Medical Devices: Page 56
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Medtronic’s bid to dismiss heart device kickback claims fails, clearing case to advance
A whistleblower accused Medtronic of violating the False Claims Act by billing the government for unnecessary medical procedures.
By Nick Paul Taylor • Updated Aug. 15, 2023 -
Courtesy of Boston Scientific
Boston Scientific’s pivotal pulsed field ablation trial expected to succeed: analysts
Positive results could position Boston Scientific to win U.S. approval for Farapulse in the second half of next year.
By Nick Paul Taylor • Aug. 14, 2023 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Permission granted by Senseonics
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.
By Elise Reuter • Aug. 11, 2023 -
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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.
By Nick Paul Taylor • Aug. 11, 2023 -
Courtesy of Getinge
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.
By Nick Paul Taylor • Aug. 11, 2023 -
Permission granted by Boston Scientific
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.
By Elise Reuter • Aug. 10, 2023 -
Permission granted by ZimVie
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.”
By Nick Paul Taylor • Aug. 10, 2023 -
Permission granted by Stryker
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.
By Susan Kelly • Aug. 9, 2023 -
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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.
By Nick Paul Taylor • Aug. 9, 2023 -
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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.
By Nick Paul Taylor • Aug. 9, 2023 -
Courtesy of GuardantHealth
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.
By Susan Kelly • Aug. 8, 2023 -
Courtesy of Abbott Laboratories
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.
By Nick Paul Taylor • Aug. 8, 2023 -
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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.”
By Nick Paul Taylor • Aug. 8, 2023 -
Permission granted by Biosense Webster
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.
By Elise Reuter • Aug. 7, 2023 -
Permission granted by Medtronic
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.
By Nick Paul Taylor • Aug. 7, 2023 -
Courtesy of Smith & Nephew
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.
By Nick Paul Taylor • Aug. 7, 2023 -
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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.
By Elise Reuter • Aug. 4, 2023 -
Permission granted by Monogram Orthopedics
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.
By Susan Kelly • Aug. 4, 2023 -
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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.
By Nick Paul Taylor • Aug. 4, 2023 -
Courtesy of Outset Medical
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.
By Nick Paul Taylor • Aug. 4, 2023 -
Permission granted by Becton Dickinson
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.
By Elise Reuter • Aug. 3, 2023 -
Courtesy of Abbott
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.
By Nick Paul Taylor • Aug. 3, 2023 -
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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.
By Elise Reuter • Aug. 2, 2023 -
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Cooper scraps $875M takeover of Cook Medical business after FTC investigation
The FTC said ending the planned acquisition “ensures that critical reproductive health markets remain competitive.”
By Nick Paul Taylor • Aug. 2, 2023 -
Retrieved from Siemsens Website on July 01, 2022
Varian logistics slow growth at Siemens Healthineers in Q3
Healthineers has worked through some logistics problems but now faces a race to install Varian equipment at customer sites.
By Nick Paul Taylor • Aug. 2, 2023
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