T2 Biosystems Inc. received a third FDA breakthrough device designation with its direct-from-blood molecular diagnostic test for Candida auris. The test joins its T2resistance panel and T2Lyme panel in gaining the breakthrough recognition and the increased access to the FDA that comes with it as the company seeks final approval or clearance. The C. auris test enables identification of the challenging pathogen in three to five hours instead of the several days often required to grow a culture traditionally.
Twelve years on, Vitalconnect Inc. continues to connect well with investors, raising $30 million in an oversubscribed series F in a still-tight market just 18 months after closing its last $39 million round and less than a year after receiving venture financing from Health Insight Capital, the investment arm of HCA Healthcare Inc. The new funds will support continued growth of the company’s wireless patient monitoring systems, which are used in hospital and home settings.
With a bruising battle with its largest investor barely behind it, Masimo Corp.’s preliminary second quarter results came in nearly $100 million below consensus, putting management in an even tougher position now that it has two new investor-aligned board members. Share price plunged from $147.16 to $110 following the after-hours announcement on Monday. By the closing bell on Tuesday, shares had recovered modestly to $117.73.
A study conducted by Cognito Therapeutics Inc. demonstrated significant changes in white matter volume and myelination in patients with Alzheimer’s disease after six months of at-home, non-invasive gamma stimulation therapy in a presentation at the Alzheimer’s Association International Conference 2023.
Curvafix Inc. sealed a $39 million series C financing round to support availability of its device, which treats fragility fractures of the pelvis (FFP). MVM Partners led the round with support from Sectoral Asset Management and other returning investors. Sectoral Asset Management led the $10.7 million series B for the company in 2020. The company has raised more than $60 million to date.
U.S. FDA clearance of Mobi pumped up Tandem Diabetes Care Inc. on Tuesday. The miniaturized insulin pump is indicated for individuals with diabetes, aged 6 years and up, with the FDA action boosting Tandem’s share price from $26.41 to $29.20 in morning trading before falling back to $27.12 by the end of the day.
South African Rugby and the U.S. National Football League (NFL) are actively studying ways to more quickly and reliably diagnose concussions and find more effective treatment for their sequelae. Researchers at the University of Birmingham and Marker Diagnostics Ltd. have identified a biomarker that signals a concussion has occurred, while a team at Electrocore Inc. is working with the NFL to address post-concussion headaches.
The U.S. FDA granted Renalytix plc de novo marketing authorization for its prognostic test for chronic kidney disease (CKD). Kidneyintelx is an artificial intelligence-enabled prognostic testing platform to guide treatment decisions for adults with type 2 diabetes and diabetes-related early stage chronic kidney disease.
A non-invasive retinal exam may soon enable clinicians to visualize the future for patients at risk of chronic kidney disease (CKD). When combined with an artificial intelligence algorithm, an exam accurately predicted CKD prior to symptom onset in a study published in Digital Medicine.
Two companies presented highlights of studies that demonstrated outstanding results for novel devices at last weekend’s American Diabetes Association’s (ADA) 83rd Scientific Sessions, while Embecta Corp. and Senseonics Holdings Inc. provided updates that position them well for long-term performance. Glyconics Ltd. revealed a fingernail scanning device that simplifies screening for diabetes and Fractyl Health Inc. showed that its Revita procedure reduced blood glucose levels and promoted weight loss.
