Bioretec announced today that published clinical trial results support the use of its bioresorbable ActivaPin implant. Helsinki-based Bioretec designed the ActivaPin implants for pediatric patients to treat severely displaced distal radius and forearm fractures. According to a news release, the results from the retrospective, multicenter study demonstrated that patients treated with ActivaPin has a significantly […]
Pediatrics
OrthoPediatrics acquires MD Orthopaedics and its clubfoot bracing technology
OrthoPediatrics (Nasdaq:KIDS) today announced that it is acquiring MD Orthopaedics in a transaction valued up to $19.6 million. The Warsaw, Indiana-based will acquire MD Orthopaedics and its bracing product lines and Mitchell Ponseti ankle-foot orthosis system to treat clubfoot. Under terms of the agreement, OrthoPediatrics is buying the Wayland, Iowa-based company for an upfront cash […]
GripAble picks Medline for exclusive U.S. hand therapy product distribution
Medline has inked an exclusive U.S. distribution agreement with GripAble, the developer of a two-in-one hand and arm function assessment and training device. The GripAble Pro was designed to help therapists serve more patients more efficiently in neurological rehabilitation, pediatrics, hand therapy and other applications. The device connects to a tablet app and tracks grip […]
Pega Medical picks Explorer Surgical’s digital case support platform
Explorer Surgical, a GHX company, announced today that it has expanded its presence in the pediatric orthopedic medical device space after bringing on Pega Medical as a customer. Founded in 1996, Pega Medical specializes in designing, developing, evaluating, and manufacturing pediatric orthopedic devices. It has business in more than 70 countries. Pega Medical’s medical device […]
Stanford startup hires Elbit’s KMC to get blood ammonia device approved and manufactured
Aza Technology has hired Elbit Systems of America’s KMC Systems medical instruments division to get the startup’s rapid blood ammonia detector approved by regulators and ready for manufacturing. Aza Technology developed the rapid ammonia monitoring device (AMD) with Stanford University and Stanford Hospital to detect hyperammonemia, which can lead to irreversible neurological damage, coma and […]
How Minnetronix helped Oculogica launch its new EyeBOX concussion diagnostic device
Less than three months after Oculogica won FDA clearance for its portable concussion diagnostic device, contract manufacturer Minnetronix is about to ship the first units to customers. “We are aspiring to be a vital sign for brain health,” Oculogica CEO Rosina Samadani said in an interview. Diagnosing a concussion used to require asking a patient […]
The top 10 catheter innovations of 2021
Last year was a big year for catheter innovation as medtech companies large and small received regulatory approvals for devices ranging from TAVR to single-use endoscopes. Catheter innovations weren’t limited to just adults; Catheter-deployed devices for premature babies and toddlers were also approved and released. And catheter-based devices made up nearly half of last year’s Prix […]
Medtronic cerebral/somatic oximetry system wins FDA clearance
Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its INVOS 7100 cerebral/somatic oximetry system. INVOS 7100, which Medtronic designed to pick up key signals to inform time-critical decisions by pediatric clinicians, received clearance for children from birth through age 18. The signals it picks up are related to hemodynamic management, ventilation and […]
5 pediatric electrophysiology devices you need to know
The National Capital Consortium for Pediatric Device Innovation recently announced five electrophysiology devices that could monitor and treat congenital heart disease and arrhythmia in pediatric patients. The five winners of the annual NCC-PDI “Make Your Medical Device Pitch for Kids!” competition will share a $150,000 FDA grant to support the advancement of pediatric medical devices. […]
BioMarin wins FDA approval for injection to increase growth in children with dwarfism
BioMarin Pharmaceutical (NSDQ:BMRN) announced today that the FDA granted accelerated approval for its Voxzogo injection. San Rafael, California-based BioMarin’s Voxzogo (vosoritide) injection has an indication to increase linear growth in pediatric patients with achondroplasia (a form of dwarfism) five years of age and older with open epiphysis (growth plates). Continued approval may be contingent upon […]
Masimo seeks to boost automation of newborn screenings in Europe
Masimo (NSDQ:MASI) announced earlier this week that it launched a new patient monitoring and connectivity hub. The first application of Dual SET Oximetry for Root offers a significant advancement to the company’s Masimo SET-guided critical congenital heart disease (CCHD) screening, according to a news release. Masimo will combine the platform with the CE-marked Masimo SET […]