Medical Devices: Page 113
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Courtesy of Abbott
Abbott gets CE mark for latest CGM with Dexcom still in the wings
The step is the latest in the rivalry between the two big players in the continuous glucose monitoring market, which Wall Street analysts contend leaves room for both to gain.
By Maria Rachal • Sept. 28, 2020 -
BD to pay $60M to settle Bard pelvic mesh deceptive marketing claims
The payout is a fraction of the at least $475 million Johnson & Johnson has been ordered to pay states over the past year and a half for similar product liability cases.
By Maria Rachal • Sept. 25, 2020 -
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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 -
FDA finalizes overhauled guidance on device conformity testing pilot
The revised outline of the program, which will allow accredited labs to carry out premarket testing of medical devices, includes an expanded explanation of what the pilot means for device manufacturers.
By Nick Paul Taylor • Sept. 25, 2020 -
Medtronic-Axonics sacral neuromod patent battle heats up
The Patent Trial and Appeal Board is moving forward on reviews requested by the bladder and bowel dysfunction-focused device maker taking on the medtech giant.
By Maria Rachal • Updated Sept. 24, 2020 -
Patient sentiment improving on elective procedures despite ongoing pandemic, survey suggests
A Needham & Company poll from this month found the time older U.S. consumers want to wait before feeling comfortable having surgeries again is shrinking compared to its August results.
By Maria Rachal • Sept. 23, 2020 -
Medtronic gets FDA breakthrough tag for device to prevent infections
The medtech giant has identified Tyrx as among the product lines to benefit from COVID-19.
By Nick Paul Taylor • Sept. 22, 2020 -
FDA De Novo OKs outpace 2019 with Spineology device, two others
A flurry of first-of-their-kind marketing authorizations comes as the agency may be receiving fewer new submissions compared to previous years, according to a MDUFA quarterly report.
By Susan Kelly • Sept. 22, 2020 -
Kendall Davis/MedTech Dive
Labs, diagnostics, dialysis sectors predicted to recover by year-end, but S&P cautious on device outlook
The analysts would "like to see the number of procedures stabilize, if not improve" before reconsidering predictions for the medical devices industry.
By Ron Shinkman • Sept. 21, 2020 -
CMS to push back radiation oncology model after industry blowback
Agency administrator Seema Verma said a six-month delay will be formalized via upcoming rulemaking because "more time is needed to prepare."
By Susan Kelly • Updated Oct. 22, 2020 -
Courtesy of Abbott
Dexcom takes another step to keep CGMs in hospitals while Abbott targets athletes
By amassing early evidence in untapped populations, the companies hope to pursue lucrative new parts of the U.S. market.
By Maria Rachal • Sept. 18, 2020 -
Trump admin unveils final kidney care payment model
The CMS policy seeks to incentivize more at-home dialysis treatment, which could have implications for device makers including Baxter and newly public Outset Medical.
By Samantha Liss • Sept. 18, 2020 -
Alex Wong via Getty Images
Nixed Philips, Hamilton, Vyaire ventilator contracts subject of expanding House probe
The oversight subcommittee wants to know if the HHS cancellation of "wasteful" contracts with the three medtechs included generous termination settlements involving payoffs to the companies.
By Greg Slabodkin • Sept. 17, 2020 -
Moody's raises medtech outlook amid testing boom at Abbott, Thermo Fisher
But the investors service warned the pace of innovation in the COVID-19 test sector may render some products obsolete and create winners and losers.
By Nick Paul Taylor • Sept. 17, 2020 -
Intersect ENT strikes €60 Fiagon buyout to expand in balloon sinuplasty
The takeover of the German electromagnetic surgical navigation specialist comes two months after a report that Medtronic moved to acquire Intersect.
By Nick Paul Taylor • Sept. 16, 2020 -
Medtronic, Stryker among CEOs weighing in on COVID-19 recovery
Execs at Boston Scientific and Edwards also presented at the Morgan Stanley Global Healthcare Conference this week, casting optimism on a year-end return to growth after springtime lows.
By Maria Rachal , Susan Kelly • Sept. 15, 2020 -
FDA finalizes voluntary consensus standard guidance
The final guidance offers updated advice for submitting requests for recognition in the premarket review process and explains when the agency may withdraw a previously recognized standard.
By Susan Kelly • Sept. 15, 2020 -
Another BD Alaris recall pegged Class I event by FDA
It's the latest in a flurry of notifications about the infusion pump line of products, which have been the subject of 18 of the high-risk recall notices since March.
By Nick Paul Taylor • Sept. 15, 2020 -
Abbott, Illumina, other medtechs shape guide conveying device risks to patients
The report from the public-private Medical Device Innovation Consortium is part of a larger movement by FDA to integrate the patient's voice in areas that include device design, clinical development and regulatory review.
By Susan Kelly • Sept. 14, 2020 -
Courtesy of Fitbit
Fitbit wins FDA clearance for EKG app
The nod brings the wearables giant up to speed with Apple and Samsung in the heart rhythm tracking arena.
By Rebecca Pifer • Sept. 14, 2020 -
FDA AI-machine learning strategy remains work in progress
Nearly 18 months since the agency's discussion paper on a proposed regulatory framework, critical pieces are still needed for the development of draft guidance, agency digital health chief Bakul Patel said.
By Greg Slabodkin • Sept. 14, 2020 -
FDA advisers support down-classing bone growth stimulators, in face of industry and lawmaker pushback
But the orthopaedic devices panelists said there should be rigorous clinical evidence standards for the class of products currently sold by Orthofix, Zimmer Biomet, Bioventus and DJO, which are yet to be defined.
By Maria Rachal • Sept. 11, 2020 -
Thermo Fisher hikes growth forecast, expects COVID-19 sales to top $3B in late 2020
The company forecasts significantly higher growth this year than it's posted in the past, despite suffering a slow first quarter due to early disruption from the pandemic.
By Nick Paul Taylor • Sept. 11, 2020 -
FDA aims to harmonize adverse event reporting with eMDR updates, makes patient problem codes public
The agency finalized adding new elements and fields to its Electronic Medical Device Reporting system, and also clarified protocols for manufacturers with EUAs or following COVID-19 enforcement policies.
By Nick Paul Taylor • Sept. 10, 2020 -
The best TAVR device? Experts opine on when to use Boston Scientific, Edwards or Medtronic valve
A JAMA Cardiology review found design differences may give each transcatheter aortic valve replacement device small competitive advantages in certain circumstances.
By Nick Paul Taylor • Sept. 10, 2020 -
Medtronic tricuspid valve replacement device wins FDA breakthrough status
Although the medtech's Intrepid device is just starting an early feasibility study, it may ultimately go up against transcatheter tricuspid valve repair options from Abbott and Edwards.
By Maria Rachal • Sept. 9, 2020
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