FDA

PhysIQ’s Proprietary Personalized Analytics to be Used for COVID-19 Care with Newly Broadened FDA Labeling

PhysIQ announces FDA-sanctioned labeling to address the COVID-19 public health emergency with its proprietary Multivariate Change Index (MCI) Deployed within the pinpointIQ® continuous remote monitoring solution, physIQ’s MCI will be used to proactively monitor homebound patients with or vulnerable to COVID-19 The sophisticated, machine learning-based algorithm uses multiple continuous vital signs from wearable sensors to detect […]

Maternal and Fetal Health-Focused Technology Startup Recognized by Global Female Founders Competition

Odonata Health, a Mayo Clinic Spinoff, Competes for Top Deeptech Company Spot MINNEAPOLIS, MN (March 18, 2020) – The second Female Founders Competition, a global contest to identify and fund top women entrepreneurs leading tech startups, has chosen Odonata Health as a U.S. deeptech company finalist to compete for its winning deeptech spot and $1 […]

Coronavirus (COVID-19) Update: FDA and CDC Take Action to Increase Access to Respirators, Including N95s, for Health Care Personnel

Today, in a joint effort, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. Today’s action allows certain National Institute for Occupational Safety […]

In the Know: Healthcare News for November 27, 2019

Starkey Livio AI: The 100 Best Inventions of 2019 In Silicon Valley, startup cofounder battles VC over the future of health insurance Cancer-killing virus designer Vyriad raises $24.4 million 3M, Medtronic lead Minnesota companies on Management Top 250 list Mayo Clinic expands out of U.S. with Abu Dhabi hospital ExceleraRx, a network for expensive specialty […]

Corvia Medical and physIQ Partner in Global Phase 3 Heart Failure Clinical Trial to Leverage Novel Digital Endpoints

The 100+ site global Phase 3 clinical trial is the first-of-its-kind to leverage continuous multivariate wearable sensor data and Artificial Intelligence-based analytics The landmark trial endpoint approach aligns with commentary at a recent FDA Public Workshop on biomarkers for heart failure clinical trials To date, hundreds of thousands of hours of continuous multivariate sensor data […]

Healthy.io Raises $60 Million in Series C Funding and Receives FDA Clearance for Smartphone-Based Test to Diagnose Chronic Kidney Disease

Former Aetna executive Gary Loveman will join Board of Directors Tel Aviv, Israel (September 12, 2019) ⁠— Today, Healthy.io, the global leader in turning the smartphone camera into a clinical-grade medical device, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its smartphone-based ACR test to be used in the aid of diagnosing chronic kidney […]

Visualize MED: Modeling the Future of Medicine

The medical device industry has traditionally relied on a combination of bench testing, animal testing, and clinical trials to guide the development and evaluation of medical devices. Indeed, regulatory agencies around the globe have established their approval processes around these three sources of evidence. In the mid to late 2000’s, it became clear that our […]

PhysIQ Inc. Receives FDA Clearance of Continuous Ambulatory Respiration Rate Algorithm Enabling Artificial Intelligence-based Analytics for Biopharma Companies and Payers

FDA 510(k) cleared Respiration Rate analytic adds to physIQ’s growing portfolio of FDA 510(k) algorithms Clearance allows physIQ to power its higher-level AI analytics with validated vital sign inputs PhysIQ’s cloud-based analytics provide flexibility to biopharma companies and payers looking for consistent output while deploying a variety of devices across different patient populations CHICAGO – PhysIQ, […]

Reprise Biomedical Raises $12.5 Million and Completes Spin-Off From Miromatrix Medical

New Minnesota-based medical device company focuses on biological medical devices manufactured using perfusion decellularization technology. Minneapolis, Minn. (July 1, 2019) – Reprise Biomedical, Inc., a Minnesota-based startup focused on commercializing biological medical devices manufactured using a proprietary perfusion decellularization technology, has successfully completed a $12.5 million private placement and commenced operations as a spin-off from […]

Up & Running with Brian Brockway, President and CEO of VivaQuant

Brian Brockway is the founder of Data Sciences Intl. (DSI), the leading provider of wireless implantable sensors and systems for preclinical testing of new drugs and biomedical research. He bootstrapped DSI with SBIR grants into a highly profitable business with over $40 million in revenue where he developed domestic and international direct sales and distribution […]

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