Medical Devices: Page 68
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EPA. (2022). “https://www.epa.gov/hazardous-air-pollutants-ethylene-oxide/forms/columbus-nebraska-becton-dickinson-pharmaceutical” [Photo]. Retrieved from EPA.gov.
Ethylene oxide regulation may disrupt device supply, AdvaMed warns White House
The trade group has asked President Joe Biden to consider the potential threat to patient care if facilities are shut down.
By Nick Paul Taylor • Jan. 23, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA demands additional data on Abbott rival to Medtronic balloon, setting back approval timeline
Abbott’s partner Surmodics is “evaluating options” to reduce its spending while preparing a response to the regulator’s requests.
By Nick Paul Taylor • Jan. 20, 2023 -
Explore the Trendline➔
Sara Silbiger via Getty Images
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 -
Permission granted by Dexcom
Q&ADexcom CEO discusses 2023 plans, expanding to more patients with Type 2 diabetes
MedTech Dive caught up with Kevin Sayer for a conversation about forthcoming product launches and long-term plans to expand CGMs to a broader group of patients.
By Elise Reuter • Updated Jan. 20, 2023 -
N/A via Getty Images
Medtech hazards: Problems with Philips’ recall put safety of home-use devices at top of danger list
Patient safety group ECRI is challenging manufacturers to provide easy-to-follow device registration instructions and write simply worded recall notices.
By Nick Paul Taylor • Jan. 19, 2023 -
Courtesy of Abbott
Abbott’s FDA approval for TAVI device tees up challenge to Edwards, Medtronic: analysts
Abbott has captured about 9% of the European market and aims to become a “credible third player” in the U.S.
By Nick Paul Taylor • Jan. 18, 2023 -
Courtesy of Shockwave Medical
Shockwave to pay $100M for Neovasc, adding refractory angina treatment to device pipeline
Neovasc already has a CE mark for the device and last year said it was targeting a 2025 approval by the FDA.
By Nick Paul Taylor • Jan. 18, 2023 -
Jacob Bell/MedTech Dive
Medtech companies start 2023 on ‘optimistic’ note amid earnings forecasts, staffing: J.P. Morgan
Executive comments at the healthcare conference in San Francisco suggest companies expect staffing pressures and supply constraints to improve in 2023, analysts say.
By Elise Reuter • Jan. 17, 2023 -
yodiyim via Getty Images
AI predicts lung cancer risk six years into the future using single CT scan: study
A research team has made the deep learning model publicly available and says it has no intention to commercialize it.
By Nick Paul Taylor • Jan. 17, 2023 -
Permission granted by iRhythm Technologies
iRhythm shows signs of progress even as it ‘still has a way to go’ on key challenges: William Blair
The company should come close to its revenue estimate when reporting fourth quarter results, according to analysts.
By Nick Paul Taylor • Jan. 13, 2023 -
Portra via Getty Images
‘Mixed signals’ from medtech management suggest industry had bumpy end to 2022: analysts
The recovery of procedure volumes was “muted and uneven” in the fourth quarter with growth throttled by hospital staffing issues and worker absenteeism.
By Nick Paul Taylor • Jan. 13, 2023 -
Olena Yakobchuk via Getty Images
Olympus gets two FDA warning letters over safety of reprocessed endoscopes
The regulator said the companies didn’t adequately test the device assembly process and waited too long to report problems from complaints.
By Elise Reuter • Jan. 12, 2023 -
Courtesy of Press release https://verily.com/blog/verily-expands-stephen-gillett-s-role-to-president-and-chief-operating-officer/
Google sibling Verily to lay off about 200 workers as it focuses on precision risk business
The company, which has more than 1,600 employees, will stop work on some products including its healthcare analytics software program.
By Nick Paul Taylor • Jan. 12, 2023 -
Courtesy of Intuitive Surgical
Intuitive forecasts 12%-16% growth in procedures in 2023 even as da Vinci robot sales slowed in Q4
For hospitals that have been reporting growth in robotic procedures, “da Vinci is a relative priority in their capital budgets,” the company said.
By Elise Reuter • Jan. 11, 2023 -
Courtesy of Imactis
GE HealthCare to buy France’s IMACTIS in first acquisition as independent firm
IMACTIS’s CT-Navigation system is used to help surgeons in minimally invasive operations and reduce procedure time.
By Peter Green • Jan. 11, 2023 -
Courtesy of U.S. Food and Drug Administration
Rethinking 510(k): Studies show risk of using recalled devices as predicates for FDA clearance
Two studies found devices cleared through the FDA’s 510(k) pathway that listed recalled predicate devices were more likely to face recalls themselves.
By Nick Paul Taylor • Jan. 11, 2023 -
Courtesy of Sterigenics
Sterigenics reaches $408M ethylene oxide settlement to resolve hundreds of lawsuits in Illinois
Sterigenics said “years of biased media coverage in the greater Chicago area” underpinned its decision to settle.
By Nick Paul Taylor • Jan. 11, 2023 -
Permission granted by Abbott Laboratories
How Abbott plans to make its Freestyle Libre a $10B product
CEO Robert Ford discussed plans to grow the market for Abbott’s continuous glucose monitors, and its broader diabetes strategy.
By Elise Reuter • Jan. 10, 2023 -
Courtesy of Beta Bionics
Beta Bionics hires Harvard diabetes expert as CMO ahead of artificial pancreas launch
Steven Russell has joined the company as chief medical officer, completing a new leadership team that began taking shape with the appointment of Sean Saint as CEO last year.
By Nick Paul Taylor • Jan. 10, 2023 -
Permission granted by ResMed
ResMed responds to ‘humanitarian emergency’ over demand for CPAP devices with new factory
The company has scaled up its manufacturing capacity and struck agreements with chip suppliers even as patients still face waits for the devices amid ongoing recall woes at Philips.
By Elise Reuter • Jan. 10, 2023 -
Permission granted by iRhythm Technologies
Cardiac wearable maker iRhythm sees ‘nice progress’ in recovering from Q3 challenges
The company reported more than 20% growth in patient registration and improvement in its returned device rate.
By Nick Paul Taylor • Jan. 10, 2023 -
Permission granted by Medtronic
Medtronic CEO Martha: No more divestitures planned for 2023, but review continues
“The portfolio review is ongoing,” CEO Geoff Martha said, even as the world’s largest medtech company plans to divest dialysis, respiratory interventions and patient monitoring businesses.
By Elise Reuter • Jan. 9, 2023 -
John Moore via Getty Images
Dental medtech market remains steady amid ‘robust’ US employment: Henry Schein
Analysts said the update from company executives is encouraging, although there are potential concerns about pricing.
By Nick Paul Taylor • Jan. 9, 2023 -
artJazz via Getty Images
European Commission formalizes plan to extend MDR transition out to 2027, 2028
Having accepted that notified body capacity “remains insufficient,” the Commission wants to give manufacturers more time to get their devices designated under MDR.
By Nick Paul Taylor • Jan. 9, 2023 -
Tim Boyle via Getty Images
Baxter to spin off renal care, acute therapies units
The company is also considering the sale of its Biopharma Solutions business.
By Elise Reuter • Jan. 6, 2023 -
Sarah Silbiger via Getty Images
Vivos bounces back from FDA rejection to land 510(k) clearance for sleep apnea treatment
Shares in Vivos increased by more than 150% on the day of the news.
By Nick Paul Taylor • Jan. 6, 2023
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