Annoviant recently announced it was awarded a $2.99 million National Institutes of Health grant to advance its TxGuard pulmonary-valved conduit for pediatric heart disease. The grant, an SBIR Phase 2 b grant, will help the Atlanta-based company accelerate the development and commercialization of its technology. It builds upon the company’s previous Phase 2 NIH grant […]
Pediatrics
PathKeeper Surgical, Mayo Clinic sign know-how agreement for pediatric spine surgery radiation research
PathKeeper Surgical has entered into a know-how agreement with the Mayo Clinic to research radiation levels in pediatric spine surgeries. The research will focus on reducing patient radiation exposure using minimally invasive optical navigation and using intraoperative measurement tools for scoliosis correction. Mayo Clinic pediatric spine surgeons Drs. Noelle Larson and Todd Milbrandt are collaborating […]
Owlet to raise $9M to support infant monitoring tech
Owlet (NYSE:OWLT) announced today that it entered into agreements for a private placement worth proceeds of approximately $9 million. Lehi, Utah-based Owlet’s placement relates to the sale of shares of its newly issued Series B convertible preferred stock and warrants to purchase Class A common stock. The conversion ratio for the stock and warrants reflects […]
FDA clears latest Philips TEE transducer for cardiac care
Philips announced today that the FDA granted 510(k) clearance to its latest TEE transducer technology. The Dutch medtech giant designed its transesophageal echocardiography (TEE) ultrasound transducer to help in the early diagnosis of structural heart disease. TEE helps cardiologists by providing highly detailed images of the heart and its internal structures. Additionally, TEE can help […]
Owlet launches new wearables for infants
Owlet recently announced it launched two infant monitoring devices. The Dream Sock and BabySat devices deliver real-time health insights with medical-grade accuracy for at-home infant care. They recently received FDA 510(k) clearance. “We are on a mission to help parents monitor what matters most and are proud to now offer two FDA-cleared, at-home infant monitors […]
Asensus makes first pediatric surgical robot placement in Japan
Asensus Surgical (NYSE:ASXC) announced today that Nagoya University Hospital in Japan agreed to lease a surgical robot system. The hospital entered into an agreement to utilize the Senhance surgical system in its pediatric surgery department. This agreement took place at the end of December. It marks the first pediatric installation in Japan and the fourth […]
OrthoPediatrics to acquire Boston Orthotics & Prosthetics
OrthoPediatrics today announced it acquired Boston Orthotics & Prosthetics for an undisclosed amount. In addition to the acquisition, OrthoPediatrics closed a debt financing with MidCap Financial to provide up to $80 million of capital through the combination of a term loan and revolving loan to replace its prior unused $50 million line of credit. Boston […]
J&J’s Acclarent wins FDA nod for pediatric ear tube balloon dilation system
Johnson & Johnson MedTech unit Acclarent announced that it won a new FDA clearance for its Aera Eustachian tube balloon dilation system. While Acclarent still belongs to Johnson & Johnson, Integra Lifesciences is set to buy it for $275 million next year. While the completion of that deal awaits, the company cleared a regulatory hurdle […]
Align Technology wins FDA nod for Invisalign palatal expander system
Align Technology (Nasdaq:ALGN) announced today that the FDA granted 510(k) clearance for its Invisalign palatal expander system. The direct 3D-printed device provides rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw). It enables primary, mixed or permanent dentition during the treatment of growing patients. FDA clearance covers broad patient applicability, including […]
FDA clears Masimo Stork home baby monitoring system
The FDA today published a 510(k) premarket notification granting clearance to the Stork baby monitoring system from Masimo . Stork offers a continuous and accurate view of a baby’s health data. It leverages Masimo’s noninvasive neonate monitoring technologies. Masimo’s smart home baby monitoring system officially received its clearance on Dec. 15. The company already began its […]
FDA clears Owlet over-the-counter pulse oximeter sock for infants
Owlet announced today that the FDA granted de novo clearance for its Dream Sock over-the-counter pulse oximetry solution for infants. Lehi, Utah-based Owlet designed the system to enable caregivers to better care for babies at home through advanced digital technologies. According to a news release, the now-cleared Dream Sock monitors and displays live health readings […]