FDA Archives - Page 6 of 103 - Medical Design Sourcing

EndoQuest Robotics earns spot in FDA’s Safer Technologies Program

[Image from EndoQuest’s website]EndoQuest Robotics announced today that the FDA’s Safer Technologies Program (STeP) accepted its flexible surgical robotic system.

STeP, a collaborative program, helps reduce the time needed to develop and obtain marketing authorization for eligible devices. The FDA launched STeP in 2021, modeling the program on its breakthrough devices designation program. STeP covers devices that could improve the safety of treatments or diagnostics. They treat underlying diseases or conditions considered less serious than those treated or diagnosed by devices eligible for breakthrough designation.

According to EndoQuest, joining this program enables a streamlined development and review process. The company expects it to ensure expedited access without compromising the standards of FDA approval.

EndoQuest designed its surgical robot platform to address unmet needs in gastrointestinal and other endoluminal surgeries. It developed…

Pulse Biosciences seeks FDA nod for pulsed-field ablation cardiac clamp

Pulse Biosciences (Nasdaq:PLSE) announced today that it filed for FDA 510(k) clearance for its novel CellFX nsPFA Cardiac Clamp.

Hayward, California-based Pulse designed its CellFX nanosecond pulsed-field ablation (nsPFA) technology to treat AFib. The company utilized this technology with a catheter for the first time in humans last month.

Pulse’s Cardiac Clamp produces continuous linear transmural ablations during concomitant cardiac surgical procedures using CellFX. The bipolar clamp uses the proprietary nsPFA nonthermal ablation technology developed by Pulse.

According to a news release, preclinical data suggests this ablation method could offer safety and performance benefits over current thermal cardiac ablation technologies. Pulsed-field ablation competition has continued to heat up recently in general. Earlier this month, Medtronic became the first company to win an FDA nod for PFA to treat paroxysmal and persistent AFib. Boston Scientific j…

PharmaSens submits insulin patch pump for FDA approval

The Niia Essential insulin patch pump. [Image from PharmaSens on LinkedIn]PharmaSens announced today that it submitted an application for FDA approval for its Niia Essential insulin patch pump system.

FDA submission follows the pump’s recent ISO 13485 certification for the Switzerland-based company. This encompassed the entire process of design, development, manufacturing and distribution for insulin infusion pumps and accessories.

Niia Essential, the first of three patch pumps from PharmaSens, features a patient-centric design aimed at enhancing ease of use. The company says it aims to address unmet needs in the diabetes management market. Patch pumps are an intriguing space, currently dominated by Insulet and its automated Omnipod 5 system. Tandem Diabetes Care made its entry into the market with FDA clearance of the Mobi pump earlier this year.

Medtronic sought to enter through a $738 million acquisition of South Korea-based EOFlow. However, that d…

FDA approves expanded label for CVRx neuromod tech

CVRx’s Barostim Neo [Image courtesy of CVRx]CVRx (Nasdaq:CVRX) announced today that it received FDA approval for revised instructions for use for its Barostim neuromodulation system.

The new instructions for use incorporate key long-term data from the Minneapolis-based company’s BeAT-HF randomized clinical trial.

CVRx designed Barostim to deliver electrical pulses to baroreceptors in the wall of the carotid artery. These activate the body’s baroreflex, triggering an autonomic response to the heart. CVRx designed the therapy to restore balance to the autonomic nervous system, reducing the symptoms of heart failure.

The system holds FDA breakthrough device designation and FDA approval for use in heart failure patients in the U.S. It also holds CE mark approval for heart failure and resistant hypertension in Europe.

“We are very pleased to receive this important validation from FDA of the long-term results of the post-market phase of the BeA…

Philips recalls MRI system due to risk of exploding

[Image courtesy of the FDA/Philips]The FDA says a recall of Philips (NYSE: PHG) + Panorama 1.0T HFO magnetic resonance imaging (MRI) systems is Class I, the most serious kind.

Philips recalled the MRI system due to a risk of explosion during a quench procedure. The excessive pressure buildup of helium gas could cause this.

To date, Philips has received reports of one explosion event in 22 years of use. It reports no injuries or death related to this issue.

There has been one reported event of an explosion in 22 years of use. There have been no reports of injury or death.

During a quench — which Philips said is “not common” — a large amount of helium evaporates and vents outside the building through a venting system. If an unknown blockage is present in the venting system and the pressure exceeds design limits, it could compromise the structural integrity of the system.

Philips says the mag…

Medtronic has a Class I recall for its surgical navigation software

The FDA deemed the recall of Medtronic (NYSE: MDT) + StealthStation S8 software Class I, the most serious kind.

This recall — a correction, not a product removal — relates to StealthStation S8 Application Version 2.0 and 2.0.1. It affects 2,109 devices distributed in the U.S. between Jan. 7, 2022, and Oct. 2, 2023. Medtronic initiated the recall on Sept. 27, 2023.

StealthStation is used for any medical condition in which the use of stereotactic surgery may be appropriate. It keeps track of surgical tools’ locations in relation to a patient’s anatomy by using images of the patient. The system shows the surgeon a tool’s location and the surgeon can plan the path for the tools and see how they should move.

