Medical Devices
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FDA OKs device to avert traumatic brain injury during sports
Approval was based in part on a study of 284 U.S. high school football players, suggesting the neck-worn product can minimize "slosh" in the brain that occurs in unprotected athletes who suffer head impacts.
By Nick Paul Taylor • March 01, 2021 -
Permission granted by iRhythm
iRhythm still faces reimbursement uncertainty after meetings with Medicare rate negotiator
CEO Michael Coyle said the cardiac monitoring company and other industry representatives met with a Medicare Administrative Contractor twice, but added that there are no assurances rates will come up.
By Ricky Zipp • Feb. 26, 2021 -
Explore the Trendline➔
Kendall Davis/MedTech Dive, original photos courtesy of Abbott and Dexcom
TrendlineThe MedTech Dive Outlook on 2021
The pandemic will keep disrupting the industry in the year ahead, as COVID-19 testing wanes and elective procedures slowly ease back. We look at the risks, challenges and opportunities.
By MedTech Dive staff -
NuVasive buys Simplify Medical in play for $2.6B cervical spine market
The $150 million acquisition will add to the pandemic-related challenges for NuVasive in 2021, with investments to train surgeons and run clinical trials offsetting the low anticipated sales this year.
By Nick Paul Taylor • Feb. 26, 2021 -
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Axonics adds incontinence device to portfolio in $200M Contura takeover
The targeted prescribers of Contura's urethral bulking agent are the same physicians who use Axonics' implantable sacral neuromodulation to treat urinary disorders. Analysts said the business logic seems sound.
By Nick Paul Taylor • Feb. 26, 2021 -
Diabetes wearables look resilient through 2021, bucking broad medtech trends
Dexcom, Tandem and Insulet pointed to targeting Type 2 patients and DTC as growth drivers in posting year-end results. One analyst gushed that "the golden age of diabetes care is still here."
By Ricky Zipp • Feb. 25, 2021 -
Nevro predicts resurgent pain implant sales in 2021 after slow start to the year
William Blair analysts said market growth is likely to remain challenging in the short run as CEO Keith Grossman argued the company was not losing share to rivals, which include Medtronic and Abbott.
By Nick Paul Taylor • Feb. 25, 2021 -
UK adopts medical device legislation, setting stage for new databases and sanctions
Politicians framed the new law as furthering efforts to fix failings that delayed regulatory responses to safety problems with products including pelvic mesh.
By Nick Paul Taylor • Feb. 24, 2021 -
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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 -
Jacob Bell
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 -
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 -
shutter_m via Getty Images
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?
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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 -
Jacob Bell
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 -
Brian Tucker
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 / BioPharma 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 at 9:45 a.m. -
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 -
Getty
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 -
Getty Images
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
