Medical Devices: Page 161
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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 -
Explore the Trendlineâž”
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TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
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 -
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
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