Search Results for “medical devices” – Page 32 – media

FDA establishes new advisory committee to provide expertise on digital health

The US Food and Drug Administration (FDA) has set up a new advisory committee to provide expertise on digital health technologies (DHTs), such as artificial intelligence, digital therapeutics and remote patient monitoring. The Digital Health Advisory Committee, which should be fully operational next year, will advise the regulator on the benefits, risks and clinical outcomes associated with the use of DHTs, as well as identify risks, barriers or consequences that could result from proposed or established FDA policy or regulation for topics related to DHTs. The committee will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds, the FDA said, to “help ensure digital health medical devices are designed and targeted to meet the needs of diverse populations”. The agency said it is currently seeking nominations of “appropriately qualified” candidates, setting an application deadline of 11 December. Jeff Shuren, director of the FDA’s Center for Devices ...
- Source: drugdu
- 202
- October 18, 2023
FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech

From time to time, the FDA convenes an outside group of experts to weigh in on an experimental drug or medical device, or to offer insight on a scientific matter that raises questions. The FDA has 49 committees and panels oriented around various therapeutic areas and modalities. As regulatory submissions increasingly include digital components, the agency wants to ensure it is adequately informed about these technologies. It’s adding a digital health advisory committee charged with providing that perspective. The FDA expects the new advisory committee will become fully operational in 2024. It will discuss technologies such as artificial intelligence and machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software. In addition, topics covered by this new committee could include decentralized clinical trials, patient-generated health data, and cybersecurity. The committee will consist of a core nine voting members, including the chair. Members serve terms of up ...
- Source: drugdu
- 201
- October 17, 2023
Best Buy to sell continuous glucose monitoring systems

Dive Brief Best Buy plans to start selling continuous glucose monitors in the next few weeks, in the tech retailer’s first foray into prescription-based medical device sales. The company plans to sell the Dexcom G7 CGM at launch, and is looking to offer additional CGM systems from other manufacturers, according to the company. Customers who want to buy a CGM will be routed to virtual care platform Wheel, where clinicians will determine a patient’s eligibility and write a prescription. Pharmacy tech provider HealthDyne will receive and process prescriptions, and consumers can then purchase the CGMs on Best Buy’s website for delivery to their homes. Dive Insight Best Buy has been increasingly active in healthcare as it angles to solidify itself as a valuable partner for hospitals and health plans looking for ways to help consumers manage their health at home. The company has sold medical devices for at-home use for ...
- Source: drugdu
- 113
- October 12, 2023
CMS leader defends breakthrough device reimbursement proposal at House hearing

Dive Brief An acting director at the Centers for Medicare and Medicaid Services has defended contentious aspects of the planned breakthrough reimbursement pathway. At a hearing that lasted almost three hours, CMS’ Dora Hughes made the case for restricting the Transitional Coverage for Emerging Technologies (TCET) pathway to five reviews a year and discussed the exclusion of in vitro diagnostics from the program. Hughes is the agency’s acting chief medical officer and the acting director at its center for clinical standards and quality. Some lawmakers, while voicing support for TCET, joined medtech trade groups in calling for the CMS to expand the scope of the pathway to cover diagnostics before the plan is finalized. Dive Insight Hughes spent Tuesday morning at a House health subcommittee hearing fielding questions about how to improve seniors’ access to innovative drugs, medical devices and technology. TCET, a pathway that the CMS proposed for consultation ...
- Source: drugdu
- 97
- September 22, 2023
FDA finalizes breakthrough device changes to target health inequities

Dive Brief The Food and Drug Administration has finalized changes to its breakthrough devices guidance, adopting revisions that could accelerate development of products that address health inequities. Eleven months ago, the FDA proposed updating its breakthrough guidance to clarify that devices that improve accessibility, and thereby tackle health inequities, can qualify for the program. The proposals received broadly positive feedback, including from industry trade group AdvaMed, leading the FDA to finalize the changes with only minor revisions and schedule a webinar to discuss its new policy. Dive Insight The FDA designed the breakthrough program to support development of devices that could better treat or diagnose life-threatening or irreversibly debilitating diseases or conditions. Originally, the guidance lacked a specific reference to accessibility as a way that devices can improve care. In October, the FDA proposed updating the guidance to explain that it considers the “totality of information regarding the proposed device, ...
- Source: drugdu
- 208
- September 20, 2023
Trade groups urge CMS to expand, quickly finalize breakthrough device pathway

