Ortho, spine players Smith & Nephew, NuVasive and Globus post Q4 results

The three rivals posted healthy sales growth, with Smith & Nephew topping $5 billion in revenue for 2019.

By Nick Paul Taylor • Feb. 21, 2020

FDA deems Abbott Vascular, ResMed, Teleflex recalls high risk

Problems with the affected coronary catheters from Abbott and ventilators from ResMed each resulted in one death, the agency reported Wednesday.

By Susan Kelly • Updated Feb. 20, 2020

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

Teleflex strikes $260M deal, gaining parts used in TAVR procedures

In releasing quarterly results, the Wayne, Pennsylvania-based medtech also gave updates on a new direct-to-consumer ad campaign and headwinds expected from the coronavirus outbreak.

By Nick Paul Taylor • Feb. 20, 2020

Abbott, Dexcom outline plans for CGM compatibility with Insulet's Horizon

As a key diabetes conference gets underway, the dominant glucose monitoring medtechs specified that G6, G7 and FreeStyle Libre 2 users will be able to integrate with the tubeless, smartphone-operated insulin delivery system.

By Maria Rachal • Feb. 19, 2020

DHS warns of WannaCry-like vulnerability in Spacelabs Healthcare systems

The homeland security agency revealed certain telemetry devices suffer from the weakness, scoring 9.8 out of 10 on a cybersecurity vulnerability scale.  

By Nick Paul Taylor • Feb. 19, 2020

Senseonics' implantable CGM wins Cigna coverage, shares soar

The diabetes tech manufacturer's stock closed up 24% on the news. CEO Tim Goodnow late last year identified Cigna, along with Anthem and UnitedHealthcare, as key commercial payers to win over.

By Nick Paul Taylor • Feb. 19, 2020

Medtronic misses revenue estimates as TAVR position falters

A disappointing quarter for the medtech giant, with particular softness across pain therapies and cardiac rhythm and heart failure, sent shares down nearly 4% in morning trading Tuesday.

By Maria Rachal • Feb. 18, 2020

As CMS coverage decision nears, Abbott gears for MitraClip expansion

An expanded national coverage determination could accelerate already-strong sales of the device, and the company is planning to add manufacturing capacity and sales reps in anticipation.

By Susan Kelly • Feb. 18, 2020

FDA tracks uptick in masks, other protective gear in coronavirus update

Commissioner Stephen Hahn said the shift in ordering patterns is yet to manifest in a shortage but warned Friday the situation is “evolving and very dynamic.”

By Nick Paul Taylor • Feb. 18, 2020

Dexcom hopes wave of new customers offsets lower prices, Abbott's sweet spot

The continuous glucose monitor maker also said it's planning a third manufacturing site, this time outside of the U.S., as it prepares for demand beyond its mainstay Type 1 diabetes market.

By Maria Rachal • Feb. 14, 2020

Baxter overstated income by $278M, internal probe finds

The fallout may drag on from Baxter's use of a flawed method to calculate exchange rates over several years. The medtech continues to work with the SEC and potential investor class action lawsuits could follow.

By Nick Paul Taylor • Feb. 14, 2020

Insulet warns of defect with Dash personal diabetes manager

The notice came a day after FDA flagged a potential safety issue with certain Medtronic insulin pumps. Although the source of risk was different, the possible outcome was the same: under or over delivery of insulin.

By Maria Rachal • Feb. 13, 2020

Moody's: Coronavirus spread in US to have mixed credit effects across healthcare

Device makers — particularly Boston Scientific, BD and Abbott — will likely see a credit negative effect from supply chain disruption, even if the outbreak is contained to China.

By Shannon Muchmore • Feb. 13, 2020

FDA folds Cook Medical asks into final peripheral vascular atherectomy device 510(k) guidance

The agency made some changes to advice on premarket submissions for technologies used to help remove plaque from diseased arteries.

By Nick Paul Taylor • Feb. 13, 2020

Medtronic insulin pump recall tied to 1 death, more than 2K injuries, FDA says

A hardware issue the medtech giant flagged to certain MiniMed customers in November has generated more than 26,000 complaints, the agency said as it classified the recall in its highest-risk category.

By Maria Rachal • Feb. 12, 2020

Tenet to pay $1.4M to settle claims it unnecessarily implanted cardiac monitors

The unneeded procedures subjected patients to "needless peril, and taxpayers end up with the bill," said an HHS Office of Inspector General special agent.

By Samantha Liss • Feb. 12, 2020

FDA OKs 'Inside-Out' device for enabling hemodialysis in hard-to-treat patients

Bluegrass Vascular Technologies plans to make its De Novo-winning venous access device available at select U.S. sites in the coming months, adding to the revenue it already generates in the EU, Canada and other markets.

By Nick Paul Taylor • Feb. 12, 2020

Wearable heart rate sensor accuracy didn't vary across skin tones in small Duke study

But data from 53 individuals, published Monday, revealed differences in accuracy by device manufacturer across activity type.

By Susan Kelly • Feb. 11, 2020

Hospitals, clinics most likely to be hit with ransomware attack

But medical testing and supplies companies weren't spared among the 172 individual attacks from 2016 to 2019 that affected 6.6 million patients. 

By Shannon Muchmore • Feb. 11, 2020

Renewed calls for Impella RCT as JAMA details bleeding, death rate findings

Abiomed has cast doubt on the registry-based study, though some cardiologists argue it supports “a more restrictive use” of the circulatory support device.

By Nick Paul Taylor • Feb. 11, 2020

Medtronic faces key test in establishing US market for renal denervation

After a setback six years ago, the medtech giant is set to unveil pivotal trial data next month on a procedure to lower blood pressure. Abbott and Boston Scientific are likely watching closely.

By Susan Kelly • Feb. 10, 2020

FDA puts high-risk label on GE Healthcare anesthesia systems recall

A potential loose cable connection in more than 3,600 of the devices may result in a loss of mechanical ventilation.

By Maria Rachal • Feb. 10, 2020

Snapshot: How medtech earnings season is shaping up

Most medtechs offered financial outlooks for 2020 over the last month, but the novel coronavirus could have a longer impact than originally factored in.  

By Maria Rachal • Updated March 6, 2020

Abiomed, on defense, plans wave of trials to counter Impella criticism

The maker of the heart pump is seeking to quash doubts after two large observational studies suggested the product was more risky and pricey than alternative treatments.

By Nick Paul Taylor • Feb. 6, 2020

EU MDR notified bodies hit 11 with Irish group added

The National Standards Authority of Ireland describes itself as the country's official standards body. It's the second certified since the Commission teased last month that three more of the entities would soon be added to the count.

By Kim Dixon • Updated Feb. 13, 2020