Medical Devices
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Zimmer pulls hip implant off the market due to fracture risk
The company plans to phase out use of its CPT Hip System by December, but the FDA is still concerned about implants in new patients.
By Elise Reuter • Sept. 18, 2024 -
Courtesy of Cook Medical
Merit Medical inks $210M takeover of Cook’s lead management business
Merit predicts the portfolio, which includes devices used in procedures to remove or replace heart rhythm device leads, will add $40 million a year to its sales.
By Nick Paul Taylor • Sept. 18, 2024 -
Explore the Trendline➔
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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 -
Permission granted by Senseonics
Senseonics receives FDA clearance for one-year CGM
Commercial partner Ascensia is in discussions with insulin pump manufacturers to create an automated insulin delivery system.
By Elise Reuter • Sept. 17, 2024 -
Courtesy of Synchron
Synchron connects brain-computer interface tech to Amazon Alexa
The patient can use the implant to turn on lights, make video calls, play music and shows, read books and buy products online without using their hands or voice.
By Nick Paul Taylor • Sept. 17, 2024 -
Sarah Silbiger via Getty Images
Smiths Medical recalls airway tubes over defect linked to more than 10 injuries
Smiths has had seven Class I recalls, the most severe kind, so far in 2024.
By Elise Reuter • Sept. 16, 2024 -
Scott Olson via Getty Images
Bausch + Lomb considers sale: FT
Private equity could be “the most likely” buyer of the eye care business, analysts wrote.
By Elise Reuter • Sept. 16, 2024 -
Scott Olson via Getty Images
Apple wins FDA nod for hearing aid software for certain Airpods
Apple is the first company to receive authorization for over-the-counter hearing aid software.
By Nick Paul Taylor • Sept. 13, 2024 -
Permission granted by Roche
Roche to launch new CGM in Europe in ‘coming weeks’
Roche will roll out its Accu-Chek Smartguide in the Netherlands, Switzerland and Germany. The company hopes to stand out from competitors with features to predict hypoglycemia.
By Elise Reuter • Sept. 12, 2024 -
FangXiaNuo via Getty Images
SS Innovations expects US OK for surgical robot in 2025
The robot maker plans to conduct clinical trials for several indications, including abdominal, pelvic, thoracic and cardiac procedures.
By Susan Kelly • Sept. 12, 2024 -
Sarah Silbiger via Getty Images
FDA warns 2 Chinese labs for oversight failures, animal care violations
The FDA said the problems “raise concerns about the quality and integrity of data generated by the labs,” which provide third-party testing and validation data services for device firms.
By Nick Paul Taylor • Sept. 12, 2024 -
Courtesy of Spectrawave
J&J leads $50M financing for imaging company Spectrawave
The Series B round will support commercial expansion and product additions for Spectrawave’s system used in the treatment of coronary artery disease.
By Susan Kelly • Sept. 11, 2024 -
Sarah Silbiger via Getty Images
FDA to investigate presence of metals in tampons
Members of the Democratic Women’s Caucus last week urged FDA Commissioner Robert Califf to address the safety concerns.
By Nick Paul Taylor • Sept. 11, 2024 -
Sarah Silbiger via Getty Images
Smiths Medical links 1 death, 35 injuries to defective airway tubes
Vivek Jain, CEO of parent ICU Medical, recently told investors the company has faced more challenges than expected when it bought the Smiths medical device business in 2022.
By Susan Kelly • Sept. 10, 2024 -
Justin Sullivan via Getty Images
Apple adding sleep apnea feature to smartwatch
Apple unveiled the health feature alongside new hearing aid capabilities for its Airpods Pro 2 earbuds.
By Nick Paul Taylor • Sept. 10, 2024 -
the rads via Getty Images
Many FDA-authorized AI devices lack validation data
About 43% of all AI-enabled devices cleared or approved by the FDA through 2022 were missing validation data, and only 28% were tested prospectively, according to a Nature Medicine study.
By Elise Reuter • Sept. 9, 2024 -
Mario Tama via Getty Images
Judge orders J&J to pay Auris investors more than $1B for merger violations
J&J did not provide Auris Health with resources to achieve regulatory milestones after acquiring the robotics company in 2019, the judge found.
By Ricky Zipp • Sept. 6, 2024 -
Courtesy of Abbott
Abbott debuts Lingo over-the-counter CGM in the US
Priced at $49 for one 14-day sensor, or $89 per month, Abbott’s offering is competitive with Dexcom’s Stelo sensor.
By Elise Reuter • Sept. 6, 2024 -
Permission granted by Abbott Laboratories
Abbott partners with maker of ‘bionic pancreas’
Abbott will integrate its latest glucose sensor with Beta Bionics’ automated insulin delivery system.
By Nick Paul Taylor • Sept. 5, 2024 -
Retrieved from The Food and Drug Administration.
FDA cracks down on ozone cleaners for CPAP machines
The agency sent warning letters to four companies and reminded the public it has not authorized any devices for cleaning or disinfecting CPAPs.
By Elise Reuter • Sept. 5, 2024 -
Courtesy of Edwards Lifesciences
Edwards cuts more than 500 employees after critical care sale
An Edwards spokesperson said the layoffs, affecting 3% of its workforce, are a “one-time right-sizing” deemed necessary following the division’s sale to BD.
By Susan Kelly • Sept. 5, 2024 -
Courtesy of Insightec
Medtech venture investment recovery continues, but startup M&A remains limited: Pitchbook
Acquisitions of late-stage VC startups have been rare, a fact Pitchbook attributed to “ongoing price gaps between buyers and sellers.”
By Nick Paul Taylor • Sept. 4, 2024 -
SDI Productions via Getty Images
European heart group recommends renal denervation for some patients
The European Society of Cardiology said the treatment may be considered for certain patients with uncontrolled, drug-resistant high blood pressure but outlined lingering concerns.
By Nick Paul Taylor • Sept. 4, 2024 -
Permission granted by Nasdaq
Embecta gets FDA nod for insulin patch pump
Embecta’s first patch pump features a larger insulin reservoir, based on feedback from people with Type 2 diabetes.
By Elise Reuter • Sept. 3, 2024 -
Courtesy of Grail
Illumina avoids fine for Grail purchase in European court victory
Illumina will avoid a penalty of 432 million euros after a court ruled the European Commission did not have jurisdiction to challenge the company’s Grail acquisition.
By Susan Kelly • Sept. 3, 2024 -
Permission granted by Medtronic
Medtronic’s chief medical officer of acute care and monitoring departs for new role
Sam Ajizian leaves Medtronic six months after the company reversed a plan to split off its patient monitoring business.
By Nick Paul Taylor • Aug. 30, 2024
