The Latest
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CMS mandatory radiation oncology model should be scaled back, industry argues
The model would examine effectiveness of site-neutral episode-based payments for treatment of 17 cancer types to radiotherapy providers and suppliers in randomly selected geographic areas.
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Chronic bronchitis device wins breakthrough designation
The minimally invasive product from Gala Therapeutics delivers non-thermal energy to the airways to reduce the number of abnormal mucus-producing cells in patients’ lungs, making room for new normal cells to develop.
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Wright Medical's Cartiva woes will take time to fix: analysts
RBC Capital Markets analysts said slowing demand for Wright Medical's synthetic cartilage implant for arthritic toes is behind the sales slump.
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Sirolimus-eluting balloon wins breakthrough status
The designation boosts Orchestra BioMed's efforts to develop and market its Virtue device to treat below-the-knee peripheral artery disease, in addition to coronary in-stent restenosis.
UPDATED: Sept. 17, 2019 at 3:14 p.m. -
Zimmer Biomet recalls Rosa Brain software for rare anomaly
The problem, which occurs with use of a particular workflow, can cause a discrepancy between initial skin marking on the skull and the instrument's trajectory.
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FDA warns closure of Atlanta Sterigenics facility could impact medical device supply
Sterigenics said it aims to complete construction of technology upgrades at the plant, designed to reduce ethylene oxide emissions, by early October.
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Sanofi taps Abbott, Novo adds Medtronic for CGM integrations
The pharmas are expanding the range of glucose-sensing devices compatible with their connected insulin pens.
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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.
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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.
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Moody's: Hospitals highly vulnerable to cyberattacks
Although email phishing, EHR breaches and ransomware schemes are most common, the new report also calls attention to vulnerabilities in medical technologies like insulin pumps and cardiac devices.
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Varian buys software developer for AI cancer work
The radiation oncology company is making an undisclosed investment in privately held Oncora Medical to collaborate on development of machine learning-based software.
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FDA finalizes 4 guidances to clarify 510(k) pathways
The documents spell out the agency's initiatives for improving the 510(k) premarket review pathway to promote faster access to new medical technologies.
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American Kidney Fund lobbies White House on charitable premium assistance
Insurers are pushing for a reexamination of policies they argue allow financially interested third parties to steer end-stage renal disease patients eligible for Medicare or Medicaid to private plans.
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FDA clears GE's AI-powered x-ray algorithms for triaging collapsed lungs
GE Healthcare said the technology will help hospitals identify high-priority cases and fast track treatment.
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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.
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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.
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V-Wave gets 2nd breakthrough designation for interatrial shunt
Building on its heart failure indication, the J&J- and Edwards-backed medtech is conducting an early feasibility study of the device in patients with pulmonary arterial hypertension.
UPDATED: Sept. 12, 2019 at 5:27 p.m. -
China exempts certain radiation devices from tariffs, giving boost to Varian
Varian Medical Systems took a $15 million hit from the tariffs last quarter, but could now recoup taxes it paid.
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EU sets out requirements for MDR expert panel members
Notified bodies must consult with the panels before clearing certain high-risk devices for marketing.
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FDA awards breakthrough designation to nerve regeneration tech
Checkpoint Surgical previously said it sees an at least $1 billion opportunity in the therapeutic nerve regeneration business segment.
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Notified body BSI certifies 1st device under EU MDR
The new law will require a plethora of products that formerly didn't need certification by a notified body to undergo review.
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US needs cyber-savvy doctors as connected device use rises, FDA panel says
Patients deserve cybersecurity training as part of the informed consent process, but healthcare providers aren't well-equipped to offer it, an FDA advisory committee said Tuesday.
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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.
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Physicians push FDA to shed light on device comparators
In a paper published in JAMA Network Open on Wednesday, physicians analyzed evidence used in the authorizations of products under the Humanitarian Device Exemption pathway.
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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.
