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Pulnovo Medical reported positive results for its radiofrequency device for pulmonary arterial hypertension (PAH) in a presentation at the Transcatheter Cardiovascular Therapeutics annual scientific symposium in Boston, Mass. Read More
InBios International’s facility in Seattle, Wash., drew a Form 483 from the FDA for not following its standard operating procedures (SOP) for several activities. Read More
Boston Scientific’s Sentinel cerebral protection system did not meet the primary endpoint in a large randomized trial since “the data demonstrated a non-significant trend towards a lower rate of stroke in patients treated with the Sentinel device,” the company said in a presentation at the Transcatheter Cardiovascular Therapeutics annual scientific symposium in Boston, Mass. Read More
RIGImmune announced its acquisition of Subintro, a move the company says is focused on development of intranasal delivery of RIGImmune’s stem-loop RNA antivirals and vaccines to treat and prevent respiratory diseases caused by RNA viruses such as COVID-19, influenza, RSV and rhinoviruses. Read More
Inadequate device history records (DHRs) and other deficiencies landed Xintec, also known as Convergent Laser Technologies, a Form 483 after an inspection of its Alameda, Calif., facility. Read More
The system allows the visualization of anatomy in motion so clinicians can interpret the interaction of anatomical structures, said the company. Read More
An FDA inspection of Stuart, Fla.-based Powers Medical Devices found that the company had not been doing internal audits, according to a Form 483 the agency issued to the company. Read More
Insulin and intrathecal pain pumps, intracardiac defibrillators, mobile cardiac telemetry and pacemakers are among the devices “susceptible to cyber attacks,” according to a new FBI statement that cites a recent healthcare cybersecurity analyst’s report. Read More
Carryover funds and an undisclosed contingency plan will keep the FDA’s user fee program in motion even if Congress misses the Sept. 30 deadline for reauthorizing the Medical Device User Fee Amendment (MDUFA V), said FDA’s Jeff Shuren at the recent annual meeting of the Regulatory Affairs Professionals Society (RAPS) in Phoenix. Read More