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Median lag between FDA authorization and Medicare coverage hits 6 years: study
Fewer than 30% of novel medical devices obtain some Medicare coverage in the three years after regulatory authorization, researchers found.
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Q&A
Q&A: ‘Chaotic’ digital health market needs independent evaluation, new institute says
Independent evaluation could help the healthcare industry figure out which digital health products are backed by evidence, argues Caroline Pearson, executive director of the nonprofit Peterson Center on Healthcare.
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Getinge’s heart assist pump shutdown problem given FDA Class I recall tag
The company notified healthcare providers after receiving 26 complaints about Cardiosave devices, used to support severely ill patients, unexpectedly shutting down.
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Senseonics seeks iCGM designation for implantable glucose monitor
The company also plans to submit results of a pivotal trial for a version of its device that can be worn for a year.
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Illumina shakes up executive team, lowers 2023 outlook
The gene sequencing industry leader, which is operating under an interim CEO, named a new chief technology officer and announced the departure of its chief medical officer.
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Boston Scientific receives FDA approval for cryoablation system
The company hopes to build on interest in Europe and Japan as competitors bring new cardiac ablation devices to market.
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ZimVie wins FDA approval for smaller Mobi-C cervical disc
The device maker said the new product will “address the anatomical needs of the U.S. patient population.”
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Device volumes to hold up against threat of Wegovy, other GLP-1 drugs: analysts
Issues such as “nontrivial side effects, cost concerns and patient persistence” will mean physicians continue to use medical devices, analysts say.
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Stryker touts Mako robot in DTC ads, as device makers eye broader patient populations
The company is taking its message on the benefits of robotic orthopedic surgery directly to patients at a time when analysts say medtech firms are targeting a wider audience through advertising.
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Elon Musk’s brain implant company raises $280M to fund clinical trials
Peter Thiel's venture capital firm led the investment weeks after Neuralink secured clearance to study its device in humans.
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Guardant, Illumina agree to end litigation, extend commercial partnership
The two sides will now renew a long-term collaboration to advance cancer research, Guardant said.
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Appeals court overturns ruling in Axonics-Medtronic neurostim patent dispute
The court said the patent board’s “refusal to consider the new arguments and evidence was erroneous.”
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Abbott lands FDA clearance of Alinity complete blood count system
The company claims the device uses less floor space and has one of the highest throughputs as it competes with diagnostic systems made by Beckman Coulter and Siemens Healthineers.
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Pressure mounts for Illumina to divest Grail amid record fine, executive changes
Illumina is facing a 432 million euro fine from European regulators and is looking for a new CEO.
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J&J subsidiary gains approval for heart ablation devices to use without fluoroscopy
The expanded label could limit exposure to radiation while patients are treated for heart arrhythmias.
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Medtronic expected to prevail at FDA renal denervation vote despite data doubts: analysts
Needham analysts predict the experts will vote in favor of Medtronic and put the device on track to target a $1 billion-plus market.
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Anne-Françoise Nesmes to step down as Smith+Nephew CFO next year
The announcement comes as Smith+Nephew raised its forecast for the year to a 6% to 7% revenue increase, due to more favorable market conditions.
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Digital health funding, deals reach lowest levels in years
Digital health startups across the globe raised $3.4 billion across 348 deals in the second quarter, with mega-rounds making up more than a quarter of all funding.
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Q&A: How Monogram’s CEO plans to disrupt robotic joint replacement surgery
The robot developer’s CEO, Benjamin Sexson, tells MedTech Dive why he believes the orthopedics market needs a fresh approach to joint reconstruction.
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Stryker raises earnings forecast as procedures return to pre-pandemic levels
The company expects elevated procedure demand to continue into 2024 due to surgery backlogs.
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Penumbra says stroke device delayed at least 12 months due to FDA request
The setback stalls “a meaningful new product catalyst,” but the growth of Penumbra’s other devices could cushion the impact, analysts said.
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Outset pauses shipments of dialysis accessory after FDA warning letter, denting sales outlook
The halt prompted the company to predict it will now hit the bottom end of its full-year revenue range, a revision that surprised some analysts.
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BD prepares for relaunch of Alaris pump, raises revenue forecast
The pump relaunch isn’t expected to contribute much to this year’s revenue, but could help Becton Dickinson reach its long-term financial goals.
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Baxter recalls infusion pumps over risk of false alarms
Baxter made a software fix last year after it found pumps weren't issuing an occlusion alarm. Now, the devices might issue alarms even when there isn't a blockage.
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CMS inpatient final rule will have muted impact on medtech companies, analysts say
The CMS disclosed add-on payments that will continue in 2024 and named products that received approval under the breakthrough devices pathway.