The Latest
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Walgreens to use Microsoft's cloud, AI platform
The companies also plan to pilot up to 12 store-in-store "digital health corners" to market select healthcare-related hardware and devices.
Research -
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.
Medical Devices -
Edwards Lifesciences pays Boston Scientific $180M to settle multiple patent disputes
Edwards will make a one-time payment to Boston and the companies will drop all other patent suits and appeals related to their current portfolios of heart technologies.
UPDATED: Jan. 15, 2019 at 11:04 a.m.
Medical Devices -
Senate Democrats question Gottlieb on FDA shutdown impact
FDA Commissioner Scott Gottlieb wrote Tuesday on Twitter the agency has returned 100 inspection staff to work to oversee high-risk medical device facilities.
UPDATED: Jan. 16, 2019 at 8:48 a.m.
Medical Devices -
Uncertainties abound with growing prospect of hard Brexit
The future for medtech companies in Europe was further complicated Tuesday with Britain's government firmly rejecting PM Theresa May's EU exit deal by a vote of 432 to 202, prompting debate of a no-confidence vote Wednesday.
UPDATED: Jan. 16, 2019 at 10 a.m.
Medical Devices -
Medtech therapeutic areas to track in 2019
Cardiovascular health, diabetes and oncology diagnostics are among the areas with greatest consumer and investor interest.
Medical Devices -
Jefferies predicts upbeat 2019 medtech outlook
As the new year gets underway, the investment bank identifies growth catalysts for eight medtechs.
Medical Devices -
FDA clears absorbable foot and ankle implant
Ossio said its bioabsorbable orthopaedic fixation implant for foot and ankle conditions, made from a mineral fiber matrix, integrates into the surrounding anatomy in 18 to 24 months.
Medical Devices -
Wound therapy device wins FDA authorization
The product eliminates the need to use gauze or foam when applying negative pressure to wounds.
Medical Devices -
FDA grants breakthrough designation to wearable dialysis device
The portable, wearable peritoneal dialysis device by Singapore-based AWAK Technologies is intended for patients with end-stage renal disease as an alternative to long hours of connection to large dialysis machines.
Medical Devices -
Mobile and wearable data increasingly useful to patients, JAMA authors say
Advances in internet-connected consumer devices and personal EHRs mean the systems may finally be poised to to improve patient outcomes, according to recent physician opinions published in JAMA.
Medical Devices -
5 medtech trends to watch in 2019
FDA regulatory changes, diagnostics legislation, a sustained focus on cybersecurity, looming European Union regulations and China trade headwinds are likely to take center stage.
Medical Devices -
FDA to beef up Sentinel postmarket electronic safety system
The agency announced a five-year plan to expand and strengthen the system by adding new data types, developing analytic methods and recruiting more collaborators to the network.
Medical Devices -
Deep DiveHow AI could shape the health tech landscape in 2019
Highlights include technologies that cut costs and promote patient health, especially in the areas of imaging, diagnostics, predictive analytics and administration.
Diagnostics -
Empatica gets FDA clearance for epilepsy monitor in children
The device analyzes motion and physiological signals to detect when the wearer is having a seizure.
Medical Devices -
FDA denies citizen petition calling for electroconvulsive therapy ban
The agency dismissed claims that the devices pose an unreasonable risk of injury.
Medical Devices -
NIH researchers develop AI system to improve cervical cancer screening
The system outperformed other tests in the study but needs improvement before being used in practice.
Diagnostics -
UK updates no-deal Brexit advice as vote on withdrawal agreement nears
Companies will need a designated individual based in the U.K. to register medical devices in the country.
Medical Devices -
Intuitive ends bumper 2018 with 19% growth in da Vinci procedures
The robotic surgery leader brushed off competition concerns to deliver another quarter of forecast-topping growth.
Medical Devices -
Grassley to zoom in on drug pricing, insurance mergers as Senate panel chair
The new Republican chairman of the Senate Finance Committee laid out his agenda for the year ahead.
Medical Devices -
LabCorp and Quest prepare for year of M&A as price cuts hit small labs
The laboratory testing giants expect reimbursement reductions to wipe out profits at smaller rivals, triggering a period of heavy consolidation.
Policy & Regulation -
Few digital health companies studying impact in high-burden populations, research shows
Only 16 of the more than 100 studies the authors looked at assessed a digital health product's impact on outcomes, and none measured its effect on cost or access to care, according to the report in Health Affairs.
Research -
JPM19: FDA warns it won't be long before user fee funding runs dry
With no end in sight to the government shutdown, Commissioner Scott Gottlieb said medical device user fee programs have about two to three months of funding left.
Medical Devices -
Boston Scientific, Medtronic give glimpse into 2019 at JPM
Boston Scientific's stock ticked up after its J.P. Morgan Healthcare Conference presentation Tuesday, whereas Medtronic's shares were down 6% Monday following conservative comments from company leadership.
Medical Devices -
Medtronic recalls imaging software used in brain surgery
The systems are being recalled due to reports of inaccurate information displaying during biopsy procedures.
Medical Devices