Medical Devices: Page 168
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Philips hits sales targets despite headwinds and patchy performance
The trade war between the United States and China is taking a toll on the multinational conglomerate.
By Nick Paul Taylor • Jan. 29, 2019 -
Draeger Medical recalls single-use breathing circuits
The accessory works with a ventilator or anesthesia machine and could cause severe oxygen loss or death if the breathing hose short circuits and patients do not receive ventilation.
By Susan Kelly • Jan. 28, 2019 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
ResMed Q2 revenue miss sends shares plunging
The maker of sleep apnea and respiratory care devices reported second-quarter revenue that missed analysts' targets, sending its shares plummeting more than 19% Friday.
By Susan Kelly • Jan. 28, 2019 -
Jacob Bell/MedTech Dive
Zimmer Biomet gets 510(k) for robotic knee surgery system
With the Rosa Knee authorization, the orthopaedics device maker takes on rival Stryker and its Mako robotic platform.
By Susan Kelly • Jan. 28, 2019 -
Boston Scientific rolls out latest DBS systems targeting Parkinson's
The company said its latest systems are smaller, offer longer battery life and are more customizable than other products on the market.
By Maria Rachal • Jan. 25, 2019 -
Intuitive Surgical to step up investment outside the US
The maker of the da Vinci robotic system is looking to build its business operations in new markets including China, India and Taiwan.
By Susan Kelly • Jan. 25, 2019 -
FDA grants breakthrough status to Liberate's ventilator device
The special designation covers a muscle stimulator designed to wean patients off mechanical ventilation.
By Nick Paul Taylor • Jan. 25, 2019 -
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 -
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
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