Medical Devices: Page
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Courtesy of LivaNova
LivaNova CEO quits as firm announces higher-than-expected preliminary earnings
Analysts from Needham and Stifel had opposite takes on how McDonald’s departure will affect the company, which has struggled in recent years to bring new products to market.
By Peter Green • April 17, 2023 -
Permission granted by Abbott
Abbott gets clearance for Libre 3 reader, opening path to Medicare coverage
With a standalone reader, Abbott said it is working to make the FreeStyle Libre 3 system available to people covered by Medicare.
By Elise Reuter • April 17, 2023 -
Explore the Trendline➔
Sarah Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Shutterstock/Lukasz Pawel Szczepanski
Sponsored by EsperOvercome the top 5 device management challenges of remote patient care with ease
As more organizations adopt RPM, they’re facing increasingly complex challenges managing, updating and securing their devices.
April 17, 2023 -
Getty Images
Proxy adviser backs diabetes device developer Sernova in fight against activist investors
Institutional Shareholders Services said the activist investors “failed to present a detailed explanation” of their case and recommended that shareholders vote for Sernova’s director nominees.
By Nick Paul Taylor • April 17, 2023 -
Permission granted by Medtronic
Q&AFriday Q&A: Medtronic’s Ajizian talks connected care ahead of unit spinoff
From supporting AI-driven medical interventions to freeing up providers from administrative tasks, remote patient monitoring is raising the bar for care, says Medtronic’s CMO for patient monitoring.
By Susan Kelly • April 15, 2023 -
Courtesy of Medtronic
Medtronic, 6 months after proposing patient monitoring spinoff, remains mum on separation plan
A standalone entity could achieve faster growth, even though recent spinoffs in the medtech sector have produced mixed results, analysts say.
By Susan Kelly • April 14, 2023 -
Courtesy of Philips
Fewer Philips replacement devices have reached patients than counted, FDA says
The agency raised concerns that the discrepancy could affect the estimated wait times for patients needing a replacement sleep apnea device.
By Elise Reuter • April 14, 2023 -
Courtesy of https://news.medtronic.com/newsroom-medtronic-hits-the-road-mobile-labs
Medtronic targets June closure of Epix facility, will lay off 59 employees
The company had bought Epix for a catheter-based, temperature-controlled cardiac ablation system designed to treat patients with irregular heartbeats.
By Nick Paul Taylor • April 14, 2023 -
Michael M. Santiago via Getty Images
Digital surgery firm Surgalign faces delisting by Nasdaq for shareholder equity noncompliance
The exchange has given Surgalign 45 days to submit a plan to regain compliance.
By Nick Paul Taylor • April 14, 2023 -
Courtesy of Walgreens
OTC hearing aid matches performance of audiologist-fitted device in small trial
People who used an over-the-counter hearing aid for six weeks saw similar results to people who used an audiologist-fitted device, suggesting less costly, self-fitted hearing aids could be an option.
By Nick Paul Taylor • April 13, 2023 -
Spencer Platt/Getty via Getty Images
Medtech sector poised for growth as healthcare staffing tops pre-COVID levels: KeyBanc
The analysts are “leaning into increased medtech exposure” after determining that several challenges that have constrained the industry are easing.
By Nick Paul Taylor • April 13, 2023 -
Permission granted by Zimmer Biomet
Zimmer’s ‘smart knee’ implant may qualify for new technology payments from CMS
If finalized, the add-on payments would help cover the cost of the sensor technology included in the company’s Persona IQ knee implants.
By Elise Reuter • April 12, 2023 -
Getty Images
FDA starts device sterilization pilot program to help industry adapt to EtO emission clampdown
The FDA “recognizes the need to facilitate more timely changes” amid a push to cut EtO emissions and constraints on the supply of radioactive cobalt.
By Nick Paul Taylor • April 12, 2023 -
EPA. (2022). "https://www.epa.gov/hazardous-air-pollutants-ethylene-oxide/forms/columbus-nebraska-becton-dickinson-pharmaceutical" [Photo]. Retrieved from EPA.gov.
Medical device groups say ‘the stakes are high’ with new EtO regulations
AdvaMed, which represents medical device companies, warned that patients could face treatment delays if sterilization facilities close.
By Elise Reuter • April 11, 2023 -
EPA to limit ethylene oxide emissions from medical device sterilizers
The agency proposed new emissions limits that device sterilization companies would have 18 months to meet.
By Elise Reuter • April 11, 2023 -
Courtesy of GE Healthcare
GE HealthCare faces ‘competition from all angles’ that could constrain growth: analysts
BTIG lists 20 companies as competitors to GE HealthCare, including China’s Shenzhen Mindray Bio-Medical Electronics and Shanghai United Imaging Healthcare.
By Nick Paul Taylor • April 11, 2023 -
Getty Images
Medtech buyouts by private equity in Q4 shed light on deal-making trends in 2023: report
Medtech companies are continuing to spin off assets to realign portfolios, creating opportunities for private equity firms to buy businesses and exit existing investments.
By Nick Paul Taylor • April 11, 2023 -
Courtesy of Philips
Philips recalls 1,200 reworked sleep apnea devices over fault that can cause therapy failure
The problems keep mounting for Philips, as recently repaired respirators now need to be fixed in a recall the FDA has labeled a Class I event.
By Nick Paul Taylor • April 10, 2023 -
EPA proposes stricter ethylene oxide pollutant rules for chemical makers
Further EPA proposals involving medical device sterilization plants are expected to be forthcoming.
By Susan Kelly • April 7, 2023 -
Permission granted by Fujifilm
Q&AFriday Q&A: Fujifilm’s Henry Izawa on navigating a tough hospital equipment market
The CEO of Fujifilm Healthcare Americas discusses integrating Hitachi’s diagnostic imaging business, new product launches and how hospital budgets are changing the market for imaging.
By Elise Reuter • April 7, 2023 -
Getty Images
Sernova defends record after investors attack ‘sluggish’ progress of regenerative medicine implant
The investors accused Sernova’s board of “complacently” overseeing “a period of eroding shareholder value.”
By Nick Paul Taylor • April 7, 2023 -
Retrieved from Abbott on April 06, 2023
Abbott faces Class I recall of 4.2M glucose readers on battery fire risks
Readers for Abbott’s FreeStyle Libre glucose monitoring systems could catch fire if improperly stored or charged, the FDA says.
By Peter Green • Updated April 7, 2023 -
Courtesy of Bioventus (composite by MedTech Dive)
Bioventus CEO departs after CartiHeal acquisition unravels
Ken Reali was asked to leave after a deal to buy CartiHeal fell apart. Bioventus’ share price has fallen more than 90% in the past two years.
By Susan Kelly • April 6, 2023 -
Buda Mendes via Getty Images
Medtech servicing timelines and costs improve as technician turnover creates skills challenge
With experienced technicians retiring faster than their replacements are getting up to speed, the sector faces a potentially costly skills challenge.
By Nick Paul Taylor • April 6, 2023 -
Courtesy of Medtronic
Medtronic’s Hugo too similar to Intuitive’s surgical robot to displace the market incumbent: analysts
The analysts expect Medtronic to “find a place in specific markets” that Intuitive is yet to dominate.
By Nick Paul Taylor • April 5, 2023
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