The Latest
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Ra Medical files suit alleging rival interfered with IPO
Separately, Nasdaq notified Strata Skin Sciences on Friday it is out of compliance with the market's continued listing requirements due to delays in filing quarterly and annual reports.
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FDA classes J&J stapler recall as high risk ahead of advisory panel
More than 92,000 of the devices made by the pharma's Ethicon unit are implicated in the U.S. recall.
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Newly independent Alcon leans on surgical unit while awaiting key product launches
The full year outlook reflects rising sales of Alcon's PanOptix intraocular lenses, offset by loss of vision care market share.
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Express Scripts to launch formulary for apps, medical devices
The pharmacy benefit manager says its new formulary will include digital health solutions for a host of chronic and complex conditions, including diabetes, cardiovascular, pulmonary and behavioral health issues.
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FDA calls Essure postmarket study progress 'adequate' in adverse event update
The agency said it received roughly 6,000 medical device reports related to the permanent birth control implant last year. Bayer halted U.S. sales at the end of 2018, but doctors can implant the device through the end of 2019.
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Massachusetts grows medtech exports, but decline in clearances spurs R&D rethink
The 7.7% uptick in 2018 exports was countered by a 17% decline in 510(k) clearances.
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Titan Medical's losses balloon as robotic surgery R&D drive accelerates
The company plans to file for a CE mark and 510(k) clearance for its robotic surgery platform by the end of the fiscal year. It aims to start early U.S. commercialization in 2020.
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Physicians call for Digital Health Scorecard to validate products
Following the models of consumer product evaluation organizations, doctors want transparent evaluations of new technologies.
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B. Braun invests $1B in IV fluid manufacturing to alleviate shortages
FDA's task force on drug shortages is expected to submit a report to Congress by year's end outlining potential solutions to address root causes of scarcities.
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Haemonetics sells plant, gains expanded indication for blood analyzer systems
After reporting a 6.7% jump in quarterly revenue, the blood technologies maker has offloaded a manufacturing site to CSL Plasma and received clearance for use of its hemostasis analyzer system in adult trauma settings.
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Deep DiveWill a big needle burst the NASH bubble?
With less invasive tests still a few years off, doctors worry liver biopsies will limit access to the initial wave of NASH drugs — if any make it to market.
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Abbott, NIH collaborate on neuroscience research
The company will contribute its neuromodulation technologies to the National Institutes of Health's work on brain disorders.
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FDA extends Abiomed heart pump use to 14 days
The new label more than doubles authorized length of use of the pumps and positions physicians to give critically ill patients longer to recover before deciding on next steps.
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CMS will weigh broader mitral valve repair NCD, analysts predict
Cowen analysts think Medicare's Coverage Analysis Group is likely to reconsider the national coverage determination for mitral valve repair in the second half of the year, which could benefit MitraClip maker Abbott.
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Grail's multi-cancer blood test nabs breakthrough device status
The Bezos and Gates-backed cancer diagnostic developer said the FDA designation will expedite the early detection methylation technology it is testing. Exact Sciences, Guardant Health and others share goals in the space.
UPDATED: May 14, 2019 at 5:41 p.m. -
Same-day upper and lower endoscopies improve care, costs: JAMA
Johns Hopkins researchers used Medicare claims data to identify patterns suggesting overuse of different-day scheduling, especially when physician offices and freestanding ambulatory surgery centers did the scheduling.
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Medtronic, Boston Scientific unveil ICD data
Medtronic also released analyses indicating implantable cardioverter defibrillators and cardiac resynchronization therapy devices are underutilized in patients medically indicated for the treatments.
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Medicare contractors propose narrow coverage for glioblastoma treatment
The local coverage determination for Novocure's device will likely be finalized by late summer or early fall and go into effect after a 45-day notice period.
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AliveCor snags FDA clearance for six-lead EKG
Alongside an April clearance for its KardiaAI software to help identify bradycardia and tachycardia, the company is positioning itself to compete with the latest Apple Watch's electrocardiogram function.
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LabCorp to sell Qiagen companion diagnostic for bladder cancer
The test is designed to assess whether patients with urothelial cancer are eligible for treatment with Johnson & Johnson’s newly approved therascreen fibroblast growth factor receptor kinase inhibitor Balversa.
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Sen. Murray renews scrutiny of duodenoscope makers
The top Democrat on the HELP committee is asking manufacturers Olympus, Fujifilm and Pentax how they plan to respond to FDA data showing what the senator calls "alarmingly high rates of contamination."
UPDATED: May 13, 2019 at 9:14 a.m. -
Medtronic fuses with Titan Spine
The medtech giant will gain a portfolio of titanium interbody implants, bought for an undisclosed amount. The announcement came the same day Boston Scientific disclosed its own spinal device acquisition.
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Eye scan to detect Alzheimer's biomarker gets breakthrough status
Optina Diagnostics' retinal imaging platform uses artificial intelligence to detect amyloid plaques in the brain and is intended to improve diagnostic accuracy as a non-invasive, low-cost tool.
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Philips, Medtronic team up to create image-guided atrial fibrillation device
The system will use Philips' dielectric imaging and navigation system to facilitate cryoablation without extensive X-ray imaging.
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Bound for 3M, KCI gets De Novo for negative pressure device
The clearance expands use of the negative pressure device for reduction of superficial surgical site infections in high-risk patients. The KCI brand is marketed by Acelity, acquired by 3M last week in a $6.7 billion deal.
