1. Attune Medical gets FDA 510(k) clearance
Attune Medical announced in a Jan. 8 press release that it has received FDA 510(k) clearance for its EnsoETM model that administers tube feeds or medication while cooling or warming patients. The device manages a patient’s temperature through the esophagus while allowing for enteral fluid administration with the company’s ENFit connector.
2. Ally Bridge, LifeTech Scientific ink strategic Chinese partnership deal
Ally Bridge has entered a strategic partnership with LifeTech Scientific in China to help with commercialization and market entry in China, according to a Jan. 7 press release. Through the agreement, LifeTech has committed to invest in Ally Bridge funds and will continue to invest in other medtech companies. Additionally, ABG and LifeTech will set up a joint investment Fund to invest in other medical technologies globally.
3. ResMed launches Mobi portable oxygen concentrator
ResMed announced in a Jan. 8 press release that it has released its first portable oxygen concentrator, the Mobi. Mobi will be available to patients in the U.S. through home medical equipment providers and is currently in the process of getting clearance to launch the product in other countries.
4. Axonics wins Australian nod for sacral neuromod
Axonics has won Australian marketing approval for its Sacral Neuromodulation System, according to a Jan. 8 press release. The device is designed to treat overactive bladder, fecal incontinence and urinary retention. The approval allows the company to commercialize the device throughout Australia.
5. Synapse Biomedical gets CE Mark approval
Synapse Biomedical announced in a Jan. 8 press release that it has received CE Mark approval for its TransAeris System. The TransAeris system is a temporary diaphragm stimulator that is designed to be used in ICU patients who are on mechanical ventilation. The system gives patients life-sustaining respiration.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.