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Overarching Industry Updates
1 | OIG says Medicare race data is inaccurate and hinders health disparities assessments
AI / Imaging
1 | RapidAI receives FDA 510(k) clearance for pulmonary embolism triage & notification
2 | Singaporean medtech Us2.ai gets CE mark for automated cardiac ultrasound software
3 | Aidoc expands AI service to x-ray, receiving FDA 510(k) clearance for pneumothorax
4 | Paige Answers Call to Better Identify Breast Cancer Patients with Low Expression of HER2
Disease Management / Digital Therapeutics
3 | Former Cerebral VP Alleges Unsafe Prescribing Practices in Lawsuit
4 | Alio Receives First FDA 510(k) Clearance
5 | Alimetry Receives FDA Clearance for their Flagship Product Gastric Alimetry
Informatics / Healthcare IT Solutions
1 | Oracle's acquisition of Cerner is approved, could close June 6
2 | Doctor Anywhere taps cloud communications provider Vonage for enhanced telehealth service
4 | University of Queensland researchers develop care platform for remote neuromodulation
Overarching Industry Updates
1 | OIG says Medicare race data is inaccurate and hinders health disparities assessments
According to a recent data brief published by the Office of Inspector General (OIG), claims that Medicare data on race and ethnicity have significant inaccuracies, especially for American Indian/Alaska Native Asian/Pacific Islander, and Hispanic beneficiaries. Additionally, Medicare’s race and ethnicity enrollment data do not adhere to federal data collection standards, making it difficult to identify and improve health disparities for Medicare subscribers. Centers for Medicare and Medicaid Services (CMS) did not explicitly concur with OIG’s recommendation to develop its own source of race and ethnicity data, but it has concurred with 3 of 4 recommendations from OIG, including improving data for current beneficiaries by using self-reported race and ethnicity information, developing a process to standardize this data, and educating beneficiaries about CMS’s initiatives to improve race and ethnicity data. This could impact the digital health sector, where telehealth may help make healthcare access more equitable.
AI / Imaging
1 | RapidAI receives FDA 510(k) clearance for pulmonary embolism triage & notification
Having just received FDA 510(k) clearance for its latest artificial tool that identifies and triages cases of central pulmonary embolisms, RapidAI (also known as iSchemaView) now has six FDA 510(k) clearances. This product analyzes CT pulmonary angiogram (CPTA) images and alerts the care team via mobile and desktop app when it detects a case, allowing providers to triage patients. When building this product, RapidAI drew from its experience specializing in stroke and are confident that this tool will “help modernize PE care and meaningfully improve patient outcomes.”
2 | Singaporean medtech Us2.ai gets CE mark for automated cardiac ultrasound software
Singapore-based Us2.ai is a medtech startup specializing in heart disease. It recently received a CE mark for Us2.v1, a “completely automated decision support tool” for echocardiography. This clearance opens up opportunities for clinical use in the UK and 32 markets across Europe. The company, already possessing existing clearances in the US, Canada, Australia, New Zealand, and Singapore, also just received a Notice of Allowance from the US Patent and Trademark Office.
3 | Aidoc expands AI service to x-ray, receiving FDA 510(k) clearance for pneumothorax
Radiology artificial intelligence company Aidoc has received FDA 510(k) clearance for its triage and notification tool for pneumothorax. This software will be able to run on all x-ray machines. Aidoc’s other tools also include a triage and notification software for pulmonary embolism, triaging cervical spine fractures, and flagging acute intracranial hemorrhage.
4 | Paige Answers Call to Better Identify Breast Cancer Patients with Low Expression of HER2
Paige has received CE-IVD and UKCA designation for their digital pathology assay HER2Complete. The software is an artificial intelligence able to detect HER2 expression in HER2-negative and HER2-low H&E samples. This is an important development as novel therapeutics targeting HER2-low patients (e.g., AstraZeneca and Daiichi Sankyo’s Enhertu) are likely to drive increased demand for HER2-low assessment, which is less common in practice today and more complicated to score.
