The FDA has accepted Eyenovia Inc.’s new drug application (NDA) for Mydcombi, a fixed combination pupil dilation agent, with a PDUFA date of Oct. 28, 2021.
Thermo Fisher Scientific Inc. has launched a surveillance system that can detect SARS-CoV-2 in ambient air in indoor spaces, providing a potential complement to individual testing and other COVID-19 safety protocols. The system, called the Aerosolsense Sampler, works by capturing a sample of the ambient air on a cartridge using Thermo Fisher’s collection substrate.
Insulet Corp. reported positive results from a pivotal trial of its Omnipod 5 automated insulin delivery system for patients with type 1 diabetes. The tubeless, wearable insulin delivery system lowered hemoglobin A1c (HbA1c) – a critical diabetes measure – in children, adolescents, and adults, and improved the time that patients were in the target blood glucose range. The data was presented at ENDO 2021, the Endocrine Society’s annual meeting, which was held virtually this year.
The medical device incubator Coridea LLC and the health care investment firm Deerfield Management Co. LP are joining forces to accelerate the formation of med-tech companies on the East Coast.
Strive Health LLC has raised $140 million in a series B funding round led by Capitaig, Alphabet’s independent growth fund. The round also includes Redpoint Ventures, and current investors NEA, Town Hall Ventures, Ascension Ventures, and Echo Ventures. This funding round brings the Denver-based kidney care company’s total funding to $223.5 million.
Israeli med-tech startup Forsight Robotics Ltd. has closed a $10 million seed funding round led by Eclipse Ventures and joined by Mithril Capital. The funding will help advance the company’s work on a surgical robotic platform that employs microsurgical robotics, computer visualization and machine learning to automate many of the complex elements of ophthalmic surgery.
Medical device startup Promaxo Inc. has received 510(k) clearance from the U.S. FDA for its office-based MRI system. The portable system is intended for use by urologists and interventional/urologic radiologists who are performing surgical localization of prostatic lesions under Promaxo MRI guidance. It can be used in the office or outpatient surgical setting without the need for significant facility upgrades.
Histosonics Inc. is testing its investigational histotripsy technology to destroy liver tumors in two clinical trials in the U.S. and Europe, with the goal of seeking regulatory clearance for the platform in 2022. The technology uses the science of histotripsy, a form of therapeutic focused ultrasound, to mechanically destroy targeted primary and metastatic liver tumors from outside the body.
Truvian Sciences Inc. has closed more than $105 million in an oversubscribed series C financing round that will help jumpstart the evaluation of the company’s automated benchtop blood testing system. The round was led by TYH Ventures, Glen Tullman of 7wireventures, and Wittington Ventures.
Withings Health Solutions, the business-to-business division of the connected health company Withings SA, is launching two cellular-connected devices that allow patients to measure their weight and blood pressure at home and immediately transmit the results to a health care provider. The products – the Body Pro smart scale and the BPM Connect Pro at-home blood pressure monitor(BPM) – are being marketed directly to health professionals, as well as researchers and chronic disease management companies, for distribution to patients to use at home.
