FDA has designated a Medtronic (NYSE:MDT) recall of its HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief as Class I — its most serious level. Medtronic, according to FDA, said the outflow graft of the HVAD Pump could tear and the strain relief screw may break during assembly prior to implant, but might not be […]
ArcherDX receives FDA breakthrough device designation for gene sequencing device
ArcherDX recently said it received FDA breakthrough device designation for its next-generation sequencing device. The NGS device is designed as a companion diagnostic to detect neurotrophic receptor tyrosine kinase gene fusions that can lead to the formation and growth of cancer. ArcherDX’s technology uses Multiplex PCR chemistry that captures DNA, RNA or ctDNA from blood […]
Wicab lands patent for balance technology
Wicab recently said the U.S. Patent and Trademark Office issued a patent for the company’s impaired motor control treatment. The patent covers methods of providing rehabilitative improvement of motor control or function to a patient using the company’s BrainPort Balance Plus device, which provides biofeedback balance training during physical movement. BrainPort Balance Plus is designed […]
Smart Medical wins FDA clearance for G-Eye colonoscope
Smart Medical Systems yesterday said it received FDA 510(k) clearance for its G-Eye Colonoscope. The device is a standard colonoscope that installs the company’s G-Eye balloon on the distal bending section of the colonoscope. The G-Eye is then inserted using the standard technique with an inflated balloon. The balloon is inflated to engage the colon […]
New Jersey man charged in $45m PPE price-gouging scheme
A New Jersey man is facing charges of federal wire fraud for an alleged scheme to sell $45 million worth of personal protective equipment that prosecutors say he didn’t have. Ronald Romano, a Manalapan, N.J. used car salesman, was arrested for supposedly attempting to deceive and price gouge New York City into buying personal protective […]
Bardy Diagnostics lands CE Mark for cardiac monitor patch
Bardy Diagnostics this week said it received CE mark certification for its 14-day version of the Carnation Ambulatory Monitor patch. The patch is a P=wave centric ambulatory cardiac patch monitor and arrhythmia detection device. It gives clinicians more flexibility to monitor patients over a longer period of time while expanding the portfolio of the company’s […]
Tactile Systems Technology names new president and CEO
Tactile Medical (NSDQ: TCMD) this week appointed Daniel Reuvers as president and CEO, effective June 8. Reuvers succeeds Gerald Mattys who is retiring who will serve as a consultant for the company until June 2021. “After a comprehensive search process which yielded several highly qualified candidates, I am very pleased to announce that the Board of Directors […]
IMDRF recommends UL 2900 compliance for medical device cybersecurity
By Stewart Eisenhart, Emergo Group Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with the UL 2900 set of standards for network-connectable devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Smith & Nephew launches unicompartmental knee system
Smith & Nephew (NYSE:SNN) today announced the launch of its new Journey II Unicompartmental Knee System. The system is a highly personalized approach to partial knee arthroplasty through a modular, two tray configuration. It works by introducing a lateral specific tibia baseplate and an increased size range for femoral components and medial tibia baseplates to optimize […]
G Medical Innovations ECG Patch receives FDA EUA for use in COVID-19 patients
G Medical Innovations recently announced that it received FDA emergency use authorization for its vital signs monitoring system ECG patch for remote monitoring of patients who are being treated for COVID-19. The patch monitors the QT interval of an ECG in patients to watch for fatal arrhythmias that may occur from treatment drugs. Prolonged QT […]
Cochlear wins FDA approval to lower age to implant to 9 months
Cochlear Ltd. (ASX:COH) has received FDA approval to lower the age of cochlear implantation to nine months for children. The new approval lowers the age from the original 12 months for children with bilateral, profound sensorineural hearing loss. Cochlear implants have been FDA approved for use in children since 1990. “In light of all that has […]
- 1
- 2
- 3
- …
- 101
- Next Page »
