Search Results for “medical device” – Page 20 – media

BD hires new chief medical officer from 3M Health Care

BY JIM HAMMERAND Dr. Ron Silverman is the next chief medical officer of Becton, Dickinson & Co. [Photo courtesy of BD] Becton, Dickinson & Co. (NYSE: BDX)+ today named Dr. Ronald “Ron” Silverman as EVP and chief medical officer. He replaces BD Chief Medical Officer Dr. William Sigmund, who announced plans to retire from BD earlier this year. The change takes effect Dec. 4, 2023. Silverman comes from 3M Health Care, where he served as SVP and chief medical officer since 2021. He will lead BD’s medical affairs organization across BD’s business units, regions and central team. Franklin Lakes, New Jersey-based BD said Silverman “will use medical insights and expertise to advance BD’s pipeline of clinically relevant, innovative solutions that align with evolving patient needs, while also contributing to the safety and compliance of BD’s in-market portfolio of products.” Silverman will report to BD EVP and Chief Technology Officer Beth ...
- Source: drugdu
- 96
- November 27, 2023
UTS researcher tests new handheld device for rapidly and accurately identifying drug specimens

University of Technology Sydney (UTS) Centre for Forensic Science PhD candidate Harry Fursman is working on two fronts to prevent harm to people who use drugs: He is testing a new handheld device for rapidly and accurately identifying drug specimens and conducting ongoing chemical analysis of used syringes. Drugs that are contaminated or substituted with an unexpected substance are a leading cause of death among people who use drugs. In Sydney last week one person died and two people were taken to hospital due to heroin overdoses, after using what they thought was cocaine. Fursman aims to tackle this significant risk by providing objective insights into current trends and consumption habits among people who are injecting drugs. He will present his research on substance testing at the upcoming International Association of Forensic Sciences (IAFS) conference in Sydney on 20-24 November. Portable drug testing device: MicroNIR Fursman is testing a small ...
- Source: drugdu
- 158
- November 18, 2023
Major trial finds apixaban reduces stroke risk in patients with device-detected atrial fibrillation

The widely available blood thinner apixaban substantially reduced stroke in at-risk patients with a type of atrial fibrillation only detectable by a pacemaker or other implanted cardiac electronic device, a global study has found. The oral anticoagulant medication, which helps to prevent dangerous blood clots by thinning the blood, reduced the risk of stroke and blood clotting by 37% and reduced fatal or disabling stroke by 49% in individuals with device-detected atrial fibrillation, also known as sub-clinical atrial fibrillation (SCAF). This condition is not easily detectable through standard tests like electrocardiograms, unlike clinical atrial fibrillation. The study was published on Nov. 12 in the New England Journal of Medicine (NEJM) and simultaneously presented at the American Heart Association Scientific Sessions by lead researcher Jeff Healey, a senior scientist at the Population Health Research Institute (PHRI), a joint research institute of McMaster University and Hamilton Health Sciences. Healey and a global ...
- Source: drugdu
- 109
- November 15, 2023
FDA extends pandemic-era policy allowing certain device, production changes without prior approval

Dive Brief The Food and Drug Administration will continue to allow medical device manufacturers to make alterations to certain products or manufacturing processes without prior authorization if the changes are due to production limitations or supply chain challenges. The policy is a continuation of COVID-19 pandemic-era changes that eased some requirements on device makers during the crisis. The guidance document, issued Thursday, outlines examples of when companies would not be required to file a premarket application (PMA) or humanitarian device exemption (HDE) supplement, or a 30-day notice, before making changes. While the policy was initially created for the emergency pandemic environment, the FDA wrote in the guidance document that it has “continued to observe supply chain challenges and shortages of medical devices remain widespread.” The agency removed the policy’s expiration date, but it could make revisions in the future. Dive Insight The guidance, first issued in May 2020, was supposed ...
- Source: drugdu
- 133
- November 5, 2023
CooperCompanies buys reproductive health products from Cook Medical after failed takeover

Dive Brief CooperCompanies bought some of Cook Medical’s obstetrics, doppler monitoring and gynecology surgery products for $300 million, the companies announced on Wednesday. The acquisition follows an attempt by Cooper to acquire Cook’s reproductive health business, which was scrapped amid scrutiny from the Federal Trade Commission. The assets included in the purchase do not include any of the fertility products the companies had discussed in the original deal, Cooper said. Dive Insight Cooper paid $200 million upfront and will pay two more annual installments of $50 million each. In exchange, it will acquire Cook’s Bakri postpartum balloon, cervical ripening balloon, doppler blood flow monitor portfolio and other surgical products. Cooper CEO Al White said in the deal announcement that the acquired devices “are highly synergistic” with the company’s current portfolio and will strengthen its position in fertility and women’s health. San Ramon, California-based Cooper’s surgery segment includes fertility, gynecology and ...
- Source: drugdu
- 163
- November 4, 2023
FDA warning letter accuses Wavi of selling unapproved neurological device

Dive Brief The Food and Drug Administration has sent a warning letter to Wavi, accusing the company of selling an unauthorized device to help diagnose patients with potential neurological conditions. Wavi markets its headset, plus associated devices and software, as providing a baseline scan for patients who have a traumatic event, an injury or are worried about their brain as they age. The FDA, which sent inspectors to Wavi’s facility in Denver in March, views the technology as a medical device and sent a warning letter because the product lacks premarket approval. Dive Insight In the letter, the FDA states that Wavi promotes and distributes Wavi Desktop, a product that collects, analyzes and interprets electroencephalograph data, event-related potentials and heart rate variability data. The instruction manual “contains evidence that the device is intended to aid in the evaluation of autonomic nervous system function, head injury, depression, attention-deficit/hyperactivity disorder, anxiety, and ...
- Source: drugdu
- 220
- November 3, 2023
FDA says Philips’ testing of recalled devices is inadequate

Dive Brief The Food and Drug Administration called for further testing by Philips to evaluate the risks of soundproofing foam used in its recalled sleep apnea machines and ventilators. “We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Thursday statement that included more details on the recall and the agency’s actions. Philips has claimed use of the devices is “not expected to result in appreciable harm to health in patients,” but agreed with the FDA’s recommendations to run additional testing. Dive Insight Philips’ recall of sleep apnea devices and ventilators has continued since June 2021, when the company began an effort to repair or replace millions of devices that used polyester-based polyurethane (PE-PUR) foam for soundproofing. ...
- Source: drugdu
- 116
- October 8, 2023
FDA expands total product life cycle program to cover neurological devices

Dive Brief The Food and Drug Administration is expanding a program for accelerating device development to cover neurological and physical medicine technologies. Initially, the voluntary total product life cycle advisory program (TAP) pilot was limited to cardiovascular devices. This week, the FDA Office of Neurological and Physical Medicine Devices also began accepting enrollment requests. Expanding the program to cover cardiovascular, neurological and physical medicine devices is part of a scaling up of the pilot, which enrolled 12 products in its first year. The FDA could enroll up to 45 additional devices over the coming year. Dive Insight The FDA and industry agreed to the TAP pilot in MDUFA V. While the industry initially opposed the advisory program, the FDA secured a chance to show it can “spur more rapid development and more rapid and widespread patient access” by facilitating early engagement and coordination with external stakeholders. A year ago, the ...
- Source: drugdu
- 196
- October 4, 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
- 98
- 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
- 211
- September 20, 2023

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