Rivanna Medical, which makes an epidural needle guidance device, raised $3 million in an equity offering, according to a regulatory filing. Charlottesville, Va.-based Rivanna won 510(k) clearance from the FDA for its Accuro handheld needle guidance device indicated for spinal anesthesia in March 2015 and launched the device last November. A quintet of unnamed investors participated in […]
Anesthesia
Johnson & Johnson bails on Sedasys anesthesia device
Johnson & Johnson (NYSE:JNJ) reportedly confirmed last week that it’s discontinuing its Sedasys computerized anesthesia system, 3 years after a hard-won pre-market approval from the FDA. The federal safety watchdog denied approval for Sedasys back in 2008, prompting J&J to take another run at a PMA, which was also denied. After a rare appeal of that denial in […]
Medtronic buys Aircraft Medical for $110m
Medtronic (NYSE:MDT) said today that it paid $110 million in cash to acquire video laryngoscope maker Aircraft Medical. Edinburgh-based Aircraft’s handheld McGrath laryngoscopes are designed to facilitate intubation by anesthesiologists and critical care providers, Medtronic said. “Aircraft Medical’s offerings complement our portfolio, helping us further our commitment to reducing incidents and potential complications from respiratory compromise globally. […]
Teleflex issues Class I recall of pediatric anesthesia devices
Another recall for Spacelabs Healthcare’s Arkon anesthesia system
The FDA slapped Spacelabs Healthcare with a Class I recall after the medical device company pulled 16 of is Arkon anesthesia delivery devices due to a software bug.
The recall, of the Arkon device equipped with version 2.0 software, involves devices sold to hospitals in North Carolina and South Carolina, according to the FDA. The Class I recall status denotes a problem that could cause serious injury or death.
FDA puts highest-risk label on McKesson’s anesthesia system recall
Updated March 20, 2014, at 3:15 p.m. with comments from McKesson
GE Healthcare recall gets FDA’s highest-risk label
FDA issues warning on Vital Signs’ anesthesia devices
FDA puts highest-risk label on GE Healthcare recall
GE Healthcare warns on software issues in anesthesia systems
GE Healthcare (NYSE:GE) issued a field correction on certain of its Avance, Avance CS2 and Aisys anesthesia delivery systems, warning that they need a software update to avoid a potential safety issue.
Respiratory Motion aims to cut down on anesthesia-related hospital deaths
According to Respiratory Motion CEO Dr. Jenny Freeman, breathing problems following surgery are highly under-reported, resulting more than 50,000 deaths per year. With a new FDA clearance in hand, Freeman said the company has several "irons in the fire" for its breath-monitoring device.
