FDA panel: Neuronix Alzheimer’s therapy fails to prove efficacy

An FDA advisory panel has recommended against granting de novo clearance to Neuronix’s NeuroAD system intended to slow the progress of mild to moderate Alzheimer’s disease.

NeuroAD is approved for use in Europe, Australia and Israel, but the panel found that while it met FDA safety standards, clinical studies did not prove that it is effective.

NeuroAD uses focused transcranial magnetic stimulation (TMS) to stimulate target areas of the brain responsible for cognitive functions impaired by Alzheimer’s disease, according to the Yoqneam, Israel-based company. This stimulation is designed to induce long-term potentiation, which the company said is associated with learning and memory processes, and makes these areas of the brain more receptive to cognitive training. Patients who receive the stimulation simultaneously receive such training.

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FDA approves Otimizer Smart heart failure device from Impulse Dynamics

Impulse DynamicsThe FDA today said it approved the Optimizer Smart heart failure device developed by Impulse Dynamics under its breakthrough device designation.

The Stuttgart, Germany-based company’s device is designed to remodel the myocardium to increase the heart’s efficiency using “cardiac contractility modulation” – non-excitatory electrical pulses delivered to the heart muscle. An FDA advisory panel last December recommended approval for Optimizer Smart, voting voted 12-1 on safety, 11-2 on efficacy and 12-0, with a single abstention, that its benefits outweigh the risks. The system has had CE Mark approval in the European Union since 2002.

The FDA indication covers patients with chronic, moderate-to-severe heart failure who can’t be treated with other devices.

“Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do,” FDA director of cardiovascular devices Dr. Bram Zuckerman said in prepared remarks. “The FDA recognized the unmet need for these patients and worked with the manufacturer through our breakthrough device program to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness.”

The federal safety watchdog said it based the approval on a pair of trials covering 389 patients, all of whom received optimal medical therapy; 191 or 49.1% were treated with the Optimizer Smart device. Patients with the implant showed improved six-minute walking tests and improved heart failure symptoms, the agency said.

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Novo Nordisk seeks FDA nod for oral diabetes pill

Novo Nordisk - updated logoNovo Nordisk (NYSE:NVO) said this week that it submitted applications to the FDA for its oral formulation of semaglutide, a once-daily glucagon-like peptide-1 receptor agonist therapy.

The company is hoping its pill will be approved as an adjunct to diet and exercise to improve blood sugar control in adults with Type 2 diabetes. Novo Nordisk also submitted for approval of an indication related to risk reduction of major adverse cardiovascular events.

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Siemens wins FDA nod for Mobilett Elara Max mobile X-ray

Siemens (NYSE:SI) Healthineers said today that it won FDA 510(k) clearance for its Mobilett Elara Max mobile X-ray system.

The Erlangen, Germany-based company touted that the newly cleared system features improved IT security and secure system integration to allow access of patient data at any time.

Siemens Healthineers also said that the system features antibacterial coating and an improved ergonomic design for better maneuverability.

“Siemens Healthineers is pleased to offer the Mobilett Elara Max, a mobile X-ray system with advanced cybersecurity features that provide state-of-the-art patient data protection. The system’s virtual workstation digitalizes healthcare by allowing technologists to access important patient information right at the bedside rather than return to the radiology department,” Siemens Healthineers NA X-ray products VP Scott Watson said in a press release.

In late January, Siemens Healthineers posted first quarter fiscal year 2019 earnings that showed both sales and bottom-line growth, but saw its diagnostics and advanced therapies divisions profits shrink compared with the same period during the previous year.

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FDA warns Integra’s TEI Biosciences over quality, validation issues

Integra Lifesciences' TEI Biosciences

The FDA recently revealed a warning letter it sent to Integra LifeSciences‘ (NSDQ:IART) TEI Biosciences over four noted violations it found during an inspection of TEI’s Boston-based facilities.

The federal watchdog said that it inspected the company’s facilities where it produces collagen-based medical devices, including its Xenform soft tissue repair matrix, from last October to November last year.

The recently released letter covers both the noted violations and a number of responses from the company it received from last November to February.

The FDA’s first noted violation was a failure properly validate manufacturing processes that cannot be verified post-production.

The agency noted two issues with the validation process for the manufacturing of the company’s extracellular bovine matrix-based devices, including its Xenform soft tissue repair matrices and a failure to demonstrate bacterial endotoxin testing of the devices.

In its second violation, the federal watchdog dinged the company for failing to establish and maintain procedures to prevent contamination of its equipment or products, specifically noting issues with its water system.

