Policy & Regulation
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FDA approves Lumicell’s breast cancer imaging tool
Lumicell developed the technology to enable physicians to detect residual cancer in the breast cavity after surgery.
By Nick Paul Taylor • April 22, 2024 -
Exactech recalls shoulder devices after initially declining to act
After the FDA issued a public safety notice and sent Exactech a warning letter, the firm agreed to recall shoulder implants due to packaging issues.
By Nick Paul Taylor • April 22, 2024 -
Trendline
The EU Medical Device Regulation
While the European Union’s MDR went into effect in May 2021, device makers still face a range of uncertainties and potential problems with continued extensions and outstanding questions still in play.
By MedTech Dive staff -
Scopio Labs wins de novo nod for bone marrow analysis software
Scopio can now add the application to its imaging platforms that allow users to view blood samples digitally rather than under a microscope.
By Nick Paul Taylor • April 18, 2024 -
Boston Scientific recalls blood-blocking agent linked to 2 deaths
Seven injuries and 11 incidents were also associated with the safety issue.
By Nick Paul Taylor • April 18, 2024 -
‘An incredible undertaking’: 5 takeaways from Philips consent decree
Under the agreement, the FDA will use rare powers to require repairs, replacements or refunds for recalled respiratory machines.
By Elise Reuter • Updated April 17, 2024 -
FDA warns Soulaire to stop selling device outside authorized uses
Soulaire marketed its external counterpulsation system to grow new arteries, repair organ dysfunction and treat COVID-19, among other uses, without evidence.
By Nick Paul Taylor • April 17, 2024 -
European Commission approves Illumina’s proposed Grail split
Selling Grail to a third party would free Illumina of the need to capitalize the company, but the buyer would need the commission’s approval, analysts wrote.
By Nick Paul Taylor • April 15, 2024 -
FDA expands import alert to block all plastic syringes from Chinese manufacturer
The agency increased the blockade because Jiangsu Shenli Medical Production failed to meet device quality system requirements.
By Nick Paul Taylor • April 11, 2024 -
MMI receives de novo nod for microsurgery robot
Medical Microinstruments said the system could increase the number of physicians who can perform complicated microsurgical procedures.
By Nick Paul Taylor • April 9, 2024 -
Physicians ask FDA to revoke approval of DNA test for opioid addiction
Physicians said the test is based “on old genetic studies that have largely been abandoned” and could exacerbate the opioid crisis.
By Nick Paul Taylor • April 8, 2024 -
Beckman Coulter receives FDA warning letter
Inspectors found fault with quality practices at a facility that makes immunoassay analyzer instruments and tests.
By Nick Paul Taylor • April 5, 2024 -
Smiths Medical recalls thousands of ventilators over fault linked to 8 serious injuries
A problem with the devices can cause patients to receive the wrong amount of ventilation or too little oxygen, the FDA said in a recall notice.
By Nick Paul Taylor • April 5, 2024 -
FDA grants de novo nod to AI tool for detecting sepsis
Prenosis CEO Bobby Reddy Jr. told MedTech Dive the company sees third-party validation as important, with the FDA having clarified that certain decision support tools should be regulated as medical devices.
By Elise Reuter • April 4, 2024 -
FTC asks Boston Scientific for more info on $3.7B Axonics deal
The company has pushed back its expected closing date for the acquisition due to the second request from the Federal Trade Commission.
By Susan Kelly • April 4, 2024 -
Eko wins FDA nod for AI to detect sign of heart failure using stethoscope
The clearance adds to the list of devices the FDA has authorized this year with AI algorithms to detect health conditions.
By Nick Paul Taylor • April 4, 2024 -
Teleflex catheterization kit recall linked to 10 injuries, 1 death
Nearly 335,000 devices were recalled due to safety issues, which may cause damage to blood vessel walls, artery blockage or death.
By Nick Paul Taylor • April 4, 2024 -
Deep Dive
As cyberattacks on healthcare persist, can the FDA’s new device regs hold up?
Revamped regulations to thwart hackers are a big step forward, but issues such as legacy devices and reliance on software patches pose lingering challenges.
By Ricky Zipp • April 3, 2024 -
Baxter receives FDA clearance for delayed Novum IQ infusion pump
The clearance ends a three-year back-and-forth with the FDA to get the product to market.
By Nick Paul Taylor • April 2, 2024 -
Abbott wins FDA clearance for bedside blood concussion test
The clearance is a step towards using the test in non-healthcare settings, such as sporting events, Abbott said.
By Nick Paul Taylor • April 2, 2024 -
Infutronix pulls infusion pumps from US after nearly 3,700 complaints
The company listed six issues that can cause the pumps to stop infusions and otherwise malfunction.
By Nick Paul Taylor • April 2, 2024 -
Roche wins FDA approval for first molecular malaria blood donor screening test
The company is pitching the test as a way to improve the safety and availability of blood.
By Nick Paul Taylor • March 28, 2024 -
FDA hits Renovo with warning letter over reprocessed medical devices
The letter accuses Renovo of adding models other than the ones covered by its 510(k) clearances.
By Nick Paul Taylor • March 27, 2024 -
Neuronetics wins FDA clearance for device to treat adolescents with depression
William Blair analysts called the clearance a positive surprise, explaining that the FDA has denied several therapies in the patient population.
By Nick Paul Taylor • March 27, 2024 -
Abbott receives CE mark for 6-year insertable cardiac monitor
The device can continuously monitor a patient’s heart rhythms for either three or six years, depending on users’ needs.
By Nick Paul Taylor • March 26, 2024 -
J&J files for FDA approval of Varipulse pulsed field ablation platform
The company wants to catch up with rival PFA systems from Medtronic and Boston Scientific that have already received FDA authorization.
By Nick Paul Taylor • March 26, 2024