Medical Devices
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FDA finalizes 4 guidances to clarify 510(k) pathways
The documents spell out the agency's initiatives for improving the 510(k) premarket review pathway to promote faster access to new medical technologies.
By Susan Kelly • Sept. 13, 2019 -
American Kidney Fund lobbies White House on charitable premium assistance
Insurers are pushing for a reexamination of policies they argue allow financially interested third parties to steer end-stage renal disease patients eligible for Medicare or Medicaid to private plans.
By David Lim • Sept. 13, 2019 -
FDA awards breakthrough designation to nerve regeneration tech
Checkpoint Surgical previously said it sees an at least $1 billion opportunity in the therapeutic nerve regeneration business segment.
By Maria Rachal • Sept. 12, 2019 -
EU sets out requirements for MDR expert panel members
Notified bodies must consult with the panels before clearing certain high-risk devices for marketing.
By Nick Paul Taylor • Sept. 12, 2019 -
Brexit threatens UK robotic surgery innovation, study finds
The Imperial College London analysis indicates a hard split from the EU could cause the U.K. to lose collaborations with other member states.
By Nick Paul Taylor • Sept. 12, 2019 -
China exempts certain radiation devices from tariffs, giving boost to Varian
Varian Medical Systems took a $15 million hit from the tariffs last quarter, but could now recoup taxes it paid.
By Nick Paul Taylor • Sept. 12, 2019 -
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 -
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 -
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 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 -
SponsoredAI 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. 09, 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. 09, 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. 09, 2019 -
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. 09, 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. 09, 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. 09, 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. 09, 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. 06, 2019
