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, 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.