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➔

Medical 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

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

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