FDA drafts guidance outlining real-world evidence for medical device submissions

By issuing the new guidance, the agency is meeting the requirements of a year-end spending bill.

By Elise Reuter • Dec. 19, 2023

Illumina to part with Grail, ending battle with regulators

Activist investor Carl Icahn, who is suing the company over its acquisition of Grail, continued to push for the removal of several board members in a letter to fellow shareholders.

By Susan Kelly • Dec. 18, 2023

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Glaukos wins FDA approval for drug-releasing eye implant to treat glaucoma

William Blair analysts said the product “should revolutionize how glaucoma is treated by addressing noncompliance with drops.”

By Nick Paul Taylor • Dec. 15, 2023

In wake of Philips recall, senators urge review of FDA medical device oversight

Sens. Richard Durbin and Richard Blumenthal said the sleep apnea device maker “did nothing” while patients suffered.

By Susan Kelly • Dec. 14, 2023

Zimvie’s collaboration with Brainlab delivers 510(k) win for spinal fixation system

Amid recent struggles in its spine unit, Zimvie has been expanding its Brainlab partnership.

By Nick Paul Taylor • Dec. 13, 2023

Illumina prepares to divest Grail with Form 10 filing

The DNA sequencer is preparing to unwind its 2021 acquisition of the liquid biopsy test maker while still appealing orders to do so from regulators in the U.S. and Europe.

By Susan Kelly • Dec. 13, 2023

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

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

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

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