Medical Devices: Page 101
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Philips raises guidance as elective procedures exceed pre-pandemic levels
The Dutch conglomerate's results follow encouraging rebounds in non-emergency care from Edwards, Intuitive Surgical and J&J. Still, Philips posted a loss from continuing operations.
By Nick Paul Taylor • April 26, 2021 -
Permission granted by Biogen
FDA greenlights device to retrain muscles in stroke patients
The noninvasive brain-computer interface technology uses data from the uninjured side of a patient's brain to recover motor function in the affected arm and hand.
By Susan Kelly • April 26, 2021 -
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Sarah Silbiger via Getty Images
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 -
Alex Wong via Getty Images
Value-based care at 'critical juncture,' new CMMI chief says
Even though some testing payment models have been delayed or discarded, the new leader of CMS' innovation arm said the agency remains committed to finding models that reward value over volume.
By Rebecca Pifer • April 23, 2021 -
Courtesy of Amazon
Survey casts doubt on utility of wearable devices in healthcare
Forrester's report, based on interviews with doctors, patients and vendors, suggests data gaps and physician skepticism of the popular products is too high for widespread adoption, although design changes could remedy that.
By Ron Shinkman • April 22, 2021 -
Adeline Kon/MedTech Dive
Moody's predicts brisk pace of medtech M&A amid earnings optimism
A new report from the ratings agency echoes initial commentary by bellwethers J&J and Edwards, which released financials this week.
By Susan Kelly • April 22, 2021 -
Roundup: Medtech earnings show early signs of electives return, lingering testing uncertainty
The industry is reporting an elective care rebound in March after volumes dropped in the winter, while COVID-19 test demand appears to be softening as vaccination numbers grow.
April 22, 2021 -
Courtesy of Intuitive Surgical
Intuitive sees Q1 robot rebound in turnabout from start of year
CEO Gary Guthart called the quarter a "step in the right direction," but execs also cautioned variants and supply chain constraints could throw a wrench into the recovery.
By Susan Kelly • April 21, 2021 -
Edwards withstands winter lows, grows Q1 sales on electives recovery
CEO Michael Mussallem said volumes grew gradually through March after a significant drop, continuing the early trend of procedure-dependent medtechs reporting a return of non-emergency procedures.
By Ricky Zipp • April 21, 2021 -
Health funding shatters records in Q1, but medtech a bit of a laggard
Medical device companies were a relative outlier, raising $4.6 billion, down 23% from a peak in the fourth quarter last year, while the number of deals declined by almost 11%, according to a CB Insights report.
By Rebecca Pifer • April 20, 2021 -
Courtesy of Abbott
Abbott misses Wall Street as COVID-19 test sales softer than expected
CEO Robert Ford told investors on Tuesday that $1.8 billion in sales were from its rapid coronavirus testing platforms as he sees a shift to surveillance. But he acknowledged testing is "difficult to forecast right now."
By Greg Slabodkin • April 20, 2021 -
Permission granted by Johnson & Johnson
J&J returns to growth in Q1 as elective care rebounds in US, Asia-Pacific
The recovery was mixed among procedure types, with hips improving, while knees and spine fell. Still, CEO Alex Gorsky forecast volumes to keep rebounding throughout 2021.
By Ricky Zipp • April 20, 2021 -
Thomas Barwick via Getty Images
AdvaMed pushes CMS to implement MCIT final rule without further delay
The Medicare agency postponed the proposal from taking effect amid criticism from some doctors and safety groups that it risks promoting device use without rigorous evidence of safety and effectiveness.
By Susan Kelly • April 19, 2021 -
Permission granted by IQVIA
FDA drops 8 medical software functions from oversight
The final rule, issued without notice or comment, brings the software classifications in line with provisions of the 21st Century Cures Act and reflects the agency's current statutory authority.
By Susan Kelly • April 19, 2021 -
BD files new 510(k) submission for troubled Alaris infusion pump
The announcement comes after a spate of software and hardware recalls regarding the Alaris system throughout 2020 and 2021.
By Ricky Zipp • Updated April 26, 2021 -
Yujin Kim/MedTech Dive
Robotics startup Vicarious raises $425M, including from BD, to take on giants
Aiming for a 510(k) submission in 2023 and to grow sales to $1 billion by 2027, the firm with high-profile backers including Bill Gates will face competition from Intuitive, J&J and Medtronic.
By Nick Paul Taylor • April 16, 2021 -
Photography by Gage Skidmore / Photo Illustration by Kendall Davis/MedTech Dive
FDA scraps Trump-era 510(k) exemption bid in scathing dissection of 'flawed' plan
The agency nixed the proposal, which HHS made without consulting FDA, after strong pushback from Baxter and digital health startups, among other stakeholders, as well as its own staff.
By Nick Paul Taylor • April 16, 2021 -
EU MDR delay has not made new rules easier to stomach: exec poll
Most of the 115 respondents to the Climedo Health survey said resources and lack of clarity were top challenges, with about a third indicating compliance efforts will cost their company 5% to 10% of annual revenue.
By Ricky Zipp • April 15, 2021 -
Adeline Kon/Healthcare Dive/MedTech Dive
6 medtechs to watch when earnings kick off next week
First quarter results from Abbott, Edwards, Intuitive, J&J, Quest and Roche will help reveal the pace of procedure recovery and if the coronavirus testing boom has legs despite the rollout of vaccines.
By Nick Paul Taylor • April 15, 2021 -
FDA authorizes labs for device conformity testing pilot
The accredited laboratories will assess whether medical devices meet consensus standards. None of the initial 53 labs, which include TÜV SÜD and UL, have so far received accreditation for biocompatibility testing.
By Nick Paul Taylor • April 14, 2021 -
Mid-sized medtechs hit hardest by pandemic, though sector seen resilient: poll
The survey of more than 1,600 industry professionals from Emergo by UL also found respondents are most bullish on tapping Asian markets.
By Nick Paul Taylor • April 14, 2021 -
Adeline Kon/MedTech Dive
HHS urged to conduct 'vigorous oversight' of hospital price rule after reports of noncompliance
U.S. lawmakers want the secretary to step up oversight of the new requirement for health systems to make prices for procedures like hip and knee replacements available to the public.
By Samantha Liss • April 14, 2021 -
Permission granted by iRhythm Technologies
iRhythm's future hazy after Medicare pricing saga erases 12-month high
Wall Street analysts project the cardiac wearables maker to lose tens of millions of dollars in revenue in coming years, raising questions about the future of the once-hyped market leader.
By Ricky Zipp • April 13, 2021 -
Doubts cast on CPAP efficacy evidence in HHS agency review
A report prepared for the Agency for Healthcare Research and Quality found available studies "mostly" do not support a link between continuous positive airway pressure therapy and long-term, clinically important outcomes.
By Nick Paul Taylor • April 13, 2021 -
Medtronic launches AI-based colonoscopy device in US on heels of FDA clearance
The medtech is the exclusive global distributor of Cosmo Pharmaceutical's GI Genius module, which has been granted De Novo clearance and is compatible with colonoscope video for identifying polyps and lesions.
By Greg Slabodkin • April 12, 2021 -
Permission granted by iRhythm Technologies
iRhythm shares tank after Medicare rates surprise
CEO Michael Coyle said the wearables company will withdraw its Zio XT cardiac monitor from Medicare fee-for-service segments, adding that he was not optimistic for a reversal.
By Ricky Zipp • April 12, 2021
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