The Latest
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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.
Medical Devices -
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.
Medical Devices -
Mayo, Arizona State team up to found medtech startup accelerator
The six-month program is designed to connect startups with investors and physicians.
Medical Devices -
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%.
Medical Devices -
More seniors may soon be sporting Apple Watches with MA partnerships
Tapping into the Medicare market could be lucrative for Apple and a good business strategy for insurers, given the aging U.S. population and rising healthcare costs.
Digital Health -
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.
Medical Devices -
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.
Medical Devices -
Neural network matches cardiologists in EKG analysis study
Researchers think the algorithm could improve the triaging of patients.
Research -
After losses to Quest, LabCorp strikes exclusive Texas testing deal
The extension of the long-term relationship comes as LabCorp faces competition for key accounts.
Diagnostics -
JAMA study raises questions on lung cancer screening cost-effectiveness
Researchers found complication rates far higher than the National Lung Cancer Screening Trial did in community settings.
Research -
No one solution to patient matching challenge, GAO says
Questions about the accuracy of digital matching tools force providers to recheck results manually, according to the government watchdog.
Policy & Regulation -
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 products 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