The Latest
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Most health apps share data with third, fourth parties, BMJ analysis warns
"Clinicians should be conscious of privacy risks in their own use of apps and, when recommending apps, explain the potential for loss of privacy as part of informed consent," the study authors wrote.
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Deep DiveAs 5G looms, most hospitals watch from the sidelines
Chicago's Rush is an early mover with the tech, but many other big systems are taking a wait-and-see approach.
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FDA warns Sientra, J&J's Mentor on lax post-approval breast implant studies
The action comes a week before the agency is set to hold a public meeting on risks related to the controversial devices.
UPDATED: March 20, 2019 at 4:22 p.m. -
Illumina-backed study finds limited role for liquid biopsy in lung cancer
The "modest" true positive rate achieved by the blood test may limit its usefulness.
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FDA, NEST detail how extra funding can bolster postmarket safety
CDRH Director Jeff Shuren explained the thinking behind the FDA's support of its postmarket surveillance system in a paper with Rachael Fleurence, executive director of the National Evaluation System for health Technology.
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Alzheimer's device De Novo on the line at FDA panel
An advisory committee got started on a transcranial magnetic stimulation device Thursday morning, coming the same day as Biogen halted trials of one of the last late stage drug candidates to treat the disease.
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Lab industry pushes CMS to withdraw 'highly disruptive' coding changes
Nine trade groups called for reversal of certain lab and pathology section updates to National Correct Coding Initiative policy manuals.
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Abbott gets CE mark for molecular diagnostics machine
The device expands the company's fast-selling portfolio of Alinity laboratory testing instruments.
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FDA cybersecurity guidance draws fire from big device makers
Boston Scientific, GE Healthcare and BD are among manufacturers raising alarms over a proposal to create two tiers of cybersecurity risk buckets.
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Analysts tip UnitedHealth's preferred lab network to boost LabCorp, Quest
The big insurer will create a subgroup of lower-cost providers, which may help the lab giants win business from less-efficient competitors, according to investment bank Jefferies.
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FDA outlines new device priorities in budget justification report
A new agency document sheds light on proposed initiatives related to cybersecurity, approval pathways and special controls.
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BD wins PMA for stent treating venous occlusive disease
The company beat several contenders for the distinction of being first to market in the U.S. with a stent to reopen blocked iliac and femoral veins.
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Apple heart study: Early proof of concept, or a gimmick?
Doctors at the American College of Cardiology meeting said the Apple Watch's foray into health monitoring needs more data to prove its value.
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TAVR called 'game changing' in studies of low-risk patients
Data from Edwards Lifesciences' Partner 3 trial and Medtronic's Evolut Low Risk study prompted predictions that TAVR will become the preferred option for a wider population of heart valve patients.
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Breast implants, metal hips and other device materials under new FDA scrutiny
Symptoms such as fatigue, rash, joint and muscle pain or weakness may not appear until years after a device is implanted, FDA said.
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FDA: Avoid paclitaxel-coated PAD devices for most patients
BD Thursday joined Medtronic in pushing back against the agency's findings, saying it stands behind the safety of the Lutonix drug-coated balloon.
UPDATED: March 22, 2019 at 10:08 a.m. -
JDRF-backed Korean medtech gets breakthrough nod for closed loop system
EOFlow is developing a closed loop automated insulin delivery system for people with Type 1 diabetes as more companies aim to introduce alternatives to Medtronic's 670G MiniMed system.
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Intuitive's da Vinci SP gets FDA otolaryngology clearance
The approval is the second procedure category to be cleared for the da Vinci single port system, as the company looks to grow internationally.
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Navigating FDA's evolving device pathways: A primer
The agency is touting the biggest alterations to medtech approval processes in the decades since it began reviewing devices. Here's a roundup of the current regulatory framework and what's potentially changing.
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Abbott gains expanded indication for MitraClip valve repair device
M&A has dominated the mitral space in recent years as structural heart competitors look to follow MitraClip's growth.
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FDA ramps up major CDRH reorg, aiming for 'super office'
The restructuring will integrate pre and postmarket offices and shift to teams based on product type rather than life cycle. It kicks off Monday.
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FDA greenlights device for treating carbon monoxide exposure
The De Novo-winning Thornhill device accelerates a patient’s breathing rate to get poison out of the body.
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Fresenius gets breakthrough status for hemodialysis software
The experimental software makes recommendations to improve fluid management and thereby cut the rate of complications.
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Stryker to spend up to $220M on rotator cuff tear tech
The Kalamazoo, Michigan-based medtech announced it has closed a deal with Israeli startup OrthoSpace, which formerly drew investment from Johnson & Johnson and Smith & Nephew.
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Apple, Medtronic and more medtech to track at ACC19
Anticipated data backing the tech giant's heart rhythm-tracking watch, results from Medtronic and Edwards aimed at broader use of TAVR procedures, and an update on Abbott's MitraClip highlight the annual conference.
