Diagnostics: Page 54
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Jacob Bell/MedTech Dive
FDA designates AI software meant to boost ultrasound accessibility a breakthrough device
Led by Livongo and 23andMe veteran Andy Page, newly rebranded Caption Health anticipates pivotal data on its tech will be published in early 2020."
By Maria Rachal • Oct. 1, 2019 -
DOJ charges 35 people in $2.1B Medicare genetic testing fraud scheme
CMS also announced it took adverse administrative action against CGx testing companies and providers who filed more than $1.7 billion in claims to Medicare.
By David Lim • Sept. 30, 2019 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
AI just as effective as docs in medical imaging, study suggests
Still, researchers cautioned that the data is sparse and warned against sweeping conclusions, noting "the narrow public body of work comparing AI to human physicians."
By Rebecca Pifer Parduhn • Sept. 25, 2019 -
EU changes for IVDs called a 'sea change,' revolutionary
The new in vitro diagnostic regulation, slated to come into effect May 2022, will for the first time subject as many as 90% of these diagnostics to review. Previously, most companies could self-certify.
By Dana Elfin • Sept. 23, 2019 -
Medtechs keep shareholders happy, potentially at pipeline's expense: EY
The industry recorded its highest revenues ever within the last year, an analysis by the consultancy shows. Even as R&D spending grew 11%, those investments fell short of the proportion of cash returned to investors.
By Maria Rachal • Sept. 23, 2019 -
FDA lowers Cologuard age to 45, adding 19M to Exact's screening market
The labeling change, which some analysts say represents a more than $3 billion annual revenue opportunity, brings Exact Sciences' flagship product in line with updated screening guidelines for colorectal cancer.
By Maria Rachal • Sept. 23, 2019 -
Adaptive lands deal to provide NGS-based cancer tests to Amgen
The giant biotech will pay annual development fees, sequencing payments and regulatory milestones that could amount to a notable source of revenue for Adaptive.
By Nick Paul Taylor • Sept. 19, 2019 -
Quest didn't steal Cedars-Sinai blood test in trade secrets row, jury says
Hospitals are increasingly using intellectual property to spur transition of early-stage discoveries into products that can be commercialized through licensing agreements.
By Dana Elfin • Sept. 16, 2019 -
Nurses, physician assistants rarely interpret diagnostic images, study finds
Researchers at Emory University said the analysis suggests a need for standardized, focused training programs for non-physician professionals to formally define their roles.
By Susan Kelly • Sept. 16, 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 -
FDA finalizes guidance on HDEs after AdvaMed scrutiny
Industry advocates had criticized FDA's tight parameters on which humanitarian use devices are eligible to turn a profit, but the final guidance largely mirrors the draft.
By Susan Kelly • Sept. 6, 2019 -
Prescient gets FDA breakthrough status for colorectal cancer test
If eventually approved, the test's competition includes Exact Sciences' Cologuard and an older test for blood in fecal samples.
By Nick Paul Taylor • Sept. 5, 2019 -
Getty Images: Edited by BioPharma Dive
Laboratory for Advanced Medicine's liver cancer test gets FDA breakthrough tag
The company secured the status after showing the test detects hepatocellular carcinoma with a specificity and sensitivity in excess of 95%.
By Nick Paul Taylor • Sept. 4, 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 -
Deep Dive
Pharmacogenetic test makers cheer UnitedHealth coverage. Other payers aren't there yet.
"I've been concerned that the hype around pharmacogenetics, at least for depression, has gotten out ahead of the data," James Potash, director of psychiatry at the Johns Hopkins University, said.
By Graison Dangor • Aug. 27, 2019 -
Lawmakers to update VALID this fall, but industry still clashing over details
With Republican Sen. Richard Burr as a new lead sponsor, Congress is working toward releasing an updated Leading-edge IVCT Development Act in the coming months, multiple sources familiar with the issue told MedTech Dive.
By David Lim • Aug. 26, 2019 -
Medicare draft decisions may boost Natera, Myriad tests
Cowen analysts called proposed local coverage for Natera's colorectal cancer test as "materially broader and quicker than expected," while documents on pharmacogenomic tests gave a mixed outlook for Myriad Genetics' products.
By Nick Paul Taylor • Aug. 23, 2019 -
Jacob Bell/MedTech Dive
FDA scolds diagnostic manufacturer over production practices
An early 2019 inspection of Polymer Technology Systems' operations prompted regulators to conclude the company had failed to inform FDA of certain reportable events, among other production process shortcomings.
By Nick Paul Taylor • Aug. 22, 2019 -
US task force expands recommended BRCA test population
The Preventive Services Task Force's update potentially boosts business for Myriad Genetics and other BRCA test makers.
By Nick Paul Taylor • Aug. 21, 2019 -
Senators push HHS for details of response to DNA test scam
Lawmakers propose pre-claim review of genetic test orders to root out fraud.
By Nick Paul Taylor • Aug. 15, 2019 -
Getty / Edited by BioPharma Dive
'Unprecedented' pricing pressures on Myriad send shares plunging
The challenges for GeneSight, the company's genetic depression test, were only the beginning of its woes during the quarter.
By Nick Paul Taylor • Aug. 14, 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 -
Guardant Q2 sales soar on liquid biopsy adoption
The company touted results this week from a study showing its blood-based Guardant360 assay compared favorably to standard-of-care tissue testing of solid tumors for a biomarker used to predict response to immunotherapy.
By Susan Kelly • Aug. 7, 2019 -
iCubate lung infection test secures FDA breakthrough status
The in vitro diagnostics maker said it can accelerate diagnosis and treatment of a disease that affects more than 80,000 people in the U.S.
By Nick Paul Taylor • Aug. 7, 2019 -
Data breaches in 2019 already double all of last year
The single largest data breach stemmed from a hack of a major medical collections agency working for companies including Quest and LabCorp, the report from Protenus found. Twenty million patient records were affected.
By Rebecca Pifer Parduhn • Aug. 2, 2019
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