FDA: Page 96
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Jacob Bell/MedTech Dive
Patient deaths following Getinge device shutdowns prompt FDA warning
The agency has reports of three patient deaths following intra-aortic balloon pump malfunctions.
By Nick Paul Taylor • Nov. 2, 2018 -
FDA warns about Roche test after reports of patient strokes
Two patients suffered serious injuries involving strokes, prompting a warning that inaccurate results from the Swiss pharma's CoaguChek could cause serious injuries or death when taken with the blood thinner warfarin.
By Nick Paul Taylor • Nov. 2, 2018 -
Explore the Trendline➔
Courtesy of Intuitive Surgical
TrendlineTop 5 stories from MedTech Dive
From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Zimmer gets FDA nod for knee implant as portfolio strategy advances
Clearance coincided with first use of the device maker's knee surgery robot. The CEO has been vague about how it will differentiate its knee and spine devices from rival products, such as those sold by Mazor Robotics and Stryker.
By Nick Paul Taylor • Nov. 1, 2018 -
23andMe wins FDA clearance for first-of-its-kind genetic test
The agency also sent a safety communication warning about the danger of relying on genetic tests that have not been reviewed by FDA making claims about patient response to individual medications.
By David Lim , Nick Paul Taylor • Nov. 1, 2018 -
A timeline of Anthem's bold payment policies (and the fallout)
The payer's aggressive moves to push procedures like imaging to outpatient settings and taking a hard line on emergency room visits has drawn fire from doctors and other critics.
By Samantha Liss • Oct. 31, 2018 -
Alex Wong via Getty Images
HHS opens cybersecurity coordination center after troubled year
It comes five months after a bipartisan group of lawmakers took HHS to task over stuttering attempts to coordinate cybersecurity information sharing.
By Nick Paul Taylor • Oct. 31, 2018 -
AdvaMed pitches new Anti-Kickback Statute safe harbors
The trade group wants the carve-outs for value-based pricing, warranty and risk-sharing arrangements.
By David Lim • Oct. 30, 2018 -
Deep Dive
5 sticking points in the EU medical device reg transition
Brexit and notified body capacity are among the uncertainties, as many in the medtech sector are uninformed.
By Meg Bryant • Oct. 29, 2018 -
Speedy Medicare breakthrough device coverage plan slated for March
AdvaMed has been pushing the agency to take steps to limit the delay between FDA approval and reimbursement.
By Nick Paul Taylor • Oct. 26, 2018 -
Elizabeth Regan/MedTech Dive
Novarad augmented reality system for surgery clears FDA
The OpenSight system is designed for use with Microsoft HoloLens technology.
By Meg Bryant • Oct. 25, 2018 -
Medtronic's dose-controlling app for pain pump gets FDA nod
The technology enables users to deliver doses on demand to cope with breakthrough pain.
By Nick Paul Taylor • Oct. 25, 2018 -
FDA clears Ansh Labs menopausal status test
Physicians can use the results to inform actions to prevent osteoporosis and heart disease.
By Nick Paul Taylor • Oct. 25, 2018 -
Adverse events prompt FDA to advise monitoring of Alcon implants
For now, the FDA says the problem looks to be limited to Alcon's implant. Glaukos markets a rival iStent device and saw its stock price increase by 40% when Alcon withdrew its stent.
By Nick Paul Taylor • Oct. 25, 2018 -
LabCorp blames data breach, hurricane for substandard Q3
The diagnostics branch was "particularly disappointing," said chairman and CEO Dave King.
By Rebecca Pifer Parduhn • Oct. 24, 2018 -
FDA starts 510(k) pilot to cut optical tomography processing times
The program aims to give developers of optical coherence tomography devices the chance to discuss premarket performance testing recommendations with the agency.
By Nick Paul Taylor • Oct. 24, 2018 -
Medtronic's low-profile thoracic endograft gets FDA nod
By expanding TEVAR to patients with a broader range of anatomies, Medtronic could gain an edge over rivals Bolton Medical, Cook Medical and Gore Medical.
By Nick Paul Taylor • Oct. 24, 2018 -
Viseon gets 510(k) clearance for spinal surgery device
The product enables visualization of surgical sites during minimally-invasive procedures.
By Nick Paul Taylor • Oct. 19, 2018 -
FDA sets busy year-end medical device to-do list
Improving mammography quality, revamping the De Novo classification process and revising the definition of a medical device to exclude certain medical software are some of the agency's priorities.
By David Lim • Oct. 19, 2018 -
Stakeholders call for transparency, ease of use in EHR Reporting Program
In comments, several healthcare organizations requested a centralized clearinghouse of existing health IT comparison resources.
By Meg Bryant • Oct. 18, 2018 -
FDA targets late 2019 for hearing aid proposed rule
The plan comes two weeks after Bose won clearance to sell the first self-fitting hearing aid that can be programmed without the help of a healthcare provider.
By David Lim • Oct. 18, 2018 -
FDA floats changes to cybersecurity guidance to strengthen safeguards
Proposals include creation of lists of all hardware and software components used in a device that could be vulnerable to attack.
By Nick Paul Taylor • Oct. 18, 2018 -
FDA boosts medical device cybersecurity coordination with Homeland Security
The DHS Office of Cybersecurity and Communications and FDA's device center will increase information sharing of potential and confirmed device vulnerabilities and threats.
By David Lim • Oct. 16, 2018 -
Anthem shells out $16M to settle biggest health data breach in history
The fund will pay for four years of credit monitoring and all other claims, costs and fees for affected individuals, according to the settlement.
By Rebecca Pifer Parduhn • Oct. 16, 2018 -
Endologix recalls cardiac implants amid ongoing rupture risk
The Class I recall stems from reports of some devices failing to divert blood away from aneurysms.
By Nick Paul Taylor • Oct. 16, 2018 -
Blue Button 2.0 doubles developers to 1,200, but beneficiary uptake tiny
CMS Administrator Seema Verma tells MedTech Dive that 11 organizations have "production apps" in place using live data.
By David Lim • Oct. 15, 2018
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