For patients with complex fractures, bone lost to cancer or trauma and those undergoing spine surgeries, the fear of incomplete or distorted bone growth remains an acute and well-founded concern.
Boston Scientific Corp. sent warning notices of the potential for embolisms arising from use of its Spaceoar and Spaceoar Vue systems because of “inadvertent placement of Spaceoar gel into a blood vessel and subsequent migration of the hydrogel outside of the pelvis.”
Pear Therapeutics Inc. partnered with Softbank Corp. to bring a digital therapy for sleep/wake disorders to the Japanese market. Pear will develop the app, while Softbank will evaluate Japanese market potential with an option to negotiate an exclusive license for Pear’s Japanese sleep/wake disorder therapeutics.
Biological Dynamics Inc.’s Verita platform correctly identified 96% of patients with stage I pancreatic cancer, a study in Nature Communications Medicine demonstrated. The platform uses protein biomarkers present in extracellular vesicles and showed an overall 71% sensitivity and 99.5% specificity in pathologically confirmed stage I and II pancreatic, ovarian and bladder cancer.
Sophia Genetics SA and Realm Idx Inc. established a collaboration for co-development of new genomic applications and their commercialization. The companies hope to expand next-generation sequencing research and multimodal data streams to improve cancer diagnostics and treatment outcomes.
While a number of companies cited continued supply chain issues in recent investor calls and earnings reports, few med-tech leaders have expressed concerns about serious disruption to operations or loss of revenue because of the destruction wrought by the invasion of Ukraine or the associated sanctions on Russia. Most companies derive less than 1% of their revenue from the two countries.
The FDA unloaded on Neurofield Inc. for misbranding of its products, which are only approved as class II biofeedback devices, as neurostimulation and electroencephalogram (EEG) signal processing devices. The warning letter called on “Neurofield to cease any activities that result in the adulteration or misbranding of the Neurofield X3000/X3000 Plus, Neurofield Q21, Neurofield64 and Neurofield EEG.”
Woebot Labs Inc. secured a $9.5 million investment from Leaps by Bayer, the impact investment arm of Bayer AG, to speed development of its artificial intelligence (AI)-enhanced behavioral health platform and digital therapeutics. The new infusion tops up Woebots fundraising, bringing its total to date to $123.5 million. The Woebot investment marks Leaps by Bayer’s first foray into mental health.
Prognomiq Inc. nearly doubled its fundraising to date with a new $46 million financing to further develop its multiomics platform to detect cancer and other complex diseases earlier in their development. The financing led by Bruker Corp. along with new investor Catalio Capital Management brought total funds raised $101 million since the company’s founding in 2020.
The FDA issued a rare 518(a) Notification Order to Royal Philips NV last week that requires the company to take more aggressive measures to notify patients, physicians and distributors about the June 2021 class I recall of its continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) systems. The recall stemmed from health risks posed by the deterioration of the polyester-based polyurethane (PE-PUR) noise reducing foam in the equipment.
