Cardiex Ltd. won U.S. FDA clearance for its Conneqt Pulse vascular biometric monitor. According to the digital health and wearables company, the device is the first in the world to provide measurements of both brachial blood pressure in the arm and central blood pressure in the heart and aorta, as well as arterial waveform analysis and other clinically relevant vascular biomarkers, outside the hospital, research institutions or clinical trial sites.
Andera Partners and Novo Holdings A/S led a financing round which raised $25 million for Fire1 Ltd. and will accelerate the development of the company’s remote monitoring technology that improves outcomes for heart failure patients. Andera and Novo are new investors in Fire1 and were joined in the fundraising round by existing investors Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic plc, New Enterprise Associates and Seventure Partners.
Maela SAS and Nouveal SAS reported plans to merge and become a leading player in the market for remote medical monitoring and patient pathway management.
Biobeat Technologies Ltd. expanded its U.S. FDA-cleared remote patient monitoring offerings with a double nod from the agency for its sensors to monitor stroke volume and cardiac output. The two new indications join its capabilities for measuring the five vital signs assessed in any medical visit—blood pressure, blood oxygen saturation, pulse rate, respiratory rate and body temperature—all of which can be done using photoplethysmography (PPG) on sensors embedded on either a short-term chest patch or a more durable wrist monitor.
A panel at the J.P. Morgan Healthcare Conference touched on how multiple remote patient monitoring devices and management can be streamlined via machine learning to identify patients who need follow up, in many cases in their homes, increasing value without increasing the burden on already short-staffed health care organizations. The panelists saw technology as a way around a shortage of providers that could both increase access to care and deliver more targeted acute care while also addressing factors in health disparity to prevent development of disease.
Minze Health NV closed on $4.1 million of seed funding to develop its digital solution for the treatment of urinary tract problems. Three major Belgian funds participated in this seed round, led by White Fund SA, a private equity fund focusing on med-tech. Capricorn Partners NV joined White Fund via its Digital Growth fund, alongside Flemish investment company PMV NV.
The FDA granted Adherium Ltd. 510(k) clearance for its next-generation Hailie sensor that connects with Glaxosmithkline plc’s Ellipta inhaler to enable monitoring of medication use for asthma and chronic obstructive pulmonary disorder (COPD).
Even as new waves of COVID-19 cause less direct disruption in the delivery of health care, the ongoing pandemic leaves a dramatically altered landscape for medical devices in its wake. The RBC Global Healthcare Conference revealed trends that will continue to reshape the utilization of medical technology and delivery of health care, while industry leaders drilled down into the details in a focused panel discussion. All agreed: the pandemic catapulted telemedicine and remote monitoring ahead five or more years, a hybrid delivery system with greater fluctuations in volume will emerge, devices that facilitate the movement of care out of the hospital to home or outpatient settings will remain in high demand and patient-centered control of health care will continue to attract additional industries into health care markets.
Biobeat Technologies Ltd. reported its remote patient monitoring system received FDA clearance to monitor respiratory rate and body temperature. The wireless chest and wrist monitoring device is already cleared for cuffless blood pressure monitoring, blood oxygen saturation and pulse rate. The artificial intelligence platform utilizes a photoplethysmography-based sensor at the surface of the skin that measures volumetric variations of blood circulation.
The FDA has cleared Royal Philips NV’s latest Philips Capsule Surveillance system, setting the stage for deployment in the U.S. Designed to stream data from almost any connected medical device, Philips Capsule Surveillance aggregates patient data, analyzes it to generate actionable insights and alerts and relays timely notifications to patients’ caregivers so they can intervene before further deterioration occurs.