Medical Devices: Page 50
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Permission granted by Quest Inc. / Blaine Herman
Sponsored by Quest InternationalHow OEMs can budget aftermarket service in a recession
OEMs need to rethink how to deliver scalable, flexible service, especially in economic uncertainty.
March 20, 2023 -
YakobchukOlena via Getty Images
Olympus accused of ‘troubling disregard for patient safety’ by FDA after flurry of warning letters
The agency’s investigation included a complaint that cracked endoscope caps caused a patient to suffer esophageal trauma.
By Nick Paul Taylor • March 20, 2023 -
Explore the Trendline➔
Sitthiphong via Getty Images
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 -
Sarah Silbiger via Getty Images
FDA sets end date for raft of COVID-related shortages that began early in pandemic
Shortages of home-use ventilators and clinical sample concentrators are expected to continue.
By Nick Paul Taylor • March 20, 2023 -
Permission granted by CMR Surgical
Robot maker CMR Surgical appoints new CEO as it looks to ramp system sales
Supratim Bose will now lead the rollout of the company’s Versius system.
By Susan Kelly • March 17, 2023 -
Courtesy of U.S. Food and Drug Administration
Trade group warns FDA human factors proposal is ‘too expansive,’ will strain agency resources
Other groups gave a warmer welcome to the plan, with AdvaMed suggesting specific edits without criticizing the overall approach.
By Nick Paul Taylor • March 17, 2023 -
ClarkandCompany via Getty Images
Senseonics grows sales in Q4 despite ‘softer demand’ for CGM implant in US and Germany
Demand in the U.S. was affected by “a little bit of ambiguity on pricing” ahead of a change to Medicare.
By Nick Paul Taylor • March 17, 2023 -
Courtesy of Medtronic
Medtronic wins CE mark for ablation device, invests in heart failure monitoring company
The Affera system gives physicians a choice between pulsed field ablation and radiofrequency to treat atrial fibrillation.
By Susan Kelly • March 16, 2023 -
Permission granted by iRhythm Technologies
iRhythm COO resigns amid restructuring
Douglas Devine will stay on as a consultant through 2024, as the company goes through a restructuring to become “a larger digital healthcare organization.”
By Elise Reuter • March 16, 2023 -
Courtesy of Tandem Diabetes
Tandem, targeting Medtronic and Insulet’s turf, links artificial pancreas to improved outcomes in kids
If Tandem can prove to regulators that the system can help manage young children’s diabetes, it could compete with Medtronic and Insulet, which have devices that are indicated for use in kids as young as two years.
By Nick Paul Taylor • March 16, 2023 -
Sukan Saythong via Getty Images
Getinge buys sterilization firm Ultra Clean Systems for $16M
The Sweden-based company, which already partnered with Ultra Clean as a distributor, said the deal will “significantly expand” its offerings to sterile reprocessing departments.
By Elise Reuter • March 15, 2023 -
Sittithat Tangwitthayaphum via Getty Images
Joint replacement business likely to be busy for the next year or more: BTIG analysts
A backlog of patients and improved staffing at hospitals and surgery centers have the analysts projecting four to six quarters of growth for firms including Stryker and Zimmer Biomet.
By Nick Paul Taylor • March 14, 2023 -
Mat Szwajikos via Getty Images
Illumina shares jump 17% after Icahn launches proxy fight
The activist investor said his board nominees would work to prevent Illumina from “sinking further into the quicksand” in a battle with regulators over the Grail acquisition.
By Susan Kelly • Updated March 14, 2023 -
Courtesy of Philips
Philips poaches new connected care business leader from Pear
Julia Strandberg, formerly Pear’s chief commercial officer, must revive a division still struggling with the recall of 5.5 million respirators.
By Elise Reuter • March 13, 2023 -
Justin Sullivan via Getty Images
Silicon Valley Bank’s swift collapse appears to have left established medtech firms untouched
A review of companies covered by analysts reveals no significant direct exposure to SVB’s failure, but startups dependent on venture capital cash may be affected.
By Peter Green • March 13, 2023 -
Courtesy of Baxter
Baxter issues urgent correction for ventilation system due to risk of oxygen desaturation
Patients can continue to use the devices if they are checked daily and properly maintained, the company said in an announcement posted by FDA.
By Susan Kelly • March 13, 2023 -
Courtesy of Insulet Corp.
Insulet to join S&P 500 after Silicon Valley Bank ousted
Shares of the insulin pump maker rose Monday on news that it would join the stock index.
By Elise Reuter • March 13, 2023 -
Alex Wong via Getty Images
Medtech groups lose challenge to digital piracy rule in device repair case
Repair companies will still be able to access and use operating code to fix medical devices, after the court rejected arguments by AdvaMed and the Medical Imaging & Technology Alliance.
By Susan Kelly • March 13, 2023 -
Gorodenkoff/Shutterstock.com
Sponsored by EsperDevice management for mission-critical care: Maximizing efficiency and effectiveness
Reduce the complexity of device fleet management to deliver seamless mission-critical care.
March 13, 2023 -
Courtesy of LivaNova
LivaNova receives FDA nod for heart-lung machine
After beginning its European rollout last month, the UK-based device maker hopes to bring its market-leading position to the U.S.
By Peter Green • March 10, 2023 -
Permission granted by Erik Vollebregt
Q&AFriday Q&A: A regulatory attorney breaks down the EU MDR transition
Amsterdam-based regulatory expert Erik Vollebregt explains the agreement this week to extend the deadlines to comply with the EU’s Medical Device Regulation, and the issues that still need to be addressed.
By Susan Kelly • March 10, 2023 -
Ex-medtech CEO arrested over alleged scheme to sell dummy devices, defraud Medicare
Prosecutors accuse the former Stimwave CEO of engaging in a multi-year scheme to sell a device with no medical purpose for implantation into chronic pain patients.
By Nick Paul Taylor • March 10, 2023 -
Retrieved from Titan on September 12, 2022
Titan delisted from Nasdaq, as surgical robot maker struggles to sell assets
Titan's robotic surgery device faced delays in development that forced the firm to put off a planned FDA submission. The company has laid off its technical staff as it seeks to sell its assets.
By Elise Reuter • March 9, 2023 -
Courtesy of Auris/J&J
J&J lays off 350 people at robotics units, says ‘we have to get better’ with Ottava
CFO Joe Wolk said there is “a sense of urgency” at the company as it works to come from behind in the robotic surgery market.
By Nick Paul Taylor • Updated March 10, 2023 -
juankphoto via Getty Images
More woes for breast implants, as FDA links procedure to squamous cell carcinoma
Three deaths were related to the cancer cases, the agency said.
By Elise Reuter • March 8, 2023 -
Permission granted by iRhythm Technologies
iRhythm, fighting Boston Scientific for market share, shows cardiac monitor beats rivals
An analysis of Medicare claims data found iRhythm Technologies’ Zio XT outperforms other ambulatory cardiac monitors.
By Nick Paul Taylor • March 8, 2023
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