During surgery, the software helps surgeons see if the tool position matches the plan, guiding them along the right path. The tools help find body parts during brain surgery, both open and less …

Elutia submits drug-eluting biomatrix for use with cardiac implants to FDA

Elutia (Nasdaq:ELUT) announced today that it submitted a 510(k) premarket notification to the FDA for its drug-eluting biomatrix.

The company designed its next-generation CanGarooRM for use with cardiac implantable electronic devices like pacemakers and defibrillators. A bioenvelope, CanGarooRM stabilizes the implantable devices.

Made from a natural biomaterial that promotes a regenerative healing response, the biomatrix helps lead to healthy, vascularized tissue. It also contains a slow-release formulation of rifampin and minocycline. These powerful antibiotics have demonstrated the ability to reduce bacterial colonization across a range of pathogens in preclinical testing.

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

Align Technology wins FDA nod for Invisalign palatal expander system

The Invisalign palatal expander. [Image courtesy of Align Technology]Align Technology (Nasdaq:ALGN) announced today that the FDA granted 510(k) clearance for its Invisalign palatal expander system.

The direct 3D-printed device provides rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw). It enables primary, mixed or permanent dentition during the treatment of growing patients.

FDA clearance covers broad patient applicability, including growing children, teens and adults (with surgery or other techniques).

Align Technology unveiled the technology at its September Investor Day event. The palatal expander — Align’s first direct 3D-printed orthodontic device — provides a safe, comfortable and clinically effective alternative to metal palatal expanders. Those devices requires manually turning a screw in the device in the mouth daily to achieve expansion.

The expanders feature a series of removable devices sta…

FDA clears Masimo Stork home baby monitoring system

The Stork boot on a baby next to an image of the components of Stork. [Image courtesy of Masimo]The FDA today published a 510(k) premarket notification granting clearance to the Stork baby monitoring system from Masimo (Nasdaq: MASI) + .

Stork offers a continuous and accurate view of a baby’s health data. It leverages Masimo’s noninvasive neonate monitoring technologies.

Masimo’s smart home baby monitoring system officially received its clearance on Dec. 15. The company already began its U.S. rollout to major retailers in August, having kicked off its initial launch in May. BTIG analysts Marie Thibault and Sam Eiber say the company plans to ramp up to around 250 outlets by year-end. They expect approximately 1,000 by 2024.

According to the analysts, prices range from $249 to $549 depending on the bundle for the Stork system. They say Masimo projects a market opportunity for Stork at around $500 million, making…

NuEyes wins FDA approval for augmented reality surgical visualization tech

The NuLoupes system. [Image courtesy of NuEyes]NuEyes announced today that the FDA granted approval to its patent-pending NuLoupes augmented reality smart glasses technology.

The Newport Beach, California–based company designed its system with state-of-the-art 3D stereoscopic technology. It offers practitioners in dentistry and medicine precision and live 3D visualization.

Surgeons and dentists can move from traditional fixed magnification to NuLoupes high-resolution variable digital magnification. It provides them with more versatility and viewing area. Additionally, NuEyes’ patent-pending camera system provides 3D stereoscopic imaging with near-zero latency.

According to a news release, the camera could offer sub-millimeter accurate depth perception for better environmental understanding. NuEyes says its glasses are the first that feature live 3D stereoscopic imaging to receive an FDA nod.

NuEyes offers the NuLoupes developer kit with a compl…

U.S. senators call for review of FDA following Philips recall fallout

[Image by f11photo via stock.adobe.com]Two U.S. senators sent a letter calling on the government to review the FDA’s oversight of medical device recalls amid the ongoing Philips Philips (NYSE: PHG) + Respironics recall.

Majority Whip Dick Durbin (D-IL) and Sen. Richard Blumenthal (D-CT) sent the letter to the Government Accountability Office (GAO). The letter requests an update to a 2011 GAO report entitled “Medical Devices: FDA Should Enhance Its Oversight of Recalls.”

Durbin and Blumenthal’s scrutiny of FDA oversight comes in the wake of several developments in Philips’ respiratory device recall.

Since mid-2021, more than 5 million Philips Respironics devices have been recalled due to dangerous degradation of sound abatement foam. At least 385 deaths have been reported in connection with the foam-related recall.

While the company continues to work though its remediation process, mor…

FDA approves Glaukos iDose TR glaucoma-treating drug delivery implant

The iDose ophthalmic device. [Image from Glaukos]Glaukos (NYSE:GKOS) announced today that the FDA approved a New Drug Application (NDA) for its iDose TR implant.

The approval allows for one administration per eye of iDose TR (travoprost intracameral implant) 75 mcg. The indication for the prostaglandin analog covers the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG).

iDose TR is a first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy. It continuously delivers 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods. Glaukos designed iDose TR to improve the standard of care by addressing patient non-compliance issues. The implant also addresses the chronic side effects associated with topical glaucoma medications.

Glaukos Chair and CEO Thomas Burns called the approval “a significant milestone” in a news release…