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BioWorld - Sunday, May 11, 2025
Home » FDA

Articles Tagged with ''FDA''

Woman on couch using tablet

Advertising and promotions still a major hazard for device makers

May 19, 2022
By Mark McCarty
Device makers do not engage in direct-to-consumer advertisement at the same pace as drug makers, but advertising and promotions are still a minefield of potential enforcement action for the unwary manufacturer. According to Jesse Atkins and Nate Downing of Gardner Law in Stillwater, Minn., even a minor skirmish with the FDA can result in an extensive review of standard operating procedures, a potentially expensive and time-consuming distraction from companies fighting for market share in the hotly contested U.S. market.
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Bonesupport Cerament components

Bonesupport wins FDA nod for first antibiotic-eluting bone graft

May 19, 2022
By Meg Bryant
The U.S. FDA has granted de novo approval for Bonesupport AB’s Cerament G, an antibiotic-eluting bone graft designed to osteomyelitis. The company plans to launch in the U.S. in late September or early October.
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Remedee Labs

FDA actions stimulate market for fibromyalgia devices

May 19, 2022
By Annette Boyle
In the last week, the U.S. FDA has taken two steps to expand treatment options for the millions of patients with fibromyalgia who find little relief from the three approved drugs for the condition. Neurometrix Inc. reported that the agency granted de novo authorization to its Quell device Thursday and Remedee Labs SA announced it received breakthrough device designation for its endorphin stimulation system May 12.
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Aptima CMV Box

FDA greenlights Hologic’s Aptima CMV Quant assay for transplant patients

May 18, 2022
By Annette Boyle
Hologic Inc. received FDA premarket approval for its Aptima CMV Quant assay, which enables monitoring of viral loads of transplant patients with cytomegalovirus (CMV). While CMV typically poses little risk to adults with healthy immune systems, it can cause organ rejection and death in transplant patients if untreated. The assay gained a CE mark in June 2021.
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GAO sees need for more clarity in FDA enforcement discretion for pandemic tests

May 16, 2022
By Mark McCarty
Among the policies the U.S. FDA’s device center leveraged for testing during the COVID-19 pandemic was the long-standing enforcement discretion lever, which drew less attention than the agency’s use of emergency use authorizations (EUAs). Nonetheless, the Government Accountability Office (GAO) urged the FDA to develop a formal policy for the use of enforcement discretion for pandemic-related tests, including some metrics for when that discretion would come to an end.
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Medtronic plc’s Onyx Frontier drug-eluting stent

FDA greenlights Medtronic Onyx Frontier stent

May 16, 2022
By Annette Boyle
Medtronic plc received FDA premarket approval for its Onyx Frontier drug-eluting stent, an update to the company’s Resolute Onyx stent. The Frontier is designed for treatment of patients with coronary artery disease (CAD), a leading cause of death in the U.S. Medtronic expects the stent to receive CE mark shortly.
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US FDA rejects UCB psoriasis drug Bimzelx, citing facility inspection issues

May 13, 2022
By Richard Staines
UCB SA’s share price slumped after the U.S. FDA rejected the pharma’s filing for psoriasis drug Bimzelx (bimekizumab), citing issues with “inspection observations” that must be resolved before approval. Shares in Brussels-based UCB (Brussels:UCB) fell 13.6% following the announcement that the FDA had rejected Bimzelx for treatment of adults with moderate to severe plaque psoriasis.
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Embold Fibered Detachable Coil

Boston Scientific receives FDA clearance for the Embold coil

May 12, 2022
By David Godkin
The Embold fibered detachable coil developed by Boston Scientific Corp. to obstruct or reduce the rate of blood flow during therapeutic treatment in the peripheral vasculature, has won U.S. FDA 510(k) clearance.
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Wysa Ltd.’s chatbot

FDA grants breakthrough device designation for Wysa digital therapy

May 12, 2022
By Annette Boyle
Wysa Ltd.’s artificial intelligence-based digital therapy received FDA breakthrough device designation for adults with chronic musculoskeletal pain, depression and anxiety. The device delivers cognitive behavioral therapy (CBT) via a digital companion or conversational agent on a smartphone.
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U.S. Capitol building, Washington D.C.

FDA user fee legislation passes first hurdle in House of Representatives

May 11, 2022
By Mark McCarty
The legislation that would renew a number of FDA user fee programs, the Food and Drug Amendments Act (FDA Act) of 2022, has passed the first legislative hurdle in a subcommittee of the U.S. House of Representatives, but there are several issues with the bill. According to members of the subcommittee, the issues include an absence of provisions for medical device servicing, and the absence of legislation for FDA regulation of lab-developed tests (LDTs), issues that are unlikely to be resolved before the legislation is passed out of the House.
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