BD drug-coated balloon falls short at FDA panel, signaling likely rejection

While the advisory committee largely agreed that Lutonix was safe, the majority did not believe it was effective nor that the benefits outweighed the risks.

By Ricky Zipp • Feb. 18, 2021

Smith & Nephew Q4 knee sales plummet, exceeding drops reported by Stryker and Zimmer Biomet

A challenging quarter was expected after orthopaedic rivals saw pressure on electives, but the scale of losses surprised investors.

By Nick Paul Taylor • Feb. 18, 2021

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

FDA approves 3D-printed ankle implant for humanitarian use

Additive Orthopaedics makes the devices from cobalt chromium alloy to treat avascular necrosis, a rare bone disease. It is the first patient-specific total talus replacement implant approved by the agency.

By Nick Paul Taylor • Feb. 18, 2021

Medtronic recalls thoracic stent graft after patient death in clinical trial

The company has informed physicians to immediately cease use of its Valiant Navion system, which received FDA approval in 2018 for the minimally invasive repair of all lesions of the descending thoracic aorta.

By Greg Slabodkin • Feb. 17, 2021

COVID-19 EUAs drive FDA to record 2020 novel device OKs

The tally tops the 106 novel device authorizations in 2018 that marked a 40-year high. 

By Susan Kelly • Feb. 17, 2021

BD drug-coated balloon faces uphill battle in FDA panel review

Advisers on Wednesday are weighing the PAD treatment, but the agency has said data limitations make it hard to draw conclusions about safety and effectiveness. Evercore ISI analysts predict a negative vote.

By Susan Kelly • Updated Feb. 17, 2021

In run-up to MDR, EU posts guide to legacy devices in Eudamed

The guidance explains when manufacturers need to register on the new database and walks through details such as how to link products covered by the outgoing and new regulatory frameworks.

By Nick Paul Taylor • Feb. 15, 2021

COVID-19 leads to explosion in cyberattacks, data breaches

A survey from CI Security found successful hacks involving healthcare organizations or their business associates soared in the second half of last year, leading to a jump in the number of breached patient records.

By Ron Shinkman • Feb. 12, 2021

Dexcom touts boost from Super Bowl ad, sidesteps access complaints

While acknowledging concerns of the diabetic community, CEO Kevin Sayer said the company has a business to run and "by making more people aware" of CGMs "we'd have a much more positive effect than negative."

By Ricky Zipp • Feb. 12, 2021

Abbott, Medtronic could benefit as spinal cord stim seen rebounding

Physicians plan to prescribe 28% more implants than last year, driving sales above the high hit in 2019, according to a survey of 50 doctors by Baird Equity Research.

By Nick Paul Taylor • Feb. 12, 2021

What medtech earnings tell us so far: COVID-19 testing, electives hit, and M&A

Uncertainty clouds 2021 for medtechs, with elective care likely not to rebound until the second half and testing demand vulnerable to vaccine rollouts. What's clear is that the virus is a moving target and predictions are precarious.

By Ricky Zipp , Greg Slabodkin • Feb. 11, 2021

Heart disease devices lead latest batch of FDA breakthrough nods

The cardiovascular-focused products are part of a wider group of designations including those in development at companies such as Roche. 

By Nick Paul Taylor • Feb. 10, 2021

Alinity, da Vinci top hospital purchasing execs' wish lists: UBS

The feedback from hospitals' purchasing executives, gathered in the fourth quarter of 2020, shows capital equipment budgets remain resilient in the face of COVID-19.

By Susan Kelly • Feb. 9, 2021

Dexcom's Super Bowl ad puts focus on cost, access issues in diabetes tech

The maker of continuous glucose monitors deflected the criticism, calling the ad an education move to improve access for patients. Questions remain regarding how pricing impacts access to potentially life-saving devices.

By Ricky Zipp • Feb. 9, 2021

Pandemic habits could cause US health spending to decelerate over 2 decades, Deloitte predicts

The consultancy's predictive modeling based its estimate on the rise of digital health products and more consumer engagement. Such a slowing contrasts more dire spending forecasts made prior to the COVID-19 crisis.

By Rebecca Pifer • Feb. 8, 2021

Medicare DME competitive bidding in doubt after failed round: analysts

Cowen analysts said a recent report found steep rate hikes, leading them to conclude the program is no longer such a big threat to companies like Baxter, ResMed and Philips.

By Nick Paul Taylor • Feb. 8, 2021

FDA OKs Signifier neurostim device for snoring, sleep apnea

Signifier now faces the challenge of establishing eXciteOSA in the congested snoring and sleep apnea market targeted by companies including ResMed.

By Nick Paul Taylor • Feb. 8, 2021

Roundup: Medtech earnings season continues to show COVID-19 uncertainty

BD, Quest Diagnostics and Roche all said they have a clearer view of the first quarter of 2021 but not the second half of the year, while Boston Scientific forecast electives pressure in the first quarter recovering in the second half.

Feb. 5, 2021

Zimmer takes electives hit in Q4, to spin off spine, dental units

"There's just no doubt that COVID, unfortunately, remains a challenge ... We're seeing the pandemic pressure and the surges continue and, frankly, worsen across pretty much all of our regions and markets," said CEO Bryan Hanson.

By Ricky Zipp • Feb. 5, 2021

BD posts better-than-expected COVID-19 test sales, but flagship Veritor revenues to slow

Coronavirus testing revenues totaled $867 million, primarily made up by sales for the Veritor antigen test. Execs cited new virus variants and the potential for further slowing in elective care for a conservative forecast. 

By Ricky Zipp • Feb. 4, 2021

FDA appoints first medical device cybersecurity chief

University of Michigan professor Kevin Fu will serve a one-year term as acting cyber director at the Center for Devices and Radiological Health. Experts fear the chaos of the pandemic creates the perfect storm for hackers to exploit.

By Greg Slabodkin • Feb. 3, 2021

Boston Scientific sees COVID-19 electives pressure in Q1, recovery in second half

A hit of 7.7% in sales, driven by drops in neuromodulation and interventional cardiology, missed Wall Street expectations in the medtech's fourth quarter report.

By Ricky Zipp • Feb. 3, 2021

Death, injuries prompt FDA to call Boston Scientific ICD recall Class I event

The device giant began recalling the subcutaneous implantable defibrillator system electrode late last year after learning of 26 serious injuries and one death associated with the device.

By Nick Paul Taylor • Feb. 3, 2021

From COVID-19 EUAs to 'insidious' remote care risks: ECRI's top 10 medtech hazards

Risks highlighted by the watchdog include FDA emergency use authorizations and the rapid adoption of telehealth, both of which have increased during the coronavirus pandemic.

By Susan Kelly • Feb. 1, 2021

4 key trends for medtech in 2021

With resurgence of the coronavirus and emergence of more contagious strains, COVID-19 challenges, but also opportunities, lie ahead for medical device and diagnostics companies.

By Greg Slabodkin • Jan. 29, 2021