Outset Medical (Nasdaq:OM) this week launched the newest accessory for its Tablo Hemodialysis System, the TabloCart. The San Jose, California-based company designed TabloCart to help medical professionals easily move anywhere around the hospital. It provides added maneuverability and optional prefiltration or storage. [Hear more from Outset Medical CEO Leslie Trigg at DeviceTalks West on October 20] […]
Outset Medical
10 big earnings stories from the last quarter: How are medtech stocks doing now?
Economic uncertainty appears to have produced a wide variety of medtech earnings stories during the most recent round of quarterly results. Some medical device companies received massive boosts from their quarterly performance, while others saw their stocks sink amid missed projections and other various issues. The phrase “macroeconomic headwinds” was a common phrase. Medtech faces […]
Outset Medical wins national VA contract
Outset Medical (Nasdaq:OM) announced today that it has won a national contract with the U.S. Department of Veterans Affairs to sell its Tablo hemodialysis system into the department’s 106 VA hospitals. San Jose, California–based Outset already has Tablo deployed at some VA hospitals, which overall provide dialysis for 35,000 U.S. veterans. But the new five-year […]
Law firm notifies investors of class action suit against Outset Medical
Levi & Korsinksy notified Outset Medical (Nasdaq:OM) investors today of a class action securities lawsuit against the company. In June, Outset announced that it was holding shipments of its Tablo hemodialysis system for home use as a result of a pending FDA review and clearance of a 510(k) submitted for changes made since the Tablo system’s […]
Outset Medical stock skyrockets on resumed Tablo shipments
Outset Medical (Nasdaq:OM) shares are up big today on the news that people needing dialysis will once again be able to receive Tablo systems for home use. The news of the shipment hold’s end was enough to counteract Q2 earnings misses, sending OM shares up 21.5% at $18.77 per share in midday trading. MassDevice‘s MedTech […]
Outset Medical faces shareholder lawsuit after shipment hold
Outset Medical (Nasdaq: OM) is facing a shareholder lawsuit in federal court, a month after it announced a shipping hold on its Tablo hemodialysis system for home use. The company said on June 13 that it was holding off shipments amid a pending FDA review and clearance of a 510(k) submitted for changes made since […]
Outset Medical stock down on shipment hold news
Outset Medical (Nasdaq: OM) stock lost about a third of its value today — a day after the company said it was holding shipments of its Tablo hemodialysis system for home use. OM shares were down more than 34% to $13.46 apiece by the close of trading today. MassDevice‘s MedTech 100 Index, which includes stocks of […]
MDMA elects Outset CEO Leslie Trigg as chair
The Medical Device Manufacturers Association (MDMA) has elected Outset Medical Chair and CEO Leslie Trigg as chair of the trade group’s board of directors. MDMA announced the leadership change today, following the Washington, D.C.-based industry association’s annual meeting last week. “Medical technology innovators are at the forefront of improving patient outcomes and reducing the cost […]
Outset Medical rises on Street-beating Q4 revenues, high growth projections for 2022
Outset Medical (NASDAQ:OM) shares shot up today on fourth-quarter revenues that beat the consensus forecast. OM shares were up more than 16% at $39.77 per share by late afternoon trading today. MassDevice’s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down 1.6%. The San Jose, California-based dialysis technology developer posted […]
FDA clearance enables Outset Medical to streamline manufacturing
Outset Medical (NSDQ:OM) announced that a new sterilization method for its Tablo hemodialysis system received FDA 510(k) clearance. San Jose, California-based Outset’s new sterilization method for the cartridge — utilized in the Tablo system — enables the company to start cartridge production through a manufacturing partner in Mexico. The move facilitates the localization of cartridge […]
Outset Medical achieves landmark Medicare approval for home dialysis system
Outset Medical (NSDQ:OM) announced today that it received CMS approval for a payment adjustment on its Tablo hemodialysis system. San Jose, California-based Outset said in a news release that it received the first-ever CMS approval for a Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES). The decision helps encourage healthcare providers […]