Disease Management / Digital Therapeutics
Sleepio, a sleep improvement program developed by the company Big Health, has become the first digital therapeutic to receive guidance from the National Institute for Health and Care Excellence (NICE). NICE guidelines are official recommendations for the NHS in England and Wales. The NICE guidelines recommend Sleepio for patients with insomnia, suggesting that the app both lowers sleep medication prescription rates and saves money. The app uses AI to create custom cognitive behavioral therapy for patients with insomnia. With increasing mental health demand, this first ever digital therapeutic NICE guidance will likely pave the way for more digital technology approvals that can broaden access to effective care.
Rune labs scored a 510(k) clearance from the FDA for its StrivePD software. StrivePD is an Apple Watch software that combines wearable technology with self-reported patient symptom information to enable care management for Parkinson’s. The tracking of symptoms is intended to help doctors determine when certain treatments may be needed, as well as follow how those treatments are affecting their patients. There is further intention that the mass quantities of data collected and the patients reached will help with clinical trial enrollment and therefore accelerate Parkinson's therapies coming to market. The Apple Watch’s AFib History feature also received 510(k) clearance this quarter, further adding to the wearable’s impact to heart health since it received FDA clearance for its built-in ECG in 2018.
3 | Alio Receives First FDA 510(k) Clearance
Alio Inc., has received FDA 510(k) clearance for its remote patient monitoring system. The system is currently intended for managing end stage kidney disease. Alio’s monitoring system is intended to improve the quality of life of dialysis patients and decrease hospitalization. The system includes the SmartPatch wearable sensor with a Bedside Hub that collects the patches data, and the Alio Medical Cloud to allow for clinician access to the data. The SmartPatch collects physiological data including skin temperature, auscultation sound data, and heart rate. Alio is developing artificial intelligence algorithms to allow the SmartPatch to manage numerous other chronic conditions, with several planned FDA submissions in the future.
4 | Alimetry Receives FDA Clearance for their Flagship Product Gastric Alimetry
Alimetry, a New Zealand based medical device and digital healthcare company, has received US FDA 510(k) clearance for Gastric Alimetry. Gastric Alimtery is a stretchable wearable device for testing patients in clinical settings. Patients wear the device before and after consuming a meal, and it records digestive patterns and delivers clinical reports via the cloud. The device aids in diagnosis of numerous gastric diseases to support personalized therapy. The device is already available in the UK and New Zealand, and will be commercially available in the U.S. in July, 2022.
Informatics / Healthcare IT Solutions
1 | Oracle's acquisition of Cerner is approved
Cloud platform software company Oracle finalized the acquisition of electronic health record provider Cerner for $28.5B. The acquisition, which is said to focus on transforming healthcare delivery, cements Oracle’s presence in the healthcare space. Oracle’s existing tools are expected to help modernize Cerner’s systems and interfaces. This deal is Oracle’s most expensive acquisition to date and one of software’s biggest M&A’s ever.
2 | Doctor Anywhere taps cloud communications provider Vonage for enhanced telehealth service
Doctor Anywhere, a telehealth company based in Singapore, has implemented a video application programming interface (API) from Vonage, an American cloud communication platform. The adoption of the API is to enhance telehealth service delivery, specifically to improve video capabilities to meet increasing demand for digital healthcare.
Bezyl, a digital mental health company, is collaborating with THREAD, a clinical trials technology and consulting service provider. The move will provide clinical trial participants with Bezyl’s mental health app and services. The Bezyl app has numerous functions from tracking health to communicating with providers and individual’s support systems. Offering this to trial participants is a part of THREAD’s move to further support the mental health of study participants.
4 | University of Queensland researchers develop care platform for remote neuromodulation
Researchers at the Queensland Brain Institute have created a remote care platform to support the care of neurology patients. The platform will allow providers to both monitor patients and adjust treatment remotely. The treatment adjustment is possible as patients are outfitted with electrodes that can alter brain function to alleviate symptoms. The platform has already been approved by the Australian government, the FDA and has received a CE mark in Europe.
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