Medical Devices: Page 162
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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 -
Explore the Trendline➔
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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 -
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 -
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.
By Nick Paul Taylor • Jan. 17, 2019 -
Mayo, Arizona State team up to found medtech startup accelerator
The six-month program is designed to connect startups with investors and physicians.
By Nick Paul Taylor • Jan. 17, 2019 -
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.
By David Lim • Jan. 17, 2019 -
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.
By Susan Kelly • Jan. 16, 2019 -
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.
By Susan Kelly • Jan. 16, 2019 -
Medtech therapeutic areas to track in 2019
Cardiovascular health, diabetes and oncology diagnostics are among the products with greatest consumer and investor interest.
By Maria Rachal • Jan. 15, 2019 -
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.
By Susan Kelly • Jan. 15, 2019 -
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.
By Maria Rachal • Updated Jan. 15, 2019 -
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.
By Susan Kelly • Jan. 15, 2019 -
Wound therapy device wins FDA authorization
The product eliminates the need to use gauze or foam when applying negative pressure to wounds.
By Nick Paul Taylor • Jan. 15, 2019 -
Jefferies predicts upbeat 2019 medtech outlook
As the new year gets underway, the investment bank identifies growth catalysts for eight medtechs.
By Susan Kelly • Jan. 14, 2019 -
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.
By Susan Kelly • Jan. 14, 2019 -
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.
By David Lim • Updated Jan. 16, 2019 -
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.
By Susan Kelly • Jan. 14, 2019
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