The Latest

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  Fresenius Medical Care increasing IV, dialysis solutions production to alleviate shortages

  B. Braun and Fresenius Medical Care said they will make more crucial products as the U.S. faces shortages following Hurricane Helene’s damage to a Baxter manufacturing facility.

  Medical Devices

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  Abbott enrolls pivotal PFA study 4 months ahead of schedule

  The company reported the enrollment milestone alongside news that it received clearance to sell its Advisor HD Grid X Mapping Catheter and started a trial of its Tactiflex Duo Ablation Catheter.

  Clinical Trials

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  Solventum names Egeland as chief medical officer

  Ryan Egeland, former CEO and co-founder of Crossfire Medical, rounds out the leadership team for the 3M spinoff.

  Medical Devices

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  Baxter ups IV fluid allocations amid supply shortages

  As hospitals around the U.S. report IV fluid shortages, Baxter has increased supply allocations for direct customers and distributors. It plans on returning to 90% to 100% allocation of certain supplies by the end of 2024.

  Medical Devices

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  CMR Surgical CEO Bose steps down

  Massimiliano Colella, who joined the surgical robotics firm in late 2023, was named interim CEO.

  Medical Devices

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  Shiratronics raises $66M for trial of neuromodulation migraine device

  The funding will support the trial, premarket approval application and initial commercial launch of a system that could interrupt or change the transmission of pain signals to the brain.

  Medical Devices

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  Deep Dive

  The number of AI medical devices has spiked in the past decade

  The FDA has authorized nearly 1,000 medical devices with artificial intelligence features as companies including GE Healthcare and Siemens Healthineers build out their AI efforts.

  Digital Health

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  Procept secures FDA approval to study surgical robot in prostate cancer

  The trial will compare the therapy to radical prostatectomy and could unlock a market that analysts value at $500 million.

  Clinical Trials

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  AHA asks Biden administration for relief amid IV fluid shortage from Hurricane Helene

  Hospitals have been contending with shortages of the life-saving supplies after Hurricane Helene damaged Baxter's manufacturing plant in North Carolina, according to the American Hospital Association.

  Medical Devices

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  Baxter says no structural damage at North Carolina site hit by Hurricane Helene

  The facility also has access to water and power. Baxter expects to share production plans over the next two weeks.

  Medical Devices

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  Mercury Medical recalls emergency resuscitators

  Healthcare professionals use the devices to provide newborns and infants with emergency breathing support.

  Medical Devices

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  CMS begins national coverage review for tricuspid repair

  The agency will consider national reimbursement for new tricuspid transcatheter repair devices, including Abbott’s Triclip, in Medicare patients with a leaky tricuspid heart valve.

  Medical Devices

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  Medtronic recalls Minimed insulin pumps for reduced battery life

  The company said it received 170 reports of hyperglycemia and 11 reports of diabetic ketoacidosis in the U.S. that could be linked to the problem.

  Medical Devices

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  Smiths recalls ventilators over risk of oxygen flow disruption

  Smiths has grappled with multiple quality issues and recalls over the past few years. Two recent recalls focus on problems with portable ventilators.

  Medical Devices

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  Exact Sciences wins FDA approval for Cologuard Plus colorectal cancer test

  Exact Sciences expects to launch the updated test, which has higher specificity than its predecessor, with Medicare coverage and guideline inclusion in 2025.

  FDA

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  Baxter unsure when North Carolina facility hit by Hurricane Helene will be operational

  As access challenges to the site continue, Baxter has limited purchases of certain products to avoid stockpiling, manage inventory and minimize disruption to patient care.

  Medical Devices

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  Elucid wins FDA 510(k) nod for heart plaque image analysis software

  The software turns coronary CT angiography images into 3D models that quantify and classify plaque morphology to improve predictions of heart attack and stroke risk.

  FDA

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  Tracker

  Tracking Philips Respironics recalls

  Philips recalled its Trilogy ventilators to fix new and previously reported problems with the machines. The company issued a mandatory software update and changed the devices’ instructions.

  Updated Oct. 3, 2024

  Medical Devices

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  BD agrees to settle most of its hernia mesh litigation

  The settlement terms are confidential, BD said. The company disputes the lawsuit’s allegations and backs its product designs.

  Legal

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  Independent lab fires back after Philips sues over testing results

  PSN Labs called for a jury trial, claiming Philips is attempting to deflect attention away from its own “failures, negligence, concealment and recklessness.”

  Legal