Masimo (Nasdaq:MASI) announced today that it launched its Stork at-home monitoring system for babies. Irvine, California-based Masimo designed Stork to offer parents insights into their baby’s health data. It could help them learn more about and be better connected with their baby, Masimo says. “When we set out in 1989 to reinvent pulse oximetry, we […]
Pediatrics
Avanos Medical has a serious recall of airway access device for young children
The FDA today issued a notice labeling a recall by Avanos Medical (NYSE:AVNS) as Class I, the most serious kind. Avanos’ recall regards its Ballard Access closed suction system for neonates and pediatrics. These affected devices feature the Y-manifold or elbow manifold. Avanos reported four injuries and one death related to the issue with the […]
Senseonics announces first pediatric 365-day CGM insertion
Senseonics (NYSE:SENS) announced that the first pediatric study participant received an Eversense 365-day CGM insertion. The insertion took place as part of the company’s ENHANCE clinical trial at the AMCR Institute. AMCR, a clinical research center, focuses on pre-diabetes, type 1, type 2 diabetes and obesity. The study operates under the direction of Dr. Timothy […]
Study says Medtronic leadless pacemaker is safe option for children with slow heartbeats
New research using Medtronic technology suggests that leadless pacemakers may be an effective option in children. The research ran today in Circulation: Arrhythmia and Electrophysiology, a peer-reviewed journal of the American Heart Association. It presented leadless pacemakers like the Medtronic Micra as a safe and effective short-term option for children with slow heartbeats. Children with slow […]
Study backs Tandem Control-IQ artificial pancreas in young children
Tandem Diabetes Care (Nasdaq:TNDM) announced positive study data for its artificial pancreas using Control-IQ technology. The study demonstrated improved blood sugar control in children ages 2-6 with type 1 diabetes. It evaluated an artificial pancreas using the Tandem t:slim x2 insulin pump with Control-IQ technology. Results were published in the New England Journal of Medicine. […]
ZimVie wins positive coverage decisions for pediatric scoliosis device
ZimVie (Nasdaq:ZIMV) announced today that the Highmark insurance organization issued positive medical policy decisions applicable to vertebral body tethering (VBT). Highmark is an independent licensee of the Blue Cross Blue Shield Association. It primarily covers Pennsylvania, New York, Delaware, and West Virginia and BCBS North Dakota. The new policy decisions went into effect Jan. 30, […]
Asensus Surgical expects FDA clearance for surgical robot in pediatric use this year
Asensus Surgical (NYSE:ASXC) shares dipped today on fourth-quarter results that came in mixed compared to the consensus forecast. The company provided an outlook for the year ahead that includes the expected clearance of a regulatory hurdle, though. Shares of ASXC fell 2.6% to 67¢ apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which […]
Akili lays off 46 workers
Akili announced that its board of directors approved an operating plan for 2023 that includes a 30% workforce reduction. The Boston-based digital therapeutic developer’s reduction reaches across different areas and functions. In total, 30% of Akili’s workforce amounts to 46 employees. The company communicated the decision to employees on Jan. 12 and expects to complete […]
FDA approves next-gen inhaled nitric oxide delivery system from Vero Biotech
Vero Biotech announced that it received FDA approval for its latest-generation tankless inhaled nitric oxide (iNO) delivery system. Atlanta-based Vero Biotech developed its third-generation Genosyl delivery system for respiratory therapists. Its new features include faster dosing, simpler workflow and operational efficiency. Get the full story at our sister site, Drug Delivery Business News.
SeaStar Medical, Nuwellis partner on kidney injury treatment
SeaStar Medical (Nasdaq:ICU) and Nuwellis (Nasdaq:NUWE) today announced an exclusive U.S. license and distribution agreement. Nuwellis agreed to market and distribute SeaStar’s selective cytopheretic device (SCD). The SCD treats acute kidney injury (AKI) in children. It selectively targets the most activated pro-inflammatory neutrophils and monocytes to stop cytokine storm. The system works with continuous kidney […]
Owlet seeks FDA clearance for prescription pediatric monitor
Owlet (NYSE: OWLT) announced today that it has submitted a 510(k) premarket notification to the FDA for a new prescription monitoring device for infants. The Lehi, Utah–based company’s device uses pulse oximetry technology. Physicians could prescribe it to assist with in-home monitoring of babies who are patients. Parents receive alerts from the Owlet device when […]