Medical Devices: Page 169
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FDA repeals some regs on radiation-emitting devices
The agency said it believes its revised rules will continue to protect patients and health professionals against harmful radiation exposure from electronic products and medical devices.
By Susan Kelly • April 1, 2019 -
Smith & Nephew picks up pressure injury prevention device
The medtech said Wednesday it completed its acquisition of Leaf Healthcare, following a two-year partnership with the wireless patient monitoring system startup.
By Maria Rachal • Updated April 17, 2019 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
ECRI Institute launching international device testing lab
The nonprofit patient safety organization will open its first medical device evaluation laboratory outside the United States on April 11 in Selangor, Malaysia, to test products sold in Europe and Asia.
By Susan Kelly • March 29, 2019 -
FDA floats 5-day notice for device inspections in draft guide
The agency is filling an obligation under the FDA Reauthorization Act of 2017 to adopt uniform standards around not-for-cause inspections.
By David Lim • March 29, 2019 -
Deep Dive
How AI and machine learning are changing prosthetics
"Our bodies natively have control loops at various levels, and that's really where AI comes into play" in creating next-generation prostheses, said Robert Armiger of Johns Hopkins' Advanced Physics Lab.
By Meg Bryant • March 29, 2019 -
UK provides more no-deal Brexit advice as logjam drags on
The latest guidance, covering certain types of marketing authorizations and the provision of scientific advice, comes the same week Britain had planned to leave the EU.
By Nick Paul Taylor • March 29, 2019 -
Neuronetics gets Japanese coverage for antidepressant device
The coverage decision for the transcranial magnetic stimulation device was supported by an observational study of 307 patients with major depressive disorder.
By Nick Paul Taylor • March 28, 2019 -
Stryker names J&J lawyer as chief legal officer
Rob Fletcher spent 15 years at Johnson & Johnson, taking on jobs including general counsel for medical devices.
By Nick Paul Taylor • March 28, 2019 -
Sterilizer plant shutdown prompts FDA action on device shortages
The agency is working with medtech manufacturers to prevent shortages of more than 600 types of devices after the shutdown of a large sterilization operation in Illinois and the planned closing of a second facility in Michigan.
By Susan Kelly • March 27, 2019 -
Jacob Bell/MedTech Dive
FDA clears Zimmer robot that combines brain, spine, knee functionality
The multi-function offering provides direct competition to longtime medtech rival Stryker's Mako robot.
By Susan Kelly • March 27, 2019 -
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 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 -
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 greenlights LivaNova's protocol for depression device trial
The U.K. medtech intends to begin enrollment in late 2019, in accordance with the coverage with evidence development framework supporting its vagus nerve stimulation system for use in patients with treatment-resistant depression.
By Susan Kelly • Updated Sept. 6, 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 -
LifeScan dominates Medicare diabetes test strip market, OIG finds
The analysis found LifeScan's OneTouch Ultra held 29% of the non-mail order market, more than twice as much as its nearest rival.
By Nick Paul Taylor • March 26, 2019 -
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
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