The FDA said that the company did not provide data showing it tests the water system it uses to produce extracellular bovine matrix devices for bacterial endotoxins. The agency added that TEI personnel informed that the company does not routinely perform microbial identifications on the bioburden recovered from the water system to identify the presence of gram negative and potential bacterial endotoxin contamination.

The federal watchdog said that it received responses from the company looking to correct the cited violations, but did not find the steps appropriate to resolve the issues, going as far as saying that the “deficiencies observed during our inspection are significant and demonstrate a systemic failure of your firm’s quality systems.”

The agency requested that the firm take further steps to correct the issues and said that it would require a re-inspection to ensure that the corrective actions were implemented.

In its third violation, the FDA noted several failures to control for environmental conditions, which could have an adverse effect on product quality.

The agency said that the company had not used sporicidal disinfectant in its ISO 7 clean rooms since March of 2017, adding that it identified spore-forming bacteria and fungal organisms during bioburden testing of its Xenoform product. Clean room gowns in the ISO 7 clean rooms were also noted as being re-used and “visibly dirty”, and personnel were not restricted from entering the cleaner manufacturing rooms after exiting higher contamination manufacturing rooms in the ISO 7 clean room, the FDA said.

The federal watchdog added that the company does not describe the frequency or process of cleaning the clean rooms with enough detail to prevent cross-contamination of separate areas during the process.

The agency said that it received a response outlining corrective actions to handle the violations, but said that it would need to verify them with a re-inspection.

In its final violation, the FDA said it noted a failure to maintain procedures for verifying or validating corrective and preventive actions to verify that the actions don’t adversely affect the finished products.

Again, the federal watchdog said it received a response to the issue that was inadequate, and requested more information on how the firm was correcting the issue.

The FDA gave the company the usual 15 business days to respond to the issues.

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Sage wins historic FDA nod for postpartum depression therapy

Sage TherapeuticsSage Therapeutics (NSDQ:SAGE) this week won FDA approval for the first medicine indicated to treat postpartum depression.

The Cambridge, Mass.-based company’s injection therapy, Zulresso, is slated to be available in late June.

Postpartum depression is the most common medical complication of childbirth, according to Sage, and affects roughly one in nine women who have given birth in the U.S.

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FDA warns J&J, Sientra over lack of post-approval silicone gel breast implant studies

FDA

The FDA today released warning letters it sent to Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide and Sientra (NSDQ:SIEN) over failures to conduct appropriate post-approval studies to analyze the long-term safety and risks associated with their silicone gel-filled breast implants.

The federal watchdog said that every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies of the devices to maintain appropriate data on the long-term safety and potential risks associated with the devices that premarket trials cannot foresee.

In its letter to J&J’s Mentor, the FDA noted a failure to enroll the appropriate amount of patients in the post-market study of its MemoryShape breast implant which won approval in 2013. The federal watchdog also said that Mentor had poor follow-up rates with patients and noted significant data inconsistencies in the report, including poor patient accounting and missing race and ethnicity data.

In its letter to Sientra, the federal watchdog knocked the company on its 61% follow-up rate, which falls below the target for the post-market study.

The agency said that both companies’ failure to address the raised concerns and comply with the post-approval study requirements violates its pre-market approval order. The FDA gave both companies 15 days to comply with the warnings.

“Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations. We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety. Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients,” FDA Commissioner Dr. Scott Gottlieb said in a prepared statement.

Last month, the FDA said that it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths.

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Surmodics shares down following FDA’s paclitaxel device update

Surmodics (NSDQ:SRDX) shares fell last week after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices.

In an SEC filing, the company said that it’s working with the FDA to clarify how the company should proceed with an ongoing clinical trial of its paclitaxel-coated SurVeil balloon.

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EOFlow wins breakthrough status for wearable closed-loop insulin delivery tech

EOFlowKorean medtech company EOFlow said last week that it won breakthrough status from the FDA for its closed-loop automated insulin delivery system for people with Type 1 diabetes.

The EOPancreas system features a wearable patch, continuous glucose monitoring systems and a closed-loop blood glucose control algorithm.

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Aptar Pharma touts FDA approval of nasal spray device

Aptar Pharma nasal spray deviceAptar Pharma said this week that its Bidose nasal spray device won FDA approval for use with a breakthrough depression therapy.

The Crystal Lake, Ill.-based company’s Bidose tech enables two-shot nasal drug delivery. Aptar touted its manufacturing facility in Congers, NY, which supports the manufacture of nasal and injectable drug delivery systems.

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