Clinical Trials
-
Retrieved from Spectral AI on March 18, 2025
Spectral AI algorithms beat physicians in burn tissue assessments
The company plans to file the results with the FDA by mid-2025 and launch the product in 2026.
By Nick Paul Taylor • March 18, 2025 -
Permission granted by Capstan Medical
Capstan brings surgical robot to valve replacement
Capstan Medical, a startup focused on robotic-assisted mitral and tricuspid valve replacement, recently completed its first patient implants.
By Susan Kelly • March 11, 2025 -
Sean Gallup via Getty Images
EMA creates advice portal for some high-risk medical devices
The European Medicines Agency said the portal will enable consultations with medical device expert panels that can promote faster access to new technologies.
By Nick Paul Taylor • Feb. 12, 2025 -
Retrieved from Screenshot: The Food and Drug Administration.
FDA webpages on clinical trial diversity removed after Trump orders
The website changes raise concerns about “the interference of politics with the study and the practice” of science and medicine, a physician said.
By Elise Reuter • Jan. 27, 2025 -
Courtesy of Medtronic
Medtronic links closed-loop pain device to improvements after 12 months
The Inceptiv data give Medtronic more evidence as it tries to increase sales of a product that drove double-digit growth at the company’s pain stimulation unit last quarter.
By Nick Paul Taylor • Jan. 24, 2025 -
Andrew Harnik via Getty Images
‘Research that’s desperately needed’: White House conference spotlights women’s health
“Sometimes the most under-hyped sectors are the best places to build very large businesses,” said one venture investor who attended the Dec. 11 event.
By Delilah Alvarado • Dec. 19, 2024 -
Permission granted by Movano Health
Movano receives FDA nod for smart ring’s pulse oximeter feature
Movano Health plans to market the Evie Ring to organizations that run clinical trials and healthcare companies that are helping patients manage chronic diseases.
By Nick Paul Taylor • Dec. 3, 2024 -
Courtesy of Medtronic
Medtronic, Tempus testing AI to find potential TAVR patients
The randomized trial will use Tempus’ platform to find patients who are eligible for interventions such as TAVR but do not have a treatment plan in place.
By Nick Paul Taylor • Nov. 25, 2024 -
Courtesy of Boston Scientific
Boston Scientific’s Watchman could be new option for patients post ablation: study
The trial compared the stroke prevention device for left atrial appendage closure to blood thinners in people who underwent cardiac ablation for AFib.
By Susan Kelly • Nov. 18, 2024 -
Photo by MART PRODUCTION from Pexels
Livanova hits sleep apnea trial goals, plans FDA filing
Leerink analysts said the results were largely in line with outcomes in a trial of Inspire Medical’s rival device but cautioned that Livanova may have a hard time breaking into the sleep apnea market.
By Nick Paul Taylor • Nov. 13, 2024 -
Courtesy of Johnson & Johnson
J&J’s Ottava surgical robot to begin clinical trial after FDA nod
With FDA approval of an investigational device exemption, J&J’s soft tissue robot moves a step closer to challenging Intuitive Surgical’s da Vinci system.
By Susan Kelly • Nov. 12, 2024 -
Permission granted by Boston Scientific
Boston Scientific resumes PFA trial in new patient group after pausing enrollment
Boston Scientific expects to complete enrollment in the coming months in the study comparing pulsed field ablation to anti-arrhythmic drugs in patients with persistent AFib, a spokesperson said.
By Susan Kelly • Nov. 12, 2024 -
Courtesy of Edwards Lifesciences
Edwards, Medtronic and Inari share trial data at TCT conference
The three medtech firms unveiled new data this week during TCT 2024 in Washington, D.C. Here’s what the results mean for the companies and their device markets.
By Nick Paul Taylor • Oct. 31, 2024 -
Courtesy of Boston Scientific
Boston Scientific’s Acurate Neo2 inferior to rival TAVR valves in study
Analysts said the findings complicate the outlook for a U.S. launch of Boston Scientific's aortic valve replacement device.
By Susan Kelly • Oct. 31, 2024 -
Edwards data show benefit of early TAVR over ‘watchful waiting’
Study author Philippe Genereux said the trial data “shatter 60 years of ingrained belief on the treatment for severe aortic stenosis.”
By Susan Kelly • Oct. 29, 2024 -
Courtesy of Abiomed
J&J to seek FDA approval after small-bore Impella heart pump hits trial goal
The company has predicted the narrower Impella ECP will be easier to insert and implant, as well as enable the use of small bore access and closure techniques.
By Nick Paul Taylor • Oct. 29, 2024 -
Elise Reuter/MedTech Dive
The Medtech ConferenceThat’s a wrap: 5 takeaways from The Medtech Conference
The conference — Advamed’s largest — featured an appearance by the device center’s new acting director and sessions on AI, clinical trial diversity and the FDA’s contentious LDT rule.
By Elise Reuter • Oct. 22, 2024 -
Courtesy of Abbott
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.
By Nick Paul Taylor • Oct. 11, 2024 -
Courtesy of Procept Biorobotics
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.
By Nick Paul Taylor • Oct. 9, 2024 -
halbergman via Getty Images
Top medtech conferences in 2025
The lineup includes industrywide conferences and events covering the latest medtech trends in diabetes, orthopedics, cardiac care and surgical robotics.
By Ricky Zipp • Updated Jan. 23, 2025 -
Courtesy of Synchron
Synchron’s brain-computer interface tech meets safety goal
The six-patient trial also indicated the device worked, according to Synchron, with the conversion of brain signals to motor outputs allowing people to perform digital tasks.
By Nick Paul Taylor • Oct. 1, 2024 -
Courtesy of Business Wire/Exact Sciences
Exact Sciences says data support its colon cancer blood test
Exact’s test could compete with Guardant Health’s Shield blood test, which received approval from the Food and Drug Administration in July.
By Susan Kelly • Sept. 16, 2024 -
Sarah Silbiger via Getty Images
FDA seeks feedback on health equity for medical devices
The agency plans to develop a framework for when devices should be evaluated in diverse populations to support marketing authorization.
By Nick Paul Taylor • Aug. 6, 2024 -
Sarah Silbiger/Getty Images via Getty Images
FDA finalizes guidance on studying opioid use disorder treatments
The Center for Devices and Radiological Health is aiming to help companies manage challenges such as inaccurate participant reports of drug use.
By Nick Paul Taylor • July 12, 2024 -
Sarah Silbiger via Getty Images
FDA shares draft guidance on clinical trial diversity action plans
The agency said which trials need diversity action plans and presented the timeline for implementing the requirement.
By Nick Paul Taylor • June 28, 2024
