Medical Devices

Biomagnetic imaging for chest pain wins FDA clearance

The rapid, noninvasive imaging test from Genetesis, a Mason, Ohio-based startup, measures the magnetic fields produced by the heart’s electrical activity.
By Susan Kelly • March 25, 2019
Not even money prods patients to mail-in colon tests, study suggests

The fecal immunochemical test is used to find small amounts of blood in the stool that could be a sign of cancer or polyps.
By Susan Kelly • March 25, 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
FDA approves first-of-its-kind heart failure device

The implantable system from Impulse Dynamics is indicated for patients with Class III moderate to severe heart failure who are not eligible for cardiac resynchronization therapy.
By Susan Kelly • 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
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
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 at 4:22 p.m.
Sponsored
Making software a core part of your business model

Pivoting away from devices as the primary revenue stream is proving to be a big challenge for many medtech companies.
By Dan Frey • March 19, 2019
BD wins PMA for stent treating venous occlusive disease

The company beat several contenders for the distinction of being first to market in the U.S. with a stent to reopen blocked iliac and femoral veins.
By Susan Kelly • March 19, 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
FDA cybersecurity guidance draws fire from big device makers

Boston Scientific, GE Healthcare and BD are among manufacturers raising alarms over a proposal to create two tiers of cybersecurity risk buckets.
By David Lim • 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 at 10:08 a.m.
TAVR called 'game changing' in studies of low-risk patients

Data from Edwards Lifesciences' Partner 3 trial and Medtronic's Evolut Low Risk study prompted predictions that TAVR will become the preferred option for a wider population of heart valve patients.
By Susan Kelly • March 18, 2019
Intuitive's da Vinci SP gets FDA otolaryngology clearance

The approval is the second procedure category to be cleared for the da Vinci single port system, as the company looks to grow internationally.
By Susan Kelly • March 18, 2019
Apple heart study: Early proof of concept, or a gimmick?

Doctors at the American College of Cardiology meeting said the Apple Watch's foray into health monitoring needs more data to prove its value.
By David Lim • March 16, 2019
Abbott gains expanded indication for MitraClip valve repair device

M&A has dominated the mitral space in recent years as structural heart competitors look to follow MitraClip's growth.
By Susan Kelly • March 15, 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