LumiraDx (NSDQ:LMDX) announced today that it received CE mark approval for its C-reactive protein PCR test. London-based LumiraDx designed its LumiraDx CRP test as a small and portable microfluidic immunoassay test used for the quantitative determination of C-reactive protein, delivering results within four minutes. According to a news release, the CRP measurement provides important information […]
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WHO concludes that updated COVID-19 vaccines may be needed
When confronting an onslaught of new SARS-CoV-2 variants, COVID-19 vaccine makers such as Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have tested tweaked versions of their vaccines but ultimately decided that they were unnecessary. Signs are growing that vaccines developed based on the original strain of the novel coronavirus will struggle to offer durable protection against the omicron […]
Abbott expects COVID testing demand to remain strong, Biden orders insurance coverage
Abbott (NYSE:ABT) Chair & CEO Robert B. Ford has emphasized the importance of COVID-19 testing amid the ongoing omicron variant surge. Today at the 40th Annual J.P. Morgan Healthcare Conference, Ford highlighted the role testing will play as Abbott’s BinaxNow rapid antigen test and other over-the-counter testing options remain in high demand. The need for […]
Healthcare venture funding boomed in 2021; expect a slowdown in 2022
An all-time-high $86 billion of venture capital investments in the U.S. and Europe last year bested 2020’s record haul by more than 30 percent and grew more than 150 percent from 2019, according to a new analysis by Silicon Valley Bank. After record-setting quarters in the first half, however, VC investment slowed due to poor […]
Freenome raises $290M from Roche
Freenome said today that it has raised $290 million from Roche to advance its cancer early detection platform, which uses a routine blood draw. The South San Francisco, California–based company has raised more than $1.1 billion since its founding in 2014. “With Roche’s investment and expertise, we’ll be able to further accelerate and augment the […]
Butterfly Network stock up on preliminary Q4 revenue numbers
Butterfly Network (NYSE:BFLY) is on the rise following the announcement of preliminary fourth-quarter earnings that topped Wall Street projections. Guilford, Connecticut–based Butterfly Network’s shares are trading up more than 18% at $7.48 apiece as of late afternoon trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — […]
Withings buys Impeto Medical
Withings announced today that it will acquire Impeto Medical and its technology for detecting and tracking peripheral neuropathies. The financial terms of the deal were not disclosed. Withings plans to first use the Impeto Medical tech in its Body Scan smart scale platform, which it announced last week at CES 2022. Body Scan boasts a […]
Medtronic’s Micra AV wins regulatory approval in Japan
Medtronic (NYSE:MDT) announced that it received approval from Japan’s Ministry of Health, Labor and Welfare for its Micra AV system. Japan’s approval for the Micra AV transcatheter pacing system (TPS) covers the sale and reimbursement of the platform. Medtronic plans to launch the product in the country this month. According to a news release, Micra […]
Cardiovascular Systems’ recall of its Wirion embolic protection device is Class I
The FDA determined that Cardiovascular Systems’ recall of some of its Wirion embolic protection devices is Class I, the most serious kind. St. Paul, Minnesota–based Cardiovascular Systems is recalling all products and lots of its Wirion embolic protection device due to complaints of filter breakage during retrieval. It includes devices with manufacturing dates of Jan. […]
iRhythm scores an important reimbursement win
iRhythm Technologies (NSDQ:IRTC) and other companies pioneering remote external EKG monitoring have scored a significant reimbursement win. The regional Medicare administrative contractor Novitas Solutions has set CPT codes 93243 and 93247 at roughly $223 and $233 respectively — news first reported by analysts this morning. The rates are retroactive to Jan. 1, 2022. “We would […]
Alcon closes Ivantis acquisition
Alcon (NYSE:ALC) announced today that it completed its $475 million acquisition of glaucoma surgery device maker Ivantis. Geneva, Switzerland-based Alcon initially announced the acquisition of Ivantis, which develops the Hydrus Microstent minimally invasive glaucoma surgery (MIGS) device, in November 2021. Get the full story at our sister site, Medical Tubing & Extrusion.