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Home » Topics » BioWorld MedTech, Regulatory

BioWorld MedTech, Regulatory
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BIO2025: John Crowley and Martin Makary
BIO 2025

Makary lays out FDA’s path, launches pilot review program

June 20, 2025
By Karen Carey
No Comments
On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months.
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FDA icons

FDA scrutinizing trials sending US patient cells to China

June 20, 2025
By Mari Serebrov
No Comments
Using informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient.
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Neuromark system

Rising demand spurs Neurent to open new Neuromark facility

June 18, 2025
By Shani Alexander
Amid rising demand for its Neuromark system, Neurent Medical Ltd. opened a new manufacturing facility in Ireland, which will serve as the central hub for the production of the device which treats chronic rhinitis.
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JAMA OpEd

Too much at stake for dismissed ACIP members to go quietly

June 18, 2025
By Mari Serebrov
No Comments
The 17 members abruptly terminated June 9 from the U.S. CDC’s Advisory Committee for Immunization Practices are not going gently into the night. Instead, they’re raging against what could be the dying of the light.
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Scientist, microscope and dropper

US universities developing alternative to cover indirect costs

June 18, 2025
By Mari Serebrov
No Comments
After years of conversations surrounding indirect research costs, academic groups are now under the gun to quickly come up with an alternative to the NIH’s proposed 15% across-the-board cap on indirect costs and the decades-old university-by-university negotiated rate that can exceed a 50% add-on to a grant.
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Blood clot blocking a blood vessel

Inquis, Penumbra advance thrombectomy treatments

June 17, 2025
By Annette Boyle
Two med-tech companies focused on pulmonary embolism overcame their own blockages to commercialization this week. Inquis Medical Inc.’s Aventus thrombectomy system received U.S. FDA clearance for use in pulmonary embolism, an expanded indication, while Penumbra Inc. completed enrollment in the STORM-PE clinical trial of its Lightning Flash device.
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Lungs and bronchiole

CMS agrees to cover at-home ventilation for chronic respiratory failure

June 17, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services finalized a coverage policy for at-home ventilation for patients with chronic respiratory failure. The amended policy also establishes a series of criteria for coverage of ventilation for chronic obstructive pulmonary disease.
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De novo key on keyboard

FDA releases another batch of regs for de novo decisions

June 17, 2025
By Mark McCarty
It appears the U.S. FDA believes it’s never a bad time to release regulatory information about devices granted market access via the de novo program. The agency recently posted information on the vintage de novo granted in 2018 to Imagen Technologies Inc. for the company’s Osteo Detect algorithm.
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U.S. flag on columned building

Advamed presses CMS to require MA plans to honor NTAP program

June 16, 2025
By Mark McCarty
Medicare Advantage plans have been controversial for several reasons, and the Advanced Medical Technology Association has now made the argument that the Centers for Medicare & Medicaid Services should require these plans to replicate the terms of the Medicare new technology add-on program.
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MHRA logo

MHRA advises industry that new requirements are now in place

June 16, 2025
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency is reminding industry that several new regulatory requirements are in effect as of June 16, 2025, such as a postmarket surveillance rule that says manufacturers have only 15 days to report serious incidents to the agency.
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