Medical Devices: Page 102
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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 -
Explore the Trendlineâž”
Sitthiphong via Getty Images
TrendlineMedical 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 -
Permission granted by The Boldt. Co.
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 -
Courtesy of BD/PRNewswire
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 -
[Photograph]. Retrieved from Regional Health Command Atlantic.
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 -
Adeline Kon/MedTech Dive
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 -
Low Medicare EKG device draft slams iRhythm, stock price sinks by over 30%
Wall Street analysts questioned whether the lower-than-expected rates are final and what the prospects are for renegotiation. Shares of market leader iRhythm fell over 32% on Friday.
By Ricky Zipp • Updated Feb. 1, 2021 -
Deep Dive
CGM, insulin pump players look to 2021 as watershed year for diabetes wearables market
Insulet, Dexcom and Medtronic have product launches set for this year, and all look to capitalize on the recent skyrocketing of virtual care due to the coronavirus pandemic.
By Ricky Zipp • Jan. 29, 2021 -
Permission granted by iRhythm Technologies
Q&ANew iRhythm CEO on national pricing setback, Medtronic market expansion lessons
Michael Coyle will try to build off the cardiac monitoring company's recent success amid a telehealth boom. Shares have jumped by over 175% in the last 12 months.
By Ricky Zipp • Jan. 28, 2021 -
Hospitals lost $20B by pausing electives last year
The slowdown in elective care also hurt medtechs like Abbott and Johnson & Johnson. The industry expects declines to continue into 2021 after procedure volumes dropped again in the fourth quarter due to the virus resurgence.
By Shannon Muchmore • Jan. 28, 2021 -
Edwards' US TAVR sales fall as COVID-19 disrupts referrals
Analysts expected U.S. transcatheter aortic valve replacement sales to be flat in the fourth quarter but they fell by mid-single digits. Still, the company maintains guidance for global TAVR growth of 15-20% this year.
By Nick Paul Taylor • Jan. 28, 2021 -
Stryker falls short of Q4 sales amid electives pullback, robotics a bright spot
Double-digit growth in China was offset by hits in business in the U.S. and Europe. CEO Kevin Lobo told investors after volumes rebounded through October, large declines began in November and December.
By Ricky Zipp • Jan. 27, 2021 -
Courtesy of BioNTech
Biden invokes DPA to combat supply shortages, but experts say it's no 'magic wand'
AdvaMed early in the pandemic urged against using the Defense Production Act's powers, though some companies were more open. The device lobby last week asked the administration to coordinate with industry before taking action.
By Matt Leonard • Jan. 27, 2021 -
England's NHS moves to boost access to Quidel, Roche, other medtech products
To be a part of the National Health Services' MedTech Funding Mandate, companies must be able to make the claim that their products generate net savings in their first year of use.
By Nick Paul Taylor • Jan. 27, 2021 -
Courtesy of Abbott
Abbott Q4 beat driven by COVID-19 test demand, devices come in flat
CEO Robert Ford said the company exited 2020 with "tremendous momentum" and forecast 35% growth for this year.
By Greg Slabodkin • Jan. 27, 2021 -
Surmodics drug-coated balloon on par with Medtronic's in study
The medtech is looking to distinguish itself from rivals with a lower dose, after a 2018 meta-analysis found a mortality risk for patients treated with paclitaxel-coated balloons or stents in the femoropopliteal artery of the leg.
By Susan Kelly • Jan. 26, 2021
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