Search Results for “medical device” – Page 72 – media

Medtronic wins FDA approval for Inceptiv closed-loop spinal cord stimulator

Dive Brief Medtronic has received Food and Drug Administration approval for its Inceptiv closed-loop spinal cord stimulator (SCS) for the treatment of chronic pain, the company said Friday. The closed-loop system is meant to reduce overstimulation compared to the open-loop technology used by Medtronic’s rivals, such as Abbott, Boston Scientific and Nevro. Evercore ISI analysts think Medtronic has lost share to Abbott over the past two years, and the launch of Inceptiv could help the company regain ground in the coming quarters. Dive Insight Users of open-loop SCS receive a predetermined amount of stimulation, which is set when the physician programs the device, regardless of what the patient is doing. The fixed output can result in moments of overstimulation that are uncomfortable, potentially leading users to choose a lower, less effective level of stimulation. Open-loop efficacy may fall over time, too. Closed-loop systems, such as Medtronic’s Inceptiv device, adjust their ...
- Source: drugdu
- 76
- May 2, 2024
Pharma Asia 2024

Organiser: Ecommerce Gateway Pakistan Time:20 – 22 August 2024 address：University Rd, Gulshan-e-Iqbal, Karachi- Pakistan Exhibition hall: Karachi Expo Center Product range: Medical Products exhibition area: Medical diagnostic equipment and supplies, electronic medical equipment and instruments, rescue equipment, medical reagents and equipment, etc Hospital supplies exhibition area: catheters, interventional materials, surgical hygiene products, disposable medical consumables, surgical tools, medical clothing and bedding, first aid equipment, maternal and child care equipment, disinfection equipment, etc Experimental equipment exhibition area: laboratory instruments and equipment, optical instruments and equipment, image analysis and processing system, test instruments and devices, laboratory update and transformation technology, consumables and related software, etc Medicine exhibition area: all kinds of new special medicine, proprietary Chinese medicine, Western medicine, traditional Chinese medicine health products, nutritional food, etc. Traditional medicine: Chinese medicine, herbal medicine, etc Pharmaceutical equipment exhibition area: drug production equipment and technology, drug packaging equipment, drug packaging materials, drug production, cleaning, ...
- Source: drugdu
- 167
- April 29, 2024
Exo adds FDA-cleared AI tools to handheld ultrasound system

Dive Brief Exo has made new artificial intelligence tools available on its Iris handheld ultrasound system, the company said Tuesday. The Food and Drug Administration cleared Exo’s AI tools for analyzing ultrasound images of the heart and lung last year. Exo sees the new capabilities as particularly beneficial for health systems and caregivers in rural and under-resourced settings because they simplify the collection and interpretation of images. Dive Insight Exo received a 510(k) nod for its original Iris device in 2021 and added imaging modes and indications to the clearance the following year. The clearances cover handheld portable diagnostic ultrasound systems, similar to Butterfly Network’s iQ, that enable healthcare professionals to measure body structures and fluids in adults and children. Users can view the images on smartphone screens. In 2023, Exo gained additional FDA clearances for AI products. One clearance covered software that uses machine learning to help quantify bladder ...
- Source: drugdu
- 111
- April 28, 2024
Judge approves settlement of more than $500M from Philips recall

Dive Brief District Judge Joy Flowers Conti approved a settlement on Thursday that will provide more than $500 million to people who purchased, leased or rented recalled Philips devices. Philips must put at least $467.5 million into a settlement fund for users who bought a recalled device and for devices returned to the company. The company must also set aside $34 million into a payer settlement fund. Flowers is a judge for the U.S. District Court for the Western District of Pennsylvania. The agreement does not include personal injury and medical monitoring claims, which the plaintiffs’ attorneys are pursuing separately. Dive Insight The settlement is related to Philips’ ongoing recall of sleep apnea devices and ventilators. Philips started recalling the devices in June 2021 because foam used to soundproof the machines could break down and be inhaled by patients, posing potential health risks. The majority of the funds will go ...
- Source: drugdu
- 85
- April 28, 2024
Vietnam Medipharm Expo 2024

Organiser: Ministry of Health of Vietnam Time:1 – 3 August 2024 address：Lawrence S. Ting Building 801 Nguyen Van Linh Parkway, Dist. 7 Ho Chi Minh City Vietnam Exhibition hall: Saigon Exhibition & Convention Center Product range: Medical products: medical equipment and instruments, medical consumables, medical dressings, surgical equipment, rescue equipment, diagnostic equipment and supplies, ophthalmic equipment and equipment, ENT equipment, dental equipment and supplies, medical reagents and equipment, medical health products and equipment, medical institutions and laboratory technical equipment, medical information and technical exchange, beauty equipment Analytical instruments: Optical analysis instruments, mass spectrometers, spectrometers, chromatographs, spectrometers, electrochemical analysis instruments, X-ray analysis instruments, gas chromatography, liquid chromatography, thermal analysis instruments, all kinds of portable instruments, surface analysis instruments, nuclear analysis instruments, elemental analysis instruments, process analysis instruments, composition analysis instruments, injection analysis instruments and other general analytical instruments Laboratory equipment: Laboratory instruments and equipment, laboratory automation and accessories, optical instruments and equipment, ...
- Source: drugdu
- 143
- April 23, 2024
IceCure submits final breast cancer cryoablation data to FDA

