individuals requiring multiple daily injections of insulin.

By Susan Kelly • June 28, 2021

Nevro's painful diabetic neuropathy data marred by disappointing Q2 forecast

CEO Keith Grossman said he's "frankly disappointed" at the pace of the recovery, suggesting the company may miss its sales target. Shares were down nearly 6% Monday morning.

By Nick Paul Taylor • June 28, 2021

Public Citizen calls for top FDA officials to resign following Alzheimer's drug approval

The consumer group wants Janet Woodcock, Patrizia Cavazzoni and Billy Dunn to step down over last week's controversial approval of Aduhelm, which is expected to put immense strain on healthcare budgets.

By Jacob Bell • June 16, 2021

FDA rejects Verily filing for wrist-worn Parkinson's clinical trial device

The sister company of Google developed the feature to collect data on the motor function of Parkinson's patients in between visits to trial sites. However, the agency questioned the wearable's ability to have a meaningful effect. 

By Nick Paul Taylor • June 14, 2021

Dexcom shares clinical data on G7 CGM ahead of next-gen showdown with Abbott

The results compare favorably to data on Abbott’s Libre 2, further setting the stage for the release of one of the most anticipated new products of 2021 in the diabetes tech market.

By Nick Paul Taylor • June 4, 2021

An AstraZeneca, Merck drug slows the return of genetic breast cancer. Will testing speed up?

Study results disclosed ahead of ASCO could make Lynparza a standard "adjuvant" treatment for people with an inherited form of breast cancer — as long as they know they have it. 

By Ben Fidler • June 3, 2021

In first, FDA approves KRAS-blocking cancer drug from Amgen

After decades of scientists unsuccessfully targeting the KRAS gene, Lumakras is the first drug proven effective. The FDA Friday also approved companion diagnostics from Qiagen and Guardant Health.

By Ned Pagliarulo • Updated May 29, 2021

Medtronic steps up robotics bet as its challenger to Intuitive starts clinical trial

The medtech giant seeks to double or triple sales in its 2023 fiscal year. However, analysts warned that near-term investments will pressure margins in the short term.

By Nick Paul Taylor • May 28, 2021

FDA draft guidances lay out postmarket medical device data requirements

Building on existing policy, one proposal deals with rules for Class II and III products while another relates to PMAs. 

By Nick Paul Taylor • May 27, 2021

Edwards tricuspid valve replacement cut leakage for 98% of participants in early trial results

A total of 56 patients were examined 30 days after a transcatheter tricuspid valve replacement procedure. Edwards now plans to start a pivotal trial, examining the procedure in 775 patients.

By Ricky Zipp • May 17, 2021

Edwards withstands winter lows, grows Q1 sales on electives recovery

CEO Michael Mussallem said volumes grew gradually through March after a significant drop, continuing the early trend of procedure-dependent medtechs reporting a return of non-emergency procedures.

By Ricky Zipp • April 21, 2021

FDA puts Medtronic Valiant Navion stent graft recall in Class I category

The action, which comes amid one patient death in a clinical trial, deprives Medtronic of a source of sales growth. After securing 2018 approval, then-CEO Omar Ishrak talked up the device's potential to drive incremental growth.

By Nick Paul Taylor • April 12, 2021

FDA-medtech consortium offers strategy to boost patient engagement in clinical trials

The MDIC report, created by a working group including Exact Sciences and J&J, follows the agency's late 2019 draft guidance meant to increase the influence of patients in medical device clinical trial design. 

By Nick Paul Taylor • April 7, 2021

Nevro shares full diabetic neuropathy SCS data as it pursues blockbuster opportunity

If successful, the company would be the only FDA-approved spinal cord stimulation device with an on-label indication for painful diabetic neuropathy. Nevro estimates a market worth up to $5 billion, but analysts are skeptical.

By Nick Paul Taylor • April 7, 2021

Boston Scientific links just approved liver cancer device to improved survival

Analysts at Evercore ISI estimate FDA clearance for the radioactive glass beads opens up a $150 million U.S. market opportunity, although they note lack of data from a randomized trial "could be a factor in modeling adoption."

By Nick Paul Taylor • March 26, 2021

AstraZeneca, Oxford vaccine prevents COVID-19 in big US study amid controversy overseas

A two-shot regimen was 79% effective at protecting people from COVID-19, which should support the fourth clearance of a vaccine in the U.S. and calm safety concerns abroad. 

By Ben Fidler • March 22, 2021