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AI Healthcare Company Offers Software as a Medical Device


It's probably no surprise that money is pouring into life sciences and healthcare startups during the biggest medical crisis in a century. CB Insights reported that global healthcare funding hit a new record $31.6 billion in this first quarter of 2021. It's also no shock that the two biggest trends – artificial intelligence and telehealth – also reaped record amounts of private cash. AI healthcare startups raised nearly $2.5 billion, while telehealth companies did even better by netting $4.2 billion in equity funding. That's the third consecutive quarter to hit record highs in both sectors dating back to Q3'20.

Biofourmis' Biovitals Analytics Engine Receives FDA Clearance for Ambulatory Physiologic Monitoring


Biofourmis, a fast-growing global leader in digital therapeutics, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its machine-learning and artificial intelligence (AI)-powered Biovitals Analytics Engine as a medical device for ambulatory physiological monitoring. This regulatory approval of the Biovitals Analytics Engine is part of FDA's growing recognition of machine-learning and AI in the Software as a Medical Device category. "This milestone approval is foundational to the Biovitals ecosystem, which includes not only our most advanced solution, BiovitalsHF for heart failure--but also our range of solutions across therapeutic areas, such as pain, oncology, sleep disorders and others in development," said Kuldeep Singh Rajput, CEO and founder of Biofourmis. "Receiving this important regulatory approval will only accelerate the development and commercialization of these innovative digital therapeutic solutions." This FDA approval is the second market authorization for Biofourmis, having earned the agency's approval in May 2019 for its Biovitals RhythmAnalytics platform, which is cloud-based software for automated interpretation of more than 15 types of cardiac arrhythmias.

Biofourmis Acquires Clinical-Grade Wearable Biosensor Platform Biovoation AG -


Biofourmis, a fast-growing global leader in digital therapeutics based in Boston, announced today it has reached an agreement to acquire Zürich, Switzerland-based Biovotion AG, a leading developer of a cutting-edge clinical-grade wearable biosensor platform. The acquisition includes all of Biovotion's assets, including the market-leading Everion biosensor and more than 60 global patents covering most of the wearable and sensor technology that exists for the arm or hand. The acquisition of Biovotion enables Biofourmis to offer proprietary, clinical-grade wearables as part of its Biovitals ecosystem. Clinical-grade wearables are becoming integral across all areas of healthcare, offering continuous real-time physiological data formerly only available in clinical settings. Combining Biovotion's best-in-class wearables with Biofourmis' digital therapeutics platform and it's leading artificial intelligence (AI)-driven predictive analytics creates the most comprehensive digital therapeutics solution on the market.

Innovation in Virtual Care: An Executive Panel Discussion


Remote care has a long and storied history. In The Lancet, an article from 1879 describes, "doctor's appointments through the telephone to avoid unnecessary office visits". And in the US, acute care in the home has been written about for over 25 years. With the pandemic necessitating change, CMS launched the AHCaH initiative and enabled Medicare-certified hospitals to be reimbursed for inpatient-level care in the home. During a webinar hosted by Becker's Hospital Review entitled "Virtual Care Across the Care Continuum", healthcare executives discussed the pandemic-driven expansion of virtual care, patient demand, hospital capacity issues, and shifts in regulations and reimbursement.

AI tools to predict hospital stays are hampered by a string of shortcomings


You're reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter delivered in your inbox every Tuesday and Thursday. Remote patient monitoring company Biofourmis announced a $300 million Series D round this morning, a critical investment as the firm looks to products that not only identify when patients are likely to deteriorate, but can help manage their care. The company says that 20 hospitals have signed on to use its care at home services -- which includes monitoring devices and an app -- to help prevent costly ER care and readmissions. Next up: using patient data to drive treatment decisions, like titrating drug doses.