The medical device industry weathered the COVID-19 pandemic well — and is now set to roll out a host of innovations in 2021. Economists generally expect the U.S. to see a boom as we emerge from the pandemic and resulting recession. Medtech companies appear set to ride the wave this year, with plans to seek approval or […]
Pediatrics
J&J Vision, Menicon to collaborate on therapeutic contact lens
Johnson & Johnson (NYSE:JNJ) Vision announced today that it entered into a strategic collaboration with Menicon for contact lens development. J&J Vision and Menicon are partnering to bring forward a novel portfolio of products and services to manage the progression of myopia, sometimes known as “nearsightedness,” in children, according to a news release. Menicon is […]
Medtronic recalls oxygenator used for cardiopulmonary bypass among kids
The FDA has designated a recall of a Medtronic oxygenator used on kids as Class I, its most serious level. The Affinity Pixie oxygenator and cardiotomy/venous reservoir with Balance biosurface is designed for treating newborns, infants and small pediatric patients requiring cardiopulmonary bypass. The system adds oxygen to the blood and removes carbon dioxide, while the […]
NovaSight announces pivotal trial for digital lazy eye treatment
NovaSight announced today that it is executing a large pivotal trial for its CureSight lazy eye digital treatment device. Airport City, Israel–based NovaSight’s pivotal trial has the company on track to achieving FDA 510(k) approval for the CureSight device, according to a news release. CureSight is an eye-tracking-based lazy eye treatment that NovaSight officials think […]
FDA clears once-daily ADHD capsule from Corium
Corium (NSDQ:CORI) announced today that it received FDA approval for its once-daily Azstarys oral capsule for treating ADHD symptoms. Boston-based Corium touts its Azstarys (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) drug as the first and only product containing a d-MPH oral prodrug for treating ADHD (attention deficit hyperactivity disorder) symptoms in patients aged six years and older, […]
Philips and Disney want to make MRIs easier for children: Here’s how
Royal Philips (NYSE:PHG) announced today that it is teaming up with Disney to test the effects of custom-made animation to create a relaxing atmosphere for young patients. Amsterdam-based Philips will collaborate with The Walt Disney Company EMEA to see how the animation, including specially-made Disney stories within Philips’ Ambient Experience, creates a relaxing atmosphere to improve […]
Medtronic touts newborns study involving its Nellcor pulse oximetry tech
Medtronic (NYSE:MDT) announced today that study results showed superiority for its Nellcor pulse oximeter against technology from Masimo (NSDQ:MASI). Fridley, Minn.-based Medtronic’s Nellcor bedside SpO2 patient monitoring system was compared with the Masimo Radical-7 pulse co-oximeter with both set at the highest sensitivity for electrocardiography (ECG) monitoring following the delivery of 60 term newborns by Caesarian section, according […]
Spark Biomedical wins FDA breakthrough nod for newborn opioid withdrawal relief device
Spark Biomedical announced today that the FDA granted breakthrough device designation to its transcutaneous electrical nerve stimulator designed to reduce signs and symptoms of neonatal opioid withdrawal syndrome (NOWS). NOWS results from exposure to prescription or non-prescription opioids such as methadone or heroin during pregnancy. Currently, no nationwide standard of care exists for managing NOWS, although […]
Medtronic launches pediatric blood-filtering device in U.S.
Medtronic (NYSE:MDT) announced today that it launched its Carpediem cardio-renal pediatric dialysis emergency machine in the U.S. Fridley, Minn.-based Medtronic’s Carpediem machine received FDA de novo clearance in May for providing continuous dialysis in critically ill young children. The first-of-its-kind machine is indicated for use in acute kidney injury or fluid-overloaded patients requiring hemodialyiss or hemofiltration […]
FDA clears WishBone Medical pediatric external fixation device
WishBone Medical this week announced that it received FDA 510(k) clearance for its pediatric Smart Correction external fixation system. The device features hexapod external fixator hardware and planning software for a higher accuracy and design that enable surgeons to perform strut replacement procedures. It is designed to stabilize and maintain alignment of complicated fractures, soft […]
The top 10 medical disruptors of 2021
For the past 18 years, the Cleveland Clinic has predicted what the top 10 medical disruptors will be for the following year. The list of technologies, cultivated by a panel of physicians and scientists at the clinic, was led by Dr. Will Morris, executive medical director of Cleveland Clinic Innovations, and Dr. Akhil Saklecha, managing […]
