FDA: Page 88
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FDA's Day 2 of breast implant panel mulls: Who should lead on informed consent?
Agency advisers backed research into breast implant illness and want to bridge gaps in informed consent. But pivotal educational responsibility may fall more with surgeons than regulators, the panel said.
By Maria Rachal • March 27, 2019 -
CMS set to reopen controversial cancer test policy
The potential reassessment follows accusations of "significant policy overreach" by CMS amid concerns the policy could stop early-stage cancer patients from accessing next generation sequencing tests.
By Nick Paul Taylor • March 27, 2019 -
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 -
CMS pitches new rules for TAVR coverage
Edwards Lifesciences backed a quality-based model to establish which hospitals can perform TAVR. But CMS, echoing Medtronic, contends more data are needed before abandoning the volume-based approach.
By Nick Paul Taylor • March 27, 2019 -
CMS, physician group launch AI challenge
The Artificial Intelligence Health Outcomes Challenge offers up to $1.65 million in awards. Developers will be tasked with building AI programs on Medicare data to improve health outcomes.
By Tony Abraham • March 27, 2019 -
AdvaMed responds to congressional cybersecurity inquiry
Sen. Mark Warner, D-Va., asked for information to inform the development of a "national strategy that improves the safety, resilience, and security of our health care industry."
By David Lim • March 26, 2019 -
FDA experts weigh 'man-made' cancer linked to breast implants
Panel members agreed data collection by manufacturers has been deficient and doctors aren’t doing enough to communicate risks to patients, but pushed back on a total ban of textured implants from the U.S. market.
By Maria Rachal • March 26, 2019 -
CMS due to release updated TAVR coverage determination
The agency is reconsidering its existing National Coverage Determination at the urging of physicians who argued that lower-volume heart centers should be allowed to offer the procedure.
By Susan Kelly • March 26, 2019 -
EU device group wants clarity on expert panels under MDR
The coordinating group of the bloc's member states, created to enforce the new device regulations, said the matter is urgent because it is about to launch procedures for establishing the panels.
By Susan Kelly • March 25, 2019 -
With imperfect data, FDA turns to panel for way forward on breast implants
Agency advisers convened Monday for a two-day hearing to discuss how best to characterize and track potential cancer cases linked to the devices, among other issues.
By Maria Rachal • March 22, 2019 -
DHS warns of critical cybersecurity weakness with Medtronic implants
The communication system vulnerability, in theory, could enable a hacker with limited skill to change settings on defibrillator implants.
By Nick Paul Taylor • March 22, 2019 -
Key senators demand answers about 'suspect' doctor-device maker ties
Bipartisan leaders of the Senate Finance Committee want CMS to probe whether physician-owned distributorships of medical implants are failing to meet Sunshine Act requirements.
By Nick Paul Taylor • March 22, 2019 -
FDA takes hard look at breast implant safety amid fresh cancer fears
The potential for the devices to cause autoimmune reactions may also be a talking point at Monday and Tuesday's advisory committee meeting. FDA called out potential biocompatibility problems with silicone last week.
By Maria Rachal • March 21, 2019 -
FDA, NEST detail how extra funding can bolster postmarket safety
CDRH Director Jeff Shuren explained the thinking behind the FDA's support of its postmarket surveillance system in a paper with Rachael Fleurence, executive director of the National Evaluation System for health Technology.
By Nick Paul Taylor • March 21, 2019 -
UK steps up no-deal planning as Brexit clock ticks down
MHRA updated its advice on registering devices against a backdrop of concerns about supply disruptions.
By Nick Paul Taylor • March 21, 2019 -
FDA warns Sientra, J&J's Mentor on lax post-approval breast implant studies
The action comes a week before the agency is set to hold a public meeting on risks related to the controversial devices.
By Susan Kelly • Updated March 20, 2019 -
Alzheimer's device De Novo on the line at FDA panel
An advisory committee got started on a transcranial magnetic stimulation device Thursday morning, coming the same day as Biogen halted trials of one of the last late stage drug candidates to treat the disease.
By Susan Kelly • March 20, 2019 -
Lab industry pushes CMS to withdraw 'highly disruptive' coding changes
Nine trade groups called for reversal of certain lab and pathology section updates to National Correct Coding Initiative policy manuals.
By Nick Paul Taylor • March 20, 2019 -
Abbott gets CE mark for molecular diagnostics machine
The device expands the company's fast-selling portfolio of Alinity laboratory testing instruments.
By Nick Paul Taylor • March 20, 2019 -
FDA outlines new device priorities in budget justification report
A new agency document sheds light on proposed initiatives related to cybersecurity, approval pathways and special controls.
By Susan Kelly • March 19, 2019 -
Breast implants, metal hips and other device materials under new FDA scrutiny
Symptoms such as fatigue, rash, joint and muscle pain or weakness may not appear until years after a device is implanted, FDA said.
By David Lim • March 18, 2019 -
Jacob Bell/MedTech Dive
JDRF-backed Korean medtech gets breakthrough nod for closed loop system
EOFlow is developing a closed loop automated insulin delivery system for people with Type 1 diabetes as more companies aim to introduce alternatives to Medtronic's 670G MiniMed system.
By Maria Rachal • March 18, 2019 -
FDA: Avoid paclitaxel-coated PAD devices for most patients
BD Thursday joined Medtronic in pushing back against the agency's findings, saying it stands behind the safety of the Lutonix drug-coated balloon.
By Susan Kelly • Updated March 22, 2019 -
FDA greenlights device for treating carbon monoxide exposure
The De Novo-winning Thornhill device accelerates a patient’s breathing rate to get poison out of the body.
By Nick Paul Taylor • March 15, 2019 -
Fresenius gets breakthrough status for hemodialysis software
The experimental software makes recommendations to improve fluid management and thereby cut the rate of complications.
By Nick Paul Taylor • March 15, 2019 -
FDA ramps up major CDRH reorg, aiming for 'super office'
The restructuring will integrate pre and postmarket offices and shift to teams based on product type rather than life cycle. It kicks off Monday.
By Nick Paul Taylor • March 14, 2019
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