Vaccine makers move quickly to confront omicron threat

Several companies, including Pfizer and Moderna, are already at work adapting their coronavirus shots to the newly identified variant, which experts worry could more readily evade vaccine protection.

By Ned Pagliarulo • Nov. 29, 2021

FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

The decision comes as at least 10 states have already begun opening up booster dose eligibility, with cases remaining at high levels across the country. 

By Ben Fidler • Nov. 19, 2021

Latest Abbott, Boston Scientific LAAC devices yield mixed results in first clinical comparison

No clear difference was evident in clinical outcomes at 45 days, but other endpoints did point toward potential pros and cons of the two left atrial appendage closure devices.

By Nick Paul Taylor • Nov. 8, 2021

Edwards, Medtronic bolster economic, clinical case for using TAVR over surgery

Medtronic released five-year data from the SURTAVI trial while Edwards presented a two-year study of the costs of TAVR and surgery, both of which were late-breaking clinical trials at the TCT annual scientific symposium.

By Nick Paul Taylor • Nov. 8, 2021

Siemens' Varian leads latest FDA breakthrough device designations

Varian secured the regulatory privileges for its noninvasive treatment of knee osteoarthritis based on technology acquired from Boston Scientific. Magnus Medical, Renovia and MY01 are included in the latest batch of designations.

By Nick Paul Taylor • Nov. 1, 2021

Medtronic surgical robotics head talks Hugo, taking on Intuitive, COVID-19 challenges

Megan Rosengarten spoke to MedTech Dive about challenging Intuitive Surgical's 20-year lead in soft tissue robotics, growing global robotics usage and the stress of entering a new market amid COVID-19.

By Ricky Zipp • Oct. 20, 2021

Medtronic misses bid for early FDA OK in renal denervation, stock slides

The independent data safety monitoring board found the clinical trial needs to keep enrolling patients and gather results to show if the treatment works.

By Nick Paul Taylor • Oct. 18, 2021

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

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