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The product was developed in response to requests by clinicians for a product that can be used in situations where a sealing membrane is not required, the company said. Read More
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