The Latest
-
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.
-
FDA overhauls export certificate guidance after negative feedback
AdvaMed said the draft suffered "from inaccuracies and omissions that FDA must correct." The final guidance provides more information on the appeals process and grounds for denials.
-
Hologic wins FDA approval for AI-based breast imaging tech
The imaging company claims the platform saves radiologists one hour per eight hours of interpretation.
-
Axonics wins PMA for urinary indication in sacral neuromod, potentially tripling market
The latest approval for overactive bladder positions the medtech to challenge Medtronic for dominance in the sacral neuromodulation market. Shares rose 16% in late morning trading.
-
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.
-
Boston Scientific faces lower reimbursement despite White House lobbying bid
In an Office of Management and Budget meeting days before release of CMS' hospital outpatient payment final rule, execs argued the change would deter doctors from a procedure using a device that could reduce opioid dependence.
-
TransEnterix cuts 18% of staff, doesn't take questions from analysts
The company will focus less on selling robotic surgery systems, newly appointed CEO Anthony Fernando told investors during its third quarter earnings call. Instead, he wants to expand use among existing customers.
-
Abbott names Robert Ford new CEO, ending Miles White's 21-year tenure in March
The leadership handoff to Ford, an Abbott insider currently serving as COO, is seen as a continuation of current strategy, with Freestyle Libre, Mitraclip and Alinity driving core growth.
-
Medtronic's Micra AV pacemaker meets study goals, submitted for FDA review
The company wants to expand the transcatheter pacing system first approved in 2016 to patients with atrioventricular block, a condition marked by impaired electrical signals between the heart's upper and lower chambers.
-
Nascent digital therapeutics group defines best practices, ethics code
The two-year-old group is looking to distinguish higher-risk products that claim to prevent, manage or treat a disease from more general digital health lifestyle and wellness apps.
-
Paige gets CE mark for prostate cancer detection technology
The software is designed to make it easier for pathologists to analyze biopsies for signs of cancer.
-
Eudamed 2-year delay doesn't mean free pass for manufacturers
"The Eudamed project is expensive both in time and resources. It is not just an IT project, this is a change project," said Eudamed.eu CEO Richard Houlihan.
-
Establishment Labs sees 40% rise in breast implant sales, on track for $100M benchmark in 2020
As it awaits U.S. marketing authorization, the Costa Rican medtech is expanding its direct sales force in Europe and Brazil amid a 45% year-to-date decline in Allergan's worldwide breast implant revenues.
-
FDA grants breakthrough status to AI-based gastric cancer diagnostic
The technology uses artificial intelligence to analyze endoscopy images for signs of gastric cancer.
-
Life Spine, execs settle implants kickback case for nearly $6M
The medtech said it had made significant progress strengthening its compliance program even before it began negotiations with the government.
-
Wright Medical growth slowed in run-up to Stryker deal
While Wright's Cartiva big toe treatment dragged on sales for a second straight quarter, Stryker expects the acquisition to bolster its broader extremities business, particularly in shoulder devices.
-
Deep DiveEthylene oxide plant closures put US on 'cusp of a major medical logistical failure'
FDA should consider asking HHS Secretary Alex Azar to declare a public health emergency and override state legislation to get sterilization plants back online, one advisory panel member said.
-
Deep DiveRetail makes its case, telehealth and voice tech dominate: 6 takeaways from HLTH19
Consumerism has its limits, interoperability rules face execution challenges and more from Las Vegas.
-
Duodenoscope reprocessors' poor work conditions exacerbate infection problem, FDA panel says
The advisory meeting followed FDA disclosing reports of three deaths, 45 patient infections and 159 cases of device contamination related to inadequate device reprocessing between October 2018 and March 2019.
-
Exact Sciences closes Genomic Health deal, wins breakthrough tag for liver cancer blood test
The Cologuard maker said it intends to roll out the test for hepatocellular carcinoma in the second half of 2020.
-
In latest delay, time extended for experts to apply for MDR, IVDR panels
Industry insiders said low compensation and a stringent conflict of interest policy may have discouraged experts from applying to the panels. Notified bodies must consult with the panels before clearing certain high-risk devices.
-
Triple-digit liquid biopsy growth powers Guardant to beat-and-raise quarter
Guardant Health raised its full-year revenue guidance by around 10% after blasting past expectations.
-
Medtronic reveals high-risk cyber vulnerability in electrosurgical generators
The Department of Homeland Security rated the vulnerability, which could be exploited remotely by a low-skilled hacker, a 9.8 on a 10-point risk scale.
-
Zimmer Biomet's Rosa Brain recall categorized as Class I
FDA said it's aware of five complaints, one patient injury and no deaths related to a software issue with the robot-assisted neurosurgery technology.
UPDATED: Nov. 7, 2019 at 3 p.m. -
After stumble, diabetes drives Livongo to top Q3 estimates
A triple-digit jump in diabetes members helped the digital health firm beat and raise expectations.
