Medical Devices: Page 108
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Outpatient visits steady at end of 2020 but orthopaedics, cardiology remain down: report
Visit declines in specialty categories highlighted by the Commonwealth Fund report were in line with procedure trends top medtechs outlined during fourth-quarter earnings calls.
By Samantha Liss • Feb. 23, 2021 -
Hillrom patient lift tied to 2 deaths, designated as Class I recall
The device, used to move patients in healthcare facilities from one room to another in a sitting position, could become detached from its ceiling rail system causing the motor or patient to fall.
By Susan Kelly • Feb. 23, 2021 -
Explore the Trendline➔
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TrendlineTop 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 -
Medtronic sees capital equipment uptick despite latest coronavirus surge
Still, CFO Karen Parkhill observed that in February the company has "not yet seen a turnaround" as a result of severe winter weather in the U.S.
By Greg Slabodkin • Feb. 23, 2021 -
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Sponsored by Reed TechPredicting medical device safety recalls using publicly available data
Can data points be modeled to help understand if recall events are possibly predictable in nature?
Feb. 22, 2021 -
Boston Scientific's ICD recall gets 2nd Class I label from FDA
A new agency notice covers a fault that allows moisture to enter the medical device, causing it to short circuit when it tries to shock the patient. Boston Scientific has not received reports of injuries or deaths linked to the problem.
By Nick Paul Taylor • Feb. 22, 2021 -
Retrieved from Manatt on February 18, 2021
Obama admin alum Chiquita Brooks-LaSure tapped to head CMS
AdvaMed backed the nomination, noting a new Medicare rule that gives developers of FDA-designated breakthrough devices the potential to sell them and be reimbursed on the day of market approval.
By Shannon Muchmore • Feb. 18, 2021 -
Hospital admissions not linked to COVID-19 plunged in fall, especially in Midwest
As hospital volumes dropped in 2020, the effects rippled out to large medtechs, many of which rely on elective care to drive revenues.
By Samantha Liss • Feb. 18, 2021 -
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 -
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 -
Jacob Bell/MedTech Dive
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 -
Courtesy of Dexcom, Nick Jonas Super Bowl kit
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 -
Jacob Bell/MedTech Dive
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 -
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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
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