Medical Devices: Page 145
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Baxter puts up $230M for noninvasive fluid monitor company
The medtech said it intends to incorporate Cheetah's technology, alongside its IV infusion pumps, IV fluids and medications, into a new integrated platform for patient monitoring now in development.
By Susan Kelly • Sept. 11, 2019 -
Abbott says AI technology can help diagnose heart attacks
A study in the journal Circulation concluded the algorithm, which aims to individualize testing by taking into account factors such as patient age and sex, performed better than the European Society of Cardiology rule-out pathway.
By Susan Kelly • Sept. 11, 2019 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
US needs cyber-savvy doctors as connected device use rises, FDA panel says
Patients deserve cybersecurity training as part of the informed consent process, but healthcare providers aren't well-equipped to offer it, an FDA advisory committee said Tuesday.
By Maria Rachal • Sept. 11, 2019 -
Notified body BSI certifies 1st device under EU MDR
The new law will require a plethora of products that formerly didn't need certification by a notified body to undergo review.
By Dana Elfin • Sept. 11, 2019 -
Jacob Bell/MedTech Dive
Physicians push FDA to shed light on device comparators
In a paper published in JAMA Network Open on Wednesday, physicians analyzed evidence used in the authorizations of products under the Humanitarian Device Exemption pathway.
By Nick Paul Taylor • Sept. 11, 2019 -
EBR gets FDA breakthrough tag for wireless cardiac pacing system
The device is designed to synchronize the left and right ventricles without subjecting patients to lead implantation.
By Nick Paul Taylor • Sept. 11, 2019 -
FDA
FDA looks to define 'triggers' for medical device cybersecurity warnings
When do the benefits of notifying patients of potential risks outweigh possible harms? The agency's Patient Engagement Advisory Committee is weighing in Tuesday.
By Maria Rachal • Sept. 10, 2019 -
Medtronic MiniMed insulin pump gains German reimbursement
Medtronic is counting on strong international demand for the hybrid closed loop system to maintain momentum in its diabetes business as U.S. growth slows.
By Susan Kelly • Sept. 10, 2019 -
Zimmer gets 510(k) clearance for Persona Revision knee
The device maker is counting on new products to speed a turnaround effort that saw the company notch its best growth in three years in the second quarter.
By Susan Kelly • Sept. 10, 2019 -
Sponsored by ZS
AI in medtech: Innovating in an era of uncertainty
The FDA clearance of a new AI technology empowers PCPs to better care for their diabetic patients, but what are the broader-reaching implications for AI innovators?
By Kate Templeton & Sundeep Karnik • Sept. 10, 2019 -
Doubt cast on value of Exact Sciences' Cologuard
Research commissioned by CMS found the test is "less effective and considerably more costly" than other colorectal cancer screening methods.
By Nick Paul Taylor • Sept. 10, 2019 -
Boston Scientific says Biocardia doesn't own women's health patents, denies stealing trade secrets
Boston Scientific is asking a court to determine it didn't steal BioCardia's trade secrets and to clear up patent ownership of an early-detection diagnostic tool for ovarian cancer it acquired when it purchased nVision.
By Dana Elfin • Sept. 9, 2019 -
Medtronic touts new data on DCB in dialysis patients
The IN.PACT drug coated balloon received an expanded CE mark indication in January 2016 to treat AV access for patients with end-stage renal disease.
By David Lim • Sept. 9, 2019 -
Hospital buying data point to TAVR surge in Q3: analysts
Use of Edwards Lifesciences' systems is accelerating sharply in the third quarter, according to a Jefferies model, suggesting hospitals anticipated a recent FDA decision expanding the procedure's indicated population.
By Susan Kelly • Sept. 9, 2019 -
FDA
Pulmonary arterial hypertension device wins FDA breakthrough designation
Tel Aviv-based SoniVie's device is an ultrasound catheter inserted into the pulmonary artery in a right heart procedure to ablate nerves associated with disease activity.
By Susan Kelly • Sept. 9, 2019 -
FDA finalizes guidance for accepting De Novo requests
In the guidance, the agency explains procedures and criteria for assessing whether a device manufacturer's De Novo classification request should be accepted for a substantive review.
By Susan Kelly • Sept. 9, 2019 -
Telemedicine CEO pleads guilty in $424M Medicare kickback scheme
The executive admitted to seeking and getting bribes from patient recruiters, pharmacies and brace suppliers in return for arranging for doctors to order medically unnecessary orthotic braces.
By Dana Elfin • Sept. 9, 2019 -
Axonics wins PMA for sacral neuromod system, challenging Medtronic
The FDA approval allows the medtech to market its implantable, rechargeable device for treatment of fecal incontinence as it seeks further indications for overactive bladder and urinary retention.
By Maria Rachal • Sept. 9, 2019 -
NESTcc 1.0 aims to launch, be able to take unsolicited projects by end of year
The National Evaluation System for health Technology Coordinating Center Task Force is also currently developing an active surveillance roadmap it aims to issue for public comment this fall.
By David Lim • Sept. 6, 2019 -
FDA finalizes guidance on HDEs after AdvaMed scrutiny
Industry advocates had criticized FDA's tight parameters on which humanitarian use devices are eligible to turn a profit, but the final guidance largely mirrors the draft.
By Susan Kelly • Sept. 6, 2019 -
Racing Edwards, Abbott starts pivotal trial of tricuspid device
The product, a sibling of MitraClip, could become the first transcatheter tricuspid device of its kind on the U.S. market.
By Nick Paul Taylor • Sept. 6, 2019 -
Jacob Bell/MedTech Dive
FDA floats idea for assessing the risk-benefit profile of weight-loss devices
Concerned that some patients lack access to effective weight-loss devices, the agency is seeking feedback to inform guidance that it says will help device developers offer a wider variety of tools.
By Nick Paul Taylor • Sept. 6, 2019 -
Livongo posts 'good enough' first earnings since IPO, but stock tanks
The digital health company beat analysts' revenue targets, but a greater-than-expected loss on earnings per share contributed to a double-digit hit to its stock price in morning trading.
By Maria Rachal • Sept. 5, 2019 -
With partner iRhythm, Verily ramps up AFib efforts
iRhythm committed almost $18 million to Verily to boost development of technology that helps deliver earlier warnings to individuals with asymptomatic or silent atrial fibrillation.
By Maria Rachal • Sept. 5, 2019 -
Robotic tech used for cardiac intervention from 20 miles away
Patients were treated remotely using telerobotic technology from Corindus, which was recently acquired by Siemens Healthineers.
By Nick Paul Taylor • Sept. 5, 2019
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