Medical Devices: Page 111
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Brexit deal creates regulatory barriers to UK-EU medical device trade
The new arrangement lacks provisions for the mutual recognition of standards, forcing products made in the U.K. to undergo an extra certification step to enter the EU market.
By Nick Paul Taylor • Jan. 4, 2021 -
Medtronic, J&J and Edwards among medtechs to headline at JP Morgan
Players in the COVID-19 diagnostic sector and red-hot liquid biopsy space are also set to present, making the event a chance to assess the state of the industry as it tries to move on from a turbulent 2020.
By Nick Paul Taylor • Jan. 4, 2021 -
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 -
The top medtech deals of 2020 (and one that got away)
M&A activity bounced back in the second half of the year, with deals ranging from Teladoc's $18.5 billion Livongo buy to Stryker's drawn-out $4 billion acquisition of Wright Medical.
By Susan Kelly • Jan. 4, 2021 -
Permission granted by The Boldt. Co.
Hospital finances bleak as 2020 nears a close, Kaufman Hall says
As COVID-19 cases keep rising, both hospitals and medical device companies face economic challenges early next year.
By Hailey Mensik • Dec. 23, 2020 -
Jacob Bell/MedTech Dive
FDA 2020 recall roundup: A rough year for infusion pumps
The agency listed a total of nine entries for recalls of infusion pumps or components and one update of an earlier action, for models made by Baxter, BD, CME America and Smiths Medical. BD's Alaris line accounted for half.
By Susan Kelly • Dec. 23, 2020 -
Getty / Edited by Healthcare Dive
Hospital giant Tenet goes big on ASCs
A shift in focus to outpatient settings is also occurring among medical device companies. Both Stryker and Zimmer Biomet have made ASCs more of a priority over the last several years.
By Samantha Liss • Dec. 22, 2020 -
Notified bodies warn MDR certification bottleneck could lead to medical device shortages
With more than 7,000 certificates set to expire in 2024, Team-NB wants the European Union to act now by allowing remote audits under the Medical Device Regulation.
By Nick Paul Taylor • Dec. 21, 2020 -
Medtronic, GE, Philips embrace AI amid regulatory limbo around algorithms
The focus comes as FDA action seems stalled. It's been a year and a half since the agency issued a discussion paper on its proposed regulatory framework for machine learning-based software as a medical device.
By Greg Slabodkin • Dec. 21, 2020 -
Medtech's COVID-19 recovery will have to wait for second half of 2021: analysts
Wall Street expects declines in elective care to continue as coronavirus cases keep rising. However, a more widespread rollout of vaccines could spur momentum later in the year.
By Ricky Zipp • Dec. 21, 2020 -
Philips buys cardiac monitoring company BioTelemetry in $2.8B deal
The Dutch conglomerate said that the move will expand its remote patient monitoring business beyond the hospital space. Baird called the pact a surprise but the valuation fair.
By Ricky Zipp • Dec. 18, 2020 -
Courtesy of Miach Orthopaedics
NFL player-backed implant to fix ACL tears gets FDA De Novo
Miach Orthopaedics' synthetic device, made from bovine collagen, offers an alternative to traditional reconstruction for one of the most common knee injuries in the U.S.
By Greg Slabodkin • Dec. 17, 2020 -
At FDA's request, Penumbra recalls catheter device after 14 patient deaths
"There's no way around the fact that this is a disappointing blow to the company's credibility given the positive commentary we've received from the company since the initial July warning notice," J.P. Morgan analysts wrote.
By Ricky Zipp • Dec. 17, 2020 -
Stryker, Zimmer shift strategies to capitalize on growing ASC market
Now that Medicare has caught up to private payers opening up coverage policies, experts see procedure migration away from hospitals accelerating. Pricing pressure is a risk, though.
By Ricky Zipp • Dec. 16, 2020 -
Breakthrough designations go to renal denervation devices in latest FDA batch
ReCor and SoniVie disclosed the regulatory privileges within a day of each other, boosting their efforts to enter a market targeted by Medtronic.
By Nick Paul Taylor • Dec. 16, 2020 -
Boston Scientific, Nevro agree to nix 1 patent lawsuit, but other legal fights go on
While the parties agreed to dismiss Nevro's case involving high-frequency spinal cord stimulation therapy against the medtech giant, separate disputes are active over related technology.
By Greg Slabodkin • Dec. 15, 2020 -
FDA lays out alternative 510(k) path criteria for 3 device types
The agency finalized guidance documents covering several product categories — spinal plating systems, orthopaedic bone screws and magnetic resonance coils — as it pushes forward with its Safety and Performance Based Pathway.
By Susan Kelly • Dec. 15, 2020 -
Permission granted by iRhythm Technologies
Medtronic's Coyle to replace iRhythm CEO King in switch-up
The leadership change comes after a series of ups and downs for iRhythm, but the cardiac digital health company is still performing better than expectations. Wall Street analysts were mixed on the impact.
By Ricky Zipp • Dec. 15, 2020 -
Deep Dive
MDR-IVDR bottleneck persists as EU launches 1st Eudamed module
"Very few notified bodies at this moment in time are taking new products on under the old directive, because a medical device doesn't just get certified overnight," an official at Ireland's National Standards Authority said.
By Nicholas Wallace • Dec. 14, 2020 -
BD calls for 'Zero Trust' to combat rising healthcare hacking amid pandemic
The medtech warns threats are plaguing the industry as providers increasingly rely on telehealth and remote monitoring to deliver care to patients.
By Susan Kelly • Dec. 14, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
Trump admin defends national stockpile as PPE, equipment shortages persist
"We’re not the Walmart that you can walk into on a daily basis to get your standard needs to treat patients and get PPE. We are a 911 response team," an HHS official said, adding the stockpile hasn't denied a single state request.
By Rebecca Pifer • Dec. 14, 2020 -
Alex Wong via Getty Images
Trump admin proposes easing HIPAA to foster value-based care, COVID-19 contact tracing
One goal in revamping the privacy regulations was to make information sharing more efficient, especially during health crises like the opioid epidemic and the coronavirus outbreak, according to top health officials.
By Rebecca Pifer • Dec. 11, 2020 -
UK shares post-Brexit device guidance as uncertainty around EU split looms
MHRA this week outlined which medtech manufacturers will need to register and when. The timeline is determined by the previously disclosed grace period which ends Jan. 1, 2021.
By Nick Paul Taylor • Dec. 11, 2020 -
Edwards plots TAVR comeback even as COVID-19 surge hits harder
"We've seen a fall-off and we felt it globally, but it's probably more predominant in the U.S.," CEO Michael Mussallem said of the impact of some hospitals limiting elective surgeries.
By Ricky Zipp • Dec. 10, 2020 -
Dexcom lays out strategy to double revenue by 2025, eyes hospitals, new markets
Wall Street analysts called the five-year guidance by the maker of continuous glucose monitors conservative, but investors were not so sure, sending shares down more than 4% on Wednesday.
By Ricky Zipp • Dec. 9, 2020 -
Registry finds no link between paclitaxel-coated devices and mortality risk: NEJM
The data add to evidence accumulating since a 2018 meta-analysis led the FDA to hold an advisory meeting and add new label warnings, putting pressure on medtechs like Boston Scientific and Medtronic.
By Nick Paul Taylor • Dec. 9, 2020
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