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Home » FDA

Articles Tagged with ''FDA''

Toy bulldozer moving FDA letter blocks

OUS device makers on FDA’s short list for warning letters

Feb. 10, 2023
By Mark McCarty
It may still be true that a majority of medical devices are manufactured in the U.S., but that doesn’t stop the FDA from dropping a warning letter on facilities located outside the U.S. (OUS). In one of these warning letters, Microvention Inc., of Aliso Viejo, Calif., received a warning letter for its plant in Costa Rica, although the FDA waited until the second week of February to post the Sept. 30, 2022, warning.
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Reflexion Medical - X1 platform

Cancers of all stages now target for FDA cleared Scintix biology-guided radiotherapy

Feb. 10, 2023
By David Godkin
Reflexion Medical Inc. has been granted U.S. FDA marketing clearance for biology-guided radiotherapy to treat early and late-stage cancers. An expansion of the company’s existing X1 platform, Scintix is indicated for patients with lung and bone tumors which may arise from primary cancers or from metastatic lesions spread from other cancers in the body.
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Seastar Medical - Selective Cytopheretic Device

Seastar Medical wins FDA nod for study of device to treat damaged kidneys

Feb. 10, 2023
By Meg Bryant
The U.S. FDA has cleared the way for Seastar Medical Holding Corp.. to conduct a pivotal IDE study of its Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI). The Denver-based company plans to begin enrolling patients as early as next month.
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FDA icons and doctor

CDS Coalition petitions FDA to rewrite clinical decision support final guidance

Feb. 8, 2023
By Mark McCarty
The U.S. FDA raised some hackles with its final guidance for clinical decision support (CDS) software, thanks to provisions that some stakeholders argued flew against congressional intent regarding the regulatory status of some device functions. That final guidance is now the target of a petition by the CDS Coalition to withdraw and rewrite the final guidance, arguing that the agency is “doing an end run” around the limitations established by Congress regarding the FDA’s oversight of software as a medical device (SaMD).
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World map with supply chain icons

FDA, industry team up in effort to improve product quality, supply chain resiliency

Feb. 7, 2023
By Mark McCarty
The U.S. FDA and makers of medical devices have several collaborative programs, but the two sides have joined forces yet again in a new collaboration, this time to address both product quality issues and supply chain resiliency. 
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Chief product security officer a key in cybersecurity program maturity

Feb. 7, 2023
By Mark McCarty
The Medical Device Innovation Consortium (MDIC) has played a key role in fostering a stronger industrial appreciation for the need for robust cybersecurity, but a recent MDIC report noted that many device makers are deficient in pushing cybersecurity considerations into the domain of design controls. However, the most critical element in cybersecurity may be whether a company has a chief product security officer (CPSO), the presence of absence of which seems to correlate strongly and uniformly with all aspects of cybersecurity in a manufacturer’s products.
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Renalguard therapy awarded breakthrough designation for cardiac surgery-associated AKI

Feb. 7, 2023
By David Godkin
Cardiorenal Systems Inc. has scored a U.S. FDA breakthrough device designation for technology to prevent patients undergoing cardiac surgery from developing acute kidney injury (AKI). AKI is reported in up to 30% of approximately 780,000 cardiac surgeries performed each year in the U.S., Europe and the Middle East, complicating patient recovery, prolonging ICU hospitalization and contributing to patient mortality after surgery.
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Varian Halcyon

Varian receives FDA 510(k), CE mark for Halcyon and Ethos radiotherapy systems with Hypersight

Feb. 6, 2023
By Annette Boyle
Varian’s Halcyon and Ethos radiotherapy systems received two regulatory nods in short succession, with both U.S. FDA 510(k) clearance and CE marking. In addition, the company reported that the first patient in the world underwent treatment with a Halcyon system with Hypersight last week.
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Orthogen granted IDE approval for medical technology for knee osteoarthritis

Feb. 3, 2023
By Bernard Banga
Orthogen AG received an investigational device exemption (IDE) from the U.S. FDA for its Orthogen technology device. This approval allows the company to start a pivotal trial on the device, used for treating patients with mild stage (II) to severe stage (IV) knee osteoarthritis. The trial will compare improvements in pain levels and function using standalone glucocorticoid injection, the current standard of care, against the Orthogen device.
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MDMA’s Leahey says Medicare breakthrough device coverage still a work in progress

Feb. 3, 2023
By Mark McCarty
The Medical Device Manufacturers Association (MDMA) has led the policy charge for smaller medical device manufacturers for decades, but each year brings its own unique set of hazards and opportunities. In an interview with BioWorld, MDMA President and CEO Mark Leahey said that while the Medicare policy for coverage of breakthrough devices has gone through some unanticipated twists and turns, that policy is not yet fixed and thus there is still some prospect that such a policy will not devolve into a stew of leftovers drawn from existing coverage mechanisms.
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