The FDA announced today that it authorized the Q-Collar made by Q30 Sports Science for protecting the brain during sports activities. Q30 Sports Science’s Q-Collar is a C-shaped collar worn around the neck designed to apply compressive force to the neck and increase blood volume to help reduce movement of the brain within the cranial […]
FDA
Pfizer wins FDA nod to store COVID vaccine at normal freezer temps
The FDA announced today that it is allowing undiluted, frozen vials of the Pfizer-BioNTech COVID-19 vaccine to be transported and stored for up to two weeks at conventional temperatures commonly found in pharmaceutical freezers. The decision should allow for wider distribution of the vaccine to sites that do not have ultra-low temperature freezers. Get the […]
FDA analysis finds J&J’s single-done COVID-19 vaccine is safe, effective
An FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective. The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted the EUA […]
Conformis soars on news of FDA clearance
Conformis (NSDQ:CFMS) recently received FDA 510(k) clearance for its ITotal Identity cruciate-retaining knee replacement system. According to a report from SeekingAlpha, Billerica, Mass.-based Conformis received 510(k) clearance for the ITotal Identity posterior-stabilizing knee replacement system along with the cruciate-retaining knee replacement system. The knee replacements have customized fitting properties with specificity for each patient receiving one. […]
FDA issues guidelines to address COVID-19 variants
The FDA today issued guidance for medical product developers to address the emergence of variants of SARS-CoV-2, which causes COVID-19. Variants of the virus have been detected in multiple countries across the globe, including the U.S., and they pose a major threat to potentially ending the COVID-19 pandemic as protocols such as mask-wearing and hand-washing […]
Boston Scientific has another serious recall on the same heart device
The FDA has declared a second Class I recall within a month on a Boston Scientific implantable cardioverter defibrillator (ICD). This recall, which the company initiated with a trio of warnings in December, notified physicians that 3,350 Emblem S-ICD model A209 and A219 devices may exhibit electrical overstress while delivering high-voltage therapy. Variations in header assembly may […]
MedTech 100 roundup: Slight dip after all-time best for industry
The medtech industry’s stocks rose higher than they ever had to begin last week before eventually dropping to a slightly more normal level. MassDevice‘s MedTech 100 index ended the week (Feb. 19) at 108.72 points, marking a -1.7% dip from the 110.63-point mark set at the end of the previous week (Feb. 12). On Monday (Feb. […]
Fifth round of medtech user fee talks set to begin soon
Every five years, the FDA, the medtech industry and the public sit down and hammer out how the agency should spend the money it collects in fees from medical device developers seeking approvals and clearances. The agency also uses the Medical Device User Fee Amendment (MDUFA) to set fees for biologics license applications, 513(g) requests for information and de […]
New FDA medtech cybersecurity chief: Guidance to debut in 2021
The FDA’s first medical device cybersecurity chief says he will work across private and public lines to lower the threat of cyberattacks against medical devices and the healthcare systems and patients who use them. Medical device manufacturers can expect a new FDA cybersecurity draft guidance for new medical devices sometime this year, according to the […]
FDA approves expanded labeling for Medtronic InterStim SureScan MRI leads
Medtronic (NYSE:MDT) announced today that it received FDA approval for expanded MRI labeling of its InterStim SNM systems. Fridley, Minn.-based Medtronic’s InterStim II and InterStim Micro sacral neuromodulation (SNM) systems that use SureScan MRI leads were approved under updated MRI guidelines allowing for a wider range of MRI scan parameters and shorter wait times between scans, […]
FDA lets Everlywell sell its COVID-19 home collection kit direct to consumers
Everlywell announced today that it received FDA emergency use authorization for its COVID-19 test home collection kit DTC. Under EUA, the home collection kit made by Everlywell can now be used directly by individuals who are not experiencing symptoms and have no suspected exposure and who are without a doctor’s prescription, according to a news […]
