RapidAI announced today that it received FDA 510(k) clearance for its Rapid PE Triage & Notification product. San Mateo, California-based RapidAI designed its Rapid PE Triage & Notification product for the fast identification and communication of suspected central pulmonary embolism (PE). According to a news release, Rapid PE Triage & Notification works in conjunction with […]
Diagnostics
Avanos Medical recall of Cortrak 2 enteral access system is Class I
The FDA determined that Avanos Medical’s recall of some of its Cortrak 2 enteral access systems is Class I, the most serious kind. Alpharetta, Georgia-based Avanos Medical is recalling certain Cortrak 2 general access systems due to reports of injuries and patient deaths following nasoenteric or nasogastric tube misplacement. The recall includes all serial numbers […]
FDA authorizes Labcorp’s non-prescription COVID-19 test that also detects flu, RSV
The FDA authorized Labcorp’s seasonal respiratory virus RT-PCR DTC test for use without a prescription. Individuals with symptoms of respiratory viral infection consistent with COVID-19 can use the seasonal respiratory virus test that can identify and differentiate multiple respiratory viruses at the same time, which marks the first direct-to-consumer, multi-analyte COVID-19 test authorized by FDA. […]
Labcorp launches at-home collection device for diabetes risk testing
Labcorp (NYSE:LH) announced today that it launched an at-home collection kit that measures HbA1c from a small blood sample. Burlington, North Carolina-based Labcorp’s first-of-its-kind diagnostic offering uses a collection device from Weavr Health and is offered through its Labcorp OnDemand platform. Get the full story at our sister site, Drug Delivery Business News.
DermaSensor wins MedTech Innovator Mid-Stage Companies Pitch Event
DermaSensor Inc. — the creator of a handheld, point-and-click device to quickly assess skin lesions for cancer risk — is the winner of the MedTech Innovator Mid-Stage Companies Pitch Event. The Miami-based mid-stage company beat out 1,000 applicants, more than 20 of which competed on-site May 10–11, 2022 at DeviceTalks Boston. DermaSensor walked away with […]
Lucira Health asks FDA for EUA on molecular at-home COVID/flu test
Lucira Health (Nasdaq: LHDX) today said it has asked the FDA for an emergency use authorization (EUA) for its combination COVID-19 and flu test. Emeryville, California-based Lucira said the at-home test would be available with a prescription to test for SARS-CoV-2, Influenza A and Influenza B. The Nucleic Acid Amplification Test (NAAT) platform has a […]
BD launches automated infectious disease diagnostic platform in the U.S.
BD (NYSE:BDX) announced today that it began the U.S. launch of its new, fully automated, high-throughput diagnostic platform. Franklin Lakes, New Jersey-based BD designed the BD COR MX instrument option, which now has FDA 510(k) clearance, for molecular diagnostics for infectious disease. According to a news release, the first test available on the instrument option […]
GE Healthcare partners with Alliance Medical to improve healthcare with AI in the UK
GE Healthcare (NYSE:GE) announced today that it signed an agreement with Alliance Medical to create a new digital health solution. Under the collaboration, the companies will use advanced data analytics and artificial intelligence (AI) to bring together tools that streamline daily management and enable problem-solving, specifically for diagnostics in radiology departments. Alliance Medical, a provider […]
gBETA Medtech accelerator picks its next startups
The gBETA Medtech virtual accelerator today named the five startups that will participate in the spring program leading up to the June 21 showcase day. “We’re so fortunate to have such a diverse set of founders with expertise across the healthcare continuum,” gBETA Medtech Director KC Caine said in a news release. “Our founders are […]
iRhythm stock soars on Street-beating Q1; C-Suite changes continue
iRhythm Technologies (Nasdaq:IRTC) posted first-quarter results that beat the consensus forecast on Wall Street and increased its outlook for the rest of the year, sending the stock up more than 10% by this morning. The San Francisco-based developer of remote external electrocardiogram monitors reported a net loss of $50.6 million, or -$1.71 per share, on […]
BD ticks up as Q1 earnings beat The Street
BD (NYSE:BDX) shares are on the rise today on first-quarter results that came in well ahead of the consensus forecast. The Franklin Lakes, New Jersey-based company posted profits of $431 million, or $1.50 per share, on sales of just over $5 billion for the three months ended March 31, 2022, for a 55.6% bottom-line gain […]
