FDA: Page 16
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BD receives 510(k) clearance for fingerstick blood test sample collection device
The clearance positions BD and partner Babson Diagnostics to support blood collection from community sites such as pharmacies.
By Nick Paul Taylor • Dec. 8, 2023 -
White House sets April target for finalization of FDA rule on lab developed tests
TD Cowen analysts said it is “unclear if and when FDA will finalize the rule as it has faced considerable opposition.”
By Nick Paul Taylor • Dec. 8, 2023 -
Laboratory trade group, providers oppose FDA’s lab developed test proposal
A CDRH spokesperson confirmed to MedTech Dive that a discrepancy in the submission system used for the proposed rule led to an initial overcount of public comments.
By Nick Paul Taylor • Updated Dec. 7, 2023 -
Baxter sends another safety notice about syringe infusion pump errors
The company shared “reinforced guidance” to mitigate the risk of underdosing and interruptions to treatment.
By Nick Paul Taylor • Updated Dec. 6, 2023 -
BD tells customers not to use Cardinal’s Monoject syringes with Alaris pumps
The FDA labeled BD's safety notice as a Class I event. The warning comes amid several actions from the agency on the safety of syringes.
By Nick Paul Taylor • Dec. 4, 2023 -
Vivos receives FDA 510(k) clearance for oral devices to treat severe sleep apnea
The clearance positions the company to offer an alternative to continuous positive airway pressure devices and neurostimulation implants.
By Nick Paul Taylor • Nov. 30, 2023 -
Anna Shvets via Pexels
GE HealthCare gets 510(k) clearance for algorithm to detect collapsed lungs
The system provides immediate notifications to support the triaging of emergency room patients.
By Nick Paul Taylor • Nov. 29, 2023 -
Unomedical recall of infusion sets tagged as Class I by FDA
The company notified Tandem Diabetes Care, its sole consignee, in October of the risk for infusion sets to detach from insulin pumps, disrupting insulin delivery.
By Nick Paul Taylor • Nov. 28, 2023 -
Deep Dive
Why medical device companies are worried about the EPA’s planned sterilization regs
The EPA is expected to finalize new regulations in March that would limit ethylene oxide emissions from companies that sterilize medical devices.
By Elise Reuter , Shaun Lucas • Nov. 27, 2023 -
FDA withdraws from Global Harmonization Working Party
The agency has become “concerned with the divergent harmonization efforts for medical devices” and will focus on working with the International Medical Device Regulators Forum going forward.
By Elise Reuter • Nov. 27, 2023 -
FDA weighs in on SoClean’s field correction for CPAP cleaning machines
SoClean announced a voluntary field action last week to address user complaints related to improper set-up and unauthorized modifications.
By Nick Paul Taylor • Nov. 22, 2023 -
Medtronic wins pulsed field ablation CE mark, teeing up 2-front challenge to Boston Scientific
Medtronic received the mark for its single-shot PFA device, clearing the company to expand its portfolio of European atrial fibrillation devices.
By Nick Paul Taylor • Nov. 22, 2023 -
FDA concerned Cardinal Health failed to mitigate risk of incompatible syringes
Days after posting the Class 1 recall notice, the FDA said changes made to certain syringes could lead to overdose, underdose, or delays in therapy or alarms.
By Nick Paul Taylor • Nov. 21, 2023 -
B. Braun infusion pump safety correction linked to 51 complaints, one death
While no devices need to be removed, the FDA labeled the correction a Class I recall due to the risk of injury or death for patients.
By Nick Paul Taylor • Nov. 20, 2023 -
FDA acts on industry call for clarity about scope of device shortage reporting rules
The agency posted a final guidance and draft guidance on medical device shortage reporting requirements, addressing industry concerns.
By Nick Paul Taylor • Nov. 17, 2023 -
Q&A
Abbott Diabetes Care CMO Mahmood Kazemi on expanding CGM access
Kazemi hopes anyone with diabetes will be able to access the technology, even people who don’t take insulin.
By Elise Reuter • Nov. 17, 2023 -
Top FDA official Woodcock to retire early next year
The 37-year veteran helmed the agency’s pandemic response, and was a key decision-maker in controversial calls on opioids, an Alzheimer's therapy and muscular dystrophy drugs.
By Jonathan Gardner • Nov. 17, 2023 -
FDA seeks feedback on racial bias of pulse oximeters, convenes advisory committee
The agency published a paper on improving the evaluation of pulse oximeters to take skin pigmentation into account.
By Nick Paul Taylor • Nov. 17, 2023 -
LetsGetChecked secures first FDA authorization for at-home chlamydia and gonorrhea test
Jeff Shuren, director of the Center for Devices and Radiological Health, said the test will give patients “more information about their health from the privacy of their own home.”
By Nick Paul Taylor • Nov. 16, 2023 -
Congress delays Medicare lab payment cuts for one year
The American Clinical Laboratory Association said it remains focused on getting legislation passed that would mitigate pending Medicare payment reductions.
By Susan Kelly • Nov. 16, 2023 -
FDA-ordered report tackles how to manage cybersecurity risks of legacy devices
The report from MITRE proposes multiple actions for protecting older medical devices, including research into more modular devices and collecting data on cyber risks.
By Nick Paul Taylor • Nov. 16, 2023 -
Retrieved from Food and Drug Administration.
Cardinal’s changes to disposable syringes trigger FDA Class I recall notice
The problem is linked to 15 reports of delayed therapy and 13 reports of inaccurate dispensing.
By Nick Paul Taylor • Nov. 15, 2023 -
Biden initiative aims to accelerate women’s health research
AdvaMed endorsed the White House effort, stressing the need for equitable development and funding of new technologies.
By Susan Kelly • Nov. 14, 2023 -
Olympus receives Class I recall label for another bronchoscope safety issue
The company's latest corrective action follows four reports of “endobronchial combustion” during procedures with its bronchoscopes.
By Ricky Zipp • Updated Dec. 21, 2023 -
FDA warns providers about using surgical mesh for breast surgery after BD label update
The regulator reminded providers that there are “no surgical mesh products cleared or approved by the FDA for use in breast surgery.”
By Nick Paul Taylor • Nov. 13, 2023