Research
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FDA advisers: Metal implants need beefed up ingredient labels
Industry representative Whitney Christian, a toxicologist at Medtronic, told the panel that medical device manufacturers support patients' and doctors' "right to know" what's in implants and are willing to work with FDA on the issue.
By Maria Rachal • Nov. 15, 2019 -
Landmark Apple Watch AFib study has mixed results
Researchers touted an apparent low incidence of false positives, but many who didn't receive a notification were subsequently diagnosed with atrial fibrillation, according to research published in the New England Journal of Medicine.
By David Lim • Nov. 14, 2019 -
FDA experts weigh evidence on patients' adverse reactions to common device metals
Suggestions from speakers at Wednesday's advisory panel included conducting comparative effectiveness studies, bolstering the informed consent process and requiring more stringent adverse event reporting.
By Maria Rachal • Nov. 13, 2019 -
SponsoredNew product launches: Some matter more than others
Answering two simple questions can enable medtech companies to both prioritize launches and determine the right approach for each launch.
By Matt Singer • Nov. 05, 2019 -
Researchers question safety benefit of robotic colectomies
Despite a sharp rise in robot-assisted colon removal procedures using devices like Intuitive Surgical's da Vinci system, research published in JAMA Surgery found a laparoscopic approach has a comparable rate of complications.
By Nick Paul Taylor • Oct. 17, 2019 -
SponsoredStreamlining your portfolio can actually improve profitability. Here's how.
Retiring products is not an easy decision, but taking this step can have a real and positive impact on the P&L, customer, cross-functional teams and the ability to drive innovation.
By Matt Singer • Oct. 08, 2019 -
Paclitaxel device makers roll out revised labels, fresh safety analyses
Philips and BD highlighted independent analyses published this week defending their drug-coated balloons as manufacturers update product labels acknowledging a late mortality signal in peripheral artery disease patients.
By Maria Rachal • Oct. 03, 2019 -
NESTcc, ophthalmic imaging first up in FDA medical device 'collaborative communities'
Creation of these groups of manufacturers, payers, regulators, patients and health professionals is one of the device center's 2018-2020 strategic priorities.
By David Lim • Sept. 20, 2019 -
Researchers use MRI technique to predict dementia risk
Authors of a study published in the journal Stroke said the imaging technique can help physicians monitor stroke patients and identify individuals who may benefit from early treatment.
By Nick Paul Taylor • Sept. 13, 2019 -
Brexit threatens UK robotic surgery innovation, study finds
The Imperial College London analysis indicates a hard split from the EU could cause the U.K. to lose collaborations with other member states.
By Nick Paul Taylor • Sept. 12, 2019 -
Apple to start trio of research studies on hearing, heart and women's health
The studies, which will be organized through a new Apple Research app this fall, are being conducted in partnership with various universities, hospitals, associations and the U.S. government.
By David Lim • Sept. 11, 2019 -
Abbott says AI technology can help diagnose heart attacks
A study in the journal Circulation concluded the algorithm, which aims to individualize testing by taking into account factors such as patient age and sex, performed better than the European Society of Cardiology rule-out pathway.
By Susan Kelly • Sept. 11, 2019 -
NESTcc 1.0 aims to launch, be able to take unsolicited projects by end of year
The National Evaluation System for health Technology Coordinating Center Task Force is also currently developing an active surveillance roadmap it aims to issue for public comment this fall.
By David Lim • Sept. 06, 2019 -
With partner iRhythm, Verily ramps up AFib efforts
iRhythm committed almost $18 million to Verily to boost development of technology that helps deliver earlier warnings to individuals with asymptomatic or silent atrial fibrillation.
By Maria Rachal • Sept. 05, 2019 -
Imaging test usage is reaccelerating, JAMA study finds
Neither financial incentives nor a campaign to reduce the use of medical imaging have been completely effective, research suggests.
By Susan Kelly • Sept. 04, 2019 -
Weight-loss surgery for Type 2 diabetes could cut major heart risks, study suggests
Published in JAMA and funded by Medtronic, results from the retrospective study have yet to be confirmed by randomized clinical trials.
By Maria Rachal • Sept. 03, 2019 -
Titan Medical delays 510(k) submission until 2020 amid cash burn concerns
The company plans to use the delay to spread out its spending while working to implement the robotic surgery system's sterile instrument interface components, software improvements and training tools.
By David Lim • Aug. 27, 2019 -
Abbott touts potential of 15-minute concussion detection
Highlighting research from the TRACK-TBI study, the company said its in-development point-of-care test could help diagnose concussion in patients whose CT scans miss signs of mild traumatic brain injury.
By Maria Rachal • Aug. 27, 2019 -
Blood test to detect breast cancer recurrence, guide treatment, shows promise in small study
Researchers hope the liquid biopsy test, which demonstrated high accuracy in detecting residual disease in a small study, can help breast cancer patients avoid unnecessary surgeries.
By Susan Kelly • Aug. 12, 2019 -
Apple, Eli Lilly research whether devices can detect dementia signs
The two companies, along with health tech startup Evidation, found promising initial results but concluded additional research is needed.
By Rebecca Pifer • Aug. 08, 2019 -
FDA to update paclitaxel device labels with mortality signal warning
The agency and manufacturers such as BD, Medtronic and Boston Scientific are planning research into the devices' long-term safety profile using new randomized trials and registry datasets.
By David Lim • UPDATED: Aug. 8, 2019 at 10:08 a.m. -
Cardiac device complications vary 'substantially' by implanting hospital, study finds
The analysis of 98 hospitals, published this week in the Annals of Internal Medicine, uncovered an up-to-threefold difference in cardiac implant complication rates.
By Nick Paul Taylor • Aug. 01, 2019 -
Mayo, Boston Scientific deepen ties with medtech accelerator launch
The joint venture, called Motion Medical, is expected to open in Rochester, Minnesota this fall with the purpose of bringing minimally invasive treatments to market for unmet health needs.
By Susan Kelly • July 30, 2019 -
Edwards discontinues Centera valve, goes all in on Sapien 3 TAVR line
Executives said the company anticipates FDA will approve the transcatheter aortic valve replacement product for patients with low surgical risk during the third quarter.
By David Lim • July 24, 2019 -
PCORI, MD Anderson team up on lung cancer screening aid
Funded by the Patient-Centered Outcomes Research Institute, the project targets high-risk smokers for lung cancer screening. A second program looks to expand care for adolescents with behavior problems after traumatic brain injury.
By Susan Kelly • July 24, 2019
