Medical Devices: Page 164
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FDA redefines 'least burdensome' as critics fear chilling effect on reviewers
A watchdog argues the guidance is the agency's latest step to speed device approvals at the expense of robust patient protection.
By David Lim • Feb. 5, 2019 -
Oxipit AI-based tool for chest X-ray analysis gets CE mark
The Lithuania-based startup is betting the system can help radiologists increase productivity, detect hard-to-catch pathologies, decrease error rates and serve as a second opinion.
By Susan Kelly • Feb. 4, 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 -
FDA announces warfarin test strips, IV fluid transfer systems recalls
The agency identified separate Class I recalls addressing malfunctions in certain Roche Diagnostics test strips and Vial2Bag fluid transfer systems made by West Pharmaceutical Services.
By Susan Kelly • Feb. 4, 2019 -
Stryker issues voluntary field action after 6 deaths linked to defibrillator bug
The device giant obtained the product as part of its $1.28 billion acquisition of Physio-Control in 2016.
By Susan Kelly • Feb. 4, 2019 -
Zimmer Biomet narrowly beats Q4 expectations, looks to Rosa knee soft launch
RBC Capital Markets analysts predicted the company's second half of 2019 is primed for faster growth once Rosa and other new knee product launches kick in.
By David Lim • Feb. 1, 2019 -
Edwards' sales on track, but outlook cautious
The device maker is rolling out new transcatheter aortic valve replacement products at a measured pace to give surgeons time to become familiar with the technology.
By Susan Kelly • Feb. 1, 2019 -
Abiomed posts 30% growth on rising heart pump demand
Analysts think the medtech can sustain its rapid growth because of its potential to enter new indications and geographies.
By Nick Paul Taylor • Feb. 1, 2019 -
Digital health must catch up to years of hype in 2019, HIMSS says
The Healthcare Information and Management Systems Society also forecasts the sector will face rising consumer pressures and see increased use of social determinants of health data.
By Rebecca Pifer • Jan. 31, 2019 -
FDA sets neurology, microbiology device panel meetings for March
Advisory committees will discuss a De Novo application for an Alzheimer's therapy and new approaches to evaluate HPV screening devices.
By Maria Rachal • Jan. 31, 2019 -
HHS to seek changes to anti-kickback laws by year end
The bid to overhaul the Stark Law and Anti-Kickback Statute comes as lawmakers propose legislation to facilitate value-based arrangements connecting the price of a medical device or drug to clinical effectiveness.
By David Lim • Jan. 31, 2019 -
Breast health and diagnostics drive Hologic to beat-and-raise quarter
Double-digit growth by Hologic's core businesses offset ongoing underperformance by its Cynosure medical aesthetics unit.
By Nick Paul Taylor • Jan. 31, 2019 -
Baxter beats estimates despite ongoing medication delivery woes
To drive long-term growth, Baxter is "very aggressively" looking for takeover targets, CEO José Almeida said on an earnings call.
By Nick Paul Taylor • Jan. 31, 2019 -
Cybersecurity device plan seeks alignment of industry, regulators
A team led by representatives from BD, Mayo Clinic and FDA released a guide on managing the security of medical devices in clinical practice.
By Susan Kelly • Jan. 30, 2019 -
Stryker impresses in Q4, sets bold forecasts
The Kalamazoo, Michigan-based medical device maker forecast organic sales growth in the range of 6.5% to 7.5% in 2019 that represents its strongest outlook in a decade.
By Susan Kelly • Jan. 30, 2019 -
Tumbling breast implant sales drag on Allergan's Q4 results
The loss of a CE mark contributed to a 74% drop in European sales of the devices.
By Nick Paul Taylor • Jan. 30, 2019 -
Gottlieb, Shuren tout 2018 as 'record' year for novel devices
The FDA officials also cited progress with real world evidence, pondered expanding authorities to revamp the 510(k) system and floated creating a fast-track pathway for products addressing non-life-threatening diseases.
By Maria Rachal • Jan. 29, 2019 -
J&J data suggests its stapler reduces more lung surgery air leaks than competitor
The company pointed to research indicating use of its Ethicon surgical stapler in a lung cancer procedure led to less than half the rate of air leak complications than Medtronic's design did.
By Susan Kelly • Jan. 29, 2019 -
FDA sets March date for breast implant panel meeting
The agency plans to re-examine the benefit-risk profile of the controversial medical devices amid revival of a long-running debate over safety.
By Susan Kelly • Jan. 29, 2019 -
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 -
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 -
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
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