Medical Devices: Page 165
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Varian begins 2019 with guidance-beating quarter
Strong global demand for radiotherapy devices enabled the Palo Alto-based oncology treatment and software manufacturer to brush off the impact of tariffs.
By Nick Paul Taylor • Jan. 25, 2019 -
Medtronic buys Epix to boost cardiac ablation unit
Terms for the acquisition were not disclosed, but the device giant said the company is pre-revenue and the deal will be dilutive.
By David Lim • Jan. 25, 2019 -
Explore the Trendline➔
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TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
Device lobby pushes bill to let FDA take user fees amid shutdown
But the proposal does not appear to be poised for movement. Democrats on the House Energy & Commerce Committee oppose the legislation, a Democratic committee staffer told MedTech Dive.
By David Lim • Jan. 24, 2019 -
Double-digit growth in hip and knee replacements spikes health spending
The analysis shows a growing proportion of Blue Cross Blue Shield members are electing to undergo the orthopaedic procedures.
By Nick Paul Taylor • Jan. 24, 2019 -
Hospitals call on medtech to ease interoperability by boosting security
"Medical device manufacturers must do more to confront the privacy challenges that unsecurable devices may pose to hospitals and health systems," the American Hospital Association and six other groups said in a report.
By Meg Bryant • Jan. 23, 2019 -
J&J hit with $120M bill in 46-state hip implant marketing settlement
South Carolina and Texas led the effort alleging Johnson & Johnson mischaracterized the longevity and safety of two DePuy Orthopaedics hip replacement products no longer on the market.
By Maria Rachal • Jan. 23, 2019 -
Medtronic data show no paclitaxel-mortality link amid FDA warnings
A study of peripheral artery disease patients treated using paclitaxel-coated balloons differed in conclusions from a meta-analysis that prompted an agency safety alert last week.
By Susan Kelly • Jan. 23, 2019 -
Illumina TruSight assay gets FDA breakthrough designation
The DNA sequencing company is seeking clearance of the assay as a companion diagnostic.
By Susan Kelly • Jan. 23, 2019 -
FDA expands Abbreviated 510(k) guidance, seeks predicate input
FDA Thursday extended the comment period by 30 days for its request for feedback on its proposal to overhaul the 510(k) program to encourage use of more modern predicate devices.
By David Lim • Updated April 12, 2019 -
Abbott misses sales expectations despite device, diagnostic unit growth
The medical device unit had the strongest quarter of four divisions, with double-digit growth in sales of diabetes, electrophysiology and structural heart products fueling its performance.
By Nick Paul Taylor • Jan. 23, 2019 -
M&A, robotics among medtech growth drivers for 2019: Moody's
At the same time, slowing economies in both developed and developing countries could constrain volumes and pricing in the sector.
By Susan Kelly • Jan. 22, 2019 -
Verily Study Watch gets FDA nod for EKG
Unlike the FDA-cleared EKG on Apple Watch, the Google-backed company's Study Watch is a prescription-only device.
By Susan Kelly • Jan. 22, 2019 -
Bigfoot could shake up insulin delivery market, analyst says
Medtronic, Dexcom and Insulet will have to contend with the developer of insulin-delivery devices targeted for launch next year, Jefferies predicts.
By Susan Kelly • Jan. 22, 2019 -
J&J posts $27B in 2018 medical device sales in slight bump
Though fourth quarter sales were down 4.4% compared to 2017, the device unit managed 1.1% yearly operational sales growth for 2018.
By Maria Rachal • Jan. 22, 2019 -
NESTcc plans pay-for services once FDA funding ends
Once a business plan is in place, the Medical Device Innovation Consortium's real-world evidence center intends to create products and services to sell to the medical device industry.
By Nick Paul Taylor • Jan. 22, 2019 -
FDA flags mortality risk of paclitaxel with stents, balloons for PAD
The letter to physicians follows a study identifying increased risk of death for patients two years after treatment for peripheral artery disease with a drug-coated balloon or drug-eluting stent.
By Susan Kelly • Jan. 18, 2019 -
LivaNova highlights studies into efficacy, value of sutureless aortic valve
The research suggests the valve, Perceval, may have advantages over competing technologies.
By Nick Paul Taylor • Jan. 18, 2019 -
BD, Mercy ally to use clinical data to boost device use
The agreement follows similar deals between the health system and J&J and Medtronic. BD also on Thursday morning reaffirmed its 2019 revenue growth guidance of 8.5% to 9.5%.
By Nick Paul Taylor • Jan. 17, 2019 -
Abbott inks Cephea buyout to boost mitral valve pipeline
The takeover gives Abbott another valve replacement device to rival those owned by Edwards and Medtronic.
By Nick Paul Taylor • Jan. 17, 2019 -
Mayo, Arizona State team up to found medtech startup accelerator
The six-month program is designed to connect startups with investors and physicians.
By Nick Paul Taylor • Jan. 17, 2019 -
Top House Democrat to focus on diagnostics revamp, drug prices in 2019
With Democrats now in power, the new chair of a key oversight subcommittee laid out her priorities, including proposals she argues will bolster the Affordable Care Act.
By David Lim • Jan. 17, 2019 -
FDA clears energy tools for TransEnterix robotic surgery system
The company has received FDA 510(k) clearance for a set of advanced energy instruments that can be used with its Senhance robotic surgical system.
By Susan Kelly • Jan. 16, 2019 -
Medtronic links patients' pacemakers with their smartphones
The MyCareLink Heart mobile app is compatible with the company's BlueSync technology-enabled pacemakers and eliminates the need for other remote monitoring hardware.
By Susan Kelly • Jan. 16, 2019 -
Medtech therapeutic areas to track in 2019
Cardiovascular health, diabetes and oncology diagnostics are among the products with greatest consumer and investor interest.
By Maria Rachal • Jan. 15, 2019 -
Abbott heart device for premature babies wins FDA approval
The device for sealing a hole in the heart of premature infants is smaller than a pea and can treat newborns weighing as little as 2 pounds.
By Susan Kelly • Jan. 15, 2019
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