Medical Devices: Page 104
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FDA clamps down on bogus device 'registration certificates' amid rising use during pandemic
The agency sent letters to 25 companies after identifying a boost in use of materials "deceptively indicating" it had assessed medical devices.
By Nick Paul Taylor • March 4, 2021 -
Boston Scientific puts up $1B in cash to buy Lumenis surgical line from private equity
Wall Street analysts generally applauded the deal, which will see the medtech leader acquiring a portfolio of laser systems with potential to reach fast-growing markets like China.
By Ricky Zipp • Updated March 4, 2021 -
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TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
FDA breakthrough roundup: Cook Medical is latest in round of cardio-themed nods
The company, among a slew of recent designations granting enhanced feedback and speedier review, plans to file to run a pivotal trial of its Zenith Fenestrated+ Endovascular Graft this year.
By Nick Paul Taylor • March 3, 2021 -
Medtronic's HeartWare receives another Class I recall after more patient deaths
The medical device giant is recalling 157 HVAD Pump Implant Kits from the U.S. after receiving complaints that some devices failed to start or restart promptly.
By Nick Paul Taylor • March 2, 2021 -
Hillrom steps back from $375M BardyDx deal on reimbursement setback
The hospital products maker said a Medicare contractor's unexpected drop in payment rates for BardyDx's cardiac monitoring technology meant closing conditions for the transaction had not been satisfied.
By Susan Kelly • March 1, 2021 -
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 1, 2021 -
Permission granted by iRhythm Technologies
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 -
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 -
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 -
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 -
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 -
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
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