Dive Brief Medtech trade groups have voiced support for the Centers for Medicare and Medicaid Services’ plan to accelerate reimbursement of certain breakthrough devices. In letters sent on the same day, AdvaMed and the Medical Device Manufacturers Association (MDMA) urged CMS to quickly finalize the program, while also naming changes they want the centers to make. The trade groups recommended changes including the expansion of the CMS program to cover breakthrough diagnostics, products authorized in the previous three years and medical devices that are nearing approval. Dive Insight In June, CMS released a draft version of the Transitional Coverage for Emerging Technologies (TCET) pathway for consultation. The path could fill a gap created by the repeal of the contentious Medicare Coverage for Innovative Medical Technologies plan and address industry calls to cut the gap between device approval and reimbursement. AdvaMed and MDMA submitted feedback on the new proposal to CMS ...
- Source: drugdu
- 146
- September 1, 2023
Amazon Pharmacy to provide automated discounts for insulin in the US

Amazon has announced that its online healthcare business, Amazon Pharmacy, will provide automated manufacturer-sponsored coupons for over 15 insulin and diabetes medicines to help patients access discounts pledged by the drug industry. The company said that patients will not need to search for and manually enter coupons using the new automatic coupon programme for three insulin makers: Novo Nordisk, Eli Lilly and Sanofi, lowering costs to as little as $35 a month. In March 2023, Novo, Lilly and Sanofi announced that they would be lowering their insulin prices by around 70% by or in 2024. A report published in July by Senator Elizabeth Warren said that some patients were struggling to get already discounted generic insulin from pharmacies at the guaranteed lower price. After Lilly lowered its Insulin Lispro list price in May to $25 per vial, patients were still being quoted up to $330 for the medicine and were ...
- Source: drugdu
- 120
- August 20, 2023
J&J Exceeds Q2 Expectations, Oncology and Immunology Top Pharma Drivers

Pictured: Johnson & Johnson Sign in Silicon Valley/Shutterstock, Michael Vi Johnson & Johnson exceeded Wall Street expectations in its second quarter performance. The healthcare products giant posted sales of $25.5 billion in its earnings report on Thursday. Worldwide sales numbers reflected a 6.3% growth for J&J with revenue close to $1 billion higher than analysts expected, thanks in particular to a nearly 10% increase in its medtech sales. Medtech has been on the rebound since patients have returned to non-emergent surgeries like knee and hip replacements, which saw a significant drop during the pandemic. Operational sales for the company’s pharma arm, suffering growth points due to dwindling COVID-19 vaccine sales, was up 3.9%. The second quarter posted no U.S. sales of J&J’s COVID vaccine, with no domestic revenue expected beyond the $747 million from outside the U.S. reported last quarter. Its government contracts are now complete. Primary growth drivers were J&J’s oncology and immunology ...
- Source: drugdu
- 107
- July 24, 2023
Medicaid MCOs Denied 1 out of 8 Prior Authorization Requests in 2019

Medicaid managed care organizations deny prior authorization requests at high rates, according to a recent report by the Office of Inspector General. Of the 115 MCOs the OIG analyzed, 12 had prior authorization denial rates above 25%. Medicaid Managed Care Organizations (MCOs) denied one out of eight prior authorization requests in 2019, according to a new report from the Office of Inspector General (OIG). The OIG review included seven MCO parent companies that operated 115 MCOs across 37 states and covered 29.8 million people in 2019. The organization received a congressional request to review MCOs and their prior authorization practices. “Medicaid managed care organizations play an increasingly important role in ensuring that people with Medicaid have access to medically necessary, covered services,” the OIG stated. “In recent years, allegations have surfaced that some MCOs inappropriately delayed or denied care for thousands of people enrolled in Medicaid, including patients ...
- Source: drugdu
- 129
- July 21, 2023
Medtronic identifies cybersecurity vulnerability in cardiac data system

Dive Brief Medtronic has found a cybersecurity vulnerability in an optional messaging feature in its Paceart Optima cardiac device data workflow system and reported the problem to the U.S. Cybersecurity & Infrastructure Security Agency. Medtronic has not observed any unauthorized access or patient harm related to the issue, the device maker said in an emailed statement. The company said it has notified healthcare delivery organizations about the vulnerability and has provided them with instructions to eliminate it. Dive Insight The number of data breaches in healthcare continues to climb as the industry has become a prime target for cyber criminals who seek to access its troves of patient information. As more connected medical devices make their way into patient homes, ransomware, phishing and software vulnerabilities are among the biggest challenges facing the sector. Medtronic’s Paceart Optima software application, which runs on a hospital’s Windows server, collects cardiac device data from ...
- Source: drugdu
- 115
- July 7, 2023

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