Medical Devices: Page 141
-
FDA OKs Abbott clinical trial of MitraClip in moderate risk patients
The transcatheter mitral valve repair device, used to treat primary mitral regurgitation, is currently only indicated for patients at a prohibitive risk for surgery.
By David Lim • Jan. 13, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound
FDA's device center issued just nine warning letters in the most recent fiscal year, down from 81 in 2015. But with a major reorganization complete, regulators say they can respond to compliance issues more quickly.
By David Lim • Jan. 10, 2020 -
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 -
Intuitive closes 2019 by topping Q4 expectations
Intuitive's 19% procedure growth helped it increase sales by 22%, according to preliminary results. But Medtronic, J&J and CMR Surgical are among the competitors that will press for share in the next few years.
By Nick Paul Taylor • Jan. 10, 2020 -
JenaValve TAVR tech amid wave to get breakthrough device status from FDA
Other devices recently designated include 3Derm Systems' AI to detect skin cancers, KDx Diagnostics' urine-based bladder cancer test, and Reflow Medical's retrievable stent for use in below-the-knee peripheral artery disease.
By Nick Paul Taylor • Jan. 10, 2020 -
Medtronic buys new spinal cord tech to boost pain therapies unit
Amid a broader slowdown in the spinal cord stimulation market, Medtronic is acquiring technology from Stimgenics that offers a new way of programming its Intellis implant.
By Maria Rachal • Jan. 9, 2020 -
Study links paclitaxel devices to better survival in PAD, muddying debate
New research comes about six months after FDA held an advisory panel in response to a meta-analysis that found an increased risk of death associated with the use of coated balloons and stents in an artery of the lower limbs.
By David Lim • Jan. 9, 2020 -
MedTech Europe pushes urgent action to keep devices on sale after MDR
The trade group wants the EU to fix perceived problems with the grace period to allow devices to stay on the market and be reviewed by an MDR-designated notified body.
By Nick Paul Taylor • Jan. 9, 2020 -
Abbott sets CFO transition in motion
The company plans to install a new chief financial officer a month before incoming CEO Robert Ford takes the helm.
By Maria Rachal • Jan. 8, 2020 -
FDA OKs alternative to open heart surgery for Abbott's HeartMate 3 pump
The less invasive procedure allows the left ventricular assist device to be implanted via an incision between the patient's ribs, an approval Medtronic received for its HeartWare product in 2018.
By Susan Kelly • Jan. 8, 2020 -
EU group offers guidance on meeting MDR's cybersecurity standards
The document says it's important to reference the International Medical Device Regulators Forum's cybersecurity guidance, and policies like the General Data Protection Regulation and the EU Cybersecurity Act "might apply in parallel."
By Susan Kelly • Jan. 7, 2020 -
Medtronic warns of Mazor X detachment issue in robotic surgery
In an urgent field safety notice, the medtech giant said one piece may detach from the OR table unexpectedly, which could lead to blunt injury to a patient.
By Maria Rachal • Jan. 7, 2020 -
Latest FDA clinical decision support software draft a step forward, industry says
The American Medical Association wrote the guide could "lead to the proliferation of CDS tools for 'non-serious conditions' that are faulty, inaccurate, and without validation, potentially leading to patient harm."
By David Lim • Jan. 7, 2020 -
OrthoPediatrics sells Vilex assets in preparation for more M&A
The device maker sold the adult piece of the Vilex business, which it acquired last year, for $25 million.
By Nick Paul Taylor • Jan. 7, 2020 -
Industry, doctors, patients diverge on FDA outline for breast implant labels
The Medical Device Manufacturers Association took issue with inclusion of the term "breast implant illness" and called a proposal that manufacturers continually update risk info "impracticable."
By Maria Rachal • Updated Feb. 3, 2020 -
Jacob Bell/MedTech Dive
Terumo subsidiary gains FDA nod for aneurysm flow diverter
MicroVention earned its third premarket approval in under two years. Stryker, Johnson & Johnson and Medtronic are also focused on treatments.
By Susan Kelly • Jan. 6, 2020 -
Simplified devices, pharmacy access among 2020 catalysts for diabetes tech: analysts
Baird Equity Research analysts expect this year will represent "an even greater technological leap forward than in 2018," previously thought to be the most significant new product launch year in more than a decade.
By Susan Kelly • Jan. 6, 2020 -
NuVasive replaces CFO with former Mallinckrodt executive
The company sought to allay concerns arising from the C-suite change by reiterating its expectation that 2019 revenues will total $1.16 billion.
By Nick Paul Taylor • Jan. 3, 2020 -
Getty / Edited by Industry Dive
FTC slaps Stryker, Wright Medical with second request
In a second amendment to its tender offer statement for Wright Medical, Stryker acknowledged a Wright shareholder's class action lawsuit alleging Wright's solicitation statement was false and misleading.
By David Lim , Maria Rachal • Updated Jan. 23, 2020 -
FDA finalizes exemptions for certain devices from 510(k) review
Newly exempted devices are still subject to other regulatory controls, such as good manufacturing practice requirements.
By Susan Kelly • Dec. 31, 2019 -
Notified bodies MedCert, BSI gain new EU MDR and IVDR designations
The European Commission's latest nods bring total notified bodies designated for the Medical Device Regulation to nine and for the In Vitro Diagnostic Regulation to three.
By Nick Paul Taylor • Dec. 31, 2019 -
FDA creates best practices for combination product developers
The 21st Century Cures Act requires the agency to provide final guidance on aspects of the submission process including how companies should obtain feedback.
By Nick Paul Taylor • Dec. 24, 2019 -
Medtech manufacturing lags pharma in emerging markets, McKinsey report says
Due to growth through acquisitions, many medtech companies find themselves wrestling with costly, fragmented manufacturing and distribution footprints in need of an overhaul, a new McKinsey analysis suggests.
By Susan Kelly • Dec. 23, 2019 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Roundup 2019: Breast implants, mesh, paclitaxel-coated devices among hot topics at FDA expert panels
The public meetings in some cases instigated voluntary recalls and led to required market removals. Nearly all called for further research or more robust medical device monitoring.
By Maria Rachal • Dec. 23, 2019 -
LivaNova recalls vagus nerve implant amid reset problems
FDA received 14 reports of an error causing the device to stop delivering treatment for major depressive episodes and seizures associated with epilepsy. Four patients have needed revision surgery as a result.
By Susan Kelly • Dec. 23, 2019 -
Medical device tax disappears, capping decade of industry lobbying
President Donald Trump signed a spending package into law Friday, permanently repealing the ACA tax. The device industry garnered bipartisan backing to nix the 2.3% levy.
By David Lim • Updated Dec. 23, 2019
Previous
