BioWorld MedTech Nov. 9, 2022

FDA grants breakthrough device designations to Avita’s Recell device for soft tissue repair, vitiligo

Avita Medical Ltd.’s Recell system won FDA breakthrough device designations in soft tissue repair and vitiligo. Melbourne-headquartered Avita, a regenerative medicine company developed the Recell system, a technology platform that enables point-of-care autologous skin restoration. Read More

Premarket demands for pulse oximetry devices likely to become more stringent

The U.S. FDA recently convened an advisory committee to address accuracy issues with pulse oximetry devices, with a significant focus on skin pigmentation as a source of noise in the results generated by these class II devices. However, a number of other factors, including obesity and finger size/diameter, also cloud the values generated by pulse oximeters, all of which combine into a large set of variables that premarket studies may have to address before the FDA will issue new marketing authorizations. Read More

Tivic acquires Reliefband, expands bioelectronic offerings

Tivic Health Systems Inc. agreed to acquire the assets of Reliefband Technologies LLC for $33.5 million. Reliefband makes a line of wearable electronic nerve stimulators for treatment of nausea and vomiting, while Tivic’s portfolio of bioelectronic products centers on its Clearup device, which has FDA approval for relief of sinus pain and congestion. The deal is expected to close in either late 2022 or early 2023. Read More

So the U.S. had an election – what’s next?

Election day has come and gone in the U.S., but the question of which party will control Congress remains unanswered, signaling that the country is as divided as ever politically and ideologically. While Democrats and Republicans may agree on problems in the life sciences sector, they often disagree on how to address them. Read More