The Latest
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Heparin device guidance to cut overdose risk finalized
The text addresses the labeling and safety testing of heparin-containing devices and combination products.
Medical Devices -
FDA says Florence unlikely to cause critical device shortages
The agency is closely monitoring 10 sites that make critically important devices and biological products.
Policy & Regulation -
Thermo Fisher licenses CRISPR tech from Broad Institute
The instruments maker aims to meet the growing demand for contracting services from companies using CRISPR in drug R&D.
Diagnostics -
BioSig uplists to small-cap Nasdaq exchange amid cardiac device push
The company's device for acquiring cardiac signals recently won 510(k) clearance from the FDA.
Medical Devices -
Medtronic to study TAVR in low-risk bicuspid patients
FDA also approved a revised label for the Evolut valve that removes a precaution for patients with aortic stenosis at intermediate or greater mortality risk from surgical aortic valve replacement.
Medical Devices -
Trimedx to buy Aramark unit in $300M health tech merger
Two major providers of healthcare technology management services come together in the pact.
M&A -
Ra Medical amends IPO plan
The maker of a laser-based treatment for restoring blood flow in arteries and clearing chronic skin conditions said it expects to use the proceeds on its direct sales force, marketing and clinical trials.
Medical Devices -
MYnd gets breakthrough tag for mental health decision support tool
The technology works by comparing the brain activity of a patient to those of people with similar patterns to zero in on the drugs that have worked in analogous situations in the past.
Policy & Regulation -
Athenahealth extends acquisition bid deadline
The delay is to allow for a new strategic buyer to prepare its bid, a source close to the matter said.
M&A -
ACLA, AdvaMedDx urge CMS to delay payment cuts
The clinical lab trade group sued HHS last year over data collection from labs used to set Medicare reimbursement rates.
Policy & Regulation -
AI can identify lung cancer types in images, study finds
The program determined with 97% accuracy which images showed adenocarcinoma and those showing squamous cell carcinoma.
Digital Health -
Device lobby backs FDA combo product GMP plan
AdvaMed is pushing to add a section on the annual stability expectations for drug-device products and clarify rules on sampling before finalizing the text.
Medical Devices -
FDA defends its work on breast implant safety
The agency said new research from MD Anderson Cancer Center linking silicone breast implants to a higher risk of connective tissue diseases such as rheumatoid arthritis and scleroderma has "significant shortcomings."
Medical Devices -
NIH funds study of artery imaging without contrast dyes
Researchers are looking to develop techniques that avoid gadolinium-based contrast agents, which are commonly used despite being a particular problem for patients with chronic kidney disease.
Imaging -
HHS launching database of patient safety culture at ambulatory surgical centers
The decision comes as the centers are treating more patients — a trend being pushed by payers moving care away from more expensive inpatient settings.
Policy & Regulation -
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