BY SEAN WHOOLEYIceCure Medical (Nasdaq:ICCM) announced today that it submitted final data to the FDA requesting marketing authorization for its ProSense system. Caesarea, Israel-based IceCure designed ProSense to deliver cryoablation that treats breast cancer in a 20-40-minute outpatient procedure. It seeks FDA authorization for treating patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. ProSense already holds FDA breakthrough device designation and has clearance in the U.S. for other indications. Those include treating benign tumors of the breast, and tumors in the kidney and liver. However, the FDA in 2022 denied IceCure’s de novo classification request for ProSense to treat patients with early-stage, low-risk breast cancer. In January of this year, the FDA agreed to reopen the de novo file. An affirmative response from the FDA provided IceCure with a potential pathway to clearance. The company submitted a five-year follow-up dataset from the ICE3 study and ...
- Source: drugdu
- 112
- April 22, 2024
Abbott’s latest Heartmate recall tied to 273 injuries, 14 deaths

Dive Brief Abbott is recalling thousands of Heartmate II and Heartmate 3 left ventricular assist systems because biological material can build up and obstruct the devices, making them less effective at pumping blood, the Food and Drug Administration said Monday. Reports of 273 injuries and 14 deaths have been linked to the problem, with the material typically taking two or more years to accumulate, according to the recall notice. The FDA identified the action as a Class I recall, the most serious type. Heartmate devices are used to support patients with severe left ventricular heart failure who are awaiting a heart transplant, or the device can be permanently implanted when a transplant isn’t an option. In February, Abbott told customers in an urgent correction letter there is no need to return any products to the company. Dive Insight Heartmate devices take over the pumping function of the left ventricle, the ...
- Source: drugdu
- 114
- April 17, 2024
A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health

Pharmaceutical companies use Feel Therapeutics’ technology to monitor the mental state of participants in clinical trials of behavioral medications. But the startup envisions its technology eventually also finding a place as a part of clinical care. By Frank VinluanWhen it comes to evaluating the health of a patient, each therapeutic area has its own data-gathering tools. Think glucose monitors in diabetes and heart monitors for cardiovascular disease. But in mental health, a clinician relies on what a patient says. Self-reporting is incomplete and lacks objectivity, says George Eleftheriou, CEO and co-founder of Feel Therapeutics. Feel is trying to bring more complete and objective data collection to the field of mental health. The San Francisco-based startup does it with wearable technology that continuously collects data and provides recommendations. “One of the things we hear is how poor storytellers people are and [how they] cannot truly depict what happened over the past ...
- Source: drugdu
- 132
- April 16, 2024
MMI receives de novo nod for microsurgery robot

Dive Brief Medical Microinstruments (MMI) has received de novo authorization for a robotic system that enables surgeons to reconnect tiny blood vessels, the company said Monday. The Food and Drug Administration authorized the device, called the Symani Surgical System, for soft tissue manipulation to perform microsurgery, a way to restore blood flow and redirect fluid during reconstruction or repair. CEO Mark Toland said the commercial availability of Symani could increase the number of physicians who can perform complicated microsurgical procedures. MMI plans to immediately launch the system in the U.S. Dive Insight Microsurgery and supermicrosurgery, a technique for 0.3mm to 0.8mm vessels, are microscope-assisted operations that enable physicians to take a piece of tissue from one part of the body and use it to reconstruct another area. By reconnecting blood vessels, surgeons can restore form and function to parts of the body damaged by trauma or disease. The potential for ...
- Source: drugdu
- 71
- April 15, 2024
Abbott nets FDA approval for Triclip

Dive Brief Abbott said Tuesday it received the Food and Drug Administration’s approval to market a transcatheter device for repairing the tricuspid valve in patients who are unable to withstand open-heart surgery. The go-ahead from the FDA paves the way for Abbott’s Triclip repair system to compete in the U.S. against Edwards Lifesciences’ recently approved transcatheter tricuspid valve replacement device, Evoque. Triclip uses the same clip-based technology to treat tricuspid regurgitation as Abbott’s Mitraclip for mitral valve regurgitation, a device the company has credited with driving double-digit growth in its structural heart business. Dive Insight Valve regurgitation, or leaking, occurs when the heart valve does not close correctly as it opens and shuts to circulate blood. The tricuspid valve controls blood flow from the right atrium to the right ventricle. When the valve isn’t closing properly, blood can flow backward in the heart, forcing it to work harder. Most common ...
- Source: drugdu
- 137
- April 5, 2024

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