The FDA has granted four companies’ ventilators emergency use authorization this week to treat COVID-19 patients, as well as a fifth company’s anesthesia gas machine for use as a ventilator. Gaining the latest EUAs were machines by Medtronic (NYSE:MDT), Draeger, MEK-ICS, Ventec Life Systems, and startup CoLabs. One of those EUAs went to Medtronic’s Puritan Bennett […]
Baylis Medical said today that it successfully completed the first Abbott (NYSE:ABT) MitraClip procedure with Baylis’ VersaCross transseptal solution catheter. VersaCross is a left-heart access device designed with an atraumatic radio frequency-tipped pigtail wire to achieve access and then serve as an exchange wire, reducing the number of exchanges throughout the procedure. The MitraClip is designed […]
Medical sterilization company Sterilis said yesterday it tapped former Nanosphere (NSDQ:NSPH) chief exec Michael McGarrity as its new CEO. McGarrity held the CEO position at Nanosphere from February 2013 to last June when he oversaw the company’s $76.9 million acquisition by Luminex (NSDQ:LMNX). Prior to his time as head of Nanosphere, McGarrity held positions in sales, marketing […]
Medtronic (NYSE:MDT) said today that it won an expanded indication from the FDA for its OsteoCool RF ablation device for palliative treatment of metastases in all bony anatomy. The OsteoCool RF device was previously indicated for use in the spine, according to Fridley, Minn.-based Medtronic. It’s used to ablate metastatic bone tumors. Medtronic acquired the technology […]
Medtronic (NYSE:MDT) said today that it acquired Baylis Medical’s OsteoCool device for treating cancers that metastasize to the spine after the device won 510(k) clearance from the FDA last year. The original OsteoCool device 1st won 510(k) clearance in March 2012. A 2nd version landed another 510(k) in June 2015, and Montreal-based Baylis won a nod last […]
The FDA put a Class I label on Baylis Medical’s recall of its TorFlex transseptal guiding sheath kit, the federal watchdog agency announced.
The recall was issued because the sheath could remove particulate of less than 5mm from the dilator and the particulate could end up in the bloodstream, the FDA said.