Children with autism spectrum disorder (ASD) can face a lifetime of frustration because of challenges with communication, social behaviors and flexibility of thought. Early intervention can improve outcomes, but nailing a diagnosis of ASD often takes years. Cognoa Inc. wants to change that with its digital ASD Diagnostic and is on track to apply for U.S. FDA clearance before the end of the year.
Corza Health Inc. has agreed to pay Takeda Pharmaceutical Co. Ltd. €350 million (US$409.8 million) in cash to acquire the Japanese drugmaker’s Tachosil fibrin sealant patch. The deal, which is expected to close by March 31, 2021, pending regulatory approvals, gives Corza Health a solid footing in the advanced wound care and closure market.
Following days of speculation, Illumina Inc. said today it will acquire liquid biopsy startup Grail Inc. for $8 billion in cash and stock, bringing back into the fold a company it spun out in 2016. The deal gives Illumina a major stake in the race the race to develop a less-invasive way to diagnose cancer. Since spinning out, Grail has raised nearly $2 billion from big-name investors with promises of a blood test for early cancer detection and is hoping to introduce its liquid biopsy as a laboratory-developed test (LTD) as early as next year.
Outset Medical Inc. closed its Nasdaq IPO Thursday with gross proceeds of approximately of $277.9 million. The IPO, which launched Tuesday, included nearly 10.3 million shares of common stock at $27 per share and the full exercise of underwriters’ option to purchase more than 1.3 million additional shares. Shares of the San Jose, Calif.-based company’s stock, which is trading under the ticker OM, soared to more than $60 on the first day of trading amid enthusiasm for its portable dialysis machine.
Israeli startup Olive Diagnostics Pvt. Ltd. is aiming to disrupt at-home urinalysis testing with a hands-free, noninvasive, artificial intelligence (AI)-based solution that provides remote diagnostics by detecting urine’s molecular composition. K2, as the device is called, attaches easily to the toilet rim to generate secure, personalized diagnostic data that directly links to a mobile app.
Keeping you up to date on recent developments in diagnostics, including: Intensive care scoring systems outperform miRNA in sepsis diagnosis; Report: AI falls short of potential in health care; Angiopoietin trouble can lead to lymphedema.
Advanced diagnostics startup Coremap Inc., which is developing a technology capable of identifying the drivers of atrial fibrillation (AF), scooped up $10.5 million in a series A financing led by Qure Ventures. The funds will be used to accelerate product development and future regulatory submissions. Founded in 2016, the Burlington, Vt.-based company has raised nearly $12 million to date.
Sinusitis implant company Intersect ENT Inc. has agreed to acquire Fiagon AB Medical Technologies, a manufacturer of electromagnetic surgical navigation systems, for €60 million (US$71.1 million). Under the terms of the agreement, Intersect ENT will pay €15 million at the time of the closing and €15 million annually for the ensuing three years.
In August, Cala Health Inc. reported results from its pivotal PROSPECT study showing significant improvement in hand tremors with use of its Cala Trio wearable neuromodulation therapy. Now the company has real-world evidence affirming the benefit to patients with essential tremor (ET) who used Cala Trio at home over several months.
Avinger Inc. has received U.S. FDA clearance for a its Ocelaris next-generation, image-guided chronic total occlusion (CTO) crossing system for patients with peripheral artery disease (PAD). The catheter-based system, which will be sold under the brand name Tigereye, provides real-time imaging from within the vessel during a CTO-crossing procedure. It will be available on a limited basis beginning later this year.
