FDA Archives - Page 4 of 103 - Medical Design Sourcing

FDA backs vaporized hydrogen peroxide as medical device sterilization method

The FDA recently announced that it has classified vaporized hydrogen peroxide (VHP) as an established method of medical device sterilization.

On Jan. 8, the agency said it revised its final guidance to list VHP as an Established Category A method of sterilization.

The FDA’s Category A sterilization methods also include moist heat, dry heat, ethylene oxide (EtO) and radiation. These sterilization methods all have a “long history of safe and effective use on medical devices,” the FDA said.

FDA said adding VHP to Category A should facilitate broader adoption of the sterilization method across the medical device industry. It comes as part of years of work with the EPA and medtech industry to reduce the use of EtO where possible. New EtO rules and regulations are expected in the coming weeks.

The FDA also said its backing of VHP further supports the agency’s efforts to advance medical device supply chain resiliency.

EtO, …

CroíValve wins FDA IDE for tricuspid heart valve

The Duo heart valve repair device. [Image from the CroíValve website]CroíValve announced today that it began an early feasibility study for its Duo tricuspid coaptation valve system.

The beginning of the study follows FDA investigational device (IDE) approval. Tandem II, a prospective, multi-center, non-randomized, single-arm study looks at the safety and performance of Duo in patients with severe or greater symptomatic tricuspid regurgitation (TR).

Duo features a coaptation valve that works in tandem with the native tricuspid valve to restore valve function. Delivered using percutaneous techniques, Duo is secured using a novel anchor system. This anchor system leaves the right heart and native valve apparatus untouched.

Dublin, Ireland-based CroíValve designed the straightforward implant procedure to suit a broad patient cohort. It uses standard imaging and accommodates the large anatomical variability seen in the target patient population. The companyR…

Abbott wins FDA nod for world’s smallest rechargeable DBS system

The Liberta RC DBS device. [Image from Abbott]Abbott (NYSE: ABT) + announced today that it received approval from the FDA for the launch of its Liberta RC DBS system.

Liberta RC DBS (rechargeable deep brain stimulation) features remote programming for treating people with movement disorders. Abbott says it requires the fewest recharges of any FDA-approved DBS system, needing just 10 recharge sessions a year for most users.

The system is also the first and only rechargeable DBS device compatible with Abbott’s proprietary NeuroSphere virtual clinic. NeuroSphere allows people to communicate with doctors, ensure proper settings and functionality and receive new treatment settings remotely.

This regulatory nod also comes just weeks after Medtronic won FDA approval for what it considers a “game-changing” DBS system. Abbott continues to progress with its own neurostimulation business as well. It won expa…

FDA clears Syngo Virtual Cockpit tech from Siemens Healthineers

The Syngo Virtual Cockpit. [Image courtesy of Siemens Healthineers]Siemens Healthineers announced that the FDA cleared its Syngo Virtual Cockpit, a private, secure communication platform.

The platform enables real-time image visualization, acquisition and collaboration between healthcare professionals across multiple sites. Siemens Healthineers designed the software so users can connect to CT, MR, PET and a number of other scanners. Scanners include those made by Siemens Healthineers and from other equipment vendors, regardless of location.

According to a news release, Syngo marks the first and only multi-vendor remote scanning software to win FDA clearance as a medical device.

With the software, radiologic technologists can use live audio, video and chat functionalities. They can conduct scans or provide support for up to three different remote scanners simultaneously. The company said it can help address the ongoing technologist shortage and standardize c…

FDA grants breakthrough nod for Pi-Cardia leaflet modification device for TAVR

Pi-Cardia announced today that the FDA granted breakthrough device designation for its ShortCut leaflet modification device.

ShortCut facilitates valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction. Rehovot, Israel-based Pi-Carda earned the breakthrough nod after completing enrollment in a U.S. and European pivotal study last September.

The leaflet modification system addresses the risk of coronary obstruction before implanting a valve without disrupting TAVR workflow. Pi-Cardia’s leaflet modification portfolio also includes the ShortCut Mitral for splitting leaflets following TMVR. Its Leaflex standalone, non-implant-based mechanical storing device restores leaflet mobility and improves hemodynamics.

Dr. Philippe Genereux of Morristown Medical Center (New Jersey) served as part of the Pi-Cardia clinical program. Genereux said in a news release that lifetime management of aortic stenos…

Modular Medical submits next-gen insulin pump for FDA clearance

The MODD1 insulin pump. [Image from Modular Medical]Modular Medical (Nasdaq:MODD) announced today that it submitted its next-generation MODD1 insulin pump to the FDA for 510(k) clearance.

San Diego-based Modular Medical develops patented insulin delivery technologies, aiming to improve access to glycemic control. Its founder, Paul DiPerna, previously founded leading insulin pump maker Tandem Diabetes Care. DiPerna invented and designed Tandem’s t:slim pump.

The company designed the 90-day MODD1 with new microfluidics technology to allow for the low-cost pumping of insulin. Its new intuitive design makes the product simple to use and easier to prescribe.

