Researchers at the University of Pennsylvania’s Perelman School of Medicine have shown how nanoparticles could be used to reduce neutrophil clumping in inflamed lungs – making them a pathway for diagnosis and treatment of acute lung inflammation (ALI) and acute respiratory distress syndrome (ARDS).
French remote monitoring and software startup Implicity SAS won FDA clearance for its ILR ECG Analyzer, a medical algorithm that analyzes electrocardiogram data from implantable loop recorders (ILRs). The company plans to launch the artificial intelligence (AI)-powered algorithm, which also is CE marked, in both the U.S. and Europe beginning next month.
Diabetes care will continue to evolve in 2022. New digital offerings and advanced algorithms, along with new product launches in insulin pumps and continuous glucose monitoring (CGM) will power growth in the future, according to key analysts. While many medical device sectors have suffered during the COVID-19 pandemic, diabetes care has continued to grow.
V-Wave Ltd. said on Dec. 17 that it has closed all remaining tranches of a $98 million extended series C financing led by Deerfield Management. The funds will be used to complete a pivotal IDE trial for its Ventura interatrial shunt system for the treatment of advanced heart failure (HF) and submit a PMA to the FDA for U.S. marketing approval.
The FDA has granted approval to Urotronic Inc. for its Optilume urethral drug-coated balloon (DCB) for the treatment of male urethral strictures. The device inhibits new scar tissue growth that may form after endoscopic dilations via the controlled release of paclitaxel, an antiproliferative that inhibits scar tissue formation.
Stereotaxis Corp. reported positive results showing its robotic magnetic navigation (RMN) system significantly reduces the incidence of silent cerebral embolism (SCE) in patients undergoing atrial fibrillation (AF) ablation vs. hand-held catheters. The prospective, multicenter study is believed to be the first to compare AF ablation using RMN with manual control and to highlight the benefit in lowering SCE risk.
Protein profiling startup Nomic Bio has secured $17 million in an oversubscribed series A financing led by Lux Capital. The funds will be used to expand the company’s servicing and manufacturing labs in Montreal and Boston, to broaden access to its proteomic platform by scaling profiling capacity to 100,000 samples per quarter starting in the second quarter of 2022 and by scaling its protein-detection method, called nELISA, to 500 on-boarded proteins.
Prelude Corp. (dba Preludedx) reported positive results from the SweDCIS randomized trial showing its DCISionrt test predicts radiation benefit for lowering 10-year local invasive breast cancer risk. The prognostic, artificial intelligence (AI)-based tool assesses and predicts the benefit of radiotherapy for women with ductal carcinoma in situ (DCIS) following breast-conserving surgery (BCS).
Medcura Inc. has secured $7.4 million in series A equity financing to grow its line of hemostatic and wound treatment products. Part of the proceeds from the investment will go toward further developing the company’s lead surgical candidate, Lifegel, and advancing it to clinical trials.
Merz Therapeutics GmbH is partnering with Israeli startup Vensica Therapeutics Ltd. on the development of an ultrasound-assisted delivery catheter to deliver Xeomin (incobotulinumtoxinA) to the bladder wall. The catheter, currently in clinical trials for the treatment of overactive bladder (OAB), is expected to be available in the U.S. by 2025.
