Medical Devices: Page 100
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FDA touts real-world evidence use by Abbott, Medtronic in analysis of regulatory decisions
The agency has released details of how medtechs have used RWE, such as registries and medical records, to support filings including 510(k) submissions and premarket approval applications.
By Nick Paul Taylor • March 17, 2021 -
Adeline Kon/MedTech Dive
Deep DiveAll eyes on elective care after a rollercoaster year for medtech
After shutdowns slammed procedure-dependent firms in 2020, industry and Wall Street are waiting to see when non-emergency surgeries return and what a comeback might look like.
By Ricky Zipp • March 16, 2021 -
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TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
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CMS puts the brakes on breakthrough device coverage rule
The policy would automatically OK Medicare reimbursement for devices with FDA breakthrough status, but critics contend the rule would undermine CMS authority to consider the clinical evidence backing new technologies.
By Susan Kelly • March 16, 2021 -
FDA flags risk of device fracture in Colfax's STAR ankle replacements
The products, recently divested to Colfax from Stryker, showed fractures occurring as early as three to four years after implant in an FDA analysis of post-approval study data and adverse event reports.
By Susan Kelly • March 16, 2021 -
Bayer posts second analysis of Essure adverse events taken from social media
The latest data shows reports of 11,830 serious injuries, 45 malfunctions and nine deaths, but the FDA advised against drawing conclusions. Bayer pulled the device from the U.S. market in 2018 and still defends its safety.
By Nick Paul Taylor • Updated March 17, 2021 -
Adeline Kon/MedTech Dive
1 year after COVID-19 hit: what's next for FDA, electives, testing and robotics
The medtech industry has ridden a roller coaster of steep demand for novel diagnostics and a plunge in once-stable business lines like hip and knee replacement surgeries.
March 15, 2021 -
Deep Dive
5 things medtech can expect from FDA in 2021
"What you saw under the prior administration was this concept of a kinder, softer FDA to industry," said Dennis Gucciardo, partner at Morgan Lewis. Experts now expect a shift, including more enforcement activity.
By Greg Slabodkin • March 15, 2021 -
Cardiac wearables, iRhythm, under a cloud as reimbursement questions linger
"If this [Novitas Solutions] rate is not adjusted, these companies don't make money and will be unlikely to provide the service," Baird analyst Mike Polark said.
By Ricky Zipp • March 15, 2021 -
Cardinal Health sells troubled Cordis unit to private equity firm for $1B
Hellman & Friedman's acquisition of the maker of interventional vascular technology follows Cardinal's 2015 buy of Cordis from Johnson & Johnson for $1.9 billion.
By Greg Slabodkin • March 12, 2021 -
Deep DiveHospitals lift curtain on prices, revealing giant swings for hips, knees and more
At a Sutter hospital in San Francisco, a joint replacement ranges from $22,865 to $101,571, accordind to a Healthcare Dive analysis of data hospitals are required to report as of January.
By Samantha Liss , Nami Sumida • March 11, 2021 -
Alex Wong via Getty Images
CMS pushes back kidney care payment model start date to January 2022
The rule incentivizes delivery of at-home dialysis care with increased payments. Baxter and Outset Medical are among those that pushed for the changes.
By Rebecca Pifer • March 11, 2021 -
Alex Wong via Getty Images
Docs writing in NEJM push CMS to drop breakthrough payment rule
Rescinding the rule would stop a change analysts saw as a "significant commercial tailwind" for companies including Abbott, J&J and Medtronic.
By Nick Paul Taylor • March 11, 2021 -
GE Healthcare predicts growth, hike in digital investment as pandemic eases
"We are seeing procedure volumes increasing, contributing to the rebound of our pharmaceutical diagnostics business and we see sequential market growth in imaging and ultrasound," CEO Kieran Murphy said during an investor event.
By Nick Paul Taylor • March 11, 2021 -
Vast majority of hospitals say they have an AI strategy, up from just half last year
AI technologies have also caught the attention of the medical device industry, with top medtechs like Medtronic, GE Healthcare and Philips investing in the space.
By Rebecca Pifer • March 10, 2021 -
EU remote audits under MDR in doubt as divergent national positions persist
Team-NB pulled a proposal unveiled in February amid sustained resistance. A Commission medical device group met last week but has yet to disclose a solution.
By Nick Paul Taylor • March 10, 2021 -
Intersect touts CMS coverage changes as boon for patient, physician access
The agency published an average selling price for Intersect's corticosteroid-eluting sinus implant treatment for nasal polyps, which "should help clarify payment and ease payor coverage adjudication," SVB Leerink analysts wrote.
By Nick Paul Taylor • March 9, 2021 -
Courtesy of Abbott
Abbott capitalizes on digital health boom with virtual clinic for neuromodulation therapy
The FDA-approved virtual clinic is the medtech giant's next step to gain share in the neurmod market from rivals Medtronic, Boston Scientific and Nevro.
By Nick Paul Taylor • March 9, 2021 -
Colfax to split in 2, creating over $1B orthopaedic player
The split will create a medtech company with a portfolio of orthopaedic devices forecast to generate sales of around $1.4 billion this year. The move is expected to facilitate more M&A.
By Nick Paul Taylor • March 8, 2021 -
Backing for telehealth Medicare reimbursement gains steam in Congress
Tuesday's House committee mirrored similar Senate panels. There's bipartisan support for a permanent expansion to a greater share of the population, but legislators are split on what form it should take.
By Rebecca Pifer • March 5, 2021 -
Insulin pump adoption seen climbing 21% in 2021 on wearables boom: survey
The SVB Leerink poll of 101 endocrinologists and nurse practitioners also projects a shift in market position among top players like Medtronic, Insulet and Tandem Diabetes Care.
By Ricky Zipp • March 5, 2021 -
Warchests, distressed assets drive medtech M&A flurry early in 2021
The industry is averaging more than one $100 million-plus takeover a week, as the influx of COVID-19 test revenues and pressures on companies reliant on surgical procedures create buying opportunities.
By Nick Paul Taylor • March 5, 2021 -
FDA clamps down on bogus device 'registration certificates' amid rising use during pandemic
The agency sent letters to 25 companies after identifying a boost in use of materials "deceptively indicating" it had assessed medical devices.
By Nick Paul Taylor • March 4, 2021 -
Boston Scientific puts up $1B in cash to buy Lumenis surgical line from private equity
Wall Street analysts generally applauded the deal, which will see the medtech leader acquiring a portfolio of laser systems with potential to reach fast-growing markets like China.
By Ricky Zipp • Updated March 4, 2021 -
FDA breakthrough roundup: Cook Medical is latest in round of cardio-themed nods
The company, among a slew of recent designations granting enhanced feedback and speedier review, plans to file to run a pivotal trial of its Zenith Fenestrated+ Endovascular Graft this year.
By Nick Paul Taylor • March 3, 2021 -
Medtronic's HeartWare receives another Class I recall after more patient deaths
The medical device giant is recalling 157 HVAD Pump Implant Kits from the U.S. after receiving complaints that some devices failed to start or restart promptly.
By Nick Paul Taylor • March 2, 2021
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