Get the full story at our sister site, Drug Delivery Business News.

FDA approves expanded MRI labeling for Abbott Proclaim neurostim

The Proclaim DRG neurostimulation device. [Image courtesy of Abbott]Abbott (NYSE: ABT) + announced today that the FDA approved expanded MRI labeling for its Proclaim DRG neurostimulation system.

Proclaim DRG provides targeted relief for people with complex regional pain syndrome (CRPS) types I and II of the lower limbs. It stimulates the dorsal root ganglion (DRG) clusters of nerve cells found along the spine.

Abbott says four out of five people who receive Proclaim DRG stimulation experience significant pain relief and improved quality of life.

The expanded labeling allows patients to receive full-body MRI scans while implanted with the device.

MRI can help assess the progression of CRPS. Having Proclaim DRG allow for MRI scans anywhere in the body (within approved parameters) provides value to patients and radiologists.

Expanded labeling allows for use of Abbott’s system in full-body scans for…

FDA warns on defective packaging with Exactech shoulder system

The Equinoxe shoulder system. [Image courtesy of Exactech]The FDA issued a warning related to possible health risks associated with the Exactech Equinoxe shoulder system joint replacement devices.

Equinoxe devices replace painful shoulder joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or loss of normal structure and function. The devices also improve previously failed shoulder joint replacement devices with adequate bone and soft tissue present.

Exactech manufactured these devices between 2004 and August 2021, packaging them in defective bags, the agency says. The defective bags were missing one of the oxygen barrier layers that protect devices from oxidation. This chemical reaction can degrade plastic components over time.

Oxidation can lead to faster device wear or failure, plus device component cracking or fracture. This could in turn lead to additional surgeries to replace or correct the Equionoxe shoulder implant.

The FDA …

FDA clears DermaSensor AI-powered skin cancer detection device

[Image courtesy of DermaSensor]DermaSensor announced today that the FDA cleared its real-time, non-invasive, AI-powered skin cancer evaluation system.

Miami-based DermaSensor develops a handheld device that uses ESS, a form of optical spectroscopy. It takes noninvasive samples of tissue, capturing cellular-level information. The technology uses hundreds of wavelengths of light in a manner similar to how sonar uses sound.

DermaSensor says physicians can use its AI-powered spectroscopy technology to non-invasively evaluate lesions. They can look at cellular and subcellular characteristics of a lesion in question for skin cancer. The wireless device then provides an immediate, objective result using an FDA-cleared algorithm.

A pivotal study of more than 1,000 patients found 96% sensitivity with the device across 224 skin cancers. When the device produced a negative result, it meant a 97% chance of being benign for all skin cancers. DermaSensor said its device …

FDA clears stereotactic guidance system from ClearPoint Neuro

ClearPoint Neuro (Nasdaq:CLPT) announced today that it received FDA 510(k) clearance for its SmartFrame OR stereotactic system.

Solana Beach, California-based ClearPoint Neuro developed its SmartFrame OR system with two main components. It features the SmartFrame OR technology with the ClearPointer optical navigation wand.

SmartFrame OR offers stereotactic guidance for the placement and operation of instruments or devices in neurological procedures. It helps during the planning and operation processes of these procedures, performed in conjunction with the use of a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placements and electrode introduction.

ClearPoint Neuro’s ClearPointer works in conjunction with SmartFrame OR and a compatible stereotactic optical navigation system. It helps with patient registration and navigation.

SmartFrame OR can be used with …

Fresenius Kabi has a Class I Ivenix infusion pump recall

The Ivenix infusion system. [Image courtesy of Fresenius Kabi]The FDA determined that a recall of the Fresenius Kabi Ivenix large-volume infusion pump is Class I, the most serious kind.

This recall affects the LVP-0004 model of the Ivenix large-volume pumps. Fresenius Kabi distributed these systems between Oct. 1, 2021, and July 31, 2023. In total, the company recalled 938 devices in the U.S. since initiating the recall on Nov. 29, 2023.

The company reports no injuries or deaths related to the recall, according to the FDA.

Get the full story at our sister site, Drug Delivery Business News.

FDA approves Zeiss software that treats nearsightedness

The VisuMax 800 Smile pro. [Image courtesy of Zeiss]Zeiss Medical Technology announced that the FDA approved the VisuMax 800 with Smile Pro software.

The Carl Zeiss Meditec unit designed the software to treat nearsightedness, with or without astigmatism. Its latest generation of femtosecond lasers enters the U.S. market with more than 8 million eyes already treated with Smile software.

“The increasing global adoption of Smile from Zeiss represents the positive impact the small incision lenticule extraction procedure continues to have on the quality of life for patients,” said Andrew Chang, head of global sales for Ziess Medical Technology. “With the availability of the Zeiss Smile pro software module in the U.S. market, surgeons can now offer the latest refractive technology to help expand their business and provide excellent outcomes for patients.”

VisuMax 800 with Smile pro software enables faster treatment, according to a news rel…