The Latest
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Stent to seal coronary artery perforations gets FDA nod
Biotronik's device is the first treatment for the potentially life-threatening emergency in 17 years.
Medical Devices -
FDA tests new way to shorten 510(k) review times
The agency hopes a pilot program will make submissions more efficient, cutting time to a final decision to as little as 60 days.
Medical Devices -
Welltok acquires text-based messaging platform Wellpass
Wellpass customers include Medicaid managed care and other government programs.
Digital Health -
Pilot delivers defibrillators via FAA-approved drone
During the test, a single pilot simultaneously flew several drones to deliver automated external defibrillators.
Medical Devices -
FDA softens voluntary consensus guidance after industry slams 'devastating' draft
Feedback to the agency contended the consensus standard proposals would hurt small companies. An update doesn't completely reverse course.
Policy & Regulation -
FDA rolls out plan to reduce third party 510(k) re-reviews
Commissioner Scott Gottlieb said outsourcing review of low-risk devices can enable FDA to focus more resources on high-risk and more complex devices.
Medical Devices -
Gottlieb: FDA pursuing faster approval path for diagnostics
The agency chief said it should focus its premarket reviews on a subset of higher risk or highly novel tests, companion diagnostics and tests for home use.
Policy & Regulation -
Intermountain, Geisinger form group to improve diagnostic accuracy
The two health systems are among more than 40 organizations calling for providers to take steps like improving how doctors communicate test results.
Diagnostics -
AngioDynamics to buy RadiaDyne for radiotherapy devices
RadiaDyne thinks AngioDynamics' commercial infrastructure will help it to grow sales beyond the $6 million achieved over the past 12 months.
Medical Devices -
New Apple Watch adds FDA-cleared ECG application
Agency officials touted the clearance as heralding a new age of digital health. Still, risks include false positives and negatives, which could lead to unneeded procedures or misdiagnosis.
Medical Devices -
FDA delays Inbrija drug-device combo
Regulators need more time to assess the biotech's Parkinson's drug-device combination, adding another layer of complexity to manufacturing and approval processes.
Medical Devices -
House passes bill to amend local Medicare coverage decisions
The medical device industry contends the local decisions can be arbitrary and opaque.
Policy & Regulation -
J&J buys EIT for 3D-printed titanium spinal implants
The devices are designed to increase the number of surgeries that are successful the first time.
Medical Devices -
FDA moves to single electronic filings for device submissions
The change would end the need for companies to file on paper and submit multiple copies.
Policy & Regulation -
Epic, Nuance partner on voice assistance technology aimed at busy docs
The system is compatible with Epic's Rover and Haiku workflow apps and will allow physicians to get schedules, look up patient information and check lab results and medication lists.
Digital Health -
FDA advised to step up device cybersecurity checks premarket
In response to the watchdog report, FDA said it is already working on implementing the recommendations.
Medical Devices -
Medtronic plants hit with FDA warning letters
The notices relate to two facilities that made recalled implantable cardioverter-defibrillators.
Medical Devices -
Cook resolves FDA warning letter that slammed quality processes
The close-out letter follows four years of work to improve quality management.
Medical Devices -
Companion diagnostic for bile duct cancer treatment in works
Incyte and genomic profiling company Foundation Medicine announced an agreement to develop a companion diagnostic for pemigatinib, Incyte's FGFR1/2/3 inhibitor for patients with cholangiocarcinoma.
Diagnostics -
Alcon to shift HQ to Switzerland after Novartis spinoff
The eye care unit already has operations in Geneva, and plans to list on Swiss stock exchanges upon becoming a standalone company.
M&A -
UK-based Medopad snaps up health IT startup Sherbit
Founded in 2016, Sherbit works with health systems on chronic disease management using real-time data and analytics.
M&A -
Stryker buys surgical lighting company for $190M
Photonics and intracavity lighting company Invuity is the latest acquisition in Stryker's ongoing purchasing spree.
Medical Devices -
AliveCor snags FDA breakthrough device status for bloodless hyperkalemia test
The agency has granted the designation, which fast tracks review, to 83 devices as of the end of July.
Medical Devices -
Becton Dickinson sells bioprocessing business to Thermo Fisher
Divesting the unit will allow Becton to better focus its life sciences division on disease and therapy research and clinical diagnostics.
Medical Devices -
Brigham and Women's installs first neonatal MRI in US
The scanner could cut the risk of assessing brain damage in newborns